Clinical trial NCT01201382: Depression Prevention Initiative - A Study of Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST) in School Settings
Official title: Depression Prevention Initiative - A Study of IPT-AST in School Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Depression
Prevention
Adolescents
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Rutgers University
First posted: 2010-09-14
Enrollment: 185
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: Post intervention (approximately 3 months post baseline)
measure: Presence of a Major Depressive Episode, Dysthymia or Depressive Disorder NOS on the K-SADS-PL
timeFrame: 6-months post-intervention
measure: Presence of a Major Depressive Episode, Dysthymia or Depressive Disorder NOS on the K-SADS-PL
timeFrame: 12-months post-intervention
measure: Presence of a Major Depressive Episode, Dysthymia or Depressive Disorder NOS on the K-SADS-PL
timeFrame: 18-months post-intervention
measure: Presence of a Major Depressive Episode, Dysthymia or Depressive Disorder NOS on the K-SADS-PL
timeFrame: 24-months post-intervention
Secondary outcomes:
measure: Children's Depression Rating Scale-Revised (CDRS-R)
timeFrame: Post intervention (approximately 3 months after baseline)
measure: Children's Depression Rating Scale-Revised
timeFrame: 6-months post-intervention
measure: Children's Depression Rating Scale-Revised
timeFrame: 12-months post-intervention
measure: Children's Depression Rating Scale-Revised
timeFrame: 18-months post-intervention
measure: Children's Depression Rating Scale-Revised
timeFrame: 24 months post-intervention
measure: Children's Global Assessment Scale (CGAS)
timeFrame: Post intervention (approximately 3 months following baseline)
measure: Children's Global Assessment Scale
timeFrame: 6-months post-intervention
measure: Children's Global Assessment Scale
timeFrame: 12-months post-intervention
measure: Children's Global Assessment Scale
timeFrame: 18-months post-intervention
measure: Children's Global Assessment Scale
timeFrame: 24-months post-intervention
Other outcomes:
Locations:
city: Piscataway
country: United States
facility: Rutgers University
state: New Jersey
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Jami F Young, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: