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Interactive Massage Intervention in Toddlers With Autism Spectrum Disorder

Study acronym: IMI-ASD
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
This randomized controlled trial aims to evaluate the efficacy of a 3-month maternal interactive massage intervention in toddlers aged 18-24 months with autism spectrum disorder (ASD). A total of 120 toddlers with ASD will be randomly assigned in a 1:1 ratio to either an intervention group or a usual care group. Participants in the intervention group will receive standardized maternal interactive massage in addition to usual care and ASD parenting guidance, whereas participants in the usual care group will receive usual care and ASD parenting guidance only. The interactive massage will be performed by the child's mother for 15 minutes per session, three sessions per day, six days per week, for three months. The primary outcome is parent-child interaction quality. Secondary outcomes include salivary oxytocin levels and brain responses to social versus non-social stimuli measured using functional near-infrared spectroscopy (fNIRS). Outcomes will be assessed at baseline, immediately after the 3-month intervention, and at a 1-month post-intervention follow-up.
Trial Details
NCT Number NCT07876245
Lead Sponsor Children's Hospital of Fudan University
Conditions
(from sponsor)
Autism
Related terms Autism Spectrum Disorder, Autistic Disorder
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov