Parent Mediated Intervention for Autism Spectrum Disorder in South Asia (PASS) a Randomized Control Trial

Background:  Low and middle income countries have the majority of the world’s children; simultaneously these areas are the most under resourced for services for complex neuro-developmental disabilities such as Autism Spectrum Disorders (ASD). Families of children with ASD countries face two primary challenges; firstly the lack of access to evidence based interventions which have been adapted and evaluated for acceptability, secondly the paucity of trained professionals to deliver outside the reach of specialist centres. This results in a ‘treatment gap’ leaving most children with ASD without services. 

Objectives:  This research study aimed to evaluate a systematically adapted intervention for acceptability and feasibility of a parent-mediated communication intervention through a randomised control trial. The original communication intervention, the Preschool Autism Communication Therapy (PACT); had substantial trail evidence supporting it.  The aims were to evaluate a) feasibility and acceptability of the resulting PASS intervention b) the success of the “task-shifting” approach in delivering fidelity to the intervention c) The effectiveness of the adapted intervention in replicating original treatment effects the UK trial.

Methods:  

Site: This study was carried out in two sites in South Asia; Goa, India and Rawalpindi, Pakistan. Both sites followed similar procedures in the adaptation and trial.

Participants: 30 eligible families were enrolled at each site, and the adapted intervention was delivered to fifteen per site, with an equal number in the treatment- as-usual arm. Eligibility criterion was a confirmed diagnosis of ASD in the 2-9 age group. Exclusion criterion included a non-verbal age equivalent to 12 months or younger; epilepsy with seizures in the previous six months; severe hearing or visual impairment in a parent or the child; or a parent with a severe psychiatric disorder.

Outcome assessments took place 8 months after baseline assessment. The primary outcome was the Dyadic Communication Measure for Autism, a parent-child interaction measure used in the UK trial. This consists of rating a naturalistic play session on three pre-specified variables: proportion of parental synchronous communications with the child; proportion of child communications that were initiations; and proportion of time spent in mutual shared attention.

Results:  On parental synchronous interaction, there was a substantial positive treatment effect in favour of the PASS; with adjusted mean difference (AMD) of 0.25(95% CI 0.14-0.37). There was also a positive treatment effect on Child Communication Initiations with parent; AMD 0.15 (95% CI 0.05-0.24)). In both the confidence intervals include values from a small positive to a moderate positive effect. On the third interaction outcome of shared attention there was evidence of a negative effect of treatment; AMD -0.16 with (95% CI -0.278, -0.032).

Conclusions: This moderate-sized initial randomised controlled trial is the first systematic intervention study in relation to ASD undertaken in LMIC. The trial served as a successful test of the effectiveness of the cascade training and supervision model both to achieve adequate non–specialist fidelity; as well as an initial test of whether the adapted intervention could reproduce the treatment effects found in the UK study.