NCT02106754

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
576

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 8, 2014

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
Last Updated

October 10, 2019

Status Verified

October 1, 2019

Enrollment Period

6.7 years

First QC Date

March 27, 2014

Last Update Submit

October 9, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Brief Intervention

EXPERIMENTAL

Youth may receive brief intervention from their provider based on randomization.

Behavioral: Brief Intervention

Treatment As Usual

ACTIVE COMPARATOR

Youth may receive treatment as usual from their provider based on randomization.

Behavioral: Treatment as Usual

Brief Intervention with Coaching

EXPERIMENTAL

Youth may receive brief intervention with coaching from their provider based on randomization.

Behavioral: Brief Intervention with Coaching

Interventions

Brief Intervention
Brief Intervention with Coaching
Treatment As Usual

Eligibility Criteria

Age9 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Youths 9-18 years old

You may not qualify if:

  • Age (\< 9, \>18 years)
  • Prior enrollment in a behavioral intervention study
  • PO previously engaging them with Screener

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rhode Island

Kingston, Rhode Island, 02881, United States

Location

MeSH Terms

Interventions

Crisis InterventionTherapeutics

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Lyn Stein

    URI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, University of Rhode Island

Study Record Dates

First Submitted

March 27, 2014

First Posted

April 8, 2014

Study Start

September 1, 2012

Primary Completion

May 31, 2019

Study Completion

May 31, 2019

Last Updated

October 10, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations