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临床试验/NCT05919849
NCT05919849招募中1 期

Development and Initial Trial of Two Brief Interventions to Support Parents in Affirming Their Children's Experiences of Sexuality and Gender

Yale University6 个研究点 分布在 2 个国家目标入组 129 人开始时间: 2023年11月29日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
招募中
入组人数
129
试验地点
6
主要终点
Change in Parents' Rejecting and Supportive Behaviors Measured By the Parent Non-Acceptance Scale

研究概览

简要总结

The purpose of this study is to develop and test two brief online writing interventions to improve parental acceptance of sexual and gender minority youth (SGMY) in the Southeast United States.

详细描述

The purpose of this study is to develop and test the acceptability, feasibility, and preliminary efficacy of two brief online writing interventions to improve parental acceptance of sexual and gender minority youth (SGMY) in the Southeast United States. Parental support represents the strongest predictor of sexual and gender minority youth's (SGMY) mental health. However, many parents react to their SGMY's disclosure with rejection. Even relatively accepting parents can experience discomfort, while SGMY often report lingering unmet needs from their parents into adulthood. Few interventions exist to help parents support their SGMY child and none has been tested in a randomized trial with efficacy for decreasing parental rejection and increasing support of their SGMY. This proposal will develop and test the efficacy of two theory-based interventions that aim to address this gap. Results will identify mechanisms contributing to parental rejection and develop scalable approaches to reduce these mechanisms to shrink the substantial mental health disparities affecting SGMY. If efficacious, these interventions can be scaled up through online platforms capable of bypassing barriers to parental support of SGMY across high-stigma regions.

The focus of this registration is the randomized controlled trial.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Participants will be made aware of the writing intervention they will complete.

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Parents are eligible if they meet the following criteria:
  • Be a parent, grandparent, or any other family member who considers themselves a guardian of an SGMY between 15-29 years old,
  • Live in the Southeast United States (Louisiana, Mississippi, Alabama, Georgia, South Carolina, North Carolina, Tennessee, Arkansas, Kentucky, Florida),
  • Identify as heterosexual and cisgender, and
  • Report non-acceptance of their SGMY.
  • SGMY are eligible if they meet the following criteria:
  • Self-identify as SGM,
  • Are 15-29 years old,
  • Live in the Southeast United States, and
  • Have a parent enrolled in the trial

排除标准

  • Any individual who meets any of the following criteria will be excluded from participation in this study:
  • Active mania, psychosis, or suicidality, and
  • Unable to provide informed consent.

研究组 & 干预措施

Expressive Writing (EW)

Experimental

Participants in the expressive writing (EW) condition will be instructed to write in a free-form manner about the most stressful aspects of being a parent of an SGMY, following standard EW procedures.

干预措施: Brief online writing intervention (Behavioral)

Attachment-Based Writing (ABW)

Experimental

Participants in the attachment-based writing (ABW) condition will respond to distinct prompts created for the condition based on components of attachment-based family therapy (ABFT).

干预措施: Brief online writing intervention (Behavioral)

Neutral Writing (Control)

Other

Participants in the control condition will be asked to write about what they have done since waking up that morning.

干预措施: Control condition (Other)

结局指标

主要结局

Change in Parents' Rejecting and Supportive Behaviors Measured By the Parent Non-Acceptance Scale

时间窗: Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline

The 10-item Parent Non-Acceptance Scale is a self-reported instrument assessing positive and negative indicators of parental acceptance of their SGMY. Parents report level of agreement on a scale from 1 (Strongly Disagree) to 6 (Strongly Agree), with a higher score on negative indicators representing a higher level of non-acceptance and a higher score on positive indicators representing a lower level of non-acceptance.

次要结局

  • Change in Secondary Parental Acceptance and Rejection Measured By the Five-Minute Speech Sample(Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline)
  • Change in Parent Perceived Stress Using the Perceived Stress Scale(Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline)
  • Change in Parent Report of Child Depression and Anxiety Using the PROMIS Depression and Anxiety Scales(Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline)
  • Change in Secondary Parental Acceptance and Rejection Measured By the the Parental Acceptance/Rejection Questionnaire(Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline)
  • Change in Parent Negative Emotion Using a Modified Positive and Negative Affect Schedule (PANAS)(Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline)
  • Change in Secondary Parental Acceptance and Rejection Measured By the Children's Report of Parent Behavior Inventory(Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline)
  • Change in Parent Anti-SGM Bias Assessed Using the Social Distance Scale(Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline)
  • Change in Parent Anti-SGM Bias Assessed Using the Lesbian, Gay, Bisexual Affiliate Stigma Measure(Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline)
  • Change in Parent-Child Relationship Quality and Stress Assessed by the McMaster Family Assessment Device General Functioning Subscale(Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline)
  • Change in Parent-Child Relationship Quality and Stress Assessed by the Parental Environment Questionnaire Conflict, Involvement, and Regard for Child Subscales(Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline)
  • Change in Parent Depression and Anxiety Using the PROMIS (Patient-Reported Outcomes Measurement Information System®) Depression, Anxiety, and Anger Scales(Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline)
  • Intervention Acceptability Measured By the Client Satisfaction Questionnaire(3-Month-Post-Baseline)
  • Change in Parent-Child Unresolved Conflict Measured Using the Unfinished Business Scale(Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline)
  • Change in Parent Empathy Measured By the Questionnaire of Cognitive and Affective Empathy(Baseline, 5 Days Post-Baseline, and 3 Months Post-Baseline)
  • Intervention Acceptability Measured By the Treatment Acceptability Survey(3-Month-Post-Baseline)
  • Intervention Feasibility Measured By Percentage of Fully Engaged Sessions(Measured Throughout Intervention (Up to 2 Weeks))
  • Intervention Feasibility Measured By Percentage of Intervention Sessions Completed(Measured Throughout Intervention (Up to 2 Weeks))
  • Intervention Feasibility Measured By Number of Platform Technical/Accessibility Issues(Measured Throughout Intervention (Up to 2 Weeks))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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