Feasibility and acceptability of a caregiver‐mediated early support program, delivered online, for infants at elevated familial likelihood for autism: A feasibility randomized controlled trial

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. Lay Summary The current study tries to understand if it is possible to provide an early support program called LiL' STEPS, online, in India and how acceptable it is to families of infant siblings of autistic children. The program comprised 14 sessions that ran for 12‐weeks with a focus on social‐communication and language. Caregivers were taught strategies using demonstration. Later, they received feedback based on their play‐video recordings with their infants. Findings indicate that despite challenges such as rescheduling and interruptions in network, families reported that they found the program satis