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临床试验/NCT05535348
NCT05535348已完成不适用

Evaluation of a Resiliency Program for Fathers of Children and Youth With Special Health Care Needs

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2022年5月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
1
主要终点
Feedback regarding adapted intervention acceptability by session

研究概览

简要总结

Based on findings from our prior trials with parents of children with learning and attentional disabilities and parents of children with autism spectrum disorder (Kuhlthau et al., 2020; Park et al., 2020; IRB approved: #:2016P001622 and 2016P002037 respectively), the investigators propose to pilot test and refine the adapted resiliency intervention (SMART-3RP) among fathers of children with special health care needs.

详细描述

This is an open pilot study. Based on Phase I findings (IRB #2021P002838), the investigators propose to enroll up to 12 fathers (in 2 groups) of children and youth with special health care needs (CYSHCN) in the adapted SMART-3RP intervention. The SMART-3RP is an 8-session mind-body resiliency intervention that will be conducted virtually. Participants will complete the study survey at baseline and immediately following the intervention. As this is a pilot, participants will also be asked to provide weekly feedback on program sessions and participate in an exit interview following the intervention. The intervention may be iteratively modified as the investigators receive feedback from participants.

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •Self-reported identify as father or male guardian of at least one child with special health care needs (e.g., autism spectrum disorder, cerebral palsy, dyslexia)
  • •Age 18 or older
  • •Ability to participate in group, virtual sessions including access to computer, tablet, or smartphone and internet.

排除标准

  • •unable to speak or read English
  • •unwilling or unable to participate in the study
  • •considered medically or otherwise unable to participate by the study PI.

研究组 & 干预措施

Open Pilot

Experimental

An adapted version of the Relaxation Response Resiliency Program (3RP) for fathers of CYSHCN. The adapted program incorporates the three prongs of the 3RP: RR elicitation, stress awareness, and adaptive strategies.

干预措施: Relaxation Response Resiliency Program for Father of CYSHCN (Behavioral)

结局指标

主要结局

Feedback regarding adapted intervention acceptability by session

时间窗: 6 months

Likert ratings on post-session feedback surveys (0 to 5 with 5 more acceptable), qualitative responses from exit interviews

次要结局

  • Feasibility (attendance at 6/8 sessions)(8 weeks)
  • Feasibility (data collection number completing study surveys)(3 months)
  • Acceptability helpfulness ratings of sessions and aspects of program(3 months)

研究者

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

Karen Kuhlthau

Professor, Principal Investigator

Massachusetts General Hospital

研究点 (1)

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