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临床试验/NCT05724784
NCT05724784已完成不适用

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

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2023年5月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
11
试验地点
2
主要终点
Recruitment rates of eligible participants

研究概览

简要总结

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.

详细描述

FLOURISH:

Flourish is a chatbot that will aim to improve adolescents' capacity to cope following cyberbullying and reduce their suicidal risk. The duration of Flourish is 4 weeks. Flourish is designed to be self-paced with branching logic, aiming to provide the right type of support at the right time youth need it. Therefore, the frequency with which youth interact with Flourish will differ from person to person. However, participants are expected to interact with Flourish no less than 2-3 times per week.

Onboarding. Prior to initiating Flourish, adolescents and their caregivers will participate in a session of approximately 30 minutes with a study clinician in which they will onboard to Flourish. During onboarding, the clinician will orient the adolescent to Flourish and load information onto Flourish that will be available to the adolescent throughout their use of the intervention. This will include personal crisis contacts, such as trusted adults and crisis hotlines they could contact in the event of a crisis, as well as contacts for people they could reach out to for support or distraction outside of a crisis situation, such as a close friend or a family member. Adolescents will additionally enter information to personalize their experience with Flourish, such as entering preferences for coping skills that work best for them. During the onboarding process, caregivers will be provided with resources to respond to cyberbullying s as well as information on their child's personal crisis resources.

Launch. The research team will administer brief questionnaires to adolescents 2-3 times per week during the 4-week intervention period that assess positive/supportive and negative/bullying interactions on social media. If adolescents indicate negative interactions, Flourish will automatically launch. If adolescents indicate supportive interactions (or no interactions), they will be given the option to launch Flourish to practice their coping skills, so they are prepared to respond to future cyberbullying events.

Resource Website:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
12 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

结局指标

主要结局

Recruitment rates of eligible participants

时间窗: Assessed upon recruitment to the study

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

Retention rates of eligible participants

时间窗: Assessed upon completion of the Week 12 study visits

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.

Level of intervention usage

时间窗: Assessed upon completion of the 4-week intervention period

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.

次要结局

  • Change in psychological distress from baseline to 4 weeks(Assessed at the Week 12 follow-up assessment visits.)
  • Change in suicidal ideation from baseline to 12 weeks(Assessed at the baseline and 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.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Candice Biernesser

Assistant Professor

University of Pittsburgh

研究点 (2)

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