Pennsylvania Adolescent Intervention Research Study (PAIRStudy)
|ClinicalTrials.gov Identifier: NCT00329199|
Recruitment Status : Terminated (Trial was rewritten and will no longer focus on the link between smoking and depression.)
First Posted : May 24, 2006
Last Update Posted : August 20, 2007
|Condition or disease||Intervention/treatment||Phase|
|Depression||Behavioral: Attachment-Based Family Therapy||Phase 2|
The TRIAD project aims to address the persistent and acute problem of depression in a population largely made up of low-income disadvantaged youth. There are numerous treatment studies available for depression, but few exist studying the treatment of depression via the reduction of family conflict. Through this clinical trial, we aim to investigate the efficacy of a treatment for depression for adolescents largely recruited through primary care. The primary aim of this study is to test whether Attachment-Based Family Therapy reduces depression more effectively than enhanced usual care for depression. Attachment-Based Family Therapy (ABFT) is a manualized therapy designed exclusively for anxious and depressed adolescents. Secondly, we intend to examine how reduction in family conflict mediates the effect of ABFT on depression. We will, furthermore, examine whether reduction in depression or reduction in family conflict, regardless of treatment type reduces the likelihood of smoking initiation at one year.
These aims will be accomplished through a randomized clinical trial of 240 adolescents who meet criteria for a DSM-IV depressive disorder (Major Depressive Disorder, Dysthymia, or Depression NOS). Participants will be randomized into one of two treatment conditions. The two treatment conditions are as follows: Attachment-based Family Therapy for depression or Enhanced Usual Care for Depression. Treatment for Attachment-Based Family Therapy includes anywhere from 6-12 sessions. Some of the 6-12 sessions will include the patient and or the parent meeting alone with the therapists, others will include the family meeting together for family therapy sessions. The Enhanced Usual Care condition will include referrals to outside counseling or therapy, and the number of sessions will vary by patient and practitioner desire. In addition to their treatment sessions, patients and their parents will be required to complete intake, 6-week, 12-week, 26-week, and 52-week assessments. These assessments will include a large battery of self-report measures covering numerous topics around family conflict, risk-taking behavior (including smoking) and depression. The intake, 12, 26 and 52 week assessments will include a diagnostic interview. Additionally, bi-weekly for 12 weeks, adolescent's will be asked to complete a brief set of questionnaires that will help monitor their progress and safety.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Factorial Assignment|
|Official Title:||TRIAD Project: Pennsylvania Adolescent Intervention Research Study (PAIRStudy; Project 3a)|
|Study Start Date :||December 2006|
|Actual Study Completion Date :||May 2007|
- Reduction in depression as measured by the Hamilton Depression Rating Scale-17.
- Smoking initiation or cessation at week 52, as measured by the Timeline Follow-Back.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00329199
|United States, Pennsylvania|
|Lehigh Valley Hospital|
|Allentown, Pennsylvania, United States, 18104|
|The Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19146|
|The Children's Hospital of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Guy S Diamond, Ph.D.||The Children's Hospital of Philadelphia/ University of Pennsylvania|
|Principal Investigator:||Donald Schwarz, M.D.||Children's Hospital of Philadelphia|
|Study Director:||Suzanne A Levy, Ph.D.||Children's Hospital of Philadelphia|