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

Depression Clinical Trial

Official title:

Prevention of Depression in Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00258752
• Other study ID #: K23MH071320
• Secondary ID: K23MH071320DSIR
• Status: Completed
• Phase: N/A
• Start date: November 2005
• Est. completion date: June 2009

Study information

• Verified date: October 2020
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: June 2009
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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

Other:
• Enhanced IPT-AST
Enhanced IPT-AST entails IPT-AST plus three parent-adolescent sessions.
• School counseling
Usual care consists of standard treatments, including individual counseling with guidance counselor.

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York
United States	Rutgers University	Piscataway	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	National Institute of Mental Health (NIMH), Rutgers University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score on the Center for Epidemiologic Studies Depression Scale		Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups
Primary	Rating on Children's Global Assessment Scale		Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups
Primary	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	Score on the Conflict Behavior Questionnaire		Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups
Secondary	Score on the Social Adjustment Scale		Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups
Secondary	Score on the Perceived Social Support scale		Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups