The Efficacy of Parent Involvement in the Treatment of Adolescent Depression

• Sponsor: New York State Psychiatric Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT00883519
• Collaborator: Columbia University (Other)
• Enrollment: 15
• Location: 1
• Arms: 2
• Duration (Months): 23
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder; Dysthymic Disorder; Depressive Disorder NOS; Adjustment Disorder	Behavioral: Interpersonal Psychotherapy for Depressed Adolescents; Behavioral: Interpersonal Psychotherapy for Depressed Adolescents and Parents	Phase 1/Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Efficacy of Parent Involvement in the Treatment of Adolescent Depression
• Study Start Date: Jan 1, 2009
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: IPT-A	Behavioral: Interpersonal Psychotherapy for Depressed Adolescents; 12 psychotherapy sessions delivered over 16 weeks
Active Comparator: IPT-AP	Behavioral: Interpersonal Psychotherapy for Depressed Adolescents; 12 psychotherapy sessions delivered over 16 weeks; Behavioral: Interpersonal Psychotherapy for Depressed Adolescents and Parents; 12 psychotherapy sessions delivered over 16 weeks

Outcome Measures

Primary Outcome Measures

1. Children's Depression Rating Scale [baseline, week 4, 8, 12, 16, 32]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York State Psychiatric Institute	New York	New York	United States	10032

Sponsors and Collaborators

• New York State Psychiatric Institute
• Columbia University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: New York State Psychiatric Institute
• ClinicalTrials.gov Identifier: NCT00883519
• Other Study ID Numbers: 5758
• First Posted: Apr 17, 2009
• Last Update Posted: Apr 13, 2012
• Last Verified: Apr 1, 2012

• Additional relevant MeSH terms: Disease; Depression; Depressive Disorder; Depressive Disorder, Major; Adjustment Disorders; Dysthymic Disorder

Study Results

No Results Posted as of Apr 13, 2012