Caregiver-led versus therapist-led training programme for caregivers of children with cerebral palsy in rural Malawi: A feasibility randomised controlled trial

Background Caregiver-led interventions for children with cerebral palsy are increasingly implemented in resource-limited settings to improve access to services, yet evidence on their feasibility and effectiveness remains limited. This study assessed the feasibility of a caregiver-led training programme and compared its outcomes to a therapist-led training programme in rural Malawi. Methods A two-arm feasibility randomised controlled trial was conducted in rural Mangochi, Malawi between January and August 2023, involving 83 primary caregivers of children with cerebral palsy. Participants were randomised into caregiver-led or therapist-led arms in a 1:1 ratio, receiving weekly training sessions over seven weeks using the Malamulele Onward Carer-2-Carer Training Programme. Feasibility outcomes included recruitment, randomisation, retention and fidelity of programme delivery. The main programme outcome was caregiver quality of life measured by the Paediatric Quality of Life Family Impact Measure. Data were analysed using Stata 16.1 (Stata Corporation, College Station, Texas, USA). Results A total of 74 out of 83 caregiver-child pairs recruited completed the trial (89% retention). Both expert caregivers and physiotherapists delivered the programme with 100% fidelity. Improvements were observed in all caregiver-level and child-level outcomes. The mean change in the main programme outcome, the Paediatric Quality of Life Family Impact Measure score, was 8.3 (95% CI: 5.9–10.7) on the caregiver-led versus 9.9 (95% CI: 7.2–12.7) on the therapist-led arm. The mean difference between the two groups was 1.5 (95% CI:-2.1, 5.2). Conclusion Caregiver-led training is feasible and led to outcome improvements comparable to that of the therapist-led arm. This supports its implementation as a task-sharing strategy in Malawi, with a non-inferiority trial recommended for further validation. Trial registration The Pan African Clinical Trials Registry (PACTR202306542386770), retrospectively registered on 05 June 2023