NCT06419595

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started Nov 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 17, 2024

Completed
2.5 years until next milestone

Study Start

First participant enrolled

November 1, 2026

Expected
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Last Updated

June 26, 2025

Status Verified

June 1, 2025

Enrollment Period

5 months

First QC Date

May 14, 2024

Last Update Submit

June 23, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    1 month following initial screening

  • 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)

    Immediate at time of enrollment

Secondary Outcomes (3)

  • K-CAT/WFIRS scores - preliminary effectiveness

    1 month following initial screening

  • Therapeutic Alliance

    1 month following initial screening

  • Engagement in Mental Health Treatment/Behavioral Change Activities

    1 month following initial screening

Study Arms (2)

Recruitment by Research Coordinator (RC)

OTHER

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

Recruitment by EYE

OTHER

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

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.

Recruitment by EYE

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • to 17 year old teens

You may not qualify if:

  • younger than 12 or older than 17

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Laura Podewils

    Denver Health and Hospital Authority

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Podewils, PhD

CONTACT

Taylor Witkowski, MA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2024

First Posted

May 17, 2024

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2028

Last Updated

June 26, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

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