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

Not Applicable

Completed

• Conditions: Depression
• Interventions: Behavioral: IPT-AST; Other: Enhanced IPT-AST; Other: School counseling

• Registration Number: NCT00258752
• Lead Sponsor: Children's Hospital of Philadelphia

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.

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2005-11-23
• Study First Submitted QC: 2005-11-23
• Study First Posted: 2005-11-28
• Primary Completion: 2008-01
• Study Completion: 2009-06
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-05
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	IPT-AST	Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST)
2	Enhanced IPT-AST	Enhanced IPT-AST
3	School counseling	Typical school counseling

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

New York State Psychiatric Institute; 🇺🇸 New York, New York, United States

Rutgers University; 🇺🇸 Piscataway, New Jersey, United States