Examining the Effectiveness of the FaCES Adolescent SBIRT Intervention

The study will utilize a stepped wedge cluster randomized design to examine the effectiveness of the full FaCES (Facilitating Change for Excellence in SBIRT) adolescent SBIRT change package. Primary care providers will be randomized as to when they receive training and begin delivery of FaCES with their 12 to 17 year old patients, which includes targeted feedback based on the patient's endorsed substance use level on the S2BI screening instrument.

Study Overview

• Status: Completed
• Conditions: Adolescent Behavior; Adolescent Health Services
• Intervention / Treatment: Behavioral: brief intervention; Behavioral: treatment as usual

Detailed Description

The study will utilize a stepped wedge cluster randomized design to examine the effectiveness of the full FaCES (Facilitating Change for Excellence in SBIRT) adolescent change package for 12 to 17 year old primary care patients. Primary care providers at two rural federally qualified health centers in New Mexico and Tennessee will be randomized as to when they receive training and begin delivering FaCES to their adolescent patients. FaCES includes targeted feedback based on the patient's endorsed substance use level on the S2BI screening instrument. Study participants will complete a baseline and follow-up assessment 3-months post study recruitment.

• Study Type: Interventional
• Enrollment (Actual): 1226
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Mexico
    • Lordsburg, New Mexico, United States, 88045
      • Hidalgo Medical Services
    • Silver City, New Mexico, United States, 88061
      • Hidalgo Medical Services
  • Tennessee
    • Adamsville, Tennessee, United States, 33810
      • Lifespan Health
    • Savannah, Tennessee, United States, 38372
      • Lifespan Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Ages 12 to 17 years, inclusive
• Registered patient at one of the participating FQHCs
• Able and willing to provide informed consent

Exclusion Criteria:

• Inability to comprehend the assent form
• Parent/guardian declines consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FaCES Intervention; Primary care providers will deliver anticipatory guidance for adolescents reporting no drug, alcohol or marijuana use in past year, an abbreviated brief intervention for adolescents who report using these substances one or twice in the past year, and a full brief intervention for adolescents who report using these substances monthly or weekly in the past year.	Behavioral: brief intervention; 1 minute or less of anticipatory guidance will be provided for adolescents reporting no use in the past year, a 3-5 minute abbreviated brief intervention including raising the subject, asking more questions, and correcting misinformation will be provided for adolescents reporting substance use once or twice in the past year, and a 5-10 minute full brief intervention will be provided, including the above steps as well as assessing readiness and negotiating change and scheduling a follow-up to potentially include a referral to treatment will be provided to adolescents reporting monthly to weekly use in the past year.
Active Comparator: Treatment as usual; Usual care will be delivered by primary care providers during the clinic visit	Behavioral: treatment as usual; standard care conducted by primary care providers during clinic visits

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
S2BI	S2BI score change	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ASSIST	The Alcohol, Smoking and Substance Involvement Screening Test	3 months
BSTAD	Brief Screener for Tobacco, Alcohol, and other Drug Use	3 months

Collaborators and Investigators

• Sponsor: Friends Research Institute, Inc.
• Collaborators: Conrad N. Hilton Foundation
• Investigators: Principal Investigator: Shannon G Mitchell, PhD, Friends Research Institute, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2018
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: September 19, 2019
• First Submitted That Met QC Criteria: September 19, 2019
• First Posted (Actual): September 20, 2019

Study Record Updates

• Last Update Posted (Actual): October 22, 2021
• Last Update Submitted That Met QC Criteria: October 21, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: SBIRT
• Other Study ID Numbers: 16743

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No