Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-25 @ 9:16 PM
Study NCT ID:
NCT03438656
Status:
COMPLETED
Last Update Posted:
2024-05-02
First Post:
2018-02-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Activating and Connecting Teens (ACT) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jennessj@uw.edu', 'phone': '414-331-4871', 'title': 'Assistant Professor', 'organization': 'University of Washington'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were measured across 6-months.', 'eventGroups': [{'id': 'EG000', 'title': 'Behavioral Activation Arm', 'description': 'See treatment description for information on Behavioral Activation. Participants will receive 12 weekly sessions of Behavioral Activation.\n\nBehavioral Activation: The Adolescent Behavioral Activation Program (ABAP) will be used as the BA protocol. ABAP was developed and validated by McCauley, Dimidjian et al. to adapt BA to adolescents. ABAP is a 12-week protocol that utilizes an idiographic approach to foster rewarding experiences, effective problem solving, and goal attainment, and decrease avoidance, barriers to activation, and depressive rumination that may be contributing to depression severity and maintenance.', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 0, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Activation Arm', 'description': 'See treatment description for information on Behavioral Activation. Participants will receive 12 weekly sessions of Behavioral Activation.\n\nBehavioral Activation: The Adolescent Behavioral Activation Program (ABAP) will be used as the BA protocol. ABAP was developed and validated by McCauley, Dimidjian et al. to adapt BA to adolescents. ABAP is a 12-week protocol that utilizes an idiographic approach to foster rewarding experiences, effective problem solving, and goal attainment, and decrease avoidance, barriers to activation, and depressive rumination that may be contributing to depression severity and maintenance.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.63', 'spread': '5.49', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12 (post-treatment)', 'description': 'Changes in depression symptoms will be measured with self-report on the Patient Health Questionnaire-9 (PHQ-9). Total score will be reported with a range of 0 to 27 with higher scores indicating greater symptoms of depression. Higher symptoms of depression are considered a worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Anhedonia/Activation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Behavioral Activation Arm', 'description': 'See treatment description for information on Behavioral Activation. Participants will receive 12 weekly sessions of Behavioral Activation.\n\nBehavioral Activation: The Adolescent Behavioral Activation Program (ABAP) will be used as the BA protocol. ABAP was developed and validated by McCauley, Dimidjian et al. to adapt BA to adolescents. ABAP is a 12-week protocol that utilizes an idiographic approach to foster rewarding experiences, effective problem solving, and goal attainment, and decrease avoidance, barriers to activation, and depressive rumination that may be contributing to depression severity and maintenance.'}], 'classes': [{'categories': [{'measurements': [{'value': '61.80', 'spread': '22.19', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'Changes in feelings of loss of pleasure and interest (i.e., Anhedonia) will be measured via self-report on the Behavioral Activation for Depression Scale (BADS) total score. The range on the BADS is 0 to 150, with higher scores representing less activation. Higher scores are considered a worse outcome on this measure.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Anxiety', 'timeFrame': 'Symptoms will be measured at baseline, post-treatment, and 3-month follow-up.', 'description': 'Changes in anxiety symptoms and diagnoses with diagnostic interviews and self-report (SCARED).', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2024-03'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Behavioral Problems', 'timeFrame': 'Pre- (Week 0) and post-treatment (Week 12)', 'description': 'Changes in commonly co-morbid behavioral problems with depression (i.e., attention deficit/hyperactivity disorder, conduct problems, oppositionality) and diagnoses will be measured.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2024-03'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Hopelessness', 'timeFrame': 'Pre- (Week 0) and post-treatment (Week 12)', 'description': 'Changes in feelings of hopelessness (i.e., feeling like nothing is good, everything is bad, nothing can change it) will be measured by self-report.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2024-03'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Suicidality', 'timeFrame': 'Weekly throughout treatment (Weeks 0-12) and at a 3-month follow-up (24 Week)', 'description': 'Changes in suicidal ideation, plans, and behaviors and self-harm thoughts and behaviors will be measured on a semi-structured interview and self-report.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2024-03'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Ecological Momentary Assessment (EMA)', 'timeFrame': 'Questionnaires delivered 3x/day, 2 days/week from Weeks 0 to 12', 'description': 'Changes in self-reported activity engagement and mood will be delivered through a mobile application.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2024-03'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Behavioral Activation Arm', 'description': 'See treatment description for information on Behavioral Activation. Participants will receive 12 weekly sessions of Behavioral Activation.\n\nBehavioral Activation: The Adolescent Behavioral Activation Program (ABAP) will be used as the BA protocol. ABAP was developed and validated by McCauley, Dimidjian et al. to adapt BA to adolescents. ABAP is a 12-week protocol that utilizes an idiographic approach to foster rewarding experiences, effective problem solving, and goal attainment, and decrease avoidance, barriers to activation, and depressive rumination that may be contributing to depression severity and maintenance.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'We did not assign to groups. This was a single-arm, open pilot trial'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Behavioral Activation Arm', 'description': 'See treatment description for information on Behavioral Activation. Participants will receive 12 weekly sessions of Behavioral Activation.\n\nBehavioral Activation: The Adolescent Behavioral Activation Program (ABAP) will be used as the BA protocol. ABAP was developed and validated by McCauley, Dimidjian et al. to adapt BA to adolescents. ABAP is a 12-week protocol that utilizes an idiographic approach to foster rewarding experiences, effective problem solving, and goal attainment, and decrease avoidance, barriers to activation, and depressive rumination that may be contributing to depression severity and maintenance.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '14.88', 'spread': '1.39', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Patient Health Questionnaire-9', 'classes': [{'categories': [{'measurements': [{'value': '13.94', 'spread': '6.51', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Changes in depression symptoms will be measured with self-report on the Patient Health Questionnaire-9 (PHQ-9). Total score will be reported with a range of 0 to 27 with higher scores indicating greater symptoms of depression. Higher symptoms of depression are considered a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Childhood Trauma Questionnaire', 'classes': [{'categories': [{'measurements': [{'value': '40.63', 'spread': '9.00', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'The Childhood Trauma Questionnaire (CTQ) measures lifetime experiences of sexual, physical, and emotional abuse as well as emotional neglect. The total score ranges from 5 to 125 with higher scores indicating more experiences of abuse or neglect.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Anhedonia', 'classes': [{'categories': [{'measurements': [{'value': '73.53', 'spread': '22.18', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Changes in feelings of loss of pleasure and interest (i.e., Anhedonia) will be measured via self-report on the Behavioral Activation for Depression Scale (BADS) total score. The range on the BADS is 0 to 150, with higher scores representing less activation. Higher scores are considered a worse outcome on this measure.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-03-01', 'size': 56422, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-03-13T22:59', 'hasProtocol': True}, {'date': '2020-10-02', 'size': 229052, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-04-10T16:09', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-10', 'studyFirstSubmitDate': '2018-02-05', 'resultsFirstSubmitDate': '2024-03-13', 'studyFirstSubmitQcDate': '2018-02-12', 'lastUpdatePostDateStruct': {'date': '2024-05-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-10', 'studyFirstPostDateStruct': {'date': '2018-02-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Anxiety', 'timeFrame': 'Symptoms will be measured at baseline, post-treatment, and 3-month follow-up.', 'description': 'Changes in anxiety symptoms and diagnoses with diagnostic interviews and self-report (SCARED).'}, {'measure': 'Behavioral Problems', 'timeFrame': 'Pre- (Week 0) and post-treatment (Week 12)', 'description': 'Changes in commonly co-morbid behavioral problems with depression (i.e., attention deficit/hyperactivity disorder, conduct problems, oppositionality) and diagnoses will be measured.'}, {'measure': 'Hopelessness', 'timeFrame': 'Pre- (Week 0) and post-treatment (Week 12)', 'description': 'Changes in feelings of hopelessness (i.e., feeling like nothing is good, everything is bad, nothing can change it) will be measured by self-report.'}, {'measure': 'Suicidality', 'timeFrame': 'Weekly throughout treatment (Weeks 0-12) and at a 3-month follow-up (24 Week)', 'description': 'Changes in suicidal ideation, plans, and behaviors and self-harm thoughts and behaviors will be measured on a semi-structured interview and self-report.'}, {'measure': 'Ecological Momentary Assessment (EMA)', 'timeFrame': 'Questionnaires delivered 3x/day, 2 days/week from Weeks 0 to 12', 'description': 'Changes in self-reported activity engagement and mood will be delivered through a mobile application.'}], 'primaryOutcomes': [{'measure': 'Depression', 'timeFrame': 'Week 12 (post-treatment)', 'description': 'Changes in depression symptoms will be measured with self-report on the Patient Health Questionnaire-9 (PHQ-9). Total score will be reported with a range of 0 to 27 with higher scores indicating greater symptoms of depression. Higher symptoms of depression are considered a worse outcome.'}, {'measure': 'Anhedonia/Activation', 'timeFrame': 'Week 12', 'description': 'Changes in feelings of loss of pleasure and interest (i.e., Anhedonia) will be measured via self-report on the Behavioral Activation for Depression Scale (BADS) total score. The range on the BADS is 0 to 150, with higher scores representing less activation. Higher scores are considered a worse outcome on this measure.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Depression', 'Childhood adversity', 'Behavioral Activation', 'Reward Processing'], 'conditions': ['Depression']}, 'descriptionModule': {'briefSummary': 'National data indicate over 650,000 children and adolescents are exposed to physical, sexual, or emotional abuse or physical or emotional neglect each year. Moreover, youth with a history of childhood maltreatment (CM) are at least twice as likely to develop depression and are at substantial risk for nonresponse to current best practice depression interventions (i.e., cognitive behavioral therapy and antidepressants) compared to non-maltreated peers. Research suggests that CM increases risk for depression through disruptions in the positive valence system, such as reward processing, and Behavioral Activation (BA) may be an alternative depression intervention that targets these deficits. This proposal will examine whether BA intervention reduces depression and anhedonia in a sample of depressed adolescents, aged 13-18, with variable histories of CM exposure (BA Group). A total of 30 depressed adolescents will be recruited to undergo a 12-week course of BA. All participants will undergo clinical assessment to measure depression symptoms and anhedonia at baseline (Week 0) and post- (Week 12) treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria Behavioral Activation Group:\n\n\\- current diagnosis of clinical depression (minor or major) will be recruited as study participants in the Behavioral Activation (BA) Group\n\nExclusion Criteria:\n\n* IQ \\< 80;\n* non-English speaking youth or parent;\n* current PTSD diagnosis;\n* lifetime history of a developmental (e.g., autism), neurological (e.g., epilepsy), psychotic, bipolar, or substance disorder;\n* current psychiatric (e.g., antidepressants) or other mood altering medication (e.g., steroids) other than AD/HD medication;\n* requiring a higher level of care (i.e., inpatient hospitalization) due to suicidality or other mental or physical health related problem.\n* Any youths who are currently being maltreated will not be enrolled to ensure that participants do not have active safety concerns.\n* Full course of other evidence-based depression intervention'}, 'identificationModule': {'nctId': 'NCT03438656', 'acronym': 'ACT', 'briefTitle': 'Activating and Connecting Teens (ACT) Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Targeted Intervention for Adolescents Following Child Maltreatment: Examining Neural and Behavioral Mechanisms Within the Positive Valence System', 'orgStudyIdInfo': {'id': 'STUDY00002283'}, 'secondaryIdInfos': [{'id': 'K23MH112872', 'link': 'https://reporter.nih.gov/quickSearch/K23MH112872', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Behavioral Activation Arm', 'description': 'See treatment description for information on Behavioral Activation. Participants will receive 12 weekly sessions of Behavioral Activation.', 'interventionNames': ['Behavioral: Behavioral Activation']}], 'interventions': [{'name': 'Behavioral Activation', 'type': 'BEHAVIORAL', 'description': 'The Adolescent Behavioral Activation Program (ABAP) will be used as the BA protocol. ABAP was developed and validated by McCauley, Dimidjian et al. to adapt BA to adolescents. ABAP is a 12-week protocol that utilizes an idiographic approach to foster rewarding experiences, effective problem solving, and goal attainment, and decrease avoidance, barriers to activation, and depressive rumination that may be contributing to depression severity and maintenance.', 'armGroupLabels': ['Behavioral Activation Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Seattle Children's Hospital", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Jessica L Jenness, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': "Seattle Children's Hospital", 'class': 'OTHER'}, {'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Acting Assistant Professor', 'investigatorFullName': 'Jessica Jenness', 'investigatorAffiliation': 'University of Washington'}}}}