Comparison of Three Therapy-Based Interventions for Preventing Depression in Adolescents

October 5, 2020 updated by: Children's Hospital of Philadelphia

Prevention of Depression in Adolescents

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.

Study Overview

Detailed Description

Depression is a serious medical illness that is difficult to diagnose and treat, especially in children and adolescents. Signs of depression in children may include the following behaviors: pretending to be sick; refusing to go to school; clinging to a parent; or worrying that a parent may die. Older children may sulk, behave inappropriately at school, act in a negative or grouchy manner, or feel misunderstood. Because normal behaviors vary from one childhood stage to another, it can be difficult to determine whether a child is going through a temporary "phase" or is suffering from depression. This study will compare IPT-AST, Enhanced IPT-AST, and Usual Care for the prevention of adolescent depression.

Participation in this single-blind study will last approximately 21 months. Participants will be randomly assigned to receive either IPT-AST, Enhanced IPT-AST, or Usual Care for 12 weeks. IPT-AST is a school-based group intervention program that focuses on prevention, psychoeducation, and interpersonal skill-building. Enhanced IPT-AST will entail IPT-AST plus three parent-adolescent sessions. Usual Care will consist of standard treatments and will not include IPT-AST. Study visits will occur before and during the intervention at baseline and Weeks 6 and 12. Follow-up visits will occur 6, 12, and 18 months post-intervention. Study visit assessments will include depression symptoms, anxiety symptoms, psychiatric diagnoses, overall functioning, social adjustment, parent-child conflict, perceived support from parents and peers, and service utilization.

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New Jersey
      • Piscataway, New Jersey, United States, 08554
        • Rutgers University
    • New York
      • New York, New York, United States, 10032
        • New York State Psychiatric Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST)
IPT-AST is a school based group treatment program that focuses on prevention, psychoeducation, and interpersonal skill building.
Experimental: 2
Enhanced IPT-AST
Enhanced IPT-AST entails IPT-AST plus three parent-adolescent sessions.
Active Comparator: 3
Typical school counseling
Usual care consists of standard treatments, including individual counseling with guidance counselor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Score on the Center for Epidemiologic Studies Depression Scale
Time Frame: Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups
Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups
Rating on Children's Global Assessment Scale
Time Frame: Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups
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
Time Frame: Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups
Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups

Secondary Outcome Measures

Outcome Measure
Time Frame
Score on the Conflict Behavior Questionnaire
Time Frame: Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups
Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups
Score on the Social Adjustment Scale
Time Frame: Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups
Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups
Score on the Perceived Social Support scale
Time Frame: Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups
Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jami F. Young, PhD, Rutgers University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

November 23, 2005

First Submitted That Met QC Criteria

November 23, 2005

First Posted (Estimate)

November 28, 2005

Study Record Updates

Last Update Posted (Actual)

October 8, 2020

Last Update Submitted That Met QC Criteria

October 5, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • K23MH071320 (U.S. NIH Grant/Contract)
  • DSIR 8K-RTCT (NIMH DSIR)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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