Caregiver‐Mediated Early Support Program Delivered Online Versus Care‐as‐Usual for Infants at Elevated Familial Likelihood for Autism: A Parallel, Assessor Masked, Feasibility Randomized Controlled Trial in India

LiL' STEPS (Language development & Intervention Lab's SupporTing Early social-communication and language by Promoting caregiver Sensitive responsiveness) is a novel, manualized, caregiver-mediated early support program developed in India and delivered online for infants at elevated familial likelihood for autism. The program has been found to be feasible and acceptable. The preliminary efficacy of the LiL' STEPS program, which remains to be evaluated, was assessed in this study using a feasibility randomized controlled trial design. The study was conducted at a tertiary care academic hospital in south India. Families with infants aged 9-15 months, each with an older sibling diagnosed with autism, were recruited. Thirty-six families were randomized in a 2:1 ratio to either the LiL' STEPS group (n = 24) or the care-as-usual group (CAU; n = 12) using fixed block randomization. While families in the former group received the LiL' STEPS early support program, those in the latter did not avail themselves of any early supports. Assessors were masked to group status. The primary outcome was caregiver sensitive responsiveness, assessed using the Manchester Assessment for Caregiver-Infant Interaction (MACI). Secondary outcomes included caregiver-reported measures of social communication and language. Outcomes were measured at three time points: baseline (T1), 12 weeks post-baseline (T2), and 12 weeks after program completion (T3). Intention-to-treat analyses were performed using linear mixed models. No significant treatment effects were found between baseline (T1) and endpoint (T3) on the primary or secondary outcomes. However, significant, large, positive treatment effects were observed for caregiver sensitive responsiveness (β = 1.48; 95% CI = 0.51-2.34; d = 1.15) and dyadic mutuality (β = 1.22; 95% CI = 0.03-2.15; d = 1.01) between baseline (T1) and T2, highlighting the need for ongoing support between T2 and T3-a key direction for future large scale efficacy trials.