- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00595478
Family Based Contingency Management for Adolescent Alcohol Abuse
The goal is to adapt the family-based CM treatment to target primary adolescent alcohol abuse and dependence.
Specific Aim 1 is to provide a preliminary demonstration of the efficacy of a family-based CM intervention to treat adolescent alcohol abuse and dependence. CM components include:
- an incentive program to enhance the adolescent's engagement in the treatment process and engender alcohol abstinence by providing positive reinforcement for documented abstinence via breathalyzers administered by parents regularly at home, self and parent report, and clinic-based urine drug testing; and
- a parent management training program to enhance and maintain the positive effects of the incentive program by teaching parents how to effectively use contingency management in the home environment to motivate their adolescent to achieve abstinence and improve their behavior in other domains.
A randomized trial will determine whether the CM intervention enhances outcomes when added to a standard individual cognitive behavioral therapy (CBT).
Specific Aim 2 is to determine whether and how treatment interventions modify parental and adolescent risk and protective factors using observational and laboratory measures (parenting practices, family functioning, risk taking, delay discounting, and child and parent psychopathology) and to determine whether these factors are associated with outcomes over time.
Specific Aim 3 is to test gene x environment (treatment) interactions in adolescent substance abuse. Findings will extend the scientific evidence for CM and support the ability of parents to implement CM at home. Findings that support the CM model's efficacy will make a significant contribution to research on the treatment of adolescent alcohol abuse, which has lagged behind research on adult substance abuse and on adolescent illicit drug use.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New Hampshire
-
Lebanon, New Hampshire, United States, 03766
- Geisel School of Medicine at Dartmouth
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 12-18 years old (if 18, must attend high school and live at home)
- Report using alcohol during the previous 30 days
- Have a parent/guardian who can participate
- Meet DSM criteria for either Alcohol Abuse or Dependence
- Youth who meet DSM criteria for Alcohol Dependence may also meet criteria for Marijuana Abuse or Dependence and other Drug Abuse
- Youth who meet DSM criteria for Alcohol Abuse, may also meet criteria for Marijuana or other Drug Abuse
- Live within a 30-minute drive of the clinic
Exclusion Criteria:
- Meet DSM criteria for Drug Dependence (other than Marijuana Dependence)
- Meet DSM criteria for Alcohol Abuse with Marijuana Dependence. Use of other drugs will not be excluded
- Participants will also be excluded if they exhibit an active psychosis
- Have a severe medical or psychiatric illness that will limit participation
- Are pregnant or breast-feeding
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
Motivational Enhancement Therapy (MET)/CBT+CM/BPT
|
Behavioral Treatment
|
|
Active Comparator: 2
Motivational Enhancement Therapy (MET)/CBT
|
Behavioral Treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Alcohol Abstinence
Time Frame: Weekly up to 14 weeks
|
Number of non-abstinent urinalysis (ETG-positive) samples during 14 weeks of treatment (considering missing samples as non-abstinent)
|
Weekly up to 14 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Days of Alcohol Use During 36-week Follow-up Period
Time Frame: Monthly up to 9 months (36 weeks)
|
Percentage of days alcohol used during the 36-week follow-up period after treatment ended measured via timeline follow-back.
|
Monthly up to 9 months (36 weeks)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Catherine Stanger, Ph.D., Dartmouth College
Publications and helpful links
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 (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 85846
- 1R01AA016917-01 (U.S. NIH Grant/Contract)
- 1R01AA016917-02 (U.S. NIH Grant/Contract)
- 1R01AA016917-03 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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