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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00680381
Other study ID # DA15762
Secondary ID R01DA015762
Status Completed
Phase Phase 1
First received May 16, 2008
Last updated August 4, 2014
Start date January 2004
Est. completion date July 2014

Study information

Verified date August 2014
Source Oregon Research Institute
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to test different treatments to reduce relapse for drug-abusing adolescents who have completed family therapy. Adolescents receive 12 weeks of family therapy, designed to strengthen family relationships and develop skills for helping the adolescent avoid drug use. Then they are randomly assigned to receive one of three eight-week follow-up treatments: phone calls from a project therapist, group therapy, or a customized schedule of therapist visits with the adolescent, the adolescent's family and teachers, coaches, probation officers and others who can help the adolescent reach or maintain abstinence. Families are assessed using questionnaires and interviews before, during and after treatment, to provide information about family functioning, the adolescent's drug use, the adolescent's peers and other factors that may contribute to treatment success or failure. Adolescents also provide urine specimens for drug screening at assessment visits. Study investigators expect the study will show that a functional family environment and insulating adolescents from the influence of peers who use drugs will help prevent relapse for adolescents who have received family therapy.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date July 2014
Est. primary completion date July 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 13 Years to 18 Years
Eligibility Inclusion Criteria:

1. At least one parent, step-parent, or surrogate parent willing to participate in the study

2. 13 to 18 years if age

3. meets DSM-IV (APA, 1994) diagnostic criteria for substance abuse or dependence

4. Lives in the Albuquerque metropolitan area or surrounding communities with a parent, step-parent, or surrogate parent; AND

5. Sufficient residential stability to permit probable contact at follow-up (e.g., not homeless at time of intake).

Exclusion Criteria:

1. Evidence of psychotic or organic state of sufficient severity to interfere with understanding of study instruments and procedures

2. Adolescent deemed dangerous to self or others during evaluation

3. Services other than outpatient treatment required for the adolescent (e.g., inpatient, detoxification)

4. Adolescent already has participated in treatment project at CFAR; AND

5. A sibling is already participating in project.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
MTI, Minimal Transitional Intervention
Following 12 weeks of Functional Family Therapy (FFT), semi-weekly phone calls from a therapist for eight weeks.
GTI, Group Transitional Intervention
Following 12 weeks of FFT, weekly one-hour sessions of group therapy for eight weeks.
STI, Systems Transitions Intervention
Following 12 weeks of FFT, an individualized eight-week series of therapist meetings with the adolescent, family, police, teachers, coaches and others who can support the adolescent's reduced drug use.

Locations

Country Name City State
United States Oregon Res. Inst. Center for Family & Adolescent Research (CFAR) Albuquerque New Mexico

Sponsors (1)

Lead Sponsor Collaborator
Oregon Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Drug use levels for adolescents who have received family therapy and one of the three aftercare regimens pretx and 6 wks, 4 , 7 and 12 mos. post initial therapy session No
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