- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01576393
Adolescent Involvement in Parental Substance Abuse Treatment
Adolescent Involvement in Parental Substance Abuse Treatment: Evaluation of EBFT
Given the reciprocal nature of parent-child interaction, involvement of the adolescent in their mother's substance abuse treatment plan might be associated with reductions in adult relapse and improvements in child functioning. These findings would support the assertion that focus on family dynamics in substance abuse treatment programs is an effective use of resources and an important target of intervention efforts. One hundred eighty-three substance abusing mothers and their child (n=61 assigned to each condition) will receive treatment as usual (TAU) and be randomly assigned to 1) Ecologically-based family therapy (EBFT) conducted in the home or 2) Ecologically-based family therapy conducted at the treatment center, or 3) an attention control, Women's Health Education (WHE). In order to examine the endurance of treatment effects, this project will assess the parent and child at 3, 6, 12, and 18 months post-baseline.
Hypotheses
- It is expected that 1) mothers and children assigned to home and office based family therapy will show greater reductions in substance use and improvement in individual and family functioning at post-treatment compared to those in the attention control, and 2) those assigned to home-based family therapy will show greater reductions in substance use and improved individual and family functioning at post-treatment compared to those assigned to office-based family therapy.
- It is expected that 1) those assigned to home or office based family therapy will continue to maintain improvements in substance use, individual and family domains over time (time by treatment interaction) compared to those assigned to the attention control and 2) those assigned to home-based family therapy will continue to maintain improvements in substance use, individual and family domains over time (time by treatment interaction) compared to those assigned to office-based family therapy.
- It is hypothesized that improved family interaction skills will mediate substance use, individual and family outcomes.
- It is expected that EBFT in the home and EBFT in the office will be more cost effective than TAU, and that EBFT in the home will be more cost effective than EBFT in the office
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43081
- The Ohio State University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult mothers seeking outpatient treatment for alcohol or drug abuse or dependence as measured using the computerized diagnostic interview schedule (CDIS; Shaffer, 1992), and who report substance use within the past 90 days
- A child, between the ages of 8 to 16, lives with the mother at least 50% time over the prior 2 years or continuously for the 6 months prior to the assessment interview.
- If more than one 8-16 year old lives in the home, the one with the greater problem severity will be included in the study. Substance use will be probed ("Have you ever used alcohol or drugs?"). If one youth answers yes, and the other answers no, the one who answers yes will be included. If both child answer "yes", then the Form 90 substance use section [history and current pattern] will be administered to each. The child who reports the more severe pattern and history of use [age of onset, type of drug used, frequency of current use] will be included. If neither youth reports using alcohol or drugs, then the Youth Self-Report (Achenbach & Edelbrock, 1982) will be administered and the youth with the greater total problem score will be included.
- Family lives within 60 miles of the treatment facility.
- Child and adult agree to participate in the assessment and treatment intervention.
Exclusion Criteria:
1. Evidence of unremitted psychosis or other condition which would impair their ability to understand and participate in the intervention or consent for research participation (as determined by CDISC).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Home-Based family therapy
12 home-based family therapy sessions
|
12 home-based family therapy sessions
Other Names:
|
|
Active Comparator: Office-based family therapy
12 office-based family therapy sessions
|
12 office-based family therapy sessions
Other Names:
|
|
Placebo Comparator: Women's Health Education
12 womens's health education sessions
|
12 Women's Health Education Sessions
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Substance use
Time Frame: baseline, 3, 6, 12 and 18-months
|
Change in frequency of reported substance use
|
baseline, 3, 6, 12 and 18-months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2006B0269
- R01DA023062 (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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