Department of Speech Pathology and Audiology, National Institute of Mental Health and Neurosciences, Bangalore, Karnataka, India.
Department of Allied Health Sciences, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
Autism Res. 2024 Sep;17(9):1853-1866. doi: 10.1002/aur.3217. Epub 2024 Aug 28.
Preliminary evidence indicates potential benefit of providing caregiver-mediated intervention, prior to diagnosis, for infants at elevated familial likelihood for autism and related developmental delays including language delay (EL-A). However, delivering such interventions online and in low-resource settings like India has not been reported. This study aimed to evaluate the feasibility and acceptability of delivering a novel manualized caregiver-mediated early support program, the "LiL' STEPS," online in India, for EL-A infants. LiL' STEPS stands for Language development & Intervention Lab's (LiL') Supporting Early social-communication and language by Promoting caregiver Sensitive responsiveness (STEPS). The program comprised 14 sessions with a focus on social-communication and language, conducted over 12-weeks using demonstration and video feedback. Families of 36 EL-A infants aged 9 to 15-months participated in this feasibility randomized controlled trial (RCT). Families were randomized in a 2:1 ratio (n = 24 LiL' STEPS and n = 12 care as usual groups). Information on feasibility and acceptability was collated following a mixed methods approach from caregiver interviews, fidelity forms, session notes, and study register. Findings indicated the LiL' STEPS study trial as feasible and acceptable with recruitment rate of 4 per month, 100% willingness for randomization, 8.3% attrition, and 3.03% loss of blinding. Interventionist and caregiver fidelity was maintained above 80%. Despite challenges like interruptions during sessions, 100% families found the program acceptable and satisfactory, 86% said they would recommend the program to others, and 71% preferred online modality. Caregivers' perspectives on beneficial components and experience attending the program have been described. Accordingly, recommendations for future definitive RCTs have been presented.
初步证据表明，在诊断前为具有自闭症和相关发育迟缓（包括语言迟缓）家族高风险的婴儿提供以照顾者为媒介的干预可能有益（EL-A）。然而，在印度等资源有限的环境中在线提供此类干预措施尚未有报道。本研究旨在评估在印度在线为 EL-A 婴儿提供新型的手册化照顾者介导的早期支持计划，即“LiL' STEPS”的可行性和可接受性。LiL' STEPS 代表语言发展与干预实验室（LiL'）通过促进照顾者的敏感反应（STEPS）来支持早期社交沟通和语言。该计划由 14 次课程组成，重点是社交沟通和语言，使用演示和视频反馈在 12 周内进行。36 名年龄在 9 至 15 个月的 EL-A 婴儿的家庭参加了这项可行性随机对照试验（RCT）。家庭以 2:1 的比例随机分组（n=24 名接受 LiL' STEPS 干预，n=12 名接受常规护理）。通过混合方法从照顾者访谈、保真度表、课程笔记和研究登记处收集可行性和可接受性信息。研究结果表明，LiL' STEPS 研究试验是可行且可接受的，每月招募率为 4 名，100%愿意进行随机分组，8.3%的失访率和 3.03%的失盲率。干预者和照顾者的保真度保持在 80%以上。尽管存在课程中断等挑战，但 100%的家庭认为该计划是可接受和满意的，86%的家庭表示会向他人推荐该计划，71%的家庭更喜欢在线模式。描述了照顾者对有益组成部分的看法以及参加该计划的体验。因此，提出了对未来确定性 RCT 的建议。
