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

Abstract

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 group-based knowledge and skills caregiver-led training programme and compared its outcomes to a therapist-led training programme in rural Malawi. 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 aged 9 months to 14 years. Participants were randomised 1:1 to caregiver-led or therapist-led arms and received weekly practical knowledge and skills 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 primary outcome was caregiver quality of life measured using the Paediatric Quality of Life Family Impact Measure. Child outcomes included activity and participation measured using the Pediatric Evaluation of Disability Inventory and the Child and Adolescent Scale for Participation. Data were analysed using Stata 16.1 (Stata Corporation, College Station, Texas, USA). Outcomes are presented as medians and interquartile ranges due to some skewed distributions. Thirty-nine of 42 and 37 of 41 caregiver-child pairs in the caregiver-led and therapist-led arms, respectively, completed baseline assessments and commenced the trial. Thirty-seven pairs per arm completed endline assessments and were included in the primary analysis, yielding a 97% completion rate. Programme delivery fidelity was 100% across both arms. Improvements were observed in both caregiver- and child-level outcomes, with no evidence of differences between groups. For the primary outcome, the median change in Paediatric Quality of Life Family Impact Measure score was 9.7 in both arms (median difference 0; 95% CI: -5.0 to 5.0). For child outcomes, the median change in Pediatric Evaluation of Disability Inventory was 24 [1, 2] in the caregiver-led arm and 27 [3, 4] in the therapist-led arm, with a median difference of - 3 (95% CI: -19.0 to 13.0). The caregiver-led training programme is feasible and associated with improvements in caregiver and child outcomes, with no evidence of differences compared to therapist-led delivery. These findings support progression to a fully powered non-inferiority trial. If effectiveness and non-inferiority are confirmed, this approach may offer a promising task-sharing strategy for rehabilitation services in similar low-resource settings. The Pan African Clinical Trials Registry (PACTR202306542386770), retrospectively registered on 05 June 2023(https//pactr.samrc.ac.za/TrialDisplay.aspx? TrialID=25586).