Bending Adolescent Depression Trajectories Through Personalized Prevention
Primary Purpose
Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Interpersonal Psychotherapy- Adolescent Skills Training
Coping with Stress
Sponsored by
About this trial
This is an interventional prevention trial for Depression focused on measuring Depression, Prevention, Adolescents
Eligibility Criteria
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
Sites / Locations
- University of Denver
- University of Illinois Urbana Champaign
- Rutgers University
- Children's Hospital of Philadelphia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Interpersonal Psychotherapy- Adolescent Skills Training
Coping with Stress
Arm Description
Interpersonal Psychotherapy- Adolescent Skills Training
Coping with Stress
Outcomes
Primary Outcome Measures
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)
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
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)
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
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)
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
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)
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
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)
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
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)
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
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)
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
Children's Depression Inventory (CDI)
Self-reported depression scores
Children's Depression Inventory (CDI)
Self-reported depression scores
Children's Depression Inventory (CDI)
Self-reported depression scores
Children's Depression Inventory (CDI)
Self-reported depression scores
Children's Depression Inventory (CDI)
Self-reported depression scores
Children's Depression Inventory (CDI)
Self-reported depression scores
Children's Depression Inventory (CDI)
Self-reported depression scores
Secondary Outcome Measures
Children's Global Assessment Scale (CGAS)
Assesses global functioning
Children's Global Assessment Scale (CGAS)
Assesses global functioning
Children's Global Assessment Scale (CGAS)
Assesses global functioning
Children's Global Assessment Scale (CGAS)
Assesses global functioning
Children's Global Assessment Scale (CGAS)
Assesses global functioning
Children's Global Assessment Scale (CGAS)
Assesses global functioning
Children's Global Assessment Scale (CGAS)
Assesses global functioning
Full Information
NCT ID
NCT01948167
First Posted
September 18, 2013
Last Updated
March 2, 2021
Sponsor
Children's Hospital of Philadelphia
Collaborators
National Institute of Mental Health (NIMH), University of Denver, Rutgers University, University of Illinois at Urbana-Champaign
1. Study Identification
Unique Protocol Identification Number
NCT01948167
Brief Title
Bending Adolescent Depression Trajectories Through Personalized Prevention
Official Title
Bending Adolescent Depression Trajectories Through Personalized Prevention
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
August 2019 (Actual)
Study Completion Date
August 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia
Collaborators
National Institute of Mental Health (NIMH), University of Denver, Rutgers University, University of Illinois at Urbana-Champaign
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Prevention, Adolescents
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
205 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interpersonal Psychotherapy- Adolescent Skills Training
Arm Type
Experimental
Arm Description
Interpersonal Psychotherapy- Adolescent Skills Training
Arm Title
Coping with Stress
Arm Type
Experimental
Arm Description
Coping with Stress
Intervention Type
Behavioral
Intervention Name(s)
Interpersonal Psychotherapy- Adolescent Skills Training
Other Intervention Name(s)
IPT-AST, Teen Talk
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Coping with Stress
Other Intervention Name(s)
CWS
Intervention 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.
Primary Outcome Measure Information:
Title
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)
Description
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
Time Frame
Post intervention (approximately 3 months post baseline)
Title
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)
Description
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
Time Frame
6-months post-intervention
Title
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)
Description
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
Time Frame
12-months post-intervention
Title
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)
Description
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
Time Frame
18-months post-intervention
Title
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)
Description
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
Time Frame
24-months post-intervention
Title
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)
Description
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
Time Frame
30-months post-intervention
Title
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)
Description
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
Time Frame
36-months post-intervention
Title
Children's Depression Inventory (CDI)
Description
Self-reported depression scores
Time Frame
Post intervention (approximately 3 months after baseline)
Title
Children's Depression Inventory (CDI)
Description
Self-reported depression scores
Time Frame
6-months post-intervention
Title
Children's Depression Inventory (CDI)
Description
Self-reported depression scores
Time Frame
12-months post-intervention
Title
Children's Depression Inventory (CDI)
Description
Self-reported depression scores
Time Frame
18-months post-intervention
Title
Children's Depression Inventory (CDI)
Description
Self-reported depression scores
Time Frame
24-months post-intervention
Title
Children's Depression Inventory (CDI)
Description
Self-reported depression scores
Time Frame
30-months post-intervention
Title
Children's Depression Inventory (CDI)
Description
Self-reported depression scores
Time Frame
36-months post-intervention
Secondary Outcome Measure Information:
Title
Children's Global Assessment Scale (CGAS)
Description
Assesses global functioning
Time Frame
Post Intervention (approximately 3 months following baseline)
Title
Children's Global Assessment Scale (CGAS)
Description
Assesses global functioning
Time Frame
6-months followup
Title
Children's Global Assessment Scale (CGAS)
Description
Assesses global functioning
Time Frame
12-months followup
Title
Children's Global Assessment Scale (CGAS)
Description
Assesses global functioning
Time Frame
18-months followup
Title
Children's Global Assessment Scale (CGAS)
Description
Assesses global functioning
Time Frame
24-months followup
Title
Children's Global Assessment Scale (CGAS)
Description
Assesses global functioning
Time Frame
30-months followup
Title
Children's Global Assessment Scale (CGAS)
Description
Assesses global functioning
Time Frame
36-months followup
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jami F Young, Ph.D.
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80208
Country
United States
Facility Name
University of Illinois Urbana Champaign
City
Champaign
State/Province
Illinois
ZIP/Postal Code
61820
Country
United States
Facility Name
Rutgers University
City
Piscataway
State/Province
New Jersey
ZIP/Postal Code
08854
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19146
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33189876
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.
Results Reference
derived
Learn more about this trial
Bending Adolescent Depression Trajectories Through Personalized Prevention
We'll reach out to this number within 24 hrs