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The Efficacy of Parent Involvement in the Treatment of Adolescent Depression

This study has been completed.
Sponsor:
Collaborator:
Columbia University
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00883519
First received: April 16, 2009
Last updated: April 12, 2012
Last verified: April 2012
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Efficacy of Parent Involvement in the Treatment of Adolescent Depression

Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Children's Depression Rating Scale [ Time Frame: baseline, week 4, 8, 12, 16, 32 ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: January 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00883519

Locations
United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Columbia University
  More Information

No publications provided

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00883519     History of Changes
Other Study ID Numbers: 5758
Study First Received: April 16, 2009
Last Updated: April 12, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Adjustment Disorders
Depression
Depressive Disorder
Depressive Disorder, Major
Disease
Dysthymic Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014