- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05900700
Digital Youth-Nominated Support Team (YST) Program
An Open-Label Study of the Feasibility and Usability of a Digital Psychoeducational Social Network Intervention for Suicidal Adolescents
Study Overview
Detailed Description
Assessment data from multiple stakeholders (i.e., youth, parents, and support adults) will be collected at baseline, 4 weeks, 8 weeks, and 12 weeks via self-report and semi-structured interviews.
A request to extend the record's NIH results reporting deadline to November 1, 2025 was submitted in a timely manner prior to October-November 2025 government shutdown. This request was approved retroactively once the shutdown ended on November 12. During the shutdown, the record was locked and could not be edited by the Responsible Party. Results were submitted as soon as possible upon the unlocking of the record.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Michigan
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Ann Arbor, Michigan, United States, 48109
- Michigan Medicine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Inpatient psychiatric patients who have attempted suicide or have documented Suicide ideation (SI) and a plan to harm themselves at admission.
- Understand written and spoken English.
- Own a smartphone or mobile phone.
- Willing and able to complete enrollment procedures.
- Parent or guardian and youth able to understand the nature of the study and provide written informed consent and assent for youth
- Patients who are able to provide at least one verifiable contact for emergency or tracking purposes.
Exclusion Criteria:
- Patients with active psychosis.
- Patients experiencing substance withdrawal.
- Currently enrolled in other treatment studies for the symptoms and behaviors targeted.
- Patient unwilling or unable to wear a mask during in person study procedures, if mandated due to current COVID/health safety guidelines.
- Patients who in the judgment of the investigator would have an unfavorable risk or benefit profile with respect to eYST.
- Any other psychiatric or medical condition or custody arrangement that in the investigators' opinion would preclude informed consent or assent or participation in the trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: eYST website
|
The website is a psychoeducational, social support program for adolescents at risk for suicide
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
System Usability Scale (SUS) Score - Youth Participants
Time Frame: At 4 Weeks
|
10-item measure.
Scores ranged from 0 to 100.
The researchers calculated the mean score.
A mean score of 68 was the minimal indicator of usability.
Results reflect data from Youth Participants.
|
At 4 Weeks
|
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System Usability Scale (SUS) Score - Adult Caregiver Participants
Time Frame: At 4 Weeks
|
10-item measure.
Scores ranged from 0 to 100.
The researchers calculated the mean score.
A mean score of 68 was the minimal indicator of usability.
Results reflect data from Adult Caregiver Participants.
|
At 4 Weeks
|
|
System Usability Scale (SUS) Score - Adult Support Participants
Time Frame: At 8 Weeks
|
10-item measure.
Scores ranged from 0 to 100.
The researchers calculated the mean score.
A mean score of 68 was the minimal indicator of usability.
Results reflect data from Adult Support Participants.
|
At 8 Weeks
|
|
Frequency of Use of App - Youth Participants
Time Frame: Weeks 1, 4, 8, and 12
|
Website usage metrics were captured by counting the number of website log-ins by Youth (adolescent) Participants.
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Weeks 1, 4, 8, and 12
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|
Frequency of Use of App - Adult Caregiver Participants
Time Frame: Weeks 1, 4, 8, and 12
|
Website usage metrics were captured by counting the number of website log-ins by parents/caregivers.
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Weeks 1, 4, 8, and 12
|
|
Frequency of Use of App - Adult Support Participants
Time Frame: Week 1, 4, 8, 12
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Website usage metrics were captured by counting the number of website log-ins by supporting adults.
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Week 1, 4, 8, 12
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Duration of Use of App - Youth Participants
Time Frame: Weeks 1, 4, 8, and 12
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Website usage metrics were captured by measuring the duration of website use by adolescents.
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Weeks 1, 4, 8, and 12
|
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Duration of Use of App - Adult Caregiver Participants
Time Frame: Weeks 1, 4, 8, and 12
|
Website usage metrics were captured by measuring the duration of website use by parents/caregivers.
|
Weeks 1, 4, 8, and 12
|
|
Duration of Use of App - Adult Support Participants
Time Frame: Weeks 1, 4, 8, and 12
|
Website usage metrics were captured by measuring the duration of website use by by support adults.
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Weeks 1, 4, 8, and 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of Intervention Measure (FIM) - Youth Participants
Time Frame: At 4 Weeks
|
Items were scored on a 5-point scale ranging from 1 to 5 (completely disagree to completely agree).
Higher scores indicated higher perceived intervention feasibility.
Results reflect data from Youth Participants.
|
At 4 Weeks
|
|
Feasibility of Intervention Measure (FIM) - Adult Caregiver Participants
Time Frame: At 4 Weeks
|
Items were scored on a 5-point scale ranging from 1 to 5 (completely disagree to completely agree).
Higher scores indicated higher perceived intervention feasibility.
Results reflect data from Adult Caregiver Participants.
|
At 4 Weeks
|
|
Feasibility of Intervention Measure (FIM) - Adult Support Participants
Time Frame: At 8 Weeks
|
Items were scored on a 5-point scale ranging from 1 to 5 (completely disagree to completely agree).
Higher scores indicated higher perceived intervention feasibility.
Results reflect data from Adult Support Participants.
|
At 8 Weeks
|
|
Acceptability of Intervention Measure (AIM) - Youth Participants
Time Frame: At 4 Weeks
|
Items were scored on a 5-point scale ranging from 1 to 5 (completely disagree to completely agree).
Higher scores indicated higher acceptability.
Results reflect data from Youth Participants.
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At 4 Weeks
|
|
Acceptability of Intervention Measure (AIM) - Adult Caregiver Participants
Time Frame: At 4 Weeks
|
Items were scored on a 5-point scale ranging from 1 to 5 (completely disagree to completely agree).
Higher scores indicated higher acceptability.
Results reflect data from Adult Caregiver Participants.
|
At 4 Weeks
|
|
Acceptability of Intervention Measure (AIM) - Adult Support Participants
Time Frame: At 8 Weeks
|
Items were scored on a 5-point scale ranging from 1 to 5 (completely disagree to completely agree).
Higher scores indicated higher acceptability.
Results reflect data from Adult Support Participants.
|
At 8 Weeks
|
|
Intervention Appropriateness Measure (IAM) - Youth Participants
Time Frame: At 4 Weeks
|
Items were scored on a 5-point scale ranging from 1 to 5 (completely disagree to completely agree).
Higher scores indicated higher perceived intervention appropriateness.
Results reflect data from Youth Participants.
|
At 4 Weeks
|
|
Intervention Appropriateness Measure (IAM) - Adult Caregiver Participants
Time Frame: At 4 Weeks
|
Items were scored on a 5-point scale ranging from 1 to 5 (completely disagree to completely agree).
Higher scores indicated higher perceived intervention appropriateness.
Results reflect data from Adult Caregiver Participants.
|
At 4 Weeks
|
|
Intervention Appropriateness Measure (IAM) - Adult Support Participants
Time Frame: At 8 Weeks
|
Items were scored on a 5-point scale ranging from 1 to 5 (completely disagree to completely agree).
Higher scores indicated higher perceived intervention appropriateness.
Results reflect data from Adult Support Participants.
|
At 8 Weeks
|
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Client Satisfaction Questionnaire (CSQ-I) - Youth Participants
Time Frame: At 4 Weeks
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The CSQ-I was a valid and reliable scale for measuring overall satisfaction with health and human services, including digital or internet-based intervention.
This was adapted for use with youth, parents, and support adults.
The adapted scales each had 8 items in a Likert scale ranging from 8-32 where higher numbers indicated higher satisfaction.
Results reflect data from Youth Participants.
|
At 4 Weeks
|
|
Client Satisfaction Questionnaire (CSQ-I) - Adult Caregiver Participants
Time Frame: At 4 Weeks
|
The CSQ-I was a valid and reliable scale for measuring overall satisfaction with health and human services, including digital or internet-based intervention.
This was adapted for use with youth, parents, and support adults.
The adapted scales each had 8 items in a Likert scale ranging from 8-32 where higher numbers indicated higher satisfaction.
Results reflect data from Adult Caregiver Participants.
|
At 4 Weeks
|
|
Client Satisfaction Questionnaire (CSQ-I) - Adult Support Participants
Time Frame: At 8 Weeks
|
The CSQ-I was a valid and reliable scale for measuring overall satisfaction with health and human services, including digital or internet-based intervention.
This was adapted for use with youth, parents, and support adults.
The adapted scales each had 8 items in a Likert scale ranging from 8-32 where higher numbers indicated higher satisfaction.
Results reflect data from Adult Support Participants.
|
At 8 Weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Alejandra Arango, University of Michigan
- Study Director: Patricia Simon, Oui Therapeutics, Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00221931
- 5R43MH128431-02 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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