Adolescent HealthSASYNCT06419595
Screening and Support for Youth (SASY)
A study testing Behavioral: Screening and Support for Youth (SASY) Multi-component Platform: includes screening, feedback, single session intervention, and resource information in people with Adolescent Health and Minority Health, run by Cambridge Health Alliance.
Trial 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 more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Adolescent Health, Minority Health, Mental Health
- What is being tested?
- Behavioral: Screening and Support for Youth (SASY) Multi-component Platform: includes screening, feedback, single session intervention, and resource information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 3 Jan 2022to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 12 to 17 year old teens
Who cannot join
- younger than 12 or older than 17
About this study
Official title: Screening and Support for Youth
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.
- Being tested
- Behavioral: Screening and Support for Youth (SASY) Multi-component Platform: includes screening, feedback, single session intervention, and resource information
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral: Screening and Support for Youth (SASY) Multi-component Platform: includes screening, feedback, single session intervention, and resource informationBehavioural
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.
Behavioral: Screening and Support for Youth (SASY) Multi-component Platform: includes screening, feedback, single session intervention, and resource informationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Recruitment by Research Coordinator (RC) | Other | Study participants will be randomized for recruitment follow up by research team RC. Receives: 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) Receives: Behavioral: Behavioral: Screening and Support for Youth (SASY) Multi-component Platform: includes screening, feedback, single session intervention, and resource information |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: Immediate at time of enrollment
Secondary outcomes (3)
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
Measured: 1 month following initial screening
Therapeutic Alliance
Measure of therapeutic alliance with a) recruitment, screening, feedback and b) SSI.
Measured: 1 month following initial screening
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).
Measured: 1 month following initial screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start3 Jan 2022 (estimated)
- Primary completion28 Feb 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Why it stopped: On pause
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge Health Alliance
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Podewils, Principal investigator, Denver Health and Hospital Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06419595
- Sponsor's protocol ID
- Exploratory 1
- Other IDs
- PAR-24-210
- Acronym
- SASY
- Status last verified
- Sep 2026
- First submitted
- 14 May 2024
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Information will contain health insurance portability and accountability act (HIPAA) identifiers
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening and Support for Youth
- ClinicalTrials.gov ID
- NCT06419595
- Acronym / sponsor ID
- SASY / Exploratory 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: On pause
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cambridge Health AllianceUniversity, hospital or other
- Study start
- 3 Jan 2022 (estimated)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 17 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recruitment by Research Coordinator (RC) | Other | Behavioral: Behavioral: Screening and Support for Youth (SASY) Multi-component Platform: includes screening, feedback, single session intervention, and resource informationStudy participants will be randomized for recruitment follow up by research team RC. |
| Recruitment by EYE | Other | Behavioral: Behavioral: Screening and Support for Youth (SASY) Multi-component Platform: includes screening, feedback, single session intervention, and resource informationStudy participants will be randomized for recruitment follow up by the EYE peer group (community youth research group) |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 12 to 17 year old teens
Key exclusion criteria (1 listed)
- younger than 12 or older than 17
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral: Screening and Support for Youth (SASY) Multi-component Platform: includes screening, feedback, single session intervention, and resource informationDescription: 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. | Behavioural | Recruitment by EYE |
| Behavioral: Screening and Support for Youth (SASY) Multi-component Platform: includes screening, feedback, single session intervention, and resource informationDescription: 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. | Behavioural | Recruitment by Research Coordinator (RC) |
Primary outcome
Completion of Single session intervention
Time frame: 1 month following initial screening
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.
Participation
Time frame: Immediate at time of enrollment
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)
3 secondary outcomes
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No. Information will contain health insurance portability and accountability act (HIPAA) identifiers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Podewils principal investigator
Denver Health and Hospital Authority
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral: Screening and Support for Youth (SASY) Multi-component Platform: includes screening, feedback, single session intervention, and resource information in people with Adolescent Health and Minority Health, run by Cambridge Health Alliance.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of Single session intervention (time frame: 1 month following initial screening). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.