CClinicalTrials.gg
WithdrawnNCT06419595SASYUpdated Sep 17, 2026

Screening and Support for Youth (SASY)

An interventional study of Behavioral: Screening and Support for Youth (SASY) Multi-component Platform: includes screening, feedback, single session intervention, and resource information and Behavioral: Screening and Support for Youth (SASY) Multi-component Platform: includes screening, feedback, single session intervention, and resource information in Adolescent Health, Minority Health and Mental Health, sponsored by Cambridge Health Alliance. Withdrawn. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by Cambridge Health Alliance · Not applicable, Interventional, and Prevention

Why this study was withdrawn
On pause
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
12 Years to 17 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Adolescent Health
  • Minority Health
  • Mental Health
  • Community Health Services
03

In context

Psychological Well-Being

971 studies on the registry are indexed under Psychological Well-Being; 502 are open to participants now.

Browse Psychological Well-Being studies →

Lead sponsor

Cambridge Health Alliance is the lead sponsor of 52 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 12 to 17 year old teens

Exclusion criteria

Exclusion Criteria:

  • younger than 12 or older than 17
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Other
    Recruitment by Research Coordinator (RC)

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

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

  • Other
    Recruitment by EYE

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

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

Interventions

  • BehavioralBehavioral: 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 (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.

  • BehavioralBehavioral: 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 (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.

06

What researchers measure

Primary outcomes

  1. Completion of Single session intervention

    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.

    Time frame: 1 month following initial screening

  2. Participation

    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)

    Time frame: Immediate at time of enrollment

Secondary outcomes

  1. K-CAT/WFIRS scores - preliminary effectiveness

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

    Time frame: 1 month following initial screening

  2. Therapeutic Alliance

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

    Time frame: 1 month following initial screening

  3. Engagement in Mental Health Treatment/Behavioral Change Activities

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

    Time frame: 1 month following initial screening

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — Information will contain health insurance portability and accountability act (HIPAA) identifiers

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06419595
Lead sponsor
Cambridge Health Alliance
Responsible party
Sponsor
First posted
May 17, 2024
Start date
Jan 3, 2022 (estimated)
Primary completion
Feb 28, 2024 (estimated)
Completion
Mar 31, 2024 (estimated)
Last update
Sep 17, 2026

Study contacts

Laura Podewils
principal investigator · Denver Health and Hospital Authority

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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