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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AA016917-01 | U.S. NIH Grant/Contract | View source | |
| 1R01AA016917-02 | U.S. NIH Grant/Contract | View source | |
| 1R01AA016917-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Motivational Enhancement Therapy (MET)/CBT+CM/BPT |
|
| 2 | Active Comparator | Motivational Enhancement Therapy (MET)/CBT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motivational Enhancement Therapy (MET)/CBT+CM | Behavioral | Behavioral Treatment |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine Stanger, Ph.D. | Dartmouth College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geisel School of Medicine at Dartmouth | Lebanon | New Hampshire | 03766 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28414474 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | (MET)/CBT+CM/BPT | Motivational Enhancement Therapy (MET)/CBT+CM/BPT Motivational Enhancement Therapy (MET)/CBT+CM: Behavioral Treatment |
| FG001 | (MET)/CBT | Motivational Enhancement Therapy (MET)/CBT Motivational Enhancement Therapy (MET)/CBT: Behavioral Treatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment |
| |||||||||||||
| 36-week Follow-up Period |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | (MET)/CBT+CM/BPT | Motivational Enhancement Therapy (MET)/CBT+CM/BPT Motivational Enhancement Therapy (MET)/CBT+CM: Behavioral Treatment |
| BG001 | (MET)/CBT | Motivational Enhancement Therapy (MET)/CBT Motivational Enhancement Therapy (MET)/CBT: Behavioral Treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Alcohol Abstinence | Number of non-abstinent urinalysis (ETG-positive) samples during 14 weeks of treatment (considering missing samples as non-abstinent) | Posted | Mean | Standard Deviation | Samples | Weekly up to 14 weeks |
|
9 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | (MET)/CBT+CM/BPT | Motivational Enhancement Therapy (MET)/CBT+CM/BPT Motivational Enhancement Therapy (MET)/CBT+CM: Behavioral Treatment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Catherine Stanger, Ph.D. | Dartmouth College | 603-646-7023 | catherine.stanger@dartmouth.edu |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D062405 | Motivational Interviewing |
| ID | Term |
|---|---|
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
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| Motivational Enhancement Therapy (MET)/CBT |
| Behavioral |
Behavioral Treatment |
|
| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Tobacco user | Count of Participants | Participants |
|
| Mean intake proportion of days used alcohol in past 30 days | We report the proportion of days used because not all participants provided data for the identical number of days at each assessment. Therefore the denominator differs across participants, and the proportion of days on which use was reported is the more appropriate measure of use frequency. | Mean | Standard Deviation | proportion of days used alcohol |
|
| Mean drinks per drinking day | Mean | Standard Deviation | Drinks |
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| DSM Alcohol Use Disorder | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | percentage of days used | Monthly up to 9 months (36 weeks) |
|
|
|
|
| 0 |
| 37 |
| 0 |
| 37 |
| 0 |
| 37 |
| EG001 | (MET)/CBT | Motivational Enhancement Therapy (MET)/CBT Motivational Enhancement Therapy (MET)/CBT: Behavioral Treatment | 0 | 38 | 0 | 38 | 0 | 38 |
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| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| Poisson regression |
Chi-square test with 1 degree of freedom |
| 0.007 |
| mean ratio |
| 0.74 |
| 2-Sided |
| 95 |
| .59 |
| .92 |
Mean ratio for percentage of days with alcohol use during the 36 week follow-up period, if alcohol was used: MET/CBT+CM/BPT (numerator) vs. MET/CTB (denominator) |
| Superiority |