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

NCT ID: NCT00258752

Last Updated: 2020-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2009-06-30

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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

1

Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST)

Group Type: EXPERIMENTAL

IPT-AST

Intervention Type: BEHAVIORAL

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

2

Enhanced IPT-AST

Group Type: EXPERIMENTAL

Enhanced IPT-AST

Intervention Type: OTHER

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

3

Typical school counseling

Group Type: ACTIVE_COMPARATOR

School counseling

Intervention Type: OTHER

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

Interventions

IPT-AST

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

Intervention Type: BEHAVIORAL

Enhanced IPT-AST

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

Intervention Type: OTHER

School counseling

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Rutgers University

OTHER

Sponsor Role: collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jami F. Young, PhD

Role: PRINCIPAL_INVESTIGATOR

Rutgers University

Locations

Rutgers University

Piscataway, New Jersey, United States

New York State Psychiatric Institute

New York, New York, United States

Countries

United States

Other Identifiers

K23MH071320

Identifier Type: NIH

Identifier Source: secondary_id

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DSIR 8K-RTCT

Identifier Type: -

Identifier Source: secondary_id

K23MH071320

Identifier Type: NIH

Identifier Source: org_study_id

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