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

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IPT-AST
Enhanced IPT-AST
School counseling
Sponsored by
Children's Hospital of Philadelphia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression focused on measuring Prevention, Adolescent

Eligibility Criteria

11 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rutgers University
  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

1

2

3

Arm Description

Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST)

Enhanced IPT-AST

Typical school counseling

Outcomes

Primary Outcome Measures

Score on the Center for Epidemiologic Studies Depression Scale
Rating on Children's Global Assessment Scale
Depression diagnoses on the Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) diagnostic instrument

Secondary Outcome Measures

Score on the Conflict Behavior Questionnaire
Score on the Social Adjustment Scale
Score on the Perceived Social Support scale

Full Information

First Posted
November 23, 2005
Last Updated
October 5, 2020
Sponsor
Children's Hospital of Philadelphia
Collaborators
National Institute of Mental Health (NIMH), Rutgers University
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1. Study Identification

Unique Protocol Identification Number
NCT00258752
Brief Title
Comparison of Three Therapy-Based Interventions for Preventing Depression in Adolescents
Official Title
Prevention of Depression in Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia
Collaborators
National Institute of Mental Health (NIMH), Rutgers University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Prevention, Adolescent

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST)
Arm Title
2
Arm Type
Experimental
Arm Description
Enhanced IPT-AST
Arm Title
3
Arm Type
Active Comparator
Arm Description
Typical school counseling
Intervention Type
Behavioral
Intervention Name(s)
IPT-AST
Intervention Description
IPT-AST is a school based group treatment program that focuses on prevention, psychoeducation, and interpersonal skill building.
Intervention Type
Other
Intervention Name(s)
Enhanced IPT-AST
Intervention Description
Enhanced IPT-AST entails IPT-AST plus three parent-adolescent sessions.
Intervention Type
Other
Intervention Name(s)
School counseling
Intervention Description
Usual care consists of standard treatments, including individual counseling with guidance counselor.
Primary Outcome Measure Information:
Title
Score on the Center for Epidemiologic Studies Depression Scale
Time Frame
Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups
Title
Rating on Children's Global Assessment Scale
Time Frame
Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups
Title
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
Secondary Outcome Measure Information:
Title
Score on the Conflict Behavior Questionnaire
Time Frame
Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups
Title
Score on the Social Adjustment Scale
Time Frame
Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups
Title
Score on the Perceived Social Support scale
Time Frame
Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jami F. Young, PhD
Organizational Affiliation
Rutgers University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers University
City
Piscataway
State/Province
New Jersey
ZIP/Postal Code
08554
Country
United States
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

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

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