Clinical trial NCT06699251: Effectiveness of Brief Intervention in Primary Care for Diverse Young People (Chat)
Official title: Effectiveness of Brief Intervention in Primary Care for Diverse Young People
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adolescent Drinking
Cannabis Use
Lead sponsor: RAND
Sponsor class: OTHER
Collaborators: name: AltaMed Health Services Corporation
name: University of Pittsburgh Medical Center
name: Patient-Centered Outcomes Research Institute
First posted: 2024-11-21
Enrollment: 500
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Enhanced Usual Care vs Chat Intervention
Primary purpose: PREVENTION

Brief summary: Brief motivational interviewing intervention to address alcohol use among diverse teens 12-17.

Detailed description: The six-item CRAFFT will be used to screen teens at our partner clinics for risky AC use. For those that screen in as at-risk and express interest in the study, the teen's case manager will complete an online consent/assent form with the parent and teen that contains contact information for the teen so that investigators can follow up with the teen for surveys and intervention delivery or for providing an informational brochure. When the online consent/assent form is completed, the teen will be sent a personalized link to complete their baseline survey. Upon survey completion, the teen will receive a link that has their electronic gift card payment, and the case manager will be notified that a particular ID has completed the survey. The case manager will be informed by study staff whether to schedule that ID for enhanced usual care (EUC) or the Chat intervention. Investigators expect each teen to be scheduled within 30 days of completing their baseline survey to receive EUC or Chat. The informational brochure for the EUC will be handed to the teen during the visit or securely emailed, and Chat could take place either via a virtual or in-person visit. Whether or not the teen completes EUC or Chat, every teen will be followed by the RAND Survey Research Group to complete their follow-up web-based surveys based on timing of completion of their baseline survey. Teens will receive gift card incentives for completing the 3-month, 6-month, and 12-month surveys. Investigators will begin recruitment in month 9 of the project. Briefly, investigators expect to recruit from study month 9 to month 42 for the baseline survey. Investigators expect the Chat intervention to occur from months 9 to 42 the 3-month follow-up from months 12 to 45, 6-month from months 15 to 48, and the 12-month from months 21 to 53. Out of an anticipated 5,644 clients that our partner clinics will screen, investigators expect approximately 847 (15%) to screen in as at-risk on the CRAFFT and anticipate that approximately 500 (\~60%) will consent into the study.

Eligibility criteria: Inclusion Criteria:

* receive health care at one of two participating health systems
* aged 12-17
* screen positive for being at risk for alcohol or cannabis use using the CRAFFT

Exclusion Criteria:

* if they don't meet the inclusion criteria, they will be excluded

Primary outcomes:
measure: Alcohol - change in frequency of use
timeFrame: Baseline to 3 months
measure: Alcohol - change in frequency of use
timeFrame: 3 months to 6 months
measure: Alcohol - change in frequency of use
timeFrame: 6 months to 12 months
measure: Cannabis - change in frequency of use
timeFrame: Baseline to 3 months
measure: Cannabis - change in frequency of use
timeFrame: 3 months to 6 months
measure: Cannabis - change in frequency of use
timeFrame: 6 months to 12 months
measure: Alcohol - change in consequences of use
timeFrame: Baseline to 3 months
measure: Alcohol - change in consequences of use
timeFrame: 3 months to 6 months
measure: Alcohol - change in consequences of use
timeFrame: 6 months to 12 months
measure: Cannabis - change in consequences of use
timeFrame: Baseline to 3 months
measure: Cannabis - change in consequences of use
timeFrame: 3 months to 6 months
measure: Cannabis - change in consequences of use
timeFrame: 6 months to 12 months
Secondary outcomes:
measure: Alcohol - change in time spent around peers
timeFrame: Baseline to 3 months
measure: Alcohol - change in time spent around peers
timeFrame: 3 months to 6 months
measure: Alcohol - change in time spent around peers
timeFrame: 6 months to 12 months
measure: Cannabis - change in time spent around peers
timeFrame: Baseline to 3 months
measure: Cannabis - change in time spent around peers
timeFrame: 3 months to 6 months
measure: Cannabis - change in time spent around peers
timeFrame: 6 months to 12 months
measure: Alcohol - change in motivation to change use
timeFrame: Baseline to 3 months
measure: Alcohol - change in motivation to change use
timeFrame: 3 months to 6 months
measure: Alcohol - change in motivation to change use
timeFrame: 6 months to 12 months
measure: Cannabis - change in motivation to change use
timeFrame: Baseline to 3 months
measure: Cannabis - change in motivation to change use
timeFrame: 3 months to 6 months
measure: Cannabis - change in motivation to change use
timeFrame: 6 months to 12 months
measure: Change in use of behavioral health care services
timeFrame: Baseline to 3 months
measure: Change in use of behavioral health care services
timeFrame: 3 months to 6 months
measure: Change in use of behavioral health care services
timeFrame: 6 months to 12 months
Other outcomes:
Locations:
city: Commerce
country: United States
facility: AltaMed Health Services
state: California
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center Children's Hospital
state: Pennsylvania
Study officials:
affiliation: RAND
name: Elizabeth J. D'Amico, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: RAND
name: Alina I Palimaru, PhD
role: PRINCIPAL_INVESTIGATOR
References: