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Pennsylvania Adolescent Intervention Research Study (PAIRStudy)

This study has been terminated.
(Trial was rewritten and will no longer focus on the link between smoking and depression.)
Sponsor:
Collaborators:
Children's Hospital of Philadelphia
Children's Hospital of Pittsburgh
Lehigh Valley Hospital
Information provided by:
Pennsylvania Department of Health
ClinicalTrials.gov Identifier:
NCT00329199
First received: May 22, 2006
Last updated: August 16, 2007
Last verified: August 2007
  Purpose

Through the TRIAD Project: Pennsylvania Adolescent Intervention Research Study (PAIRStudy; Project 3a) we aim to test the efficacy of a brief treatment aimed at treating depression and family conflict among a population of adolescents with depression, and thereby reducing the future chance of these adolescents initiating smoking. We will examine Attachment-Based Family Therapy (ABFT) for the treatment of depression in comparison with Enhanced Usual Care for Depression (EUCd). Reduction of depression will be measured by a clinically significant reduction of score on the Hamilton Rating Scale for Depression. Second, we will examine how reduction of family conflict mediates the effect of ABFT on depression. The third aim will be an exploratory look at the potential prevention of the onset of smoking. Specifically, we will examine if reduction of depression and/or reductions in family conflict regardless of treatment type reduces the initiation of smoking or reduces smoking behavior at 52 weeks. These aims will be accomplished by randomizing 240 adolescents to one of two treatment conditions: a) Attachment-Based Family Therapy or b) Enhanced Usual Care for Depression. Patients randomized to the ABFT condition will receive 6-12 weeks of family therapy. Patients enrolled in the EUCd condition will be referred for outpatient psychological services at an agency that fits their geographic and financial needs. Research staff will help patients navigate the referral process. All participating therapists will have carried out the full, manualized treatment with 2-3 pilot cases prior to treating any randomized cases.


Condition Intervention Phase
Depression
Behavioral: Attachment-Based Family Therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: TRIAD Project: Pennsylvania Adolescent Intervention Research Study (PAIRStudy; Project 3a)

Resource links provided by NLM:


Further study details as provided by Pennsylvania Department of Health:

Primary Outcome Measures:
  • Reduction in depression as measured by the Hamilton Depression Rating Scale-17.

Secondary Outcome Measures:
  • Smoking initiation or cessation at week 52, as measured by the Timeline Follow-Back.

Estimated Enrollment: 240
Study Start Date: December 2006
Study Completion Date: May 2007
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 12 to 17 years of age
  • HAM-D score of > 14
  • Meet diagnostic criteria for either Major Depressive Disorder, Dysthymia, or Depression NOS
  • Have a parent or guardian willing to participate

Exclusion Criteria:

  • Currently Suicidal
  • History of mental retardation or borderline intellectual functioning
  • Current psychosis
  • Primary caregiver unwilling to participate
  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: NCT00329199

Locations
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
Sponsors and Collaborators
Pennsylvania Department of Health
Children's Hospital of Philadelphia
Children's Hospital of Pittsburgh
Lehigh Valley Hospital
Investigators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00329199     History of Changes
Obsolete Identifiers: NCT00372554
Other Study ID Numbers: SAP#4100027295
Study First Received: May 22, 2006
Last Updated: August 16, 2007
Health Authority: United States: Federal Government

Keywords provided by Pennsylvania Department of Health:
Depression
Adolescents
Family Therapy
Primary Care
Family Conflict

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 19, 2014