Atif Rahman1, Gauri Divan2, Syed Usman Hamdani3, Vivek Vajaratkar2, Carol Taylor4, Kathy Leadbitter4, Catherine Aldred5, Ayesha Minhas6, Percy Cardozo2, Richard Emsley7, Vikram Patel8, Jonathan Green9. 1. University of Liverpool, Institute of Psychology, Health and Society, Academic Child Mental Health Unit, Alder Hey Children's NHS Foundation Trust, Liverpool, UK. 2. Sangath, Goa, India. 3. Human Development Research Foundation, Islamabad, Pakistan. 4. University of Manchester, Institute of Brain, Behaviour and Mental Health, Manchester, UK. 5. Stockport Foundation Trust, Stepping Hill Hospital, Stockport, UK. 6. Institute of Psychiatry, Rawalpindi Medical College, Pakistan. 7. Centre for Biostatistics, Institute of Population Health, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK. 8. Sangath, Goa, India; London School of Hygiene & Tropical Medicine, London, UK. 9. University of Manchester and Manchester Academic Health Sciences Centre, Royal Manchester Children's Hospital, Manchester, UK. Electronic address: jonathan.green@manchester.ac.uk.
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. FINDINGS: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]). INTERPRETATION: 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. FUNDING: Autism Speaks, USA.
RCT Entities:
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. FINDINGS: 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]). INTERPRETATION: 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. FUNDING: Autism Speaks, USA.
Authors: Micheal Sandbank; Kristen Bottema-Beutel; Shannon Crowley; Margaret Cassidy; Jacob I Feldman; Marcos Canihuante; Tiffany Woynaroski Journal: J Speech Lang Hear Res Date: 2020-05-08 Impact factor: 2.297
Authors: Chipo Belindah T Makombe; Nokuthula Shabalala; Marisa Viljoen; Noleen Seris; Petrus J de Vries; Lauren Franz Journal: Pediatr Med Date: 2019-08-08
Authors: Catherine Lord; Traolach S Brugha; Tony Charman; James Cusack; Guillaume Dumas; Thomas Frazier; Emily J H Jones; Rebecca M Jones; Andrew Pickles; Matthew W State; Julie Lounds Taylor; Jeremy Veenstra-VanderWeele Journal: Nat Rev Dis Primers Date: 2020-01-16 Impact factor: 52.329