Pennsylvania Adolescent Intervention Research Study (PAIRStudy)

NCT00329199 | Terminated Phase 2

• 1 other identifier: SAP#4100027295
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 3

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.

Conditions

Depression

Keywords

Depression; Adolescents; Family Therapy; Primary Care; Family Conflict

Outcome Measures

Primary Outcomes (1)

• Reduction in depression as measured by the Hamilton Depression Rating Scale-17.

Secondary Outcomes (1)

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

Interventions

Attachment-Based Family Therapy BEHAVIORAL

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Pennsylvania Department of Health: lead
• Children's Hospital of Philadelphia: collaborator
• University of Pittsburgh: collaborator
• Lehigh Valley Hospital: collaborator

Study Sites (3)

Lehigh Valley Hospital

Allentown, Pennsylvania, 18104, United States

Location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19146, United States

Location

The Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Suzanne A Levy, Ph.D.

  Children's Hospital of Philadelphia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: May 22, 2006
• First Posted: May 24, 2006
• Study Start: December 1, 2006
• Study Completion: May 1, 2007
• Last Updated: August 20, 2007

Record last verified: 2007-08

Locations

US (3)