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Completed

NCT Number: NCT00258752

Comparison of Three Therapy-Based Interventions for Preventing 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.

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Key information

Age range

11 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rutgers University, Piscataway, New Jersey, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IPT-AST

Behavioral

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

Enhanced IPT-AST

Other

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

School counseling

Other

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

Primary outcomes

  1. Score on the Center for Epidemiologic Studies Depression Scale

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

  2. Rating on Children's Global Assessment Scale

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

  3. 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 outcomes

  1. Score on the Conflict Behavior Questionnaire

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

  2. Score on the Social Adjustment Scale

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

  3. Score on the Perceived Social Support scale

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

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • Rutgers University

Registry information

Official study title

Prevention of Depression in Adolescents

Important dates

Study start
2005
Primary completion
2008
Study completion
2009
First posted
Nov 28, 2005
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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