Interpersonal Psychotherapy for Depressed Adolescents and Parents
Primary Purpose
Major Depression, Dysthymic Disorder, Adjustment Disorders
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Interpersonal Therapy for Depressed Adolescents & Parents
Sponsored by
About this trial
This is an interventional treatment trial for Major Depression focused on measuring Major Depression, Dysthymic Disorder, Adjustment Disorder, With Depressed Mood, Depressive, Disorder Not, Otherwise, Specified, Adolescent, Psychotherapy
Eligibility Criteria
Inclusion Criteria:
- Meets diagnostic criteria for major depression, dysthymic disorder, depressive disorder not otherwise specified, or adjustment disorder with depressed mood
- Score between 10 and 28 on the HRSD
- Score of 65 or less on the C-GAS
- English-speaking adolescent
- Parental or legal guardian consent to participate
Exclusion Criteria:
- Actively suicidal
- Score greater than 28 on the HRSD
- Mentally retarded
- Meets diagnostic criteria for current substance abuse, schizophrenia, bipolar disorder, psychosis, conduct disorder, or eating disorder
- Currently in active treatment for depression
- Taking antidepressant medication at the time of baseline assessment
- Medical illness likely to complicate or interfere with treatment
- Victim of ongoing or previously undisclosed child abuse
- Parent psychiatrically hospitalized within the past 3 months
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
I
Arm Description
Outcomes
Primary Outcome Measures
Clinical Global Improvement (CGI), Hamilton Rating Scale for Depression (HRSD), Center for Epidemiological Studies - Depression Scale (CES-D)
Secondary Outcome Measures
Global Assessment Scale for Children (C-GAS), Social Adjustment Scale - Self-report (SAS-SR), Conflict Behavior Questionnaire (CBQ-20), Observational assessment of parent-adolescent communication
Full Information
NCT ID
NCT00619411
First Posted
February 11, 2008
Last Updated
March 8, 2012
Sponsor
New York State Psychiatric Institute
Collaborators
Columbia University
1. Study Identification
Unique Protocol Identification Number
NCT00619411
Brief Title
Interpersonal Psychotherapy for Depressed Adolescents and Parents
Official Title
An Open Clinical Trial of Interpersonal Psychotherapy for Depressed Adolescence and Parents
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (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
Yes
5. Study Description
Brief Summary
The purpose of this study is to examine the feasibility and acceptability of an adaptation of Interpersonal Psychotherapy for Depressed Adolescents (IPT-A) that includes greater and more structured involvement of the parents in the treatment.
Detailed Description
Adolescent depression is a significant public health problem, and it increases the risk of poor psychosocial outcomes in adolescence and adulthood. Interpersonal Psychotherapy for Depressed Adolescents (IPT-A) has been found to be an effective treatment for reducing adolescents' depressive symptoms and improving their global and social functioning. The purpose of the current study is to examine the feasibility and acceptability of IPT-A when it is delivered with greater and more structured involvement of the parents in the treatment.
Participants will receive 15 weeks of Interpersonal Psychotherapy for Depressed Adolescents and Parents (IPT-AP). Eight the therapy sessions are conducted with the adolescent individually, two are with the parent(s) individually, and five are conducted with the adolescent and parent(s) together. At the end of the 15 weeks, participants who have demonstrated at least a 50% reduction in depressive symptoms will participate in three booster sessions delivered on a monthly basis. All participants will be assessed at baseline, week 5, week 10, week 15 (post-treatment), and 3 months post-treatment to measure depressive symptoms, global and social functioning, and attitudes toward treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression, Dysthymic Disorder, Adjustment Disorders, Depressive Disorder Not Otherwise Specified
Keywords
Major Depression, Dysthymic Disorder, Adjustment Disorder, With Depressed Mood, Depressive, Disorder Not, Otherwise, Specified, Adolescent, Psychotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
I
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Interpersonal Therapy for Depressed Adolescents & Parents
Intervention Description
15 weekly psychotherapy sessions
Primary Outcome Measure Information:
Title
Clinical Global Improvement (CGI), Hamilton Rating Scale for Depression (HRSD), Center for Epidemiological Studies - Depression Scale (CES-D)
Time Frame
baseline, week 5, 10, 15
Secondary Outcome Measure Information:
Title
Global Assessment Scale for Children (C-GAS), Social Adjustment Scale - Self-report (SAS-SR), Conflict Behavior Questionnaire (CBQ-20), Observational assessment of parent-adolescent communication
Time Frame
baseline, week 5, 10, 15
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Meets diagnostic criteria for major depression, dysthymic disorder, depressive disorder not otherwise specified, or adjustment disorder with depressed mood
Score between 10 and 28 on the HRSD
Score of 65 or less on the C-GAS
English-speaking adolescent
Parental or legal guardian consent to participate
Exclusion Criteria:
Actively suicidal
Score greater than 28 on the HRSD
Mentally retarded
Meets diagnostic criteria for current substance abuse, schizophrenia, bipolar disorder, psychosis, conduct disorder, or eating disorder
Currently in active treatment for depression
Taking antidepressant medication at the time of baseline assessment
Medical illness likely to complicate or interfere with treatment
Victim of ongoing or previously undisclosed child abuse
Parent psychiatrically hospitalized within the past 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meredith Gunlicks-Stoessel, Ph.D.
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Interpersonal Psychotherapy for Depressed Adolescents and Parents
We'll reach out to this number within 24 hrs