Evaluating NIAAA's Alcohol ScreenerNCT02106754
Alcohol Screening & Brief Lntervention in Juvenile Justice: Filling the Gap
A study testing Brief Intervention, Brief Intervention with Coaching and Treatment as Usual in people with Evaluating NIAAA's Alcohol Screener and Evaluating a Brief Intervention, run by University of Rhode Island at 1 site in United States.
Trial summary
This proposal is in response to RFA-AA-12-008, Evaluation of NIAAA's Alcohol Screening Guide for Children and Adolescents. Of particular interest to the agency are evaluation of the Screener in clinical and/or other settings to predict alcohol-related consequences including use disorder; its use as an initial screen… Read more about this study
- Who is it for?
- Ages 9 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Evaluating NIAAA's Alcohol Screener, Evaluating a Brief Intervention
- What is being tested?
- Brief Intervention, Brief Intervention with Coaching and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 576 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to 31 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Youths 9-18 years old
Who cannot join
- Age (< 9, >18 years)
- Prior enrollment in a behavioral intervention study
- PO previously engaging them with Screener
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rhode Island
Kingston, Rhode Island, 02881
About this study
This proposal is in response to RFA-AA-12-008, Evaluation of NIAAA's Alcohol Screening Guide for Children and Adolescents. Of particular interest to the agency are evaluation of the Screener in clinical and/or other settings to predict alcohol-related consequences including use disorder; its use as an initial screen for drug use, cigarette smoking, conduct disorder, and unprotected sex; and its performance in making predictions concurrently and prospectively. This proposal targets these areas of interest. In addition, the investigators will study implementation of the Brief Intervention (BI) associated with the Screener. There is a great need for both screening and BI in juvenile probation settings as many of these youths have great need but are underserved.Many probation departments are turning to BI to work with probationers and parolees. Screening and BI has demonstrated efficacy in these settings, and yet no randomized control trials have been conducted to evaluate effectiveness in juvenile probation settings. Probation Officers (POs; n=40) are randomized to Screener (S), Screener+BI (SBI), or coaching (CSBI). Youths (N=1000) are randomized to 1 of these 3 conditions, and all receive usual services (US). US consist of regular check-in with PO and access to referral services as needed (counseling, academic tutoring, etc.). Research staffers conduct in-depth assessment at baseline, 6- and 12- months. Sensitivity, specificity, and positive and negative predictive powers (SN, SP, PP, NP) are calculated to predict alcohol risk and consequences, as well as other risky behaviors concurrently and prospectively across age-groups. A 1-way design (S vs SBI vs CSBI) will be used to determine whether SBI and CSBI enhance youth services-use and reduce risks (e.g., alcohol use, risky sex). We examine moderators of outcomes (youth age, PO characteristics) and whether coaching (an important consideration in implementation science) in use of BI improves outcomes. This study will be the first randomized controlled trial evaluating the effectiveness of SBI in a juvenile probation setting.
Read the detailed description
- A) To evaluate SN, SP, PP and NP of the 2-question Alcohol Screener to detect: a) alcohol problems (academic, social, injuries, intoxicated driving, unprotected sex), b) abuse/dependence, c) past 4 week binge drinking. 1B) This will be repeated to predict risk prospectively over 12 months. Classification rates will be compared for race, ethnicity, gender, and age groups.
- A) To evaluate SN, SP, PP and NP of the 2-question Screener to detect a) 30-day drug use, b) 30-day cigarette use, c) conduct disorder, d) unprotected sex. 2B) This will be repeated to predict risk prospectively over 12 months. Classification rates will be compared for race, ethnicity, gender, and age groups. 3) To evaluate BI as compared to usual procedures. The investigators hypothesize those youths in BI will a) receive more services, b) be more satisfied with services, c) rate the relationship with the PO more highly, and d) have improved outcomes (alcohol, alcohol-related problems, problem recognition).
- Being tested
- Brief Intervention, Brief Intervention with Coaching, Treatment as Usual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief InterventionBehavioural
Brief Intervention with CoachingBehavioural
Treatment as UsualBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Brief Intervention | Experimental | Youth may receive brief intervention from their provider based on randomization. Receives: Behavioral: Brief Intervention |
| Treatment As Usual | Active comparator | Youth may receive treatment as usual from their provider based on randomization. Receives: Behavioral: Treatment as Usual |
| Brief Intervention with Coaching | Experimental | Youth may receive brief intervention with coaching from their provider based on randomization. Receives: Behavioral: Brief Intervention with Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of change across three points in time for alcohol, cigarette and other drug use
Time-Line Follow-Back (TLFB) measures past 30-day use of alcohol, cigarettes, and other drugs at each assessment (BL, 6- \& 12-month). It is well known, reliable and valid (Harrison \& McKee, 2008; Carey et al, 2004). Days/month used, and binge-drinking are obtained. For analyses involving classification rates, binge >
1 is considered problematic, and definitions of binge will follow Donovan (2009).
RCQ (Risks/Consequences Questionnaire; Stein et al, 2010) provides an overall
Measured: baseline, 6 month follow-up, 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study startSep 2012
- Primary completion31 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluating NIAAA's Alcohol ScreenerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 576 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rhode Island
- Sponsor type
- University, hospital or other
- Collaborators
- Brown University
- Responsible party
- Principal investigator, Lynda Stein, Ph.D., University of Rhode Island
- Investigators
- Lyn Stein, Principal investigator, URI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02106754
- Sponsor's protocol ID
- R01AA021855
- Status last verified
- Oct 2019
- First submitted
- 27 Mar 2014
- Last updated
- 10 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alcohol Screening & Brief Lntervention in Juvenile Justice: Filling the Gap
- ClinicalTrials.gov ID
- NCT02106754
- Acronym / sponsor ID
- R01AA021855
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 576 participants (actual)
- Lead sponsor
- University of Rhode IslandUniversity, hospital or other
- Collaborators
- Brown University
- Study start
- Sep 2012 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 8 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This proposal is in response to RFA-AA-12-008, Evaluation of NIAAA's Alcohol Screening Guide for Children and Adolescents. Of particular interest to the agency are evaluation of the Screener in clinical and/or other settings to predict alcohol-related consequences including use disorder; its use as an initial screen for drug use, cigarette smoking, conduct disorder, and unprotected sex; and its performance in making predictions concurrently and prospectively. This proposal targets these areas of interest. In addition, the investigators will study implementation of the Brief Intervention (BI) associated with the Screener. There is a great need for both screening and BI in juvenile probation settings as many of these youths have great need but are underserved.Many probation departments are turning to BI to work with probationers and parolees. Screening and BI has demonstrated efficacy in these settings, and yet no randomized control trials have been conducted to evaluate effectiveness in juvenile probation settings. Probation Officers (POs; n=40) are randomized to Screener (S), Screener+BI (SBI), or coaching (CSBI). Youths (N=1000) are randomized to 1 of these 3 conditions, and all receive usual services (US). US consist of regular check-in with PO and access to referral services as needed (counseling, academic tutoring, etc.). Research staffers conduct in-depth assessment at baseline, 6- and 12- months. Sensitivity, specificity, and positive and negative predictive powers (SN, SP, PP, NP) are calculated to predict alcohol risk and consequences, as well as other risky behaviors concurrently and prospectively across age-groups. A 1-way design (S vs SBI vs CSBI) will be used to determine whether SBI and CSBI enhance youth services-use and reduce risks (e.g., alcohol use, risky sex). We examine moderators of outcomes (youth age, PO characteristics) and whether coaching (an important consideration in implementation science) in use of BI improves outcomes. This study will be the first randomized controlled trial evaluating the effectiveness of SBI in a juvenile probation setting.
Detailed description
- A) To evaluate SN, SP, PP and NP of the 2-question Alcohol Screener to detect: a) alcohol problems (academic, social, injuries, intoxicated driving, unprotected sex), b) abuse/dependence, c) past 4 week binge drinking. 1B) This will be repeated to predict risk prospectively over 12 months. Classification rates will be compared for race, ethnicity, gender, and age groups.
- A) To evaluate SN, SP, PP and NP of the 2-question Screener to detect a) 30-day drug use, b) 30-day cigarette use, c) conduct disorder, d) unprotected sex. 2B) This will be repeated to predict risk prospectively over 12 months. Classification rates will be compared for race, ethnicity, gender, and age groups. 3) To evaluate BI as compared to usual procedures. The investigators hypothesize those youths in BI will a) receive more services, b) be more satisfied with services, c) rate the relationship with the PO more highly, and d) have improved outcomes (alcohol, alcohol-related problems, problem recognition).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Brief Intervention | Experimental | Behavioral: Brief InterventionYouth may receive brief intervention from their provider based on randomization. |
| Treatment As Usual | Active comparator | Behavioral: Treatment as UsualYouth may receive treatment as usual from their provider based on randomization. |
| Brief Intervention with Coaching | Experimental | Behavioral: Brief Intervention with CoachingYouth may receive brief intervention with coaching from their provider based on randomization. |
Who may qualify
- Ages
- 9 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Youths 9-18 years old
Key exclusion criteria (3 listed)
- Age (< 9, >18 years)
- Prior enrollment in a behavioral intervention study
- PO previously engaging them with Screener
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Intervention | Behavioural | Brief Intervention |
| Brief Intervention with Coaching | Behavioural | Brief Intervention with Coaching |
| Treatment as Usual | Behavioural | Treatment As Usual |
Primary outcome
Measure of change across three points in time for alcohol, cigarette and other drug use
Time frame: baseline, 6 month follow-up, 12 month follow-up
Time-Line Follow-Back (TLFB) measures past 30-day use of alcohol, cigarettes, and other drugs at each assessment (BL, 6- \& 12-month). It is well known, reliable and valid (Harrison \& McKee, 2008; Carey et al, 2004). Days/month used, and binge-drinking are obtained. For analyses involving classification rates, binge > 1 is considered problematic, and definitions of binge will follow Donovan (2009). RCQ (Risks/Consequences Questionnaire; Stein et al, 2010) provides an overall
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2019.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lyn Stein principal investigator
URI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Intervention, Brief Intervention with Coaching and Treatment as Usual in people with Evaluating NIAAA's Alcohol Screener and Evaluating a Brief Intervention, run by University of Rhode Island at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of change across three points in time for alcohol, cigarette and other drug use (time frame: baseline, 6 month follow-up, 12 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2019.