The Efficacy of Parent Involvement in the Treatment of Adolescent Depression

NCT ID: NCT00883519

Last Updated: 2012-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2010-12-31

Brief Summary

The primary aim of this study is to examine whether adolescent depression and the family context in which it develops is best treated using an individual adolescent intervention or an intervention that includes both the adolescent and the parents. This will be accomplished by conducting a randomized controlled pilot study of Interpersonal Psychotherapy for Depressed Adolescents (IPT-A) in comparison to Interpersonal Psychotherapy for Depressed Adolescents and Parents (IPT-AP).

Detailed Description

The primary aim of this project is to examine whether adolescent depression and the family context within which it develops is best treated using an individual adolescent intervention or an intervention that includes both the adolescent and the parents. This will be accomplished by conducting a randomized controlled pilot study of Interpersonal Psychotherapy for Depressed Adolescents (IPT-A) in comparison to Interpersonal Psychotherapy for Depressed Adolescents and Parents (IPT-AP). Twenty-two families with adolescents (ages 12-17) who meet criteria for major depressive disorder, dysthymic disorder, depressive disorder NOS, or adjustment disorder with depressed mood and also report elevated levels of parent-adolescent relationship problems will be randomized to receive IPT-A or IPT-AP. Assessments will be administered at screening, baseline, week 4, week 8, week 12, week 16 (post-treatment), and 4 months post-treatment. Outcome measures will include depression symptoms, quality of parent-adolescent relationships, parents' and adolescents' communication skills (assessed through observational coding of a parent-adolescent conflict negotiation task), and adolescents' physiological stress responses to negotiating conflict with a parent (assessed through collection of salivary cortisol). Identifying the best approach to treating both the adolescent's depression and the family environment in which it develops and is maintained would have significant implications for the long-term outcomes of depressed adolescents and their families.

Conditions

Major Depressive Disorder; Dysthymic Disorder; Depressive Disorder NOS; Adjustment Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IPT-A

Group Type: ACTIVE_COMPARATOR

Interpersonal Psychotherapy for Depressed Adolescents

Intervention Type: BEHAVIORAL

12 psychotherapy sessions delivered over 16 weeks

IPT-AP

Group Type: ACTIVE_COMPARATOR

Interpersonal Psychotherapy for Depressed Adolescents

Intervention Type: BEHAVIORAL

12 psychotherapy sessions delivered over 16 weeks

Interpersonal Psychotherapy for Depressed Adolescents and Parents

Intervention Type: BEHAVIORAL

12 psychotherapy sessions delivered over 16 weeks

Interventions

Interpersonal Psychotherapy for Depressed Adolescents

12 psychotherapy sessions delivered over 16 weeks

Intervention Type: BEHAVIORAL

Interpersonal Psychotherapy for Depressed Adolescents and Parents

12 psychotherapy sessions delivered over 16 weeks

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Ages 12-17
• English speaking adolescent and parent
• One parent/primary caregiver willing to participate in adolescent's treatment
• Meets diagnostic criteria for Major Depressive Disorder, Dysthymic Disorder, Depressive Disorder NOS, or Adjustment Disorder with Depressed Mood
• BDI-II > 14
• CDRS-R > 36
• CGAS > 65
• CBQ T score >65

Exclusion Criteria

• Severe episode of Major Depressive Disorder (CDRS-R > 85 and/or PI clinical assessment)
• Current significant risk for suicide (active suicidal ideation with plan; active suicidal ideation without a plan if unable to contract for safety
• Meets diagnostic criteria for substance abuse, schizophrenia, psychosis, bipolar disorder, conduct disorder, or eating disorder
• mental retardation
• medical illness likely to complicate or interfere with treatment
• currently in active treatment for depression
• currently taking medication for a psychiatric diagnosis other than ADHD or not on a stable dose of medication for ADHD (<3 months)
• Parent psychiatrically hospitalized within the past 3 months or parent psychopathology significantly severe to interfere with participation in their adolescent's treatment

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

New York State Psychiatric Institute

New York, New York, United States

Countries

United States

Other Identifiers

5758

Identifier Type: -

Identifier Source: org_study_id