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Not yet recruiting NCT06419595

Screening and Support for Youth (SASY)

No phase Interventional Adolescent Health Minority Health Mental Health Community Health Services

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Behavioral: Screening and Support for Youth (SASY) Multi-component Platform: includes screening, feedback, single session intervention, and resource information, Behavioral: Screening and Support for Youth (SASY) Multi-component Platform: includes screening, feedback, single session intervention, and resource information.
Who it may be relevant to
Registry conditions: Adolescent Health, Minority Health, Mental Health, Community Health Services. Basic parameters: 12 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Screening and Support for Youth

Overview

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.

Interventions

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

Primary outcome measures

  • Completion of Single session intervention [Time frame: 1 month following initial screening]
  • Participation [Time frame: Immediate at time of enrollment]
Secondary outcome measures (3)
  • K-CAT/WFIRS scores - preliminary effectiveness [Time frame: 1 month following initial screening]
  • Therapeutic Alliance [Time frame: 1 month following initial screening]
  • Engagement in Mental Health Treatment/Behavioral Change Activities [Time frame: 1 month following initial screening]

Eligibility criteria

Inclusion criteria

  • 12 to 17 year old teens

Exclusion criteria

  • younger than 12 or older than 17

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06419595 · Exploratory 1 · PAR-24-210

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗