Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:50 PM
Study NCT ID:
NCT05353751
Status:
RECRUITING
Last Update Posted:
2025-05-13
First Post:
2022-02-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Kind Minds Program for Youth With Anxiety and Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-07', 'studyFirstSubmitDate': '2022-02-02', 'studyFirstSubmitQcDate': '2022-04-25', 'lastUpdatePostDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Health Questionnaire-9', 'timeFrame': '12-14 weeks after baseline assessment', 'description': 'self report of depressive symptoms'}, {'measure': 'Generalized Anxiety Disorder-7', 'timeFrame': '12-14 weeks after baseline assessment', 'description': 'self report of anxiety symptoms'}, {'measure': 'SCARED -Screen for child anxiety and related emotional disorders', 'timeFrame': '12-14 weeks after baseline assessment', 'description': 'self report of anxiety symptoms'}], 'secondaryOutcomes': [{'measure': 'Kiddie Schedule for Affective Disorders and Schizophrenia interview -anxiety and depressive disorder modules', 'timeFrame': '12-14 weeks after baseline assessment', 'description': 'remission on primary anxiety or primary depressive disorder diagnosis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mindfulness', 'children', 'adolescents', 'anxiety', 'depression'], 'conditions': ['Child Anxiety', 'Depression']}, 'descriptionModule': {'briefSummary': "Rates of anxiety and depression in youth are substantial, causing a major unmet need for effective interventions. Participation in mindfulness interventions has been demonstrated to reduce anxiety and depressive symptoms among teenagers. Parents' participation in mindfulness interventions has also been shown to reduce their children's mental health symptoms. However, there is no available evidence regarding potential additional benefits for adolescents' mental health of having both the adolescent and their parent or caregiver learn and practice mindfulness simultaneously.\n\nThis pilot intervention study aims to explore potential additive effects of parent/caregiver participation in a digitally-based, kindness-focused, coached mindfulness intervention program for adolescents that lasts 9 weeks. Participating parent/caregiver-child pairs (n = 30) will include one teenager between 12 and 17 years old with a current diagnosis of an anxiety or depressive disorder and one parent/caregiver. All adolescent participants will take part in the mindfulness intervention. Half of the parents/caregivers will be randomized to also take part in the mindfulness program. Outcomes will be compared between families in which only the teen participates in the mindfulness program and families in which the teen and parent/caregiver participate in the intervention.\n\nAdolescents and parents/caregivers will take part in evaluations before, in the middle of, and after the end of the mindfulness program, meaning that participation in the study will take a total of approximately 12 weeks. Pre, mid, and post evaluations will include online questionnaires. Pre and post evaluations will also include clinical interviews via phone or video conference. Evaluations will include measures of mental health diagnoses and symptoms, mood, interpersonal and family functioning, mindfulness, and perceptions of/satisfaction with the program. Participating adolescents and parents/caregivers will also fill out weekly brief questionnaires of anxiety and depressive symptoms. The primary outcome of interest is adolescent mental health, including anxiety and depressive symptoms."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants will include:\n\n 1. one adolescent (aged 12-17 years) with a current diagnosis of an anxiety or depressive disorder)\n 2. one of their parents/caregivers.\n 3. Both adolescent and caregiver must speak English to the degree necessary to participate in the intervention program, which is only available in English.\n 4. Parent and youth must have a smart phone and be willing to download the online mindfulness program.\n\nExclusion Criteria:\n\n* Exclusion criteria apply to both caregiver and adolescent and include:\n\n 1. current alcohol or substance use disorder or suicidality\n 2. lifetime diagnosis of bipolar disorder, schizophrenia, autism, conduct disorder, or developmental delay diagnosed by an independent evaluator;\n 3. English reading level below 4th grade\n 4. non English speaking\n 5. currently receiving mindfulness-based mental health services or taking medication to treat anxiety or depression.'}, 'identificationModule': {'nctId': 'NCT05353751', 'acronym': 'KMP', 'briefTitle': 'Kind Minds Program for Youth With Anxiety and Depression', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': 'Examining the Effectiveness of a Mindfulness-based Intervention for Underserved Adolescents With and Without Caregiver Involvement', 'orgStudyIdInfo': {'id': '21-001218'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Kind Minds Program -Family', 'description': 'In the Family condition (KMP-Fam), both caregiver and adolescent will receive the KMP intervention via an online mindfulness program, augmented by weekly video conference support from a Community Health Worker (CHW) Kindness Coach', 'interventionNames': ['Behavioral: Kind Minds Program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Kind Minds Program -Teen Only', 'description': 'In the Teen-Only condition (KMP-TO), only the adolescent will receive the KMP intervention via an online mindfulness program augmented by weekly video conference support from a CHW Kindness Coach.', 'interventionNames': ['Behavioral: Kind Minds Program']}], 'interventions': [{'name': 'Kind Minds Program', 'type': 'BEHAVIORAL', 'description': 'The KMP intervention uses an online mindfulness phone based program. During the 9-week program, Community Health Worker (CHW) Kindness Coaches will meet weekly for 30 minutes via Zoom with either a) the caregiver and adolescent (in separate meetings), or b) the adolescent only to review and complete a new "session" using the online mindfulness program. Participants will be prompted to complete mindfulness activities between sessions by notifications, conducive to their school and work schedules. Weekly content and meditations/activities focus on mindfulness skills of present moment awareness, nonjudgment, compassion, and gratitude.', 'armGroupLabels': ['Kind Minds Program -Family', 'Kind Minds Program -Teen Only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92251', 'city': 'Imperial', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Joe Apodaca', 'role': 'CONTACT', 'email': 'japodaca@imperialusd.org', 'phone': '760-540-1366'}], 'facility': 'Imperial High School', 'geoPoint': {'lat': 32.84755, 'lon': -115.56944}}], 'centralContacts': [{'name': 'Denise A Chavira, PhD', 'role': 'CONTACT', 'email': 'dchavira@psych.ucla.edu', 'phone': '3108258466'}, {'name': 'Danielle Smith, PhD', 'role': 'CONTACT', 'email': 'Danielle.Sayre@gmail.com'}], 'overallOfficials': [{'name': 'Denise A Chavira, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Los Angeles'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Denise A. Chavira, PhD', 'investigatorAffiliation': 'University of California, Los Angeles'}}}}