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Interactive Massage Intervention in Toddlers With Autism Spectrum Disorder

RecruitingNAAges 18 Months - 24 MonthsAllChildren's Hospital of Fudan University
NCT07876245 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 f

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📋 Eligibility rules (as published)
Inclusion Criteria: * Aged 18-24 months, regardless of sex. * Meets the diagnostic criteria for autism spectrum disorder (ASD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), with the diagnosis confirmed by two senior developmental-behavioral pediatricians. * The caregiver is able to comply with the study assessments and intervention protocol and voluntarily provides written informed consent. * No severe motor impairment or visual or hearing impairment, and the child is able to cooperate with saliva collection, functional near-infrared spectroscopy (fNIRS) assessment, and parent-child interaction assessment. Exclusion Criteria: * Presence of other neurodevelopmental disorders, genetic or metabolic diseases, central nervous system infections, or organic lesions. * Receipt within the past 3 months of other interventions, including massage, acupuncture, or medications, that may affect neuroendocrine or brain function. * Severe emotional or behavioral problems that prevent the child from cooperating with the massage intervention or study assessments.
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What it tests

  • Maternal Interactive Massage
  • Behavioral
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Where

1 site
Children's Hospital of Fudan University
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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