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Pennsylvania Adolescent Intervention Research Study (PAIRStudy)

Primary Purpose

Depression

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Attachment-Based Family Therapy
Sponsored by
Pennsylvania Department of Health
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, Adolescents, Family Therapy, Primary Care, Family Conflict

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Lehigh Valley Hospital
  • The Children's Hospital of Philadelphia
  • The Children's Hospital of Pittsburgh

Outcomes

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.

Full Information

First Posted
May 22, 2006
Last Updated
August 16, 2007
Sponsor
Pennsylvania Department of Health
Collaborators
Children's Hospital of Philadelphia, University of Pittsburgh, Lehigh Valley Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00329199
Brief Title
Pennsylvania Adolescent Intervention Research Study (PAIRStudy)
Official Title
TRIAD Project: Pennsylvania Adolescent Intervention Research Study (PAIRStudy; Project 3a)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2007
Overall Recruitment Status
Terminated
Why Stopped
Trial was rewritten and will no longer focus on the link between smoking and depression.
Study Start Date
December 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pennsylvania Department of Health
Collaborators
Children's Hospital of Philadelphia, University of Pittsburgh, Lehigh Valley Hospital

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Adolescents, Family Therapy, Primary Care, Family Conflict

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
Single
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Attachment-Based Family Therapy
Primary Outcome Measure Information:
Title
Reduction in depression as measured by the Hamilton Depression Rating Scale-17.
Secondary Outcome Measure Information:
Title
Smoking initiation or cessation at week 52, as measured by the Timeline Follow-Back.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guy S Diamond, Ph.D.
Organizational Affiliation
The Children's Hospital of Philadelphia/ University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Donald Schwarz, M.D.
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Suzanne A Levy, Ph.D.
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Study Director
Facility Information:
Facility Name
Lehigh Valley Hospital
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
The Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19146
Country
United States
Facility Name
The Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

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Pennsylvania Adolescent Intervention Research Study (PAIRStudy)

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