Communication-centred parent-mediated treatment for autism spectrum disorder in South Asia

Not Applicable

Suspended

• Conditions: Autism spectrum disorder; Mental and Behavioural Disorders; Childhood autism

• Registration Number: ISRCTN21454676
• Lead Sponsor: niversity of Manchester

Brief Summary

2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37828540/ (added 16/10/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-22
• Study Completion: 2022-03-31
• Last Update Posted: 30 October 2023

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

1. Child aged 2 years 0 months to 9 years 11 months
2. Child has a clinical diagnosis of Autism Spectrum Disorder (ASD) and fulfils ASD criteria on the INCLEN Diagnostic Tool for Autism Spectrum Disorder (INDT-ASD), a DSM-based clinical diagnostic algorithm developed in India and validated against specialist assessment

Exclusion Criteria

1. Significant hearing or visual impairment in child or parent
2. Child developmental age of <12 month equivalent (as assessed by research team)
3. Child with epilepsy with a seizure in the previous 6 months
4. Residence outside of pre-specified recruitment area within the National Capital Region Territory (Delhi, India)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Autism symptom severity measured by the blind-rated Brief Observation of Social Communication Change at 9 months post-baseline

Secondary Outcome Measures

Name	Time	Method
Parent-child communication, child adaptation, child quality of life, and parental wellbeing measured at 9 and 15 months post-baseline