Autism Spectrum Disorder Clinical Trial
Official title:
Effectiveness of the WHO Caregivers Skills Training (CST) Program for Children With Developmental Disorders and Delays in Rural Community Settings in Pakistan: An Individual Randomized Controlled Trial (RCT)
Background: Increasing prevalence rates of developmental disorders (DDs) including Autism
Spectrum Disorders (ASD) and intellectual disability are a public health priority
particularly in Low and Middle Income countries (LIMC) and are included in the World Health
Organization (WHO) mhGAP program. However, existing mental health care facilities and
resources are insufficient in most low resource settings to cater for this increasing demand.
To address this situation, Caregiver Skills Training (CST) program for children with
developmental disorders and delays has been developed by the WHO to bridge the treatment gap
in low resource settings.
Objective: The objective of this study is to evaluate the effectiveness of the WHO CST
program plus treatment as usual (TAU) vs. TAU to improve caregiver-child interaction in
children with developmental disorders and delays, when implemented by non-specialist health
care facilitators in a low-resource rural community settings of Rawalpindi, Pakistan.
Methods: A two arm, single blind individual randomized controlled trial (RCT) will be carried
out with 160 caregiver-child dyads with development disorders and delays in community
settings of Rawalpindi, Pakistan. 160 caregiver-child dyads will be individually randomized
on 1:1 allocation ratio into intervention (n=80) and control (n=80) arms. Participants in the
intervention arm will receive 3-hours group training sessions of WHO CST program once every
week for 9 weeks and 3 individual home sessions delivered via non-specialist health care
facilitator over a duration of 3-months. The primary outcome is improvement in play-based
caregiver-child interaction at 9-months post-intervention. The secondary outcomes are
improvement in routine home-based caregiver-child interaction, child's social communication
skills, adaptive behavior, emotional and behavioral problems and parental health related
quality of life. The data on health services utilization will also be collected at 9-months
post-intervention. Qualitative process evaluation with a sub-sample of study participants and
trainers will be undertaken following the RCT. The study will be completed within an
estimated period of 11-months.
Discussion: Outcomes of the study will be the evidence on the effectiveness of WHO CST
program to improve caregiver child interaction and improvement in social communication
skills, adaptive behaviors of children with developmental disorders and delays in the low
resource setting of Pakistan.
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