Centre for Research in Intellectual and Developmental Disabilities (CIDD), University of Warwick, Coventry, UK.
School of Health Sciences, University of East Anglia, Norwich, UK.
Health Technol Assess. 2024 Oct;28(64):1-118. doi: 10.3310/LRWD7852.
There is a lack of interventions for specific phobia in children and adolescents with moderate to severe intellectual disabilities.
The objectives were to: (a) develop an intervention for specific phobia, together with an intervention fidelity checklist and logic model, and evaluate candidate outcome measures, together with parents/carers and clinicians; (b) describe treatment as usual; (c) model the intervention to determine the acceptability and feasibility for all stakeholders, judge the appropriateness of outcome measures, explore recruitment pathways, and examine the feasibility and acceptability of consent and associated processes; and (d) describe factors that facilitate or challenge the intervention.
Phase 1a: using consensus methods, an Intervention Development Group was established who met to develop the intervention, review candidate outcome measures and contribute to the development of the intervention fidelity checklists and logic model. Phase 1b: a national online survey was conducted with parents and professionals to describe treatment as usual. Phase 2: a single-group non-randomised feasibility study was designed to model the intervention and to test intervention feasibility and acceptability, outcome measures and aspects of the research process.
Phase 2: participants were recruited from National Health Service community child learning disabilities teams and special schools in England. Treatment was delivered in the child learning disabilities teams.
Children aged 5-15 years with moderate to severe learning disability and specific phobia, and their parents/carers.
The SPIRIT intervention comprised two half-day workshops and eight support sessions plus treatment as usual.
The feasibility and acceptability of the intervention and research processes, recruitment, outcome measure completion rates and acceptability, and intervention adherence. Parents completed all of the outcome measures, with very low rates of missing data. The recruitment of sites and participants was impacted by the COVID-19 pandemic.
The intervention was successfully developed and modelled with 15 participants with moderate to severe learning disabilities and their parents. The intervention was judged to be feasible and acceptable by parents/carers and therapists. Parents/carers and therapists suggested minor intervention revisions.
Randomisation was not modelled within this feasibility study, although the majority of parents and therapists indicated that this would be acceptable.
The SPIRIT intervention and associated study processes were judged to be feasible and acceptable. The intervention requires minor revisions.
The SPIRIT intervention should be tested further within a clinical trial.
Current Controlled Trials ISRCTN34766613.
This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: NIHR130177) and is published in full in ; Vol. 28, No. 64. See the NIHR Funding and Awards website for further award information.
针对中重度智力障碍的儿童和青少年的特定恐惧症,缺乏干预措施。
(a)制定针对特定恐惧症的干预措施,以及干预可信度检查表和逻辑模型,并与父母/照顾者和临床医生一起评估候选结果测量方法;(b)描述治疗常规;(c)对干预措施进行建模,以确定所有利益相关者的可接受性和可行性,判断结果测量方法的适当性,探索招募途径,并检查同意书和相关程序的可行性和可接受性;以及(d)描述促进或挑战干预措施的因素。
第 1a 阶段:使用共识方法,成立干预措施制定小组,共同制定干预措施,审查候选结果测量方法,并为干预可信度检查表和逻辑模型的制定做出贡献。第 1b 阶段:对父母和专业人员进行了全国在线调查,以描述治疗常规。第 2 阶段:设计了一项单组非随机可行性研究,对干预措施进行建模,并测试干预措施的可行性和可接受性、结果测量方法和研究过程的各个方面。
第 2 阶段:参与者从英格兰的国民保健服务社区儿童学习障碍团队和特殊学校招募。治疗在儿童学习障碍团队中进行。
年龄在 5-15 岁之间、有中度至重度学习障碍和特定恐惧症的儿童及其父母/照顾者。
SPIRIT 干预措施包括两个半天的研讨会和八次支持会议以及治疗常规。
干预措施和研究过程的可行性和可接受性、招募情况、结果测量完成率和可接受性以及干预措施的依从性。父母完成了所有的结果测量,数据缺失率非常低。由于 COVID-19 大流行,地点和参与者的招募受到了影响。
成功地制定并对 15 名患有中重度学习障碍的儿童及其父母进行了模型干预。父母/照顾者和治疗师认为该干预措施具有可行性和可接受性。父母/照顾者和治疗师建议对干预措施进行一些小的修改。
虽然大多数父母和治疗师表示可以接受,但在这项可行性研究中没有对随机化进行建模。
SPIRIT 干预措施和相关研究过程被认为是可行和可接受的。该干预措施需要进行一些小的修改。
SPIRIT 干预措施应在临床试验中进一步测试。
当前对照试验 ISRCTN34766613。
该奖项由英国国家卫生与保健研究所(NIHR)健康技术评估计划(NIHR 奖励号:NIHR130177)资助,并全文发表于;第 28 卷,第 64 期。有关进一步的奖励信息,请访问 NIHR 资助和奖励网站。