Pennsylvania Adolescent Intervention Research Study (PAIRStudy)

NCT00329199 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2007-08-20

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Attachment-Based Family Therapy

Sponsors & Collaborators

  • Children's Hospital of Philadelphia

    collaborator OTHER
  • University of Pittsburgh

    collaborator OTHER
  • Lehigh Valley Hospital

    collaborator OTHER
  • Pennsylvania Department of Health

    lead OTHER_GOV

Principal Investigators

  • Guy S Diamond, Ph.D. · The Children's Hospital of Philadelphia/ University of Pennsylvania

  • Donald Schwarz, M.D. · Children's Hospital of Philadelphia

  • Suzanne A Levy, Ph.D. · Children's Hospital of Philadelphia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
12 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-12-31
Completion
2007-05-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00329199 on ClinicalTrials.gov