NCT04097964

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,226

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2018

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 20, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

October 22, 2021

Status Verified

October 1, 2021

Enrollment Period

3.3 years

First QC Date

September 19, 2019

Last Update Submit

October 21, 2021

Conditions

Keywords

SBIRT

Outcome Measures

Primary Outcomes (1)

  • S2BI

    S2BI score change

    3 months

Secondary Outcomes (2)

  • ASSIST

    3 months

  • BSTAD

    3 months

Study Arms (2)

FaCES Intervention

EXPERIMENTAL

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

Treatment as usual

ACTIVE COMPARATOR

Usual care will be delivered by primary care providers during the clinic visit

Behavioral: treatment as usual

Interventions

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.

FaCES Intervention

standard care conducted by primary care providers during clinic visits

Treatment as usual

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hidalgo Medical Services

Lordsburg, New Mexico, 88045, United States

Location

Hidalgo Medical Services

Silver City, New Mexico, 88061, United States

Location

Lifespan Health

Adamsville, Tennessee, 33810, United States

Location

Lifespan Health

Savannah, Tennessee, 38372, United States

Location

MeSH Terms

Conditions

Adolescent Behavior

Interventions

Crisis InterventionTherapeutics

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Shannon G Mitchell, PhD

    Friends Research Institute, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2019

First Posted

September 20, 2019

Study Start

March 15, 2018

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

October 22, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations