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RECRUITING Not applicable ClinicalTrials.gov

Interactive Massage Intervention in Toddlers With Autism Spectrum Disorder

Sponsor: Children's Hospital of Fudan University • ClinicalTrials.gov ID: NCT07876245

Registry updated: 2026-10-15
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Description

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.

Interventions

  • Maternal Interactive Massage (Behavioral)
    Mothers of participants assigned to the intervention group will receive standardized training in interactive massage, including massage techniques, body areas, intensity, duration, frequency, and safety procedures. Training will include instructional videos and hands-on practice to ensure that mothers can independently and correctly perform the intervention. The interactive massage will focus on the child's head and face, trunk, limbs, and palms and soles, primarily using gentle stroking, kneading, and pressing techniques. Mothers will perform the massage for 15 minutes per session, three sessions per day, six days per week, for 3 consecutive months. Intervention adherence will be monitored. Weekly online follow-up and monthly in-person follow-up will be conducted to assess adherence and provide retraining or individualized guidance when needed. An intervention adherence rate of at least
  • Behavioral (Behavioral)
    Participants will receive routine developmental and behavioral pediatric follow-up and standardized ASD family parenting guidance for 3 months. Parenting guidance will include strategies related to social interaction skills and behavior management. No interactive massage or massage-related training will be provided to participants in the usual care group during the study period.

Eligibility criteria

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.

Conditions

Autism

Locations

  • Children's Hospital of Fudan University — Shanghai, Shanghai Municipality, China
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record