Evaluating a Brief Intervention Clinical Trial
Official title:
Alcohol Screening & Brief Lntervention in Juvenile Justice: Filling the Gap
| NCT number | NCT02106754 |
| Other study ID # | R01AA021855 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | September 2012 |
| Est. completion date | May 31, 2019 |
| Verified date | October 2019 |
| Source | University of Rhode Island |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 576 |
| Est. completion date | May 31, 2019 |
| Est. primary completion date | May 31, 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 9 Years to 18 Years |
| Eligibility |
Inclusion Criteria: - Youths 9-18 years old Exclusion Criteria: - Age (< 9, >18 years) - Prior enrollment in a behavioral intervention study - PO previously engaging them with Screener |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Rhode Island | Kingston | Rhode Island |
| Lead Sponsor | Collaborator |
|---|---|
| University of Rhode Island | Brown University |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |
baseline, 6 month follow-up, 12 month follow-up |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT06113406 -
Evaluation of Virtual Reality in Hazmat Training
|
N/A |