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Family Based Contingency Management for Adolescent Alcohol Abuse

Family Based Contingency Management for Adolescent Alcohol Abuse

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00595478
Enrollment
75
Registered
2008-01-16
Start date
2007-08-31
Completion date
2014-05-31
Last updated
2018-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Abuse

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. 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.

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.

Interventions

BEHAVIORALMotivational Enhancement Therapy (MET)/CBT+CM

Behavioral Treatment

BEHAVIORALMotivational Enhancement Therapy (MET)/CBT

Behavioral Treatment

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Alcohol AbstinenceWeekly up to 14 weeksNumber of non-abstinent urinalysis (ETG-positive) samples during 14 weeks of treatment (considering missing samples as non-abstinent)

Secondary

MeasureTime frameDescription
Days of Alcohol Use During 36-week Follow-up PeriodMonthly 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
(MET)/CBT+CM/BPT
Motivational Enhancement Therapy (MET)/CBT+CM/BPT Motivational Enhancement Therapy (MET)/CBT+CM: Behavioral Treatment
37
(MET)/CBT
Motivational Enhancement Therapy (MET)/CBT Motivational Enhancement Therapy (MET)/CBT: Behavioral Treatment
38
Total75

Withdrawals & dropouts

PeriodReasonFG000FG001
36-week Follow-up PeriodLost to Follow-up54
36-week Follow-up PeriodWithdrawal by Subject44

Baseline characteristics

Characteristic(MET)/CBT+CM/BPTTotal(MET)/CBT
Age, Continuous16.1 years
STANDARD_DEVIATION 1.2
16.1 years
STANDARD_DEVIATION 1.2
16.2 years
STANDARD_DEVIATION 1.2
DSM Alcohol Use Disorder
Abuse only
12 Participants26 Participants14 Participants
DSM Alcohol Use Disorder
Dependence
7 Participants14 Participants7 Participants
DSM Alcohol Use Disorder
None
18 Participants35 Participants17 Participants
Mean drinks per drinking day5.7 Drinks
STANDARD_DEVIATION 4.9
6.0 Drinks
STANDARD_DEVIATION 4.7
6.4 Drinks
STANDARD_DEVIATION 4.5
Mean intake proportion of days used alcohol in past 30 days0.12 proportion of days used alcohol
STANDARD_DEVIATION 0.16
0.12 proportion of days used alcohol
STANDARD_DEVIATION 0.15
0.12 proportion of days used alcohol
STANDARD_DEVIATION 0.14
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
6 Participants9 Participants3 Participants
Race (NIH/OMB)
More than one race
0 Participants2 Participants2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants3 Participants1 Participants
Race (NIH/OMB)
White
29 Participants61 Participants32 Participants
Region of Enrollment
United States
37 Participants75 Participants38 Participants
Sex: Female, Male
Female
10 Participants19 Participants9 Participants
Sex: Female, Male
Male
27 Participants56 Participants29 Participants
Tobacco user30 Participants60 Participants30 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 370 / 38
other
Total, other adverse events
0 / 370 / 38
serious
Total, serious adverse events
0 / 370 / 38

Outcome results

Primary

Alcohol Abstinence

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

ArmMeasureValue (MEAN)Dispersion
(MET)/CBT+CM/BPTAlcohol Abstinence2.9 SamplesStandard Deviation 3.5
(MET)/CBTAlcohol Abstinence2.6 SamplesStandard Deviation 3.6
p-value: 0.6695% CI: [0.29, 2.18]Poisson regression
p-value: 0.6195% CI: [0.71, 1.22]Poisson regression
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.

Time frame: Monthly up to 9 months (36 weeks)

Population: The analysis population consisted of only participants with follow-up (alcohol use) data on at least 85% of the days in the 36-week follow-up period.

ArmMeasureValue (MEAN)Dispersion
(MET)/CBT+CM/BPTDays of Alcohol Use During 36-week Follow-up Period5.6 percentage of days usedStandard Deviation 8.8
(MET)/CBTDays of Alcohol Use During 36-week Follow-up Period7.6 percentage of days usedStandard Deviation 10.6
p-value: 0.7495% CI: [0.26, 2.62]Poisson regression
p-value: 0.00795% CI: [0.59, 0.92]Poisson regression

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026