## Protocol Section
### Identification Module
**NCT ID:** NCT06419595

**Acronym:** SASY

**Brief Title:** Screening and Support for Youth (SASY) Intervention to Reduce Mental Health Disparities

**Official Title:** SASY Intervention to Reduce Mental Health Disparities

#### Organization Study ID Info
**ID:** Exploratory 1
#### Organization
**Class:** OTHER
**Full Name:** Cambridge Health Alliance
#### Secondary ID Infos
**Domain:** NIMH
**ID:** PAR-24-210
**Type:** OTHER_GRANT
### Status Module
#### Completion Date
**Date:** 2027-03-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-03-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2025-11-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Cambridge Health Alliance

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Adolescent Health

- Minority Health

- Mental Health

- Community Health Services

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 220

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Study participants will be randomized for recruitment follow up by research team RC.

**Intervention Names:**

- Behavioral: Behavioral: Screening and Support for Youth (SASY) Multi-component Platform: includes screening, feedback, single session intervention, and resource information

**Label:** Recruitment by Research Coordinator (RC)

**Type:** OTHER

#### Arm Group 2

**Description:** Study participants will be randomized for recruitment follow up by the EYE peer group (community youth research group)

**Intervention Names:**

- Behavioral: Behavioral: Screening and Support for Youth (SASY) Multi-component Platform: includes screening, feedback, single session intervention, and resource information

**Label:** Recruitment by EYE

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Recruitment by EYE

**Description:** Description: Description: Participants who interact with a QR code and express interest in participating will be randomized to receive either: 1) recruitment from a Research Coordinator (standard research staff approach) or 2) recruitment from an EYE for Prevention Youth Researcher. The process of consent, screening, providing feedback, and offering access to a Single Session Intervention and information on additional resources (per scoring on the screening into Tier 1 (low risk/normal), 2 (moderate/at risk), or 3 (high/clinical risk): Tier 1 = screening+feedback; Tier 2=screening+feedback+SSI; Tier 3=screening+feedback+SSI+resource information) will be the same in each group. The randomization is simply changing who provides the process and platform to the participant.

**Name:** Behavioral: Screening and Support for Youth (SASY) Multi-component Platform: includes screening, feedback, single session intervention, and resource information

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Recruitment by Research Coordinator (RC)

**Description:** Description: Description: Participants who interact with a QR code and express interest in participating will be randomized to receive either: 1) recruitment from a Research Coordinator (standard research staff approach) or 2) recruitment from an EYE for Prevention Youth Researcher. The process of consent, screening, providing feedback, and offering access to a Single Session Intervention and information on additional resources (per scoring on the screening into Tier 1 (low risk/normal), 2 (moderate/at risk), or 3 (high/clinical risk): Tier 1 = screening+feedback; Tier 2=screening+feedback+SSI; Tier 3=screening+feedback+SSI+resource information) will be the same in each group. The randomization is simply changing who provides the process and platform to the participant.

**Name:** Behavioral: Screening and Support for Youth (SASY) Multi-component Platform: includes screening, feedback, single session intervention, and resource information

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** Number and proportion of participants in Tiers 2 and 3 that start and/or complete the single session intervention. This will be a measure of engagement in services.

**Measure:** Completion of Single session intervention

**Time Frame:** 1 month following initial screening

**Description:** Total number and proportion of 12-17 year olds recruited by the Research Coordinator vs. EYE Youth Researchers; also will examine this by proportion racial, ethnic and linguistic (REL) minoritized youth who participate (comparing Research Coordinator vs. EYE)

**Measure:** Participation

**Time Frame:** Immediate at time of enrollment

#### Secondary Outcomes

**Description:** Change on the K-CAT/WFIRS scores between time of screening (pre-) and post-intervention (SSI as the intervention) for Tiers 2 and 3

**Measure:** K-CAT/WFIRS scores - preliminary effectiveness

**Time Frame:** 1 month following initial screening

**Description:** Measure of therapeutic alliance with a) recruitment, screening, feedback and b) SSI.

**Measure:** Therapeutic Alliance

**Time Frame:** 1 month following initial screening

**Description:** Self-reported measure of engagement for youth who scored in Tier 3 (and were provided SSI + resources).

**Measure:** Engagement in Mental Health Treatment/Behavioral Change Activities

**Time Frame:** 1 month following initial screening

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 12 to 17 year old teens

Exclusion Criteria:

* younger than 12 or older than 17

**Maximum Age:** 17 Years

**Minimum Age:** 12 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** laura.podewils@dhha.org

**Name:** Laura Podewils, PhD

**Phone:** 303-436-6000

**Role:** CONTACT

**Contact 2:**

**Email:** twitkowski@challiance.org

**Name:** Taylor Witkowski, MA

**Phone:** 617-806-8751

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Denver Health and Hospital Authority

**Name:** Laura Podewils

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** Information will contain health insurance portability and accountability act (HIPAA) identifiers

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
