- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00619411
Interpersonal Psychotherapy for Depressed Adolescents and Parents
An Open Clinical Trial of Interpersonal Psychotherapy for Depressed Adolescence and Parents
Study Overview
Status
Conditions
Intervention / 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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: I
|
15 weekly psychotherapy sessions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
baseline, week 5, 10, 15
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
baseline, week 5, 10, 15
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Meredith Gunlicks-Stoessel, Ph.D., University of Minnesota
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5549
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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