Transitional Treatment of Adolescents in Family Therapy (Transitions)
Primary Purpose
Substance Abuse
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MTI, Minimal Transitional Intervention
GTI, Group Transitional Intervention
STI, Systems Transitions Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Substance Abuse focused on measuring adolescent substance abuse
Eligibility Criteria
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.
Sites / Locations
- Oregon Res. Inst. Center for Family & Adolescent Research (CFAR)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
1
2
3
Arm Description
Following 12 weeks of Functional Family Therapy (FFT), semi-weekly therapist phone calls for eight weeks.
Following 12 weeks of FFT, weekly one-hour group therapy for eight weeks
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.
Outcomes
Primary Outcome Measures
Drug use levels for adolescents who have received family therapy and one of the three aftercare regimens
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00680381
Brief Title
Transitional Treatment of Adolescents in Family Therapy
Acronym
Transitions
Official Title
Transitional Treatment of Adolescents in Family Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oregon Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse
Keywords
adolescent substance abuse
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Following 12 weeks of Functional Family Therapy (FFT), semi-weekly therapist phone calls for eight weeks.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Following 12 weeks of FFT, weekly one-hour group therapy for eight weeks
Arm Title
3
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
MTI, Minimal Transitional Intervention
Intervention Description
Following 12 weeks of Functional Family Therapy (FFT), semi-weekly phone calls from a therapist for eight weeks.
Intervention Type
Behavioral
Intervention Name(s)
GTI, Group Transitional Intervention
Intervention Description
Following 12 weeks of FFT, weekly one-hour sessions of group therapy for eight weeks.
Intervention Type
Behavioral
Intervention Name(s)
STI, Systems Transitions Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Holly B. Waldron, Ph.D.
Organizational Affiliation
Oregon Research Institute Center for Family and Adolescent Research (ORI/CFAR)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Res. Inst. Center for Family & Adolescent Research (CFAR)
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Transitional Treatment of Adolescents in Family Therapy
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