Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06419595
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-05-14
Brief Title:
Screening and Support for Youth SASY Intervention to Reduce Mental Health Disparities
Sponsor:
Cambridge Health Alliance
Organization:
Cambridge Health Alliance
Study Overview
Official Title:
SASY Intervention to Reduce Mental Health Disparities
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SASY
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 schoolscommunity 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 teams Research Coordinators RC and either EYE or the RC will carry out the assentconsent process with youth and their parentsguardians For the subsequent non-randomized group of 50 hard-to-reach participants the EYE team will utilize various methods for recruitment and coordinate the assentconsent process with youth and their parentsguardians
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 participants 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
Includes the recruitment of 220 youth 170 from schoolscommunity 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 teams Research Coordinators RC and either EYE or the RC will carry out the assentconsent process with youth and their parentsguardians For the subsequent non-randomized group of 50 hard-to-reach participants the EYE team will utilize various methods for recruitment and coordinate the assentconsent process with youth and their parentsguardians
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 participants 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PAR-24-210 | OTHER_GRANT | NIMH | None |