NCT00595478

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:

  1. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 16, 2008

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

March 29, 2018

Completed
Last Updated

March 29, 2018

Status Verified

March 1, 2018

Enrollment Period

6.8 years

First QC Date

January 7, 2008

Results QC Date

October 30, 2017

Last Update Submit

March 1, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Days of Alcohol Use During 36-week Follow-up Period

    Monthly up to 9 months (36 weeks)

Study Arms (2)

1

EXPERIMENTAL

Motivational Enhancement Therapy (MET)/CBT+CM/BPT

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

2

ACTIVE COMPARATOR

Motivational Enhancement Therapy (MET)/CBT

Behavioral: Motivational Enhancement Therapy (MET)/CBT

Interventions

Behavioral Treatment

1

Behavioral Treatment

2

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geisel School of Medicine at Dartmouth

Lebanon, New Hampshire, 03766, United States

Location

Related 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.

MeSH Terms

Conditions

Alcoholism

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Results Point of Contact

Title
Catherine Stanger, Ph.D.
Organization
Dartmouth College

Study Officials

  • Catherine Stanger, Ph.D.

    Dartmouth College

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 7, 2008

First Posted

January 16, 2008

Study Start

August 1, 2007

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

March 29, 2018

Results First Posted

March 29, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations