The Efficacy of Parent Involvement in the Treatment of Adolescent Depression

Major Depressive Disorder Clinical Trial

Official title:

The Efficacy of Parent Involvement in the Treatment of Adolescent Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00883519
• Other study ID #: 5758
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 16, 2009
• Last updated: April 12, 2012
• Start date: January 2009
• Est. completion date: December 2010

Study information

• Verified date: April 2012
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adjustment Disorder
• Adjustment Disorders
• Depression
• Depressive Disorder
• Depressive Disorder NOS
• Depressive Disorder, Major
• Disease
• Dysthymic Disorder
• Major Depressive Disorder

Intervention

Behavioral:
• Interpersonal Psychotherapy for Depressed Adolescents
12 psychotherapy sessions delivered over 16 weeks
• Interpersonal Psychotherapy for Depressed Adolescents and Parents
12 psychotherapy sessions delivered over 16 weeks

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Children's Depression Rating Scale		baseline, week 4, 8, 12, 16, 32	No