Alcohol Abuse
Conditions
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
Behavioral Treatment
Behavioral Treatment
Sponsors
Study design
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alcohol Abstinence | Weekly up to 14 weeks | Number of non-abstinent urinalysis (ETG-positive) samples during 14 weeks of treatment (considering missing samples as non-abstinent) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Days of Alcohol Use During 36-week Follow-up Period | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| (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 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 36-week Follow-up Period | Lost to Follow-up | 5 | 4 |
| 36-week Follow-up Period | Withdrawal by Subject | 4 | 4 |
Baseline characteristics
| Characteristic | (MET)/CBT+CM/BPT | Total | (MET)/CBT |
|---|---|---|---|
| Age, Continuous | 16.1 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 Participants | 26 Participants | 14 Participants |
| DSM Alcohol Use Disorder Dependence | 7 Participants | 14 Participants | 7 Participants |
| DSM Alcohol Use Disorder None | 18 Participants | 35 Participants | 17 Participants |
| Mean drinks per drinking day | 5.7 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 days | 0.12 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 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 9 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) White | 29 Participants | 61 Participants | 32 Participants |
| Region of Enrollment United States | 37 Participants | 75 Participants | 38 Participants |
| Sex: Female, Male Female | 10 Participants | 19 Participants | 9 Participants |
| Sex: Female, Male Male | 27 Participants | 56 Participants | 29 Participants |
| Tobacco user | 30 Participants | 60 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 37 | 0 / 38 |
| other Total, other adverse events | 0 / 37 | 0 / 38 |
| serious Total, serious adverse events | 0 / 37 | 0 / 38 |
Outcome results
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| (MET)/CBT+CM/BPT | Alcohol Abstinence | 2.9 Samples | Standard Deviation 3.5 |
| (MET)/CBT | Alcohol Abstinence | 2.6 Samples | Standard Deviation 3.6 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| (MET)/CBT+CM/BPT | Days of Alcohol Use During 36-week Follow-up Period | 5.6 percentage of days used | Standard Deviation 8.8 |
| (MET)/CBT | Days of Alcohol Use During 36-week Follow-up Period | 7.6 percentage of days used | Standard Deviation 10.6 |