Clinical trial NCT00258752: Comparison of Three Therapy-Based Interventions for Preventing Depression in Adolescents
Official title: Prevention of Depression in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Prevention
Adolescent
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Rutgers University
First posted: 2005-11-28
Enrollment: 57
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Score on the Center for Epidemiologic Studies Depression Scale
timeFrame: Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups
measure: Rating on Children's Global Assessment Scale
timeFrame: Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups
measure: Depression diagnoses on the Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) diagnostic instrument
timeFrame: Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups
Secondary outcomes:
measure: Score on the Conflict Behavior Questionnaire
timeFrame: Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups
measure: Score on the Social Adjustment Scale
timeFrame: Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups
measure: Score on the Perceived Social Support scale
timeFrame: Measured immediately post-treatment and at Months 6, 12, and 18 follow-ups
Other outcomes:
Locations:
city: Piscataway
country: United States
facility: Rutgers University
state: New Jersey
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: Rutgers University
name: Jami F. Young, PhD
role: PRINCIPAL_INVESTIGATOR
References: