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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jami Young, Rutgers University
ClinicalTrials.gov Identifier:
NCT00258752
First received: November 23, 2005
Last updated: April 11, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Depression
Behavioral: IPT-AST
Other: Enhanced IPT-AST
Other: School counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Depression in Adolescents

Resource links provided by NLM:


Further study details as provided by Rutgers University:

Primary Outcome Measures:
  • Score on the Center for Epidemiologic Studies Depression Scale [ Time Frame: Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups ] [ Designated as safety issue: No ]
  • Rating on Children's Global Assessment Scale [ Time Frame: Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Score on the Conflict Behavior Questionnaire [ Time Frame: Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups ] [ Designated as safety issue: No ]
  • Score on the Social Adjustment Scale [ Time Frame: Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups ] [ Designated as safety issue: No ]
  • Score on the Perceived Social Support scale [ Time Frame: Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups ] [ Designated as safety issue: No ]

Enrollment: 57
Study Start Date: November 2005
Study Completion Date: June 2009
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST)
Behavioral: 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
Other: Enhanced IPT-AST
Enhanced IPT-AST entails IPT-AST plus three parent-adolescent sessions.
Active Comparator: 3
Typical school counseling
Other: School counseling
Usual care consists of standard treatments, including individual counseling with guidance counselor.

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.

  Eligibility

Ages Eligible for Study:   11 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00258752

Locations
United States, New Jersey
Rutgers University
Piscataway, New Jersey, United States, 08554
United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
Rutgers University
Investigators
Principal Investigator: Jami F. Young, PhD Rutgers University
  More Information

No publications provided

Responsible Party: Jami Young, Assistant Professor, Rutgers University
ClinicalTrials.gov Identifier: NCT00258752     History of Changes
Other Study ID Numbers: K23 MH71320, K23MH071320, DSIR 8K-RTCT
Study First Received: November 23, 2005
Last Updated: April 11, 2013
Health Authority: United States: Federal Government

Keywords provided by Rutgers University:
Prevention
Adolescent

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 22, 2014