Evaluation of a Resiliency Intervention for Siblings of Children With Autism Spectrum Disorder (ASD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Effectiveness of trial on improving stress coping ability (assessed using Measure of Current Status-A)
研究概览
简要总结
The proposed research has the following objectives:
Based off findings from the "Development of a Resiliency Program for Siblings of Children with Autism Spectrum Disorder" qualitative focus group study (protocol 2019P002284), the aim is to determine the feasibility and acceptability, of an 8-session Relaxation Response Resiliency (SibChat) program for siblings of children with ASD.
We primarily aim to test the preliminary effectiveness of a pilot waitlist controlled trial on improving resiliency and stress coping, This will be assessed by comparing Baseline-3 mo. scores on primary and secondary outcome measures between the Immediate and Waitlist control groups.
Among participants randomized to both conditions, we secondarily aim to investigate the extent of pre-post changes in primary and secondary outcomes. Among immediate condition group only, we also aim to assess whether end-of-treatment (3 mo. post enrollment) improvements will be sustained at 6-mo. post enrollment.
详细描述
This intervention will be a modified version of Dr. Elyse Park's evidence-based 8-week multimodal treatment which is designed to promote adaptation to stress and promotion of resiliency. The program is an 8 session, 1 hour a week multi modal intervention that incorporates relaxation techniques, stress awareness discussion, and adaptive strategies for coping with stress. This study will refine an 8-session group virtual-delivered resiliency treatment program consisting of 8 virtual group 1-1 ½ hour sessions. The goal of this study would be to advance our ultimate objective to implement a national sibling resiliency program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 14-17 years (inclusive of ages 14 and 17)
- •Being the sibling of at least one individual with ASD
- •Access to internet or smart phone
- •English speaking
排除标准
- •Diagnosis of ASD
- •Past year psychiatric hospitalization
- •There are no exclusion criteria with respect to ethnicity or socioeconomic status.
结局指标
主要结局
Effectiveness of trial on improving stress coping ability (assessed using Measure of Current Status-A)
时间窗: 3 months
Measure of Current Status-A is a questionnaire - the score on the questionnaire is used to indicate stress coping ability. A change in score indicates a change in indicated stress coping ability. Comparison of intervention and wait list control 3 months after baseline (T1).
Feasibility assessed by the number SibChat-3RP of sessions attended
时间窗: 8 weeks
Whether youth attended at least 5 out of 8 total program sessions.
Acceptability assessed using the participant feedback survey
时间窗: 3 months
The participant feedback survey is a questionnaire made up of likert scales and open ended questions designed to record acceptability of the SibChat-3RP program on topics including length of sessions, number of sessions, and virtual delivery.
Feasibility assessed by the number participants enrolled.
时间窗: 6 months
We will assess study feasibility based on number of participants enrolled in the study (target N=40)
Effectiveness of trial on improving resiliency (assessed using Current Experiences Scale)
时间窗: 3 months
Current experiences Scale is a questionnaire. Improved resiliency is measured base upon change in questionnaire score. Comparison of intervention and wait list control 3 months after baseline (T1).
Feasibility assessed by the survey retention post intervention.
时间窗: 6 months
Among participants randomized to both conditions, feasibility is assessed by the number of participants who completed the T2 and T3 surveys, 3 months and 6 months post baseline, respectively.
Acceptability assessed by relaxation response adherence
时间窗: 3 months
Among participants randomized to both conditions, relaxation response adherence is measured at T1, T2 and T3. Relaxation response adherence is a 1-item likert scale that indicates how often participants practice relaxation response exercises. Acceptability is determined based on whether participants indicate that they practice relaxation response exercises at least bimonthly 3 months post intervention.
次要结局
- Sustained improvements in primary outcomes of resiliency and stress coping as measured by sustained change in primary outcome scores.(3 months)
- Pre-post intervention changes as measured by change in primary outcome scores of resiliency and stress coping.(3 months)
研究者
Karen Kuhlthau
Principal Investigator
Massachusetts General Hospital