Physiological and Psychological Effects of Parent-Delivered Traditional Thai Massage in Children With Autism: Protocol for a Randomized Controlled Trial

BACKGROUND: Although many autistic children receive massage as a complementary therapy, it is not included in evidence-based practice for autism because evidence of its efficacy is lacking. Further, prior studies have failed to identify objective indicators of core symptoms or elucidate their mechanisms. OBJECTIVE: We developed a parent-delivered traditional Thai massage (TTM) intervention for children with autism, aiming to experimentally determine whether children with autism truly experience positive effects from parent-delivered TTM and determine possible mechanisms of the observed effects. METHODS: A 2-armed, parallel randomized controlled trial was conducted between February 2022 and June 2022. Forty-eight children with autism (aged 7-12 years) were recruited from the Hainan Special Education School and randomly assigned to either a parental TTM or control group at a ratio of 1:1 based on random numbers generated with Online Research Randomizer. The generated sequences were concealed in an opaque envelope. Individuals in the parental TTM group received 16 parent-delivered TTM sessions over 8 weeks at the school’s health room after school, and the control group maintained a normal daily routine. Outcomes were assessed on admission, after 8 weeks, and at a 2-month follow-up and included the effect of massage treatment on autism symptoms, measured with the Autism Treatment Evaluation Checklist score (evaluated by parents and a blinded teacher), physiological parameters (ie, heart rate variability and gait), and the Parenting Stress Index, Fourth Edition–Short Form. RESULTS: We finished all data collection on June 20, 2022. Data analysis will be started, and we expect to publish results in 2023. CONCLUSIONS: This study will provide further evidence for massage treatment of autism and provide support for family-based care. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2100051355; https://tinyurl.com/3dwjxsw5 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/41839