Healthy Relationships on the Autism Spectrum: Feasibility and Target Engagement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Hostile Automatic Thoughts (HATS)
研究概览
简要总结
The goal of this randomized clinical trial is to test whether the 6 sessions HEARTS Healthy Relationships classes increases the satisfaction that autistic adults feel about their friendships and dating relationships compared to a 6 weeks online discussion group. The 6 HEARTS sessions cover: healthy and unhealthy relationships, launching new relationships, neurohealth, meeting and reconnecting, boundaries, and healthy endings.
Participants who take part in this research study will be in this research study for three months. During this time, participants will be asked to complete two 30-minute and six 10-minute online surveys.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with autism by a healthcare provider or other professional
- •Willing to be randomized to either HEARTS or the active control condition (ACC)
- •Have not already participated in the study, nor in the HEARTS class previously
- •English speaking
排除标准
- •unwilling or unable to provide informed consent by themselves
- •have participated at any time previously in HEARTS research or the HEARTS class
- •are unable to understand English
研究组 & 干预措施
HEARTS NOW
Participants in the HEARTS NOW group participants will participate in a weekly six-session online HEARTS class via Zoom about relationships.
干预措施: HEARTS classes (Behavioral)
HEARTS LATER
Participants in the HEARTS LATER group will participate in a six-week online support group via Zoom about relationships. Participants in this arm will have the option of taking the HEARTS class after the study has ended.
干预措施: Online discussion group (Behavioral)
结局指标
主要结局
Hostile Automatic Thoughts (HATS)
时间窗: baseline, 12 weeks
The 25-item Hostile Automatic Thoughts (HAT) Scale is a self-report measure that assesses participants' ability to engage in perspective-taking related to perceived rejection and the extent to which they attribute hostile intentions to a person given an ambiguous situation. Completed by participant. For each item participants will select either: often, sometimes, or never. Higher scores are associated with higher levels of perceived rejection. Scale minimum possible score of 25, scale maximum possible score of 125. A higher score is less desirable and indicates more Hostile Automatic Thoughts.
Rejection Sensitivity Questionnaire
时间窗: baseline, 12 weeks
The Rejection Sensitivity Questionnaire (RSQ), a 10-item self-report measure that assesses participants' capacity to be resilient when experiencing social rejection such as sending a text message and not getting a reply. Lower scores are associated with more resilience given rejection and thus are desirable. The minimum possible score is 20 and the maximum possible score is 720.
CGI-I
时间窗: baseline, 12 weeks
This was a binary variable that represents either improvement, or no improvement. To assess improvement, we used the Clinical Global Impressions-Improvement (CGI-I) which is a global measure of improvement and functioning, and measures satisfaction with quality of close relationships. Each of the 3 items are rated on a 7-point scale from: 1 (normal) to 7 (amongst the most severely ill patients). CGI-C scores range from 7 (very much worse) to 1 (very much improved). In this study, those who scored 1, 2 or 3 were considered "improved" and those who scored 4, 5, 6 or 7 were considered "not improved."
SMI
时间窗: baseline, 12 weeks
Social motivation was assessed via the Autistic Social Health Interview. The ASHI, adapted from the Social Motivation Interview (Elias \& White, 2020), assesses the following dimensions of social health: person's satisfaction with their interpersonal relationships, motivation to socialize, quantity of social relationships and encounters, and willingness to persist in social interaction. During the interview, the interviewer enquires about behaviors over the prior two weeks. The total ASHI score can range from 0-24, with higher scores indicative of greater overall social health.
次要结局
- Intervention Acceptability(6 weeks)
- Content Acceptability, Week 1(weekly during the 6 weeks of the interventions)
- Teacher Rating of Participant Engagement and Satisfaction(weekly during the 6 weeks of the interventions)
研究者
Emily Rothman
Professor
Boston University Charles River Campus