The Efficacy of Parent Involvement in the Treatment of Adolescent Depression
Primary Purpose
Major Depressive Disorder, Dysthymic Disorder, Depressive Disorder NOS
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Interpersonal Psychotherapy for Depressed Adolescents
Interpersonal Psychotherapy for Depressed Adolescents and Parents
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder
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
Sites / Locations
- New York State Psychiatric Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
IPT-A
IPT-AP
Arm Description
Outcomes
Primary Outcome Measures
Children's Depression Rating Scale
Secondary Outcome Measures
Full Information
NCT ID
NCT00883519
First Posted
April 16, 2009
Last Updated
April 12, 2012
Sponsor
New York State Psychiatric Institute
Collaborators
Columbia University
1. Study Identification
Unique Protocol Identification Number
NCT00883519
Brief Title
The Efficacy of Parent Involvement in the Treatment of Adolescent Depression
Official Title
The Efficacy of Parent Involvement in the Treatment of Adolescent Depression
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
Columbia University
4. Oversight
Data Monitoring Committee
No
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Dysthymic Disorder, Depressive Disorder NOS, Adjustment Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IPT-A
Arm Type
Active Comparator
Arm Title
IPT-AP
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Interpersonal Psychotherapy for Depressed Adolescents
Intervention Description
12 psychotherapy sessions delivered over 16 weeks
Intervention Type
Behavioral
Intervention Name(s)
Interpersonal Psychotherapy for Depressed Adolescents and Parents
Intervention Description
12 psychotherapy sessions delivered over 16 weeks
Primary Outcome Measure Information:
Title
Children's Depression Rating Scale
Time Frame
baseline, week 4, 8, 12, 16, 32
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Efficacy of Parent Involvement in the Treatment of Adolescent Depression
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