- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01948167
Bending Adolescent Depression Trajectories Through Personalized Prevention
March 2, 2021 updated by: Children's Hospital of Philadelphia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
205
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
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Denver, Colorado, United States, 80208
- University of Denver
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Illinois
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Champaign, Illinois, United States, 61820
- University of Illinois Urbana Champaign
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New Jersey
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Piscataway, New Jersey, United States, 08854
- Rutgers University
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19146
- Children's Hospital of Philadelphia
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Currently in the 6th to 11th grades
- Adolescent and parent must be English-speaking
- Parental consent and adolescent consent
Exclusion Criteria:
- Presence of current Major Depressive Disorder, dysthymia, bipolar disorder, or significant psychosis
- Suicide attempt in the past week or significant suicidal ideation in the past week
- Presence of significant psychopathology or significant pervasive developmental delays that would make the group inappropriate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Interpersonal Psychotherapy- Adolescent Skills Training
|
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.
Other Names:
|
|
Experimental: Coping with Stress
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
Time Frame: Post intervention (approximately 3 months post baseline)
|
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
|
Post intervention (approximately 3 months post baseline)
|
|
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)
Time Frame: 6-months post-intervention
|
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
|
6-months post-intervention
|
|
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)
Time Frame: 12-months post-intervention
|
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
|
12-months post-intervention
|
|
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)
Time Frame: 18-months post-intervention
|
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
|
18-months post-intervention
|
|
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)
Time Frame: 24-months post-intervention
|
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
|
24-months post-intervention
|
|
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)
Time Frame: 30-months post-intervention
|
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
|
30-months post-intervention
|
|
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)
Time Frame: 36-months post-intervention
|
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
|
36-months post-intervention
|
|
Children's Depression Inventory (CDI)
Time Frame: Post intervention (approximately 3 months after baseline)
|
Self-reported depression scores
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Post intervention (approximately 3 months after baseline)
|
|
Children's Depression Inventory (CDI)
Time Frame: 6-months post-intervention
|
Self-reported depression scores
|
6-months post-intervention
|
|
Children's Depression Inventory (CDI)
Time Frame: 12-months post-intervention
|
Self-reported depression scores
|
12-months post-intervention
|
|
Children's Depression Inventory (CDI)
Time Frame: 18-months post-intervention
|
Self-reported depression scores
|
18-months post-intervention
|
|
Children's Depression Inventory (CDI)
Time Frame: 24-months post-intervention
|
Self-reported depression scores
|
24-months post-intervention
|
|
Children's Depression Inventory (CDI)
Time Frame: 30-months post-intervention
|
Self-reported depression scores
|
30-months post-intervention
|
|
Children's Depression Inventory (CDI)
Time Frame: 36-months post-intervention
|
Self-reported depression scores
|
36-months post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Children's Global Assessment Scale (CGAS)
Time Frame: Post Intervention (approximately 3 months following baseline)
|
Assesses global functioning
|
Post Intervention (approximately 3 months following baseline)
|
|
Children's Global Assessment Scale (CGAS)
Time Frame: 6-months followup
|
Assesses global functioning
|
6-months followup
|
|
Children's Global Assessment Scale (CGAS)
Time Frame: 12-months followup
|
Assesses global functioning
|
12-months followup
|
|
Children's Global Assessment Scale (CGAS)
Time Frame: 18-months followup
|
Assesses global functioning
|
18-months followup
|
|
Children's Global Assessment Scale (CGAS)
Time Frame: 24-months followup
|
Assesses global functioning
|
24-months followup
|
|
Children's Global Assessment Scale (CGAS)
Time Frame: 30-months followup
|
Assesses global functioning
|
30-months followup
|
|
Children's Global Assessment Scale (CGAS)
Time Frame: 36-months followup
|
Assesses global functioning
|
36-months followup
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Jami F Young, Ph.D., Children's Hospital of Philadelphia
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2013
Primary Completion (Actual)
August 1, 2019
Study Completion (Actual)
August 1, 2019
Study Registration Dates
First Submitted
September 18, 2013
First Submitted That Met QC Criteria
September 18, 2013
First Posted (Estimate)
September 23, 2013
Study Record Updates
Last Update Posted (Actual)
March 4, 2021
Last Update Submitted That Met QC Criteria
March 2, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-013831
- R01MH077178 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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