title: Effectiveness of the parent-mediated intervention for children with autism spectrum disorder in south Asia in India and Pakistan (PASS): a randomised controlled trial.
abstract: BACKGROUND
  Autism spectrum disorder affects more than 5 million children in south Asia. Although early interventions have been used for the treatment of children in high-income countries, no substantive trials have been done of the interventions adapted for use in low-income and middle-income countries (LMICs). We therefore assessed the feasibility and acceptability of the parent-mediated intervention for autism spectrum disorder in south Asia (PASS) in India and Pakistan.
  
  
  METHODS
  A single-blind randomised trial of the comparison of 12 sessions of PASS (plus treatment as usual) with treatment as usual alone delivered by non-specialist health workers was done at two centres in Goa, India, and Rawalpindi, Pakistan. Children aged 2-9 years with autism spectrum disorder were randomly assigned (1:1) by use of probabilistic minimisation, controlling for treatment centre (Goa or Rawalpindi), age (<6 years or ≥6 years), and functional impairment (Vineland Adaptive Behaviour Scale Composite score <65 or ≥65). The primary outcome was quality of parent-child interaction on the Dyadic Communication Measure for Autism at 8 months. Analysis was by intention to treat. The study is registered with ISRCTN, number ISRCTN79675498.
  
  
  RESULTS
  From Jan 1 to July 30, 2013, 65 children were randomly allocated, 32 to the PASS group (15 in Goa and 17 in Rawalpindi) and 33 to the treatment-as-usual group (15 in Goa and 18 in Rawalpindi). 26 (81%) of 32 participants completed the intervention. After adjustment for minimisation factors and baseline outcome, the primary outcome showed a treatment effect in favour of PASS in parental synchrony (adjusted mean difference 0·25 [95% CI 0·14 to 0·36]; effect size 1·61 [95% CI 0·90 to 2·32]) and initiation of communication by the child with the parent (0·15 [0·04 to 0·26]; effect size 0·99 [0·29 to 1·68]), but time in mutual shared attention was reduced (-0·16 [-0·26 to -0·05]; effect size -0·70 [-1·16 to -0·23]).
  
  
  CONCLUSIONS
  Our results show the feasibility of adapting and task-shifting an intervention used in a high-income context to LMICs. The findings also replicate the positive primary outcome treatment effects of a parent-mediated communication-focused intervention in the original UK Preschool Autism Communication Trial, with one negative effect not reported previously.
  
  
  BACKGROUND
  Autism Speaks, USA.
authors.affiliation: University of Liverpool, Institute of Psychology, Health and Society, Academic Child Mental Health Unit, Alder Hey Children's NHS Foundation Trust, Liverpool, UK.
authors.forename: Atif
authors.initials: A
authors.lastname: Rahman
authors.affiliation: Sangath, Goa, India.
authors.forename: Gauri
authors.initials: G
authors.lastname: Divan
authors.affiliation: Human Development Research Foundation, Islamabad, Pakistan.
authors.forename: Syed Usman
authors.initials: SU
authors.lastname: Hamdani
authors.affiliation: Sangath, Goa, India.
authors.forename: Vivek
authors.initials: V
authors.lastname: Vajaratkar
authors.affiliation: University of Manchester, Institute of Brain, Behaviour and Mental Health, Manchester, UK.
authors.forename: Carol
authors.initials: C
authors.lastname: Taylor
authors.affiliation: University of Manchester, Institute of Brain, Behaviour and Mental Health, Manchester, UK.
authors.forename: Kathy
authors.initials: K
authors.lastname: Leadbitter
authors.affiliation: Stockport Foundation Trust, Stepping Hill Hospital, Stockport, UK.
authors.forename: Catherine
authors.initials: C
authors.lastname: Aldred
authors.affiliation: Institute of Psychiatry, Rawalpindi Medical College, Pakistan.
authors.forename: Ayesha
authors.initials: A
authors.lastname: Minhas
authors.affiliation: Sangath, Goa, India.
authors.forename: Percy
authors.initials: P
authors.lastname: Cardozo
authors.affiliation: Centre for Biostatistics, Institute of Population Health, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.
authors.forename: Richard
authors.initials: R
authors.lastname: Emsley
authors.affiliation: Sangath, Goa, India; London School of Hygiene & Tropical Medicine, London, UK.
authors.forename: Vikram
authors.initials: V
authors.lastname: Patel
authors.affiliation: University of Manchester and Manchester Academic Health Sciences Centre, Royal Manchester Children's Hospital, Manchester, UK. Electronic address: jonathan.green@manchester.ac.uk.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Green
mesh_terms: D000067877:Autism Spectrum Disorder / Q000628:therapy*; D002648:Child; D002675:Child, Preschool; D003142:Communication; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007194:India; D008297:Male; D010154:Pakistan; D010287:Parent-Child Relations; D010290:Parents / Q000523:psychology*; D016037:Single-Blind Method; D016896:Treatment Outcome