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Examining the Effectiveness of the FaCES Adolescent SBIRT Intervention

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ClinicalTrials.gov Identifier: NCT04097964
Recruitment Status : Recruiting
First Posted : September 20, 2019
Last Update Posted : September 20, 2019
Sponsor:
Collaborator:
Conrad N. Hilton Foundation
Information provided by (Responsible Party):
Friends Research Institute, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Adolescent Health Services Adolescent Behavior Behavioral: brief intervention Behavioral: treatment as usual Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Examining the Effectiveness of the FaCES Adolescent SBIRT Intervention
Actual Study Start Date : March 15, 2018
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2022

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




Primary Outcome Measures :
  1. S2BI [ Time Frame: 3 months ]
    S2BI score change


Secondary Outcome Measures :
  1. ASSIST [ Time Frame: 3 months ]
    The Alcohol, Smoking and Substance Involvement Screening Test

  2. BSTAD [ Time Frame: 3 months ]
    Brief Screener for Tobacco, Alcohol, and other Drug Use



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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04097964


Contacts
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Contact: Shannon G Mitchell, PhD 410-837-3977 ext 238 smitchell@friendsresearch.org
Contact: Laura B Monico, PhD 410-837-3977 ext 248 lmonico@friendsresearch.org

Locations
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United States, New Mexico
Hidalgo Medical Services Recruiting
Lordsburg, New Mexico, United States, 88045
Contact: Darrick Nelson, MD    575-542-8384    dnelson@hmsnm.org   
Hidalgo Medical Services Recruiting
Silver City, New Mexico, United States, 88061
Contact: Darrick Nelson, MD    888-271-3596    dnelson@hmsnm.org   
United States, Tennessee
Lifespan Health Recruiting
Adamsville, Tennessee, United States, 33810
Contact: Christa Franks    731-926-8930 ext 8930    christa.franks@lifespanhealth.com   
Lifespan Health Recruiting
Savannah, Tennessee, United States, 38372
Contact: Christa Franks    731-926-8930 ext 8930    christa.franks@lifespanhealth.com   
Sponsors and Collaborators
Friends Research Institute, Inc.
Conrad N. Hilton Foundation
Investigators
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Principal Investigator: Shannon G Mitchell, PhD Friends Research Institute, Inc.

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Responsible Party: Friends Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT04097964     History of Changes
Other Study ID Numbers: 16743
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Friends Research Institute, Inc.:
SBIRT