Back to resultsDigital Youth-Nominated Support Team (YST) Program
Primary Purpose
Suicide
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
eYST website
Sponsored by
About this trial
This is an interventional prevention trial for Suicide focused on measuring Social network, Website
Eligibility Criteria
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.
Sites / Locations
- Michigan Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
eYST website
Arm Description
Outcomes
Primary Outcome Measures
System Usability Scale (SUS) score System Usability Scale (SUS)
10-item measure. Scores range from 0 to 100. The researchers will calculate the mean score. A mean score of 68 is the minimal indicator of usability.
Frequency of use of app
Frequency of eYST platform use will be tracked for each participant user. The researchers will record the number of logins.
Duration of use of app
The researchers will record the duration of app use.
Secondary Outcome Measures
Feasibility of Intervention Measure (FIM)
Items are scored on a 5-point scale ranging from 1 to 5 (completely disagree to completely agree). Higher scores indicated higher perceived intervention feasibility.
Acceptability of Intervention Measure (AIM)
Items are scored on a 5-point scale ranging from 1 to 5 (completely disagree to completely agree). Higher scores indicate higher acceptability.
Intervention Appropriateness Measure (IAM)
Items are scored on a 5-point scale ranging from 1 to 5 (completely disagree to completely agree). Higher scores indicate higher perceived intervention appropriateness.
Client Satisfaction Questionnaire (CSQ-I)
The CSQ-I is a valid and reliable scale for measuring overall satisfaction with health and human services, including digital or internet-based intervention. This will be adapted for use with youth, parents and support adults. The adapted scales each have 8 items in a likert scale ranging from 8-32 where higher numbers indicate higher satisfaction.
Full Information
NCT ID
NCT05900700
First Posted
June 2, 2023
Last Updated
September 8, 2023
Sponsor
University of Michigan
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT05900700
Brief Title
Digital Youth-Nominated Support Team (YST) Program
Official Title
An Open-Label Study of the Feasibility and Usability of a Digital Psychoeducational Social Network Intervention for Suicidal Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The Electronic Youth-Nominated Support Team (eYST), is experimental. The purpose of this study is to get feedback from users about eYST. Another purpose of this study is to learn how well eYST helps youth.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide
Keywords
Social network, Website
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
eYST website
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
eYST website
Intervention Description
The website is a psychoeducational, social support program for adolescents at risk for suicide
Primary Outcome Measure Information:
Title
System Usability Scale (SUS) score System Usability Scale (SUS)
Description
10-item measure. Scores range from 0 to 100. The researchers will calculate the mean score. A mean score of 68 is the minimal indicator of usability.
Time Frame
Up to week 14
Title
Frequency of use of app
Description
Frequency of eYST platform use will be tracked for each participant user. The researchers will record the number of logins.
Time Frame
Up to week 12
Title
Duration of use of app
Description
The researchers will record the duration of app use.
Time Frame
Up to week 12
Secondary Outcome Measure Information:
Title
Feasibility of Intervention Measure (FIM)
Description
Items are scored on a 5-point scale ranging from 1 to 5 (completely disagree to completely agree). Higher scores indicated higher perceived intervention feasibility.
Time Frame
Up to week 14
Title
Acceptability of Intervention Measure (AIM)
Description
Items are scored on a 5-point scale ranging from 1 to 5 (completely disagree to completely agree). Higher scores indicate higher acceptability.
Time Frame
Up to week 14
Title
Intervention Appropriateness Measure (IAM)
Description
Items are scored on a 5-point scale ranging from 1 to 5 (completely disagree to completely agree). Higher scores indicate higher perceived intervention appropriateness.
Time Frame
Up to week 14
Title
Client Satisfaction Questionnaire (CSQ-I)
Description
The CSQ-I is a valid and reliable scale for measuring overall satisfaction with health and human services, including digital or internet-based intervention. This will be adapted for use with youth, parents and support adults. The adapted scales each have 8 items in a likert scale ranging from 8-32 where higher numbers indicate higher satisfaction.
Time Frame
Up to week 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alejandra Arango
Phone
734-764-0231
Email
arango@med.umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alejandra Arango
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Patricia Simon
Organizational Affiliation
Oui Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Michigan Medicine
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alejandra Arango
Phone
734-764-0231
Email
arango@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Alejandra Arango
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Digital Youth-Nominated Support Team (YST) Program
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