- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00680381
Transitional Treatment of Adolescents in Family Therapy (Transitions)
August 4, 2014 updated by: Oregon Research Institute
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87102
- Oregon Res. Inst. Center for Family & Adolescent Research (CFAR)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- At least one parent, step-parent, or surrogate parent willing to participate in the study
- 13 to 18 years if age
- meets DSM-IV (APA, 1994) diagnostic criteria for substance abuse or dependence
- Lives in the Albuquerque metropolitan area or surrounding communities with a parent, step-parent, or surrogate parent; AND
- Sufficient residential stability to permit probable contact at follow-up (e.g., not homeless at time of intake).
Exclusion Criteria:
- Evidence of psychotic or organic state of sufficient severity to interfere with understanding of study instruments and procedures
- Adolescent deemed dangerous to self or others during evaluation
- Services other than outpatient treatment required for the adolescent (e.g., inpatient, detoxification)
- Adolescent already has participated in treatment project at CFAR; AND
- A sibling is already participating in project.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
Following 12 weeks of Functional Family Therapy (FFT), semi-weekly therapist phone calls for eight weeks.
|
Following 12 weeks of Functional Family Therapy (FFT), semi-weekly phone calls from a therapist for eight weeks.
|
Active Comparator: 2
Following 12 weeks of FFT, weekly one-hour group therapy for eight weeks
|
Following 12 weeks of FFT, weekly one-hour sessions of group therapy for eight weeks.
|
Active Comparator: 3
Following 12 weeks of FFT, an eight-week, customized series of therapist visits with the adolescent, family, teachers, coaches and others who can support the adolescent's reduced level of drug use.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Drug use levels for adolescents who have received family therapy and one of the three aftercare regimens
Time Frame: pretx and 6 wks, 4 , 7 and 12 mos. post initial therapy session
|
pretx and 6 wks, 4 , 7 and 12 mos. post initial therapy session
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Holly B. Waldron, Ph.D., Oregon Research Institute Center for Family and Adolescent Research (ORI/CFAR)
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2004
Primary Completion (Actual)
July 1, 2014
Study Completion (Actual)
July 1, 2014
Study Registration Dates
First Submitted
May 16, 2008
First Submitted That Met QC Criteria
May 19, 2008
First Posted (Estimate)
May 20, 2008
Study Record Updates
Last Update Posted (Estimate)
August 5, 2014
Last Update Submitted That Met QC Criteria
August 4, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DA15762
- R01DA015762 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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