Digital Youth-Nominated Support Team (YST) Program

Suicide Clinical Trial

Official title:

An Open-Label Study of the Feasibility and Usability of a Digital Psychoeducational Social Network Intervention for Suicidal Adolescents

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05900700
• Other study ID #: HUM00221931
• Secondary ID: 1R43MH128431
• Status: Recruiting
• Phase: N/A
• Start date: November 27, 2023
• Est. completion date: September 2024

Study information

• Verified date: December 2023
• Source: University of Michigan
• Contact: Alejandra Arango
• Phone: 734-764-0231
• Email: arango[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: September 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

Inclusion Criteria:

1. Inpatient psychiatric patients who have attempted suicide or have documented Suicide ideation (SI) and a plan to harm themselves at admission.

2. Understand written and spoken English.

3. Own a smartphone or mobile phone.

4. Willing and able to complete enrollment procedures.

5. Parent or guardian and youth able to understand the nature of the study and provide written informed consent and assent for youth

6. Patients who are able to provide at least one verifiable contact for emergency or tracking purposes.

Exclusion Criteria:

1. Patients with active psychosis.

2. Patients experiencing substance withdrawal.

3. Currently enrolled in other treatment studies for the symptoms and behaviors targeted.

4. Patient unwilling or unable to wear a mask during in person study procedures, if mandated due to current COVID/health safety guidelines.

5. Patients who in the judgment of the investigator would have an unfavorable risk or benefit profile with respect to eYST.

6. 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.

Related Conditions & MeSH terms

• Suicide

Intervention

Behavioral:
• eYST website
The website is a psychoeducational, social support program for adolescents at risk for suicide

Locations

Country	Name	City	State
United States	Michigan Medicine	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to week 14
Primary	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.	Up to week 12
Primary	Duration of use of app	The researchers will record the duration of app use.	Up to week 12
Secondary	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.	Up to week 14
Secondary	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.	Up to week 14
Secondary	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.	Up to week 14
Secondary	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.	Up to week 14