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Interactive Massage Intervention in Toddlers With Autism Spectrum Disorder
Sponsor: Children's Hospital of Fudan University
Summary
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.
Official title: Efficacy of Interactive Massage Intervention in Toddlers With Autism Spectrum Disorder: A Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Months - 24 Months
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2025-09-01
Completion Date
2028-06-30
Last Updated
2026-10-15
Healthy Volunteers
Yes
Conditions
Interventions
Maternal Interactive Massage
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
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.
Locations (1)
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China