Development and Feasibility Testing of a Suicide Prevention Intervention for Sexual and Gender Minority Youth

NCT05724784 | Completed

• 1 other identifier: STUDY22120062
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to develop and test a brief, digital, suicide prevention intervention for sexual and gender minority (SGM) youth who have experienced cyberbullying. Leading up to this phase, the study team completed two prior study aims, focused on identifying perspectives of SGM youth's regarding their experiences with cyberbullying and priorities for an intervention, and a phase in which SGM youth codesigned the study's intervention with the study team. This resulted in the development of study's intervention, Flourish, which leverages a text messaging-based chatbot to reduce suicide risk following cyberbullying among SGM youth through improving distress tolerance, motivation for help-seeking, and social problem-solving. Current Study Aim: Conduct an open trial to assess the feasibility and acceptability of Flourish among cyberbullied SGM youth, ages 12-17 (N=10). Hypotheses: Feasibility will be evidenced by recruitment/retention rates \> 80% and use of Flourish among \> 70% of SGM youth. At follow-up, adolescents will report improved problem-solving capacity, distress tolerance, and motivation for help-seeking and reduced psychological distress and suicidal ideation compared to baseline.

Conditions

Psychological Distress; Suicidal Ideation

Outcome Measures

Primary Outcomes (3)

• Recruitment rates of eligible participants

  Feasibility will be measured through recruitment rates of eligible participants, using a cut-off score of 80% for desirable recruitment rates.

  Assessed upon recruitment to the study

• Retention rates of eligible participants

  Feasibility will be measured through retention rates of eligible participants, using a cut-off score of 80% for desirable retention rates across the 12-week study period.

  Assessed upon completion of the Week 12 study visits

• Level of intervention usage

  Usage of the intervention will be assessed by engagement with the text messaging intervention one or more times during the study period. A cut-off score of 70% of youth using the intervention one or more times will be used as a minimum requirement for acceptable usage.

  Assessed upon completion of the 4-week intervention period

Secondary Outcomes (6)

• Change in psychological distress from baseline to 4 weeks

  Assessed at the baseline and Week 4 follow-up assessment visits.

• Change in psychological distress from baseline to 4 weeks

  Assessed at the Week 12 follow-up assessment visits.

• Change in severity of suicidal ideation and behavior from baseline to 4 weeks

  Assessed at baseline and Week 4 follow-up assessment visits.

• Change in severity of suicidal ideation and behavior from baseline to 12 weeks

  Assessed at baseline and Week 12 follow-up assessment visits.

• Change in suicidal ideation from baseline to 4 weeks

  Assessed at the baseline and Week 4 assessment visits.

Other Outcomes (6)

• Change in distress tolerance from baseline to 4 weeks

  Assessed at the baseline and Week 4 assessment visits

• Change in distress tolerance from baseline to 12 weeks

  Assessed at the baseline and Week 12 assessment visit.

• Change in motivation for help-seeking from baseline to 4 weeks

  Assessed at the baseline and Week 4assessment visits.

Study Arms (1)

Flourish

EXPERIMENTAL

Participants will be onboarded to Flourish by a research study clinician, following which they will receive a text messaging program for 4 weeks as well as an accompanying resources website.

Behavioral: Flourish

Interventions

Flourish BEHAVIORAL

Flourish is a text messaging program that aims to improve coping following cyberbullying and reduce suicide risk among youth.

Flourish

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• self-reported SGM identity
• English-speaking
• access to a phone or device to complete the study's intervention
• past-month history of cyberbullying or online discrimination, assessed by the cybervictimization subscale of the traditional and cyberbullying victimization and perpetration scale or a discrimination measure developed as part of the Adolescent Brain and Cognitive Development (ABCD) study
• lifetime history of suicidal ideation or behavior (assessed by the Ask Suicide Screen)

You may not qualify if:

• intellectual challenges, low literacy levels, or other conditions that might inhibit adolescents' ability to effectively engage with Flourish (reported by parents and, if needed, confirmed through the age-appropriate Wechsler Intelligence scale)
• acuity levels suggesting need for a higher level of care (e.g., inpatient hospitalization) or referral for emergency services

Sponsors & Collaborators

• University of Pittsburgh: lead
• American Foundation for Suicide Prevention: collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Suicidal Ideation

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Candice L Biernesser, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The study design is an open trial.

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 13, 2023
• Study Start: May 24, 2023
• Primary Completion: October 16, 2023
• Study Completion: September 30, 2024
• Last Updated: October 3, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: These data will be released following acceptance of the project's main outcomes manuscript.
• Access Criteria: Data requests may be sent to the PI for review, who will provide data to interested and qualified investigators.

Locations

US (1)