Supporting African communities to increase resilience and mental health of kids with developmental disabilities and their caregivers using the World Health Organization’s Caregiver Skills Training Programme (SPARK trial): study protocol for a cluster randomised clinical controlled trial
Melissa Washington-Nortey,
Vibian Angwenyi,
Mekdes Demissie,
Eva Mwangome,
Tigist Eshetu,
Hanna Negussie,
Kimberley Goldsmith,
Andrew Healey,
Merga Feyasa,
Girmay Medhin,
Amanuel Belay,
Temesgen Azmeraw,
Medhanit Getachew,
Rahel Birhane,
Carophine Nasambu,
Tsegereda Haile Kifle,
Angela Kairu,
Beatrice Mkubwa,
Fikirte Girma,
Rehana Abdurahman,
Ruth Tsigebrhan,
Liya Tesfaye,
Leonard Mbonani,
Nadine Seward,
Tony Charman,
Andrew Pickles,
Erica Salomone,
Chiara Servili,
Edwine Barasa,
Charles R. Newton,
Charlotte Hanlon,
Amina Abubakar,
Rosa A. Hoekstra
Affiliations
Melissa Washington-Nortey
Department of Psychology, Institute of Psychology, Psychiatry and Neuroscience (IoPPN), King’s College London
Vibian Angwenyi
Institute for Human Development, Aga Khan University
Mekdes Demissie
Centre for Innovative Drug Development and Therapeutic Trials for Africa, College of Health Sciences, Addis Ababa University
Eva Mwangome
Neuroscience Group KEMRI-Wellcome Trust Research Programme, Centre for Geographic Medicine Research (Coast)
Tigist Eshetu
Centre for Innovative Drug Development and Therapeutic Trials for Africa, College of Health Sciences, Addis Ababa University
Hanna Negussie
Centre for Innovative Drug Development and Therapeutic Trials for Africa, College of Health Sciences, Addis Ababa University
Kimberley Goldsmith
Department of Biostatistics and Health Informatics, Institute of Psychology, Psychiatry and Neuroscience (IoPPN), King’s College London
Andrew Healey
Health Service and Population Research, Institute of Psychology, Psychiatry and Neuroscience (IoPPN), King’s College London
Merga Feyasa
Centre for Innovative Drug Development and Therapeutic Trials for Africa, College of Health Sciences, Addis Ababa University
Girmay Medhin
Centre for Innovative Drug Development and Therapeutic Trials for Africa, College of Health Sciences, Addis Ababa University
Amanuel Belay
Centre for Innovative Drug Development and Therapeutic Trials for Africa, College of Health Sciences, Addis Ababa University
Temesgen Azmeraw
Centre for Innovative Drug Development and Therapeutic Trials for Africa, College of Health Sciences, Addis Ababa University
Medhanit Getachew
Centre for Innovative Drug Development and Therapeutic Trials for Africa, College of Health Sciences, Addis Ababa University
Rahel Birhane
Centre for Innovative Drug Development and Therapeutic Trials for Africa, College of Health Sciences, Addis Ababa University
Carophine Nasambu
Neuroscience Group KEMRI-Wellcome Trust Research Programme, Centre for Geographic Medicine Research (Coast)
Tsegereda Haile Kifle
Department of Psychology, Institute of Psychology, Psychiatry and Neuroscience (IoPPN), King’s College London
Angela Kairu
Neuroscience Group KEMRI-Wellcome Trust Research Programme, Centre for Geographic Medicine Research (Coast)
Beatrice Mkubwa
Institute for Human Development, Aga Khan University
Fikirte Girma
Centre for Innovative Drug Development and Therapeutic Trials for Africa, College of Health Sciences, Addis Ababa University
Rehana Abdurahman
Yekatit 12 Hospital Medical College
Ruth Tsigebrhan
Centre for Innovative Drug Development and Therapeutic Trials for Africa, College of Health Sciences, Addis Ababa University
Liya Tesfaye
Nia Foundation, Joy Center for Autism
Leonard Mbonani
Kuhenza for Children’s Foundation
Nadine Seward
School of Health and Social Science, University of Edinburgh
Tony Charman
Department of Psychology, Institute of Psychology, Psychiatry and Neuroscience (IoPPN), King’s College London
Andrew Pickles
Department of Biostatistics and Health Informatics, Institute of Psychology, Psychiatry and Neuroscience (IoPPN), King’s College London
Erica Salomone
University of Milano-Bicocca
Chiara Servili
Department of Mental Health and Substance Abuse, World Health Organization
Edwine Barasa
Neuroscience Group KEMRI-Wellcome Trust Research Programme, Centre for Geographic Medicine Research (Coast)
Charles R. Newton
Neuroscience Group KEMRI-Wellcome Trust Research Programme, Centre for Geographic Medicine Research (Coast)
Charlotte Hanlon
Centre for Innovative Drug Development and Therapeutic Trials for Africa, College of Health Sciences, Addis Ababa University
Amina Abubakar
Institute for Human Development, Aga Khan University
Rosa A. Hoekstra
Department of Psychology, Institute of Psychology, Psychiatry and Neuroscience (IoPPN), King’s College London
Abstract Background Most children with developmental disabilities (DD) live in low- and middle-income countries, but access to services is limited, impacting their ability to thrive. Pilot study findings of the World Health Organization’s Caregiver Skills Training (WHO CST) intervention, which equips caregivers with strategies to facilitate learning and adaptive behaviours in children with DD, are promising but evidence from an appropriately powered trial delivered by non-specialist facilitators is lacking. This study will investigate the effectiveness and the resource impacts and costs and consequences of the WHO CST intervention in four sites in rural and urban Kenya and Ethiopia. Methods This is a 2-arm multi-site hybrid type-1 effectiveness implementation cluster randomised controlled superiority trial. After baseline assessments (T0) are completed by participants in clusters comprising 7 to 10 caregiver-child dyads, the clusters will be randomised to either the WHO CST intervention arm or a waitlist enhanced care as usual control arm. Further assessments will be completed at endpoint (T1, 18 ± 2 weeks after randomisation) and follow-up (T2, 44 ± 2 weeks after randomisation). The intervention comprises three individualised home visits and nine group sessions with trained non-specialist facilitators. Participants in the control arm will receive the intervention after completing follow-up assessments. We aim to recruit 544 child-caregiver dyads, evenly distributed across the two arms and countries. The co-primary outcomes are the child-focused Child Behavior Checklist (assessing emotional and behavioural problems) and the caregiver-focused Pediatric Quality of Life Inventory (assessing caregiver quality of life), both assessed at endpoint. Secondary outcome measures comprise the two co-primary outcomes at follow-up and ten additional outcome measures at endpoint, assessing stigma-based experiences, depressive symptoms, household food insecurity, child disciplinary strategies and beliefs, CST knowledge and skill competencies, caregiver and child quality of life, social support, and children’s communication modes and functions. After quantitative follow-up assessments are completed, a mixed-methods evaluation approach will be used to investigate implementation processes and acceptability, feasibility, and potential sustainability of the intervention. Discussion The study’s findings will provide evidence of the effectiveness and resource impacts and costs and consequences of a non-specialist-delivered intervention in under-resourced contexts in one low-income and one middle-income country in East Africa. Findings will inform future research, intervention, and policy efforts to support children with DD and their families in under-resourced majority world contexts. Trial registration Pan African Clinical Trial Registry PACTR202310908063134. Registered on October 16, 2023.