Institute of Education, University of Plymouth, Plymouth, UK
Department of Clinical Psychology, University of Plymouth, Plymouth, UK.
BMJ Open. 2020 Dec 31;10(12):e038411. doi: 10.1136/bmjopen-2020-038411.
To establish the feasibility of a definitive randomised controlled trial of Systemic Autism-related Family Enabling (SAFE), an intervention for families of children with autism.
A randomised, controlled, multicentred feasibility study.
Participants were identified from three National Health Service (NHS) diagnosing centres in Plymouth and Cornwall and a community pathway.
34 families of a child with a diagnosis of autism severity level 1 or 2 between 3 and 16 years. Four families were lost to follow-up.
SAFE is a manualised five-session family therapy-based intervention delivered over 16 weeks and designed for families of children with autism. SAFE involves families attending five 3-hour sessions led by systemic practitioners.
The proposed primary outcome measure was the Systemic CORE 15 (SCORE-15). Proposed secondary outcome measures: Patient Health Questionnaire-Somatic Anxiety Depressive Symptoms, the Coding of Attachment-Related Parenting for use with children with Autism, the Child Behaviour Checklist (CBCL), the Reflective Functioning Questionnaire (RFQ) and the Caregiving Helplessness Questionnaire. Outcome measures were collected at baseline and 24 weeks post randomisation.
All primary caregivers retained in the study completed the SCORE-15 at both time points. 34 of the target of 36 families were recruited and 88% of families were retained. Training for therapists was effective. Feedback revealed willingness to undergo randomisation. There was 100% attendance at appropriate sessions for core family members. The SCORE-15 showed reduction in scores for families receiving SAFE compared with controls suggesting positive change. Qualitative data also revealed that families found the study acceptable and families receiving SAFE experienced positive change. Feedback indicated that the SCORE-15 should be retained as a primary measure in a future trial, but secondary measures should be reduced.
This study indicates that a larger trial of SAFE is feasible. Findings suggest that SAFE can address current gaps in recommended care, can be confidently delivered by NHS staff and has potential as a beneficial treatment.
ISCTRN83964946 and IRAS213527.
确定自闭症相关家庭赋能系统（SAFE）的确定性随机对照试验的可行性，SAFE 是一种针对自闭症儿童家庭的干预措施。
随机、对照、多中心可行性研究。
参与者从普利茅斯和康沃尔的三个英国国家医疗服务体系（NHS）诊断中心和一个社区途径中确定。
34 名自闭症严重程度为 1 级或 2 级的儿童的家庭，年龄在 3 至 16 岁之间。有 4 个家庭失访。
SAFE 是一种基于家庭治疗的五节系统干预措施，共 16 周，专为自闭症儿童的家庭设计。SAFE 涉及家庭参加由系统从业人员领导的五次 3 小时的会议。
拟议的主要结果测量是系统 CORE 15（SCORE-15）。拟议的次要结果测量：患者健康问卷-躯体焦虑抑郁症状、用于自闭症儿童的依恋相关育儿编码、儿童行为检查表（CBCL）、反思功能问卷（RFQ）和护理无助感问卷。在随机分组后 24 周收集结果测量。
所有保留在研究中的主要照顾者在两个时间点都完成了 SCORE-15。36 个目标家庭中的 34 个被招募，88%的家庭被保留。治疗师的培训是有效的。反馈表明愿意进行随机分组。核心家庭成员参加适当的会议的出勤率为 100%。与对照组相比，接受 SAFE 的家庭的 SCORE-15 评分显示出降低，表明有积极的变化。定性数据还表明，家庭认为该研究是可以接受的，接受 SAFE 的家庭经历了积极的变化。反馈表明，SCORE-15 应该作为未来试验的主要指标保留，但次要指标应该减少。
这项研究表明，SAFE 的更大规模试验是可行的。研究结果表明，SAFE 可以解决推荐护理中的现有差距，可以由英国国家医疗服务体系的工作人员自信地提供，并具有作为有益治疗的潜力。
ISCTRN83964946 和 IRAS213527。
Zotero 插件
