NCT00258752

Brief Summary

This study will compare Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST), IPT-AST plus parent involvement (Enhanced IPT-AST), and Usual Care for the prevention of adolescent depression.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Nov 2005

Longer than P75 for not_applicable depression

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

November 23, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 28, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

2.2 years

First QC Date

November 23, 2005

Last Update Submit

October 5, 2020

Conditions

Depression

Keywords

PreventionAdolescent

Outcome Measures

Primary Outcomes (3)

  • Score on the Center for Epidemiologic Studies Depression Scale

    Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups

  • Rating on Children's Global Assessment Scale

    Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups

  • Depression diagnoses on the Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) diagnostic instrument

    Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups

Secondary Outcomes (3)

  • Score on the Conflict Behavior Questionnaire

    Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups

  • Score on the Social Adjustment Scale

    Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups

  • Score on the Perceived Social Support scale

    Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups

Study Arms (3)

1

EXPERIMENTAL

Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST)

Behavioral: IPT-AST

2

EXPERIMENTAL

Enhanced IPT-AST

Other: Enhanced IPT-AST

3

ACTIVE COMPARATOR

Typical school counseling

Other: School counseling

Interventions

IPT-ASTBEHAVIORAL

IPT-AST is a school based group treatment program that focuses on prevention, psychoeducation, and interpersonal skill building.

1
Enhanced IPT-ASTOTHER

Enhanced IPT-AST entails IPT-AST plus three parent-adolescent sessions.

2
School counselingOTHER

Usual care consists of standard treatments, including individual counseling with guidance counselor.

3

Eligibility Criteria

Age11 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Between grades 7 and 10 in school
  • Score of at least 16 on the Center for Epidemiologic Studies Short Depression Scale (CES-D)
  • Currently experiencing at least 2 symptoms on the K-SADS depression section, one of which is either depressed mood, irritability, or an inability to feel pleasure during normal activities
  • Score of at least 61 on the Children's Global Assessment Scale (CGAS), indicating mild to moderate impairment
  • English-speaking

You may not qualify if:

  • Score of 15 or less on the CES-D scale
  • Currently experiencing fewer than 2 depression symptoms on the K-SADS or 2 or more symptoms on the K-SADS with no report of depressed mood, irritability, or anhedonia
  • Attempted suicide or self-mutilation in the year prior to study entry
  • 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
  • Current major depressive disorder or dysthymia as determined by K-SADS
  • Current DSM-IV diagnosis of psychosis, substance abuse or dependence, bipolar disorder, obsessive compulsive disorder, post-traumatic stress disorder, panic disorder, or conduct disorder as determined by K-SADS
  • Score of 60 or less on the CGAS, indicating substantial functional impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rutgers University

Piscataway, New Jersey, 08554, United States

Location

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Jami F. Young, PhD

    Rutgers University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2005

First Posted

November 28, 2005

Study Start

November 1, 2005

Primary Completion

January 1, 2008

Study Completion

June 1, 2009

Last Updated

October 8, 2020

Record last verified: 2020-10

Locations

US(2)