Clinical trial NCT06419595: Screening and Support for Youth (SASY) Intervention to Reduce Mental Health Disparities
Official title: SASY Intervention to Reduce Mental Health Disparities
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Adolescent Health
Minority Health
Mental Health
Community Health Services
Lead sponsor: Cambridge Health Alliance
Sponsor class: OTHER
First posted: 2024-05-17
Enrollment: 220
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To adapt the Screening and Support for Youth (SASY) intervention and approach to recruitment for racial, ethnic and linguistic diverse youth aged 12-17 in the Denver Health catchment area

Detailed description: To adapt the Screening and Support for Youth (SASY) intervention and approach to recruitment for racial, ethnic and linguistic diverse youth aged 12-17 in the Denver Health catchment area.

Includes the recruitment of 220 youth (170 from schools/community and 50 hard-to-reach).

170 participants will be recruited by QR codes available on flyers that will be distributed in schools and community settings. This group will then be randomized to either follow up with the Engaging Youth Expertise for Prevention (EYE) or one of the study team's Research Coordinators (RC) and either EYE or the RC will carry out the assent/consent process with youth and their parents/guardians. For the subsequent (non-randomized) group of 50 hard-to-reach participants, the EYE team will utilize various methods for recruitment, and coordinate the assent/consent process with youth and their parents/guardians.

All 200 participants will be offered a SASY screening which will include the K-CAT, Weiss Functional Impairment Scale (WFIRS-S), CAT-MH social determinants of health (SDOH), and assessment of current mental health treatment. All survey instruments will be delivered via REDCap. Each participant will be assigned a record identification (ID) and an acrostic, so their data can not be identifiable during analysis. All data will stay within the Cambridge Health Alliance (CHA) firewall and only the study team will have access to the results. These products are available in English and Spanish.

A clinical risk score is generated by an algorithm combining symptoms and functional impairment based on national norms. Tier 1 is within normal, Tier 2 is at clinical risk, and Tier 3 is clinically ill. All participants will receive a motivational feedback session to discuss the results of the screening. The discussion will focus on the participant's reflections on how they feel, their perception of their symptoms and functioning, what changes they wish to make in their life, and what might support that change. The feedback will be given to the teens using non-clinical and non-research terms based upon the students' responses on the screening measures. Tier 1 participants will be offered screening and feedback on the screening results. Tier 2 participants will be offered screening, feedback on the screening results and a single session intervention (SSI). Tier 3 participants will be offered screening, feedback on the screening results, a single session intervention and information on community resources. The SSI will be accessed by a unique link provided to the participants, and includes several modules to choose from that participants can complete on their own and at their own pace.

All participants will be invited for a follow-up survey at 1 month following initial screening. The follow-up survey will re-assess the KCAT and WFIRS, therapeutic alliance, and engagement in mental health treatment or behavioral interventions.

All participants will be offered a $20 incentive for the initial screening and $20 for completing the follow-up survey.

Eligibility criteria: Inclusion Criteria:

* 12 to 17 year old teens

Exclusion Criteria:

* younger than 12 or older than 17

Primary outcomes:
measure: Completion of Single session intervention
timeFrame: 1 month following initial screening
measure: Participation
timeFrame: Immediate at time of enrollment
Secondary outcomes:
measure: K-CAT/WFIRS scores - preliminary effectiveness
timeFrame: 1 month following initial screening
measure: Therapeutic Alliance
timeFrame: 1 month following initial screening
measure: Engagement in Mental Health Treatment/Behavioral Change Activities
timeFrame: 1 month following initial screening
Other outcomes:
Locations:
Study officials:
affiliation: Denver Health and Hospital Authority
name: Laura Podewils
role: PRINCIPAL_INVESTIGATOR
References: