Family Based Contingency Management for Adolescent Alcohol Abuse
Primary Purpose
Alcohol Abuse
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational Enhancement Therapy (MET)/CBT+CM
Motivational Enhancement Therapy (MET)/CBT
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Abuse
Eligibility Criteria
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
Sites / Locations
- Geisel School of Medicine at Dartmouth
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Motivational Enhancement Therapy (MET)/CBT+CM/BPT
Motivational Enhancement Therapy (MET)/CBT
Outcomes
Primary Outcome Measures
Alcohol Abstinence
Number of non-abstinent urinalysis (ETG-positive) samples during 14 weeks of treatment (considering missing samples as non-abstinent)
Secondary Outcome Measures
Days of Alcohol Use During 36-week Follow-up Period
Percentage of days alcohol used during the 36-week follow-up period after treatment ended measured via timeline follow-back.
Full Information
NCT ID
NCT00595478
First Posted
January 7, 2008
Last Updated
March 1, 2018
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT00595478
Brief Title
Family Based Contingency Management for Adolescent Alcohol Abuse
Official Title
Family Based Contingency Management for Adolescent Alcohol Abuse
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
Approximately 1.5 million youth ages 12-17 (representing 6.1% of all youth in that age range) are in need of treatment for alcohol abuse, yet only 7.2% of those in need of treatment received it. Importantly, most youth (90.5%) who were classified as needing treatment based on their self report of Adolescent Alcohol Study Plan; v.2; 3/30/12Page 2 of 35 symptoms, perceived no need for treatment. Thus, there is a need to develop treatments that target populations of alcohol abusing youth who are not highly motivated to change their substance use. New outpatient family based and contingency management interventions for adolescent marijuana abuse have been developed, yet none of these interventions has specifically targeted adolescent alcohol use. It is important to target primary alcohol abuse and dependence in adolescence as approximately 20% of treatment-seeking youth report primary problems with alcohol. The primary aim of this proposal is to adapt our family-based contingency-management treatment to target adolescent alcohol abuse and dependence. This project will develop, manualize, and pilot a contingency management intervention that includes two components. First, an incentive program will 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. Second, a parent management training program will 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Motivational Enhancement Therapy (MET)/CBT+CM/BPT
Arm Title
2
Arm Type
Active Comparator
Arm Description
Motivational Enhancement Therapy (MET)/CBT
Intervention Type
Behavioral
Intervention Name(s)
Motivational Enhancement Therapy (MET)/CBT+CM
Intervention Description
Behavioral Treatment
Intervention Type
Behavioral
Intervention Name(s)
Motivational Enhancement Therapy (MET)/CBT
Intervention Description
Behavioral Treatment
Primary Outcome Measure Information:
Title
Alcohol Abstinence
Description
Number of non-abstinent urinalysis (ETG-positive) samples during 14 weeks of treatment (considering missing samples as non-abstinent)
Time Frame
Weekly up to 14 weeks
Secondary Outcome Measure Information:
Title
Days of Alcohol Use During 36-week Follow-up Period
Description
Percentage of days alcohol used during the 36-week follow-up period after treatment ended measured via timeline follow-back.
Time Frame
Monthly up to 9 months (36 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Stanger, Ph.D.
Organizational Affiliation
Dartmouth College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geisel School of Medicine at Dartmouth
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03766
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28414474
Citation
Stanger C, Scherer EA, Babbin SF, Ryan SR, Budney AJ. Abstinence based incentives plus parent training for adolescent alcohol and other substance misuse. Psychol Addict Behav. 2017 Jun;31(4):385-392. doi: 10.1037/adb0000279. Epub 2017 Apr 17.
Results Reference
result
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Family Based Contingency Management for Adolescent Alcohol Abuse
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