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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00595478
Other study ID # 85846
Secondary ID 1R01AA016917-011
Status Completed
Phase N/A
First received January 7, 2008
Last updated March 1, 2018
Start date August 2007
Est. completion date May 2014

Study information

Verified date March 2018
Source Dartmouth-Hitchcock Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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:

1. 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

2. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 75
Est. completion date May 2014
Est. primary completion date May 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Motivational Enhancement Therapy (MET)/CBT+CM
Behavioral Treatment
Motivational Enhancement Therapy (MET)/CBT
Behavioral Treatment

Locations

Country Name City State
United States Geisel School of Medicine at Dartmouth Lebanon New Hampshire

Sponsors (2)

Lead Sponsor Collaborator
Dartmouth-Hitchcock Medical Center National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Alcohol Abstinence 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 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. Monthly up to 9 months (36 weeks)
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