Viewing Study NCT03900416


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Ignite Modification Date: 2025-12-26 @ 11:49 AM
Study NCT ID: NCT03900416
Status: COMPLETED
Last Update Posted: 2021-11-08
First Post: 2019-03-22
Is NOT Gene Therapy: False
Has Adverse Events: True

Brief Title: Adolescent Mindfulness Mobile App Study (RCT)
Sponsor:
Organization:

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000079562', 'term': 'Rumination Syndrome'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D016728', 'term': 'Self-Injurious Behavior'}], 'ancestors': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lori.m.hilt@lawrence.edu', 'phone': '920-832-7050', 'title': 'Dr. Lori Hilt', 'organization': 'Lawrence University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Baseline through 6-month follow-up.', 'eventGroups': [{'id': 'EG000', 'title': 'Mindfulness App', 'description': 'Guided mindfulness exercises will be delivered via mobile app for three weeks.\n\nMindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.', 'otherNumAtRisk': 72, 'deathsNumAtRisk': 72, 'otherNumAffected': 8, 'seriousNumAtRisk': 72, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Control Condition', 'description': 'Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.', 'otherNumAtRisk': 80, 'deathsNumAtRisk': 80, 'otherNumAffected': 5, 'seriousNumAtRisk': 80, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Stress from noticing negative emotions', 'notes': 'Adolescents rated how anxious or sad they were feeling in the present moment when using the app. Some adolescents reported discomfort surrounding the acknowledgment of negative emotions.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Onset of Non-suicidal Self-Injury', 'notes': 'Adolescents reported the onset of self-injury.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Onset of Passive Suicidal Ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Discomfort from Mindfulness Activity', 'notes': 'One adolescent reported focusing on sounds sometimes made them stressed when they were meditating in a chaotic environment.\n\nAnother participant noticed that they had a headache once when completing a mindfulness exercise from focusing.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Suicide Attempt', 'notes': 'An adolescent participant reported a suicide attempt on their survey. We immediately intervened with both the parent and child. This adolescent was already seeing a mental health professional.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 72, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Children's Response Styles Questionnaire", 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness App', 'description': 'Guided mindfulness exercises will be delivered via mobile app for three weeks.\n\nMindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': 'Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.'}], 'classes': [{'categories': [{'measurements': [{'value': '33.47', 'spread': '9.64', 'groupId': 'OG000'}, {'value': '30.73', 'spread': '9.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'description': 'trait rumination (range = 0-39 with higher scores indicating more rumination)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Children's Response Styles Questionnaire", 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness App', 'description': 'Guided mindfulness exercises will be delivered via mobile app for three weeks.\n\nMindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': 'Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.48', 'spread': '9.89', 'groupId': 'OG000'}, {'value': '30.76', 'spread': '10.12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 weeks (i.e., immediately post-intervention)', 'description': 'trait rumination (range = 0-39 with higher scores indicating more rumination)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number analyzed determined by number of adolescents that completed the questionnaire.'}, {'type': 'PRIMARY', 'title': "Children's Response Styles Questionnaire", 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness App', 'description': 'Guided mindfulness exercises will be delivered via mobile app for three weeks.\n\nMindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': 'Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.71', 'spread': '9.46', 'groupId': 'OG000'}, {'value': '29.17', 'spread': '10.64', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks post intervention', 'description': 'trait rumination (range = 0-39 with higher scores indicating more rumination)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Children's Response Styles Questionnaire", 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness App', 'description': 'Guided mindfulness exercises will be delivered via mobile app for three weeks.\n\nMindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': 'Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.27', 'spread': '10.22', 'groupId': 'OG000'}, {'value': '28.45', 'spread': '9.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks post intervention', 'description': 'trait rumination (range = 0-39 with higher scores indicating more rumination)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Children's Response Styles Questionnaire", 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness App', 'description': 'Guided mindfulness exercises will be delivered via mobile app for three weeks.\n\nMindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': 'Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.4', 'spread': '10.79', 'groupId': 'OG000'}, {'value': '29.77', 'spread': '10.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months post intervention', 'description': 'trait rumination (range = 0-39 with higher scores indicating more rumination)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Children's Depression Inventory", 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness App', 'description': 'Guided mindfulness exercises will be delivered via mobile app for three weeks.\n\nMindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': 'Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.4', 'spread': '8.77', 'groupId': 'OG000'}, {'value': '12.04', 'spread': '7.72', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'description': 'self-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Children's Depression Inventory", 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness App', 'description': 'Guided mindfulness exercises will be delivered via mobile app for three weeks.\n\nMindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': 'Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.52', 'spread': '9.54', 'groupId': 'OG000'}, {'value': '12.22', 'spread': '8.57', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 weeks (immediately post-intervention)', 'description': 'self-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Children's Depression Inventory", 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness App', 'description': 'Guided mindfulness exercises will be delivered via mobile app for three weeks.\n\nMindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': 'Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.68', 'spread': '9.04', 'groupId': 'OG000'}, {'value': '10.82', 'spread': '8.23', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks post intervention', 'description': 'self-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Children's Depression Inventory", 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness App', 'description': 'Guided mindfulness exercises will be delivered via mobile app for three weeks.\n\nMindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': 'Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.33', 'spread': '7.97', 'groupId': 'OG000'}, {'value': '10.54', 'spread': '8.57', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks post intervention', 'description': 'self-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': "Children's Depression Inventory", 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness App', 'description': 'Guided mindfulness exercises will be delivered via mobile app for three weeks.\n\nMindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': 'Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.84', 'spread': '8.02', 'groupId': 'OG000'}, {'value': '10.42', 'spread': '8.97', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months post intervention', 'description': 'self-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Multidimensional Anxiety Scale for Children', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness App', 'description': 'Guided mindfulness exercises will be delivered via mobile app for three weeks.\n\nMindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': 'Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.'}], 'classes': [{'categories': [{'measurements': [{'value': '53.47', 'spread': '16.51', 'groupId': 'OG000'}, {'value': '50.84', 'spread': '17.35', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'description': 'self-reported anxiety symptoms (range = 0-117 with higher scores indicating more anxiety)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Multidimensional Anxiety Scale for Children', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness App', 'description': 'Guided mindfulness exercises will be delivered via mobile app for three weeks.\n\nMindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': 'Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.94', 'spread': '16.82', 'groupId': 'OG000'}, {'value': '52.37', 'spread': '17.64', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 weeks (i.e., immediately post-intervention)', 'description': 'self-reported anxiety symptoms (range = 0-117 with higher scores indicating more anxiety)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Multidimensional Anxiety Scale for Children', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness App', 'description': 'Guided mindfulness exercises will be delivered via mobile app for three weeks.\n\nMindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': 'Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.'}], 'classes': [{'categories': [{'measurements': [{'value': '51.00', 'spread': '16.52', 'groupId': 'OG000'}, {'value': '49.88', 'spread': '19.25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks post intervention', 'description': 'self-reported anxiety symptoms (range = 0-117 with higher scores indicating more anxiety)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Multidimensional Anxiety Scale for Children', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness App', 'description': 'Guided mindfulness exercises will be delivered via mobile app for three weeks.\n\nMindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': 'Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.'}], 'classes': [{'categories': [{'measurements': [{'value': '50.34', 'spread': '18.18', 'groupId': 'OG000'}, {'value': '49.82', 'spread': '19.11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks post intervention', 'description': 'self-reported anxiety symptoms (range = 0-117 with higher scores indicating more anxiety)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Multidimensional Anxiety Scale for Children', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness App', 'description': 'Guided mindfulness exercises will be delivered via mobile app for three weeks.\n\nMindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': 'Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.'}], 'classes': [{'categories': [{'measurements': [{'value': '49.29', 'spread': '16.74', 'groupId': 'OG000'}, {'value': '49.56', 'spread': '20.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months post intervention', 'description': 'self-reported anxiety symptoms (range = 0-117 with higher scores indicating more anxiety)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Self-injurious Thoughts and Behaviors Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness App', 'description': 'Guided mindfulness exercises will be delivered via mobile app for three weeks.\n\nMindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': 'Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline', 'description': 'percent of participants engaged in self-injury over the past year', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Self-injurious Thoughts and Behaviors Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness App', 'description': 'Guided mindfulness exercises will be delivered via mobile app for three weeks.\n\nMindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': 'Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 weeks (i.e., immediately post-intervention)', 'description': 'percent of participants that engaged in self-injury over the past 3 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Self-injurious Thoughts and Behaviors Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness App', 'description': 'Guided mindfulness exercises will be delivered via mobile app for three weeks.\n\nMindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': 'Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 weeks post intervention', 'description': 'percent of participants that engaged in self-injury over the past 6 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Self-injurious Thoughts and Behaviors Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness App', 'description': 'Guided mindfulness exercises will be delivered via mobile app for three weeks.\n\nMindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': 'Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks post intervention', 'description': 'percent of time engaged in self-injury over the past 6 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Self-injurious Thoughts and Behaviors Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness App', 'description': 'Guided mindfulness exercises will be delivered via mobile app for three weeks.\n\nMindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': 'Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months post intervention', 'description': 'percent of time engaged in self-injury over the past 3 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Pediatric Symptom Checklist Internalizing Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness App', 'description': 'Guided mindfulness exercises will be delivered via mobile app for three weeks.\n\nMindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': 'Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.64', 'spread': '2.38', 'groupId': 'OG000'}, {'value': '3.88', 'spread': '2.45', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'description': 'parent-reported internalizing symptoms (range = 0-10 with higher scores indicating more internalizing symptoms)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Pediatric Symptom Checklist Internalizing Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness App', 'description': 'Guided mindfulness exercises will be delivered via mobile app for three weeks.\n\nMindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': 'Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.49', 'spread': '2.21', 'groupId': 'OG000'}, {'value': '2.46', 'spread': '1.99', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 weeks (i.e., immediately post-intervention)', 'description': 'parent-reported internalizing symptoms (range = 0-10 with higher scores indicating more internalizing symptoms)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Pediatric Symptom Checklist Internalizing Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness App', 'description': 'Guided mindfulness exercises will be delivered via mobile app for three weeks.\n\nMindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': 'Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.38', 'spread': '2.05', 'groupId': 'OG000'}, {'value': '2.41', 'spread': '2.09', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks post intervention', 'description': 'parent-reported internalizing symptoms (range = 0-10 with higher scores indicating more internalizing symptoms)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Pediatric Symptom Checklist Internalizing Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness App', 'description': 'Guided mindfulness exercises will be delivered via mobile app for three weeks.\n\nMindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': 'Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.49', 'spread': '2.14', 'groupId': 'OG000'}, {'value': '2.35', 'spread': '2.14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks post intervention', 'description': 'parent-reported internalizing symptoms (range = 0-10 with higher scores indicating more internalizing symptoms)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Pediatric Symptom Checklist Internalizing Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness App', 'description': 'Guided mindfulness exercises will be delivered via mobile app for three weeks.\n\nMindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': 'Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.38', 'spread': '1.96', 'groupId': 'OG000'}, {'value': '2.68', 'spread': '2.26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months post intervention', 'description': 'parent-reported internalizing symptoms (range = 0-10 with higher scores indicating more internalizing symptoms)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'State Rumination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness App', 'description': 'Guided mindfulness exercises will be delivered via mobile app for three weeks.\n\nMindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': 'Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.'}], 'classes': [{'title': 'Emotion-Focused Rumination', 'categories': [{'measurements': [{'value': '41.88', 'spread': '20.44', 'groupId': 'OG000'}, {'value': '42.53', 'spread': '20.17', 'groupId': 'OG001'}]}]}, {'title': 'Problem-Focused Rumination', 'categories': [{'measurements': [{'value': '34.80', 'spread': '18.47', 'groupId': 'OG000'}, {'value': '37.58', 'spread': '18.69', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 weeks (i.e., immediately post-intervention)', 'description': 'average state rumination during intervention period rated on a visual analog scale (range = 0-100 with higher scores indicating more rumination)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'State Mood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness App', 'description': 'Guided mindfulness exercises will be delivered via mobile app for three weeks.\n\nMindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': 'Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.'}], 'classes': [{'title': 'Anxiety', 'categories': [{'measurements': [{'value': '36.62', 'spread': '19.35', 'groupId': 'OG000'}, {'value': '39.08', 'spread': '20.05', 'groupId': 'OG001'}]}]}, {'title': 'Sadness', 'categories': [{'measurements': [{'value': '25.00', 'spread': '17.72', 'groupId': 'OG000'}, {'value': '25.02', 'spread': '14.10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 weeks (i.e., immediately post-intervention)', 'description': 'average sadness and anxiety during intervention period rated on visual analog scales (range = 0-100 with higher scores indicating more rumination)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Daily App Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness App', 'description': 'Guided mindfulness exercises will be delivered via mobile app for three weeks.\n\nMindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': 'Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.'}], 'classes': [{'categories': [{'measurements': [{'value': '51.72', 'spread': '16.37', 'groupId': 'OG000'}, {'value': '54.26', 'spread': '15.26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 weeks (i.e., immediately post-intervention)', 'description': 'Daily app use was determined by how many complete app uses were logged during the three-week intervention period.', 'unitOfMeasure': 'App uses', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Continued Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness App', 'description': 'Guided mindfulness exercises will be delivered via mobile app for three weeks.\n\nMindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': 'Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.'}], 'classes': [{'categories': [{'measurements': [{'value': '40.24', 'spread': '78.98', 'groupId': 'OG000'}, {'value': '39.74', 'spread': '70.22', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months post intervention', 'description': 'Number of times app was used after the 3 week intervention period', 'unitOfMeasure': 'number of app uses', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Ease of Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness App', 'description': 'Guided mindfulness exercises will be delivered via mobile app for three weeks.\n\nMindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': 'Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.13', 'spread': '1.19', 'groupId': 'OG000'}, {'value': '6.27', 'spread': '1.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 weeks (i.e., immediately post-intervention)', 'description': 'how easy app was to use (range = 1-7 with higher being easier to use)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Five Facet Mindfulness Questionnaire Observing Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness App', 'description': 'Guided mindfulness exercises will be delivered via mobile app for three weeks.\n\nMindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': 'Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.28', 'spread': '6.23', 'groupId': 'OG000'}, {'value': '21.38', 'spread': '6.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'description': 'trait mindfulness observing (range = 8-40 with higher scores indicating greater mindfulness)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Five Facet Mindfulness Questionnaire Observing Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness App', 'description': 'Guided mindfulness exercises will be delivered via mobile app for three weeks.\n\nMindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': 'Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.66', 'spread': '6.39', 'groupId': 'OG000'}, {'value': '22.05', 'spread': '6.22', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 weeks (i.e., immediately post-intervention)', 'description': 'trait mindfulness observing (range = 8-40 with higher scores indicating greater mindfulness)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Five Facet Mindfulness Questionnaire Observing Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness App', 'description': 'Guided mindfulness exercises will be delivered via mobile app for three weeks.\n\nMindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': 'Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.05', 'spread': '5.69', 'groupId': 'OG000'}, {'value': '21.97', 'spread': '5.74', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks post intervention', 'description': 'trait mindfulness observing (range = 8-40 with higher scores indicating greater mindfulness)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Five Facet Mindfulness Questionnaire Observing Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness App', 'description': 'Guided mindfulness exercises will be delivered via mobile app for three weeks.\n\nMindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': 'Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.77', 'spread': '5.83', 'groupId': 'OG000'}, {'value': '22.45', 'spread': '5.95', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks post intervention', 'description': 'trait mindfulness observing (range = 8-40 with higher scores indicating greater mindfulness)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Five Facet Mindfulness Questionnaire Observing Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness App', 'description': 'Guided mindfulness exercises will be delivered via mobile app for three weeks.\n\nMindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': 'Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.19', 'spread': '5.76', 'groupId': 'OG000'}, {'value': '21.48', 'spread': '6.99', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months post intervention', 'description': 'trait mindfulness observing (range = 8-40 with higher scores indicating greater mindfulness)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Five Facet Mindfulness Questionnaire Describing Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness App', 'description': 'Guided mindfulness exercises will be delivered via mobile app for three weeks.\n\nMindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': 'Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.26', 'spread': '5.75', 'groupId': 'OG000'}, {'value': '24.69', 'spread': '5.75', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'description': 'trait mindfulness describing (range = 8-40 with higher scores indicating greater mindfulness)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Five Facet Mindfulness Questionnaire Describing Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness App', 'description': 'Guided mindfulness exercises will be delivered via mobile app for three weeks.\n\nMindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': 'Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'spread': '5.98', 'groupId': 'OG000'}, {'value': '23.94', 'spread': '5.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 weeks (i.e., immediately post-intervention)', 'description': 'trait mindfulness describing (range = 8-40 with higher scores indicating greater mindfulness)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Five Facet Mindfulness Questionnaire Describing Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness App', 'description': 'Guided mindfulness exercises will be delivered via mobile app for three weeks.\n\nMindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': 'Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.17', 'spread': '6.17', 'groupId': 'OG000'}, {'value': '25.25', 'spread': '5.35', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks post intervention', 'description': 'trait mindfulness describing (range = 8-40 with higher scores indicating greater mindfulness)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Five Facet Mindfulness Questionnaire Describing Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness App', 'description': 'Guided mindfulness exercises will be delivered via mobile app for three weeks.\n\nMindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': 'Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.55', 'spread': '5.96', 'groupId': 'OG000'}, {'value': '24.3', 'spread': '5.41', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks post intervention', 'description': 'trait mindfulness describing (range = 8-40 with higher scores indicating greater mindfulness)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Five Facet Mindfulness Questionnaire Describing Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness App', 'description': 'Guided mindfulness exercises will be delivered via mobile app for three weeks.\n\nMindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': 'Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.56', 'spread': '6.16', 'groupId': 'OG000'}, {'value': '24.97', 'spread': '5.54', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months post intervention', 'description': 'trait mindfulness describing (range = 8-40 with higher scores indicating greater mindfulness)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Five Facet Mindfulness Questionnaire Awareness Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness App', 'description': 'Guided mindfulness exercises will be delivered via mobile app for three weeks.\n\nMindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': 'Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.03', 'spread': '6.23', 'groupId': 'OG000'}, {'value': '26.18', 'spread': '5.84', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'description': 'trait mindfulness acting with awareness (range = 8-40 with higher scores indicating greater mindfulness)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Five Facet Mindfulness Questionnaire Awareness Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness App', 'description': 'Guided mindfulness exercises will be delivered via mobile app for three weeks.\n\nMindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': 'Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.42', 'spread': '6.55', 'groupId': 'OG000'}, {'value': '24.94', 'spread': '6.41', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 weeks (i.e., immediately post-intervention)', 'description': 'trait mindfulness acting with awareness (range = 8-40 with higher scores indicating greater mindfulness)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Five Facet Mindfulness Questionnaire Awareness Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness App', 'description': 'Guided mindfulness exercises will be delivered via mobile app for three weeks.\n\nMindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': 'Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.12', 'spread': '6.34', 'groupId': 'OG000'}, {'value': '25.7', 'spread': '5.42', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks post intervention', 'description': 'trait mindfulness acting with awareness (range = 8-40 with higher scores indicating greater mindfulness)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Five Facet Mindfulness Questionnaire Awareness Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness App', 'description': 'Guided mindfulness exercises will be delivered via mobile app for three weeks.\n\nMindfulness App: Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': 'Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.98', 'spread': '5.9', 'groupId': 'OG000'}, {'value': '25.27', 'spread': '5.62', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks post intervention', 'description': 'trait mindfulness acting with awareness (range = 8-40 with higher scores indicating greater mindfulness)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Five Facet Mindfulness Questionnaire Awareness Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness App', 'description': 'Guided mindfulness exercises will be delivered via mobile app for three weeks.\n\nMindfulness App: Mindfulness exercises will last 1-12 minutes. 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Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.'}, {'id': 'OG001', 'title': 'Control Condition', 'description': 'Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.56', 'spread': '7.46', 'groupId': 'OG000'}, {'value': '27.49', 'spread': '7.58', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'description': 'trait mindfulness non-judging of inner experience (range = 8-40 with higher scores indicating greater mindfulness)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Five Facet Mindfulness Questionnaire Nonjudging Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mindfulness App', 'description': 'Guided mindfulness exercises will be delivered via mobile app for three weeks.\n\nMindfulness App: Mindfulness exercises will last 1-12 minutes. 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'classes': [{'categories': [{'measurements': [{'value': '13.4', 'spread': '8.77', 'groupId': 'BG000'}, {'value': '12.04', 'spread': '7.72', 'groupId': 'BG001'}, {'value': '12.68', 'spread': '8.23', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'self-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Multidimensional Anxiety Scale for Children', 'classes': [{'categories': [{'measurements': [{'value': '53.47', 'spread': '16.51', 'groupId': 'BG000'}, {'value': '50.84', 'spread': '17.35', 'groupId': 'BG001'}, {'value': '52.09', 'spread': '16.95', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'self-reported anxiety symptoms (range = 0-117 with higher scores indicating more anxiety)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Self-injurious Thoughts and Behaviors Questionnaire', 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Self-reported lifetime engagement in nonsuicidal self-injury', 'unitOfMeasure': 'Participants'}, {'title': 'Pediatric Symptom Checklist Internalizing Scale', 'classes': [{'categories': [{'measurements': [{'value': '3.64', 'spread': '2.38', 'groupId': 'BG000'}, {'value': '3.88', 'spread': '2.45', 'groupId': 'BG001'}, {'value': '3.76', 'spread': '2.411', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'parent-reported internalizing symptoms (range = 0-10 with higher scores indicating more internalizing symptoms)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Five Facet Mindfulness Questionnaire Observing Subscale', 'classes': [{'categories': [{'measurements': [{'value': '22.28', 'spread': '6.23', 'groupId': 'BG000'}, {'value': '21.38', 'spread': '6.2', 'groupId': 'BG001'}, {'value': '21.80', 'spread': '6.206', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'trait mindfulness observing (range = 8-40 with higher scores indicating greater mindfulness)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Five Facet Mindfulness Questionnaire Describing Subscale', 'classes': [{'categories': [{'measurements': [{'value': '24.26', 'spread': '5.75', 'groupId': 'BG000'}, {'value': '24.69', 'spread': '5.75', 'groupId': 'BG001'}, {'value': '24.49', 'spread': '5.74', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'trait mindfulness describing (range = 8-40 with higher scores indicating greater mindfulness)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Five Facet Mindfulness Questionnaire Awareness Subscale', 'classes': [{'categories': [{'measurements': [{'value': '25.03', 'spread': '6.23', 'groupId': 'BG000'}, {'value': '26.17', 'spread': '5.84', 'groupId': 'BG001'}, {'value': '25.63', 'spread': '6.04', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'trait mindfulness acting with awareness (range = 8-40 with higher scores indicating greater mindfulness)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Five Facet Mindfulness Questionnaire Nonjudging Subscale', 'classes': [{'categories': [{'measurements': [{'value': '25.56', 'spread': '7.46', 'groupId': 'BG000'}, {'value': '27.49', 'spread': '7.58', 'groupId': 'BG001'}, {'value': '26.57', 'spread': '7.561', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'trait mindfulness non-judging of inner experience (range = 8-40 with higher scores indicating greater mindfulness)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Five Facet Mindfulness Questionnaire Nonreactivity Subscale', 'classes': [{'categories': [{'measurements': [{'value': '19.58', 'spread': '4.58', 'groupId': 'BG000'}, {'value': '19.44', 'spread': '3.99', 'groupId': 'BG001'}, {'value': '19.51', 'spread': '4.268', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'trait mindfulness non-reactivity to inner experience (range = 7-35 with higher scores indicating greater mindfulness)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-01-01', 'size': 509243, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-10-10T21:51', 'hasProtocol': True}, {'date': '2019-03-25', 'size': 568111, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-10-10T21:52', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomly assigned to the intervention group (i.e., mindfulness with ecological momentary assessment) or the control group (i.e., ecological momentary assessment only).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 152}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-11', 'studyFirstSubmitDate': '2019-03-22', 'resultsFirstSubmitDate': '2021-09-03', 'studyFirstSubmitQcDate': '2019-03-30', 'lastUpdatePostDateStruct': {'date': '2021-11-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-10-11', 'studyFirstPostDateStruct': {'date': '2019-04-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Children's Response Styles Questionnaire", 'timeFrame': 'baseline', 'description': 'trait rumination (range = 0-39 with higher scores indicating more rumination)'}, {'measure': "Children's Response Styles Questionnaire", 'timeFrame': '3 weeks (i.e., immediately post-intervention)', 'description': 'trait rumination (range = 0-39 with higher scores indicating more rumination)'}, {'measure': "Children's Response Styles Questionnaire", 'timeFrame': '6 weeks post intervention', 'description': 'trait rumination (range = 0-39 with higher scores indicating more rumination)'}, {'measure': "Children's Response Styles Questionnaire", 'timeFrame': '12 weeks post intervention', 'description': 'trait rumination (range = 0-39 with higher scores indicating more rumination)'}, {'measure': "Children's Response Styles Questionnaire", 'timeFrame': '6 months post intervention', 'description': 'trait rumination (range = 0-39 with higher scores indicating more rumination)'}, {'measure': "Children's Depression Inventory", 'timeFrame': 'baseline', 'description': 'self-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms)'}, {'measure': "Children's Depression Inventory", 'timeFrame': '3 weeks (immediately post-intervention)', 'description': 'self-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms)'}, {'measure': "Children's Depression Inventory", 'timeFrame': '6 weeks post intervention', 'description': 'self-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms)'}, {'measure': "Children's Depression Inventory", 'timeFrame': '12 weeks post intervention', 'description': 'self-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms)'}, {'measure': "Children's Depression Inventory", 'timeFrame': '6 months post intervention', 'description': 'self-reported depressive symptoms (range = 0-54 with higher scores indicating more symptoms)'}, {'measure': 'Multidimensional Anxiety Scale for Children', 'timeFrame': 'baseline', 'description': 'self-reported anxiety symptoms (range = 0-117 with higher scores indicating more anxiety)'}, {'measure': 'Multidimensional Anxiety Scale for Children', 'timeFrame': '3 weeks (i.e., immediately post-intervention)', 'description': 'self-reported anxiety symptoms (range = 0-117 with higher scores indicating more anxiety)'}, {'measure': 'Multidimensional Anxiety Scale for Children', 'timeFrame': '6 weeks post intervention', 'description': 'self-reported anxiety symptoms (range = 0-117 with higher scores indicating more anxiety)'}, {'measure': 'Multidimensional Anxiety Scale for Children', 'timeFrame': '12 weeks post intervention', 'description': 'self-reported anxiety symptoms (range = 0-117 with higher scores indicating more anxiety)'}, {'measure': 'Multidimensional Anxiety Scale for Children', 'timeFrame': '6 months post intervention', 'description': 'self-reported anxiety symptoms (range = 0-117 with higher scores indicating more anxiety)'}, {'measure': 'Self-injurious Thoughts and Behaviors Questionnaire', 'timeFrame': 'baseline', 'description': 'percent of participants engaged in self-injury over the past year'}, {'measure': 'Self-injurious Thoughts and Behaviors Questionnaire', 'timeFrame': '3 weeks (i.e., immediately post-intervention)', 'description': 'percent of participants that engaged in self-injury over the past 3 weeks'}, {'measure': 'Self-injurious Thoughts and Behaviors Questionnaire', 'timeFrame': '6 weeks post intervention', 'description': 'percent of participants that engaged in self-injury over the past 6 weeks'}, {'measure': 'Self-injurious Thoughts and Behaviors Questionnaire', 'timeFrame': '12 weeks post intervention', 'description': 'percent of time engaged in self-injury over the past 6 weeks'}, {'measure': 'Self-injurious Thoughts and Behaviors Questionnaire', 'timeFrame': '6 months post intervention', 'description': 'percent of time engaged in self-injury over the past 3 months'}, {'measure': 'Pediatric Symptom Checklist Internalizing Scale', 'timeFrame': 'baseline', 'description': 'parent-reported internalizing symptoms (range = 0-10 with higher scores indicating more internalizing symptoms)'}, {'measure': 'Pediatric Symptom Checklist Internalizing Scale', 'timeFrame': '3 weeks (i.e., immediately post-intervention)', 'description': 'parent-reported internalizing symptoms (range = 0-10 with higher scores indicating more internalizing symptoms)'}, {'measure': 'Pediatric Symptom Checklist Internalizing Scale', 'timeFrame': '6 weeks post intervention', 'description': 'parent-reported internalizing symptoms (range = 0-10 with higher scores indicating more internalizing symptoms)'}, {'measure': 'Pediatric Symptom Checklist Internalizing Scale', 'timeFrame': '12 weeks post intervention', 'description': 'parent-reported internalizing symptoms (range = 0-10 with higher scores indicating more internalizing symptoms)'}, {'measure': 'Pediatric Symptom Checklist Internalizing Scale', 'timeFrame': '6 months post intervention', 'description': 'parent-reported internalizing symptoms (range = 0-10 with higher scores indicating more internalizing symptoms)'}, {'measure': 'State Rumination', 'timeFrame': '3 weeks (i.e., immediately post-intervention)', 'description': 'average state rumination during intervention period rated on a visual analog scale (range = 0-100 with higher scores indicating more rumination)'}, {'measure': 'State Mood', 'timeFrame': '3 weeks (i.e., immediately post-intervention)', 'description': 'average sadness and anxiety during intervention period rated on visual analog scales (range = 0-100 with higher scores indicating more rumination)'}, {'measure': 'Daily App Use', 'timeFrame': '3 weeks (i.e., immediately post-intervention)', 'description': 'Daily app use was determined by how many complete app uses were logged during the three-week intervention period.'}, {'measure': 'Continued Use', 'timeFrame': '6 months post intervention', 'description': 'Number of times app was used after the 3 week intervention period'}, {'measure': 'Ease of Use', 'timeFrame': '3 weeks (i.e., immediately post-intervention)', 'description': 'how easy app was to use (range = 1-7 with higher being easier to use)'}], 'secondaryOutcomes': [{'measure': 'Five Facet Mindfulness Questionnaire Observing Subscale', 'timeFrame': 'baseline', 'description': 'trait mindfulness observing (range = 8-40 with higher scores indicating greater mindfulness)'}, {'measure': 'Five Facet Mindfulness Questionnaire Observing Subscale', 'timeFrame': '3 weeks (i.e., immediately post-intervention)', 'description': 'trait mindfulness observing (range = 8-40 with higher scores indicating greater mindfulness)'}, {'measure': 'Five Facet Mindfulness Questionnaire Observing Subscale', 'timeFrame': '6 weeks post intervention', 'description': 'trait mindfulness observing (range = 8-40 with higher scores indicating greater mindfulness)'}, {'measure': 'Five Facet Mindfulness Questionnaire Observing Subscale', 'timeFrame': '12 weeks post intervention', 'description': 'trait mindfulness observing (range = 8-40 with higher scores indicating greater mindfulness)'}, {'measure': 'Five Facet Mindfulness Questionnaire Observing Subscale', 'timeFrame': '6 months post intervention', 'description': 'trait mindfulness observing (range = 8-40 with higher scores indicating greater mindfulness)'}, {'measure': 'Five Facet Mindfulness Questionnaire Describing Subscale', 'timeFrame': 'baseline', 'description': 'trait mindfulness describing (range = 8-40 with higher scores indicating greater mindfulness)'}, {'measure': 'Five Facet Mindfulness Questionnaire Describing Subscale', 'timeFrame': '3 weeks (i.e., immediately post-intervention)', 'description': 'trait mindfulness describing (range = 8-40 with higher scores indicating greater mindfulness)'}, {'measure': 'Five Facet Mindfulness Questionnaire Describing Subscale', 'timeFrame': '6 weeks post intervention', 'description': 'trait mindfulness describing (range = 8-40 with higher scores indicating greater mindfulness)'}, {'measure': 'Five Facet Mindfulness Questionnaire Describing Subscale', 'timeFrame': '12 weeks post intervention', 'description': 'trait mindfulness describing (range = 8-40 with higher scores indicating greater mindfulness)'}, {'measure': 'Five Facet Mindfulness Questionnaire Describing Subscale', 'timeFrame': '6 months post intervention', 'description': 'trait mindfulness describing (range = 8-40 with higher scores indicating greater mindfulness)'}, {'measure': 'Five Facet Mindfulness Questionnaire Awareness Subscale', 'timeFrame': 'baseline', 'description': 'trait mindfulness acting with awareness (range = 8-40 with higher scores indicating greater mindfulness)'}, {'measure': 'Five Facet Mindfulness Questionnaire Awareness Subscale', 'timeFrame': '3 weeks (i.e., immediately post-intervention)', 'description': 'trait mindfulness acting with awareness (range = 8-40 with higher scores indicating greater mindfulness)'}, {'measure': 'Five Facet Mindfulness Questionnaire Awareness Subscale', 'timeFrame': '6 weeks post intervention', 'description': 'trait mindfulness acting with awareness (range = 8-40 with higher scores indicating greater mindfulness)'}, {'measure': 'Five Facet Mindfulness Questionnaire Awareness Subscale', 'timeFrame': '12 weeks post intervention', 'description': 'trait mindfulness acting with awareness (range = 8-40 with higher scores indicating greater mindfulness)'}, {'measure': 'Five Facet Mindfulness Questionnaire Awareness Subscale', 'timeFrame': '6 months post intervention', 'description': 'trait mindfulness acting with awareness (range = 8-40 with higher scores indicating greater mindfulness)'}, {'measure': 'Five Facet Mindfulness Questionnaire Nonjudging Subscale', 'timeFrame': 'baseline', 'description': 'trait mindfulness non-judging of inner experience (range = 8-40 with higher scores indicating greater mindfulness)'}, {'measure': 'Five Facet Mindfulness Questionnaire Nonjudging Subscale', 'timeFrame': '3 weeks (i.e., immediately post-intervention)', 'description': 'trait mindfulness non-judging of inner experience (range = 8-40 with higher scores indicating greater mindfulness)'}, {'measure': 'Five Facet Mindfulness Questionnaire Nonjudging Subscale', 'timeFrame': '6 weeks post intervention', 'description': 'trait mindfulness non-judging of inner experience (range = 8-40 with higher scores indicating greater mindfulness)'}, {'measure': 'Five Facet Mindfulness Questionnaire Nonjudging Subscale', 'timeFrame': '12 weeks post intervention', 'description': 'trait mindfulness non-judging of inner experience (range = 8-40 with higher scores indicating greater mindfulness)'}, {'measure': 'Five Facet Mindfulness Questionnaire Nonjudging Subscale', 'timeFrame': '6 months post intervention', 'description': 'trait mindfulness non-judging of inner experience (range = 8-40 with higher scores indicating greater mindfulness)'}, {'measure': 'Five Facet Mindfulness Questionnaire Nonreactivity Subscale', 'timeFrame': 'baseline', 'description': 'trait mindfulness non-reactivity to inner experience (range = 7-35 with higher scores indicating greater mindfulness)'}, {'measure': 'Five Facet Mindfulness Questionnaire Nonreactivity Subscale', 'timeFrame': '3 weeks (i.e., immediately post-intervention)', 'description': 'trait mindfulness non-reactivity to inner experience (range = 7-35 with higher scores indicating greater mindfulness)'}, {'measure': 'Five Facet Mindfulness Questionnaire Nonreactivity Subscale', 'timeFrame': '6 weeks post intervention)', 'description': 'trait mindfulness non-reactivity to inner experience (range = 7-35 with higher scores indicating greater mindfulness)'}, {'measure': 'Five Facet Mindfulness Questionnaire Nonreactivity Subscale', 'timeFrame': '12 weeks post intervention)', 'description': 'trait mindfulness non-reactivity to inner experience (range = 7-35 with higher scores indicating greater mindfulness)'}, {'measure': 'Five Facet Mindfulness Questionnaire Nonreactivity Subscale', 'timeFrame': '6 months post intervention)', 'description': 'trait mindfulness non-reactivity to inner experience (range = 7-35 with higher scores indicating greater mindfulness)'}, {'measure': 'State Mindfulness Bodily Sensations', 'timeFrame': '3 weeks (i.e., immediately post-intervention)', 'description': 'average focus on bodily sensations during intervention period rated on visual analog scale (range = 0-100 with higher scores indicating more mindfulness)'}, {'measure': 'State Mindfulness Present Focus', 'timeFrame': '3 weeks (i.e., immediately post-intervention)', 'description': 'average % focus on present moment (as opposed to past or future focus) during intervention period indicating more mindfulness'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mindfulness', 'Mobile Intervention', 'Brief Intervention', 'Adolescence'], 'conditions': ['Rumination', 'Depression', 'Anxiety', 'Self-Injurious Behavior']}, 'referencesModule': {'references': [{'pmid': '36622879', 'type': 'DERIVED', 'citation': 'Hilt LM, Swords CM, Webb CA. Randomized Controlled Trial of a Mindfulness Mobile Application for Ruminative Adolescents. J Clin Child Adolesc Psychol. 2025 Jan-Feb;54(1):99-112. doi: 10.1080/15374416.2022.2158840. Epub 2023 Jan 9.'}, {'pmid': '36279218', 'type': 'DERIVED', 'citation': 'Webb CA, Swords CM, Lawrence HR, Hilt LM. Which adolescents are well-suited to app-based mindfulness training? A randomized clinical trial and data-driven approach for personalized recommendations. J Consult Clin Psychol. 2022 Sep;90(9):655-669. doi: 10.1037/ccp0000763.'}]}, 'descriptionModule': {'briefSummary': 'Rumination involves focusing on negative emotions repeatedly and is a risk factor for developing depression, anxiety, and self-injury. These negative outcomes increase in adolescence. The main goal of this study is to examine whether a mobile application designed to reduce rumination works with adolescents. The mobile application involves mindfulness exercises. Mindfulness means nonjudgmentally and deliberately paying attention. Adolescents will be randomly assigned to either the mindfulness group or a control group who uses a mobile application without mindfulness exercises. Both groups will use the app three times per day for three weeks and we will follow up with participants for six months. The investigators hypothesize that the mindfulness group will experience a reduction in rumination and symptoms of depression, anxiety and self-injury. They also expect that the mindfulness group will find the mobile app to be more engaging and will continue to use it beyond the 3 weeks.', 'detailedDescription': 'Rumination, a perseverative cognitive process that involves dwelling on negative emotions, is a transdiagnostic risk factor for the development of depression, anxiety, and self-injurious behaviors. Thus, reducing the tendency to ruminate in adolescence, a time when many psychological disorders often first develop, has the potential for a large public health impact. This protocol involves testing the acceptability and efficacy of a newly developed mindfulness mobile application designed to reduce rumination.\n\nMindfulness involves paying attention to the present moment without judgement. If negative emotions arise, one notices them and how the body is feeling without becoming caught up in the emotion so that it can pass. In adult clinical studies, intensive mindfulness practice has been associated with successful treatment of psychopathology, including preventing the recurrence of depression, possibly through reducing rumination. Research with adolescents has suggested that a brief mindfulness exercise can interrupt the ruminative process. Thus, mindfulness appears to be a promising strategy to reduce the tendency to ruminate and prevent psychopathology.\n\nA diverse sample of 150 high-ruminating 12-15 year-olds will be recruited from the community and randomly assigned to a 3-week mobile mindfulness intervention or an ecological momentary assessment (EMA)-only control condition. In both conditions, adolescents will be notified to use the mobile app three times per day to complete EMA questions. Based on mood ratings, participants in the mindfulness condition have a chance to receive a brief mindfulness exercise (i.e., 1-12 minutes long) at each use. At pre- and post-intervention and three follow-up periods (6 weeks,12 weeks, and 6 months), participants and their parents will report on adolescent anxiety and depression. Adolescents will also report on self-injurious thoughts and behaviors (SITBs), trait rumination, and mindfulness. During the intervention period, participants will report on state levels of rumination, mindfulness, and mood using the app. Participants will also report on their satisfaction with the app, while their optional continued use of the app will be monitored electronically for 6 months following the intervention period. The investigators will test intervention effects using multilevel modeling, examining the role of both state- and trait-level mediators. Based on preliminary pilot data, the investigators expect that the mindfulness intervention will reduce symptoms, and we anticipate this effect to be due to the mediating role of decreased rumination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adolescent between the ages of 12 and 15 years\n* at least moderate levels of rumination (mean score of 2 or above on a 1-4 scale) on the two screening questions\n\nExclusion Criteria:\n\n* serious physical or cognitive disability that prevents adolescent from using a mobile device, because that is the intervention delivery method\n* inadequate English proficiency to complete questionnaires'}, 'identificationModule': {'nctId': 'NCT03900416', 'acronym': 'AMMASRCT', 'briefTitle': 'Adolescent Mindfulness Mobile App Study (RCT)', 'organization': {'class': 'OTHER', 'fullName': 'Lawrence University'}, 'officialTitle': 'Mindfulness-based Mobile Application to Reduce Rumination in Adolescents', 'orgStudyIdInfo': {'id': '7_25_18_Hilt'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mindfulness App', 'description': 'Guided mindfulness exercises will be delivered via mobile app for three weeks.', 'interventionNames': ['Behavioral: Mindfulness App']}, {'type': 'NO_INTERVENTION', 'label': 'Control condition', 'description': 'Participants will use app for assessment for three weeks, but no mindfulness exercises will be delivered.'}], 'interventions': [{'name': 'Mindfulness App', 'type': 'BEHAVIORAL', 'description': 'Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.', 'armGroupLabels': ['Mindfulness App']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54911', 'city': 'Appleton', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Lawrence University', 'geoPoint': {'lat': 44.26193, 'lon': -88.41538}}], 'overallOfficials': [{'name': 'Lori M Hilt, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lawrence University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lawrence University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Psychology', 'investigatorFullName': 'Lori Hilt', 'investigatorAffiliation': 'Lawrence University'}}}}