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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.

Tracking Information
First Submitted Date  ICMJE September 19, 2019
First Posted Date  ICMJE September 20, 2019
Last Update Posted Date September 20, 2019
Actual Study Start Date  ICMJE March 15, 2018
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2019)
S2BI [ Time Frame: 3 months ]
S2BI score change
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2019)
  • ASSIST [ Time Frame: 3 months ]
    The Alcohol, Smoking and Substance Involvement Screening Test
  • BSTAD [ Time Frame: 3 months ]
    Brief Screener for Tobacco, Alcohol, and other Drug Use
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Examining the Effectiveness of the FaCES Adolescent SBIRT Intervention
Official Title  ICMJE Examining the Effectiveness of the FaCES Adolescent SBIRT Intervention
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Adolescent Health Services
  • Adolescent Behavior
Intervention  ICMJE
  • 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.
  • Behavioral: treatment as usual
    standard care conducted by primary care providers during clinic visits
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: brief intervention
  • Active Comparator: Treatment as usual
    Usual care will be delivered by primary care providers during the clinic visit
    Intervention: Behavioral: treatment as usual
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 19, 2019)
3300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2022
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
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
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04097964
Other Study ID Numbers  ICMJE 16743
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Friends Research Institute, Inc.
Study Sponsor  ICMJE Friends Research Institute, Inc.
Collaborators  ICMJE Conrad N. Hilton Foundation
Investigators  ICMJE
Principal Investigator: Shannon G Mitchell, PhD Friends Research Institute, Inc.
PRS Account Friends Research Institute, Inc.
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP