Bending Adolescent Depression Trajectories Through Personalized Prevention

Depression Clinical Trial

Official title:

Bending Adolescent Depression Trajectories Through Personalized Prevention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01948167
• Other study ID #: 17-013831
• Secondary ID: R01MH077178
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: August 2019

Study information

• Verified date: March 2021
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: August 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Illinois Urbana Champaign	Champaign	Illinois
United States	University of Denver	Denver	Colorado
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Rutgers University	Piscataway	New Jersey

Sponsors (5)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	National Institute of Mental Health (NIMH), Rutgers University, University of Denver, University of Illinois at Urbana-Champaign

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Post intervention (approximately 3 months post baseline)
Primary	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.	6-months post-intervention
Primary	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.	12-months post-intervention
Primary	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.	18-months post-intervention
Primary	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.	24-months post-intervention
Primary	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.	30-months post-intervention
Primary	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.	36-months post-intervention
Primary	Children's Depression Inventory (CDI)	Self-reported depression scores	Post intervention (approximately 3 months after baseline)
Primary	Children's Depression Inventory (CDI)	Self-reported depression scores	6-months post-intervention
Primary	Children's Depression Inventory (CDI)	Self-reported depression scores	12-months post-intervention
Primary	Children's Depression Inventory (CDI)	Self-reported depression scores	18-months post-intervention
Primary	Children's Depression Inventory (CDI)	Self-reported depression scores	24-months post-intervention
Primary	Children's Depression Inventory (CDI)	Self-reported depression scores	30-months post-intervention
Primary	Children's Depression Inventory (CDI)	Self-reported depression scores	36-months post-intervention
Secondary	Children's Global Assessment Scale (CGAS)	Assesses global functioning	Post Intervention (approximately 3 months following baseline)
Secondary	Children's Global Assessment Scale (CGAS)	Assesses global functioning	6-months followup
Secondary	Children's Global Assessment Scale (CGAS)	Assesses global functioning	12-months followup
Secondary	Children's Global Assessment Scale (CGAS)	Assesses global functioning	18-months followup
Secondary	Children's Global Assessment Scale (CGAS)	Assesses global functioning	24-months followup
Secondary	Children's Global Assessment Scale (CGAS)	Assesses global functioning	30-months followup
Secondary	Children's Global Assessment Scale (CGAS)	Assesses global functioning	36-months followup