Examining the Effectiveness of the FaCES Adolescent SBIRT Intervention

Adolescent Behavior Clinical Trial

Official title:

Examining the Effectiveness of the FaCES Adolescent SBIRT Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04097964
• Other study ID #: 16743
• Status: Completed
• Phase: N/A
• Start date: March 15, 2018
• Est. completion date: June 30, 2021

Study information

• Verified date: October 2021
• Source: Friends Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1226
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Behavior
• Adolescent Health Services

Intervention

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.
• treatment as usual
standard care conducted by primary care providers during clinic visits

Locations

Country	Name	City	State
United States	Lifespan Health	Adamsville	Tennessee
United States	Hidalgo Medical Services	Lordsburg	New Mexico
United States	Lifespan Health	Savannah	Tennessee
United States	Hidalgo Medical Services	Silver City	New Mexico

Sponsors (2)

Lead Sponsor	Collaborator
Friends Research Institute, Inc.	Conrad N. Hilton Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	S2BI	S2BI score change	3 months
Secondary	ASSIST	The Alcohol, Smoking and Substance Involvement Screening Test	3 months
Secondary	BSTAD	Brief Screener for Tobacco, Alcohol, and other Drug Use	3 months