Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 10:33 PM
Study NCT ID:
NCT01948167
Status:
COMPLETED
Last Update Posted:
2021-03-04
First Post:
2013-09-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bending Adolescent Depression Trajectories Through Personalized Prevention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000097813', 'term': 'Coping Skills'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-04-18', 'size': 610160, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-03-02T14:26', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 205}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2019-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-02', 'studyFirstSubmitDate': '2013-09-18', 'studyFirstSubmitQcDate': '2013-09-18', 'lastUpdatePostDateStruct': {'date': '2021-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of a Major Depressive Episode or Dysthymia on the Schedule for Affective Disorders for School Aged Children - Present and Life Time Version (K-SADS-PL)', 'timeFrame': 'Post intervention (approximately 3 months post baseline)', 'description': 'Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.'}, {'measure': 'Presence of A Major Depressive Episode or Dysthymia on the Schedule for Affective Disorders for School Aged Children - Present and Life Time Version (K-SADS-PL)', 'timeFrame': '6-months post-intervention', 'description': 'Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.'}, {'measure': 'Presence of A Major Depressive Episode or Dysthymia on the Schedule for Affective Disorders for School Aged Children - Present and Life Time Version (K-SADS-PL)', 'timeFrame': '12-months post-intervention', 'description': 'Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.'}, {'measure': 'Presence of A Major Depressive Episode or Dysthymia on the Schedule for Affective Disorders for School Aged Children - Present and Life Time Version (K-SADS-PL)', 'timeFrame': '18-months post-intervention', 'description': 'Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.'}, {'measure': 'Presence of A Major Depressive Episode or Dysthymia on the Schedule for Affective Disorders for School Aged Children - Present and Life Time Version (K-SADS-PL)', 'timeFrame': '24-months post-intervention', 'description': 'Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.'}, {'measure': 'Presence of A Major Depressive Episode or Dysthymia on the Schedule for Affective Disorders for School Aged Children - Present and Life Time Version (K-SADS-PL)', 'timeFrame': '30-months post-intervention', 'description': 'Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.'}, {'measure': 'Presence of A Major Depressive Episode or Dysthymia on the Schedule for Affective Disorders for School Aged Children - Present and Life Time Version (K-SADS-PL)', 'timeFrame': '36-months post-intervention', 'description': 'Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.'}, {'measure': "Children's Depression Inventory (CDI)", 'timeFrame': 'Post intervention (approximately 3 months after baseline)', 'description': 'Self-reported depression scores'}, {'measure': "Children's Depression Inventory (CDI)", 'timeFrame': '6-months post-intervention', 'description': 'Self-reported depression scores'}, {'measure': "Children's Depression Inventory (CDI)", 'timeFrame': '12-months post-intervention', 'description': 'Self-reported depression scores'}, {'measure': "Children's Depression Inventory (CDI)", 'timeFrame': '18-months post-intervention', 'description': 'Self-reported depression scores'}, {'measure': "Children's Depression Inventory (CDI)", 'timeFrame': '24-months post-intervention', 'description': 'Self-reported depression scores'}, {'measure': "Children's Depression Inventory (CDI)", 'timeFrame': '30-months post-intervention', 'description': 'Self-reported depression scores'}, {'measure': "Children's Depression Inventory (CDI)", 'timeFrame': '36-months post-intervention', 'description': 'Self-reported depression scores'}], 'secondaryOutcomes': [{'measure': "Children's Global Assessment Scale (CGAS)", 'timeFrame': 'Post Intervention (approximately 3 months following baseline)', 'description': 'Assesses global functioning'}, {'measure': "Children's Global Assessment Scale (CGAS)", 'timeFrame': '6-months followup', 'description': 'Assesses global functioning'}, {'measure': "Children's Global Assessment Scale (CGAS)", 'timeFrame': '12-months followup', 'description': 'Assesses global functioning'}, {'measure': "Children's Global Assessment Scale (CGAS)", 'timeFrame': '18-months followup', 'description': 'Assesses global functioning'}, {'measure': "Children's Global Assessment Scale (CGAS)", 'timeFrame': '24-months followup', 'description': 'Assesses global functioning'}, {'measure': "Children's Global Assessment Scale (CGAS)", 'timeFrame': '30-months followup', 'description': 'Assesses global functioning'}, {'measure': "Children's Global Assessment Scale (CGAS)", 'timeFrame': '36-months followup', 'description': 'Assesses global functioning'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Depression', 'Prevention', 'Adolescents'], 'conditions': ['Depression']}, 'referencesModule': {'references': [{'pmid': '38635190', 'type': 'DERIVED', 'citation': 'Jones JD, Schwartz KTG, Davis M, Gallop R, Hankin BL, Young JF. Cognitive and interpersonal moderators of two evidence-based depression prevention programs. J Consult Clin Psychol. 2024 Jul;92(7):432-444. doi: 10.1037/ccp0000886. Epub 2024 Apr 18.'}, {'pmid': '33189876', 'type': 'DERIVED', 'citation': 'Young JF, Jones JD, Gallop R, Benas JS, Schueler CM, Garber J, Hankin BL. Personalized Depression Prevention: A Randomized Controlled Trial to Optimize Effects Through Risk-Informed Personalization. J Am Acad Child Adolesc Psychiatry. 2021 Sep;60(9):1116-1126.e1. doi: 10.1016/j.jaac.2020.11.004. Epub 2020 Nov 13.'}]}, 'descriptionModule': {'briefSummary': 'Investigators will combine risk factor research and evidence-based prevention programs, to advance knowledge on personalized approaches to prevention that may be able to better "bend trajectories" of depression that surge throughout adolescence.', 'detailedDescription': 'Investigators will innovatively combine risk factor research and evidence-based prevention programs, to advance knowledge on personalized approaches to prevention that may be able to better "bend trajectories" of depression that surge throughout adolescence. A randomized controlled trial will examine the benefits of matching youth to two depression prevention programs of Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST) and Coping with Stress (CWS) for the prevention of depression in adolescents. These two programs are designed to address distinct risk factors for depression - CWS addresses cognitive risks and IPT-AST addresses interpersonal risks. A total of 210 participants across two sites, University of Denver and Rutgers University, will be stratified on cognitive and interpersonal risk and randomized to the two conditions. The goals of the study are to (1) demonstrate that prevention programs can modify depression trajectories among youth by examining within person changes in trajectories over time (three years before and three years after the prevention programs) and by comparing trajectories of prevention youth with changes in same aged cohorts; (2) evaluate a personalized prevention approach to bending depression trajectories by matching and mismatching youth to either CWS or IPT-AST based on individual risk profiles; (3) examine mechanisms of bending depression trajectories and test whether the prevention programs operate via their hypothesized processes; and (4) explore how genetic susceptibility, emotion regulation, and temperament may affect individual response to IPT-AST and CWS. By implementing evidence-based prevention programs after 3-years of prospective naturalistic data collection, this study will contribute essential data on personalized medicine and altering developmental trajectories of first-onset depression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Currently in the 6th to 11th grades\n* Adolescent and parent must be English-speaking\n* Parental consent and adolescent consent\n\nExclusion Criteria:\n\n* Presence of current Major Depressive Disorder, dysthymia, bipolar disorder, or significant psychosis\n* Suicide attempt in the past week or significant suicidal ideation in the past week\n* Presence of significant psychopathology or significant pervasive developmental delays that would make the group inappropriate'}, 'identificationModule': {'nctId': 'NCT01948167', 'briefTitle': 'Bending Adolescent Depression Trajectories Through Personalized Prevention', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Philadelphia"}, 'officialTitle': 'Bending Adolescent Depression Trajectories Through Personalized Prevention', 'orgStudyIdInfo': {'id': '17-013831'}, 'secondaryIdInfos': [{'id': 'R01MH077178', 'link': 'https://reporter.nih.gov/quickSearch/R01MH077178', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interpersonal Psychotherapy- Adolescent Skills Training', 'description': 'Interpersonal Psychotherapy- Adolescent Skills Training', 'interventionNames': ['Behavioral: Interpersonal Psychotherapy- Adolescent Skills Training']}, {'type': 'EXPERIMENTAL', 'label': 'Coping with Stress', 'description': 'Coping with Stress', 'interventionNames': ['Behavioral: Coping with Stress']}], 'interventions': [{'name': 'Interpersonal Psychotherapy- Adolescent Skills Training', 'type': 'BEHAVIORAL', 'otherNames': ['IPT-AST', 'Teen Talk'], 'description': 'A group prevention program that includes a 60-minute pre-group session, 8 weekly 90-minute group sessions, a 60-minute mid-group session, and 3 60-minute booster sessions. IPT-AST focuses on psychoeducation and interpersonal skill-building to decrease interpersonal conflict and increase interpersonal support and competence.', 'armGroupLabels': ['Interpersonal Psychotherapy- Adolescent Skills Training']}, {'name': 'Coping with Stress', 'type': 'BEHAVIORAL', 'otherNames': ['CWS'], 'description': 'A group prevention program that consists of 8 acute 90-minute group sessions, 2 parent group sessions, and 3 continuation sessions lasting 60 minutes each. Participants are taught to apply cognitive techniques to their personal thoughts, with the goal of generating effective counterarguments to unrealistic negative beliefs.', 'armGroupLabels': ['Coping with Stress']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80208', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Denver', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '61820', 'city': 'Champaign', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois Urbana Champaign', 'geoPoint': {'lat': 40.11642, 'lon': -88.24338}}, {'zip': '08854', 'city': 'Piscataway', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rutgers University', 'geoPoint': {'lat': 40.49927, 'lon': -74.39904}}, {'zip': '19146', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Jami F Young, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Philadelphia"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Philadelphia", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}, {'name': 'University of Denver', 'class': 'OTHER'}, {'name': 'Rutgers University', 'class': 'OTHER'}, {'name': 'University of Illinois at Urbana-Champaign', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}