Depression Prevention Initiative - A Study of Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST) in School Settings

Depression Clinical Trial

Official title:

Depression Prevention Initiative - A Study of IPT-AST in School Settings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01201382
• Other study ID #: MH087481
• Secondary ID: R01MH087481
• Status: Completed
• Phase: N/A
• Start date: October 2010
• Est. completion date: June 2017

Study information

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

Clinical Trial Summary

This study is a randomized controlled trial comparing Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST) to group counseling (GC) for the prevention of depression in adolescents. The project will: (1) identify adolescents with elevated depressive symptoms but who do not meet criteria for a current mood disorder diagnosis; (2) randomize eligible adolescents to either IPT-AST (N = 100) or GC (N = 100); (3) assess depressive symptoms, depressive disorders, global functioning, interpersonal functioning, comorbid conditions and school related indices at baseline, mid-intervention, post-intervention, and at 6-, 12-, 18-, and 24-month follow-up; (4) examine the effects of IPT-AST on depression and various domains of functioning at each time point; and (5) conduct analyses to examine potential mediators and moderators of the association between IPT-AST and depression outcomes. This study will yield data on the efficacy of IPT-AST relative to GC for the prevention of depressive symptoms and depressive disorders. It will also provide information about the mechanisms of action of IPT-AST and determine for whom IPT-AST is most effective.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: June 2017
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

Inclusion Criteria:

• In 7th-10th grades at intake

• Center for Epidemiologic Studies Depression Scale(CES-D) Score > 16

• At least 2 symptoms on the K-SADS depression section (score of 2 or 3), one of which is either depressed mood, irritability, or anhedonia

• Adolescent must be English-speaking

• Parent speaks English or Spanish

Exclusion Criteria:

• CES-D Score < 15

• Fewer than 2 depression symptoms on the K-SADS (score of 2 or 3) or 2 or more symptoms on the K-SADS with no report of depressed mood, irritability, or anhedonia

• Suicide attempt or self-mutilation in the past year, current active suicidal ideation, and/or history of a clinically significant suicidal behavior (i.e., with intent to die and high medical lethality) or repeated patterns of self-injurious behavior

• Presence of current Major Depressive Disorder, dysthymia, substance abuse, schizophrenia, bipolar disorder, conduct disorder, or psychosis

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• IPT-AST
A school-based group prevention program that includes 2 individual pre-group sessions, 8 weekly 90 minute group sessions, an individual mid-group session and 4 booster sessions
• Group Counseling
Usual group counseling as delivered by school counselors; 1 pre-group session, 1 mid-group session, 8 90-minute group sessions, 4 booster sessions

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Rutgers University	Piscataway	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	National Institute of Mental Health (NIMH), Rutgers University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of a Major Depressive Episode, Dysthymia or Depressive Disorder Not Otherwise Specified (NOS) 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, Dysthymia or Depressive Disorder NOS on the K-SADS-PL		6-months post-intervention
Primary	Presence of a Major Depressive Episode, Dysthymia or Depressive Disorder NOS on the K-SADS-PL		12-months post-intervention
Primary	Presence of a Major Depressive Episode, Dysthymia or Depressive Disorder NOS on the K-SADS-PL		18-months post-intervention
Primary	Presence of a Major Depressive Episode, Dysthymia or Depressive Disorder NOS on the K-SADS-PL		24-months post-intervention
Secondary	Children's Depression Rating Scale-Revised (CDRS-R)	Scores on the CDRS-R	Post intervention (approximately 3 months after baseline)
Secondary	Children's Depression Rating Scale-Revised		6-months post-intervention
Secondary	Children's Depression Rating Scale-Revised		12-months post-intervention
Secondary	Children's Depression Rating Scale-Revised		18-months post-intervention
Secondary	Children's Depression Rating Scale-Revised		24 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		6-months post-intervention
Secondary	Children's Global Assessment Scale		12-months post-intervention
Secondary	Children's Global Assessment Scale		18-months post-intervention
Secondary	Children's Global Assessment Scale		24-months post-intervention