Pediatric Tuina in children with autism spectrum disorder: a study protocol for a randomized controlled trial.

Researchers are planning a study to test whether Pediatric Tuina (a type of traditional Chinese massage therapy) can help children with autism when added to their usual treatments. They will compare children who receive both Tuina and regular therapy to those who only get regular therapy. The study will measure autism symptoms before and after 30 treatment sessions, then follow children for 6 months to see if benefits last.

This study protocol describes a planned randomized controlled trial investigating Pediatric Tuina, a traditional Chinese medicine therapy, for children with autism spectrum disorder. The trial will compare Pediatric Tuina plus conventional treatment versus conventional treatment alone using a 1:1 randomization. Primary outcomes will be measured using the Childhood Autism Rating Scale, with secondary outcomes assessed via the Autism Treatment Evaluation Checklist. The study aims to evaluate effectiveness after 30 treatment sessions with a 6-month follow-up period.

This represents an effort to provide evidence-based evaluation of a traditional therapy that has been used for ASD but lacks large-scale research support.

No clinical implications can be determined as this is a protocol paper without results. Once completed, this RCT could provide valuable evidence about Pediatric Tuina's effectiveness for ASD, addressing a gap in evidence-based research for this traditional intervention.

This is a protocol paper with no results reported. The actual sample size is not specified, and the study's completion status is unclear. No data on effectiveness, safety, or clinical outcomes are available until the trial is completed.

Autism spectrum disorder (ASD) is a neurodevelopmental condition characterized by repetitive stereotypical behavior and communication deficits. Currently, it lacks a specific clinical treatment method. Pediatric Tuina is a recent therapy in traditional Chinese medicine (TCM) and has been used to treat children with ASD. Nonetheless, it remains uncommon given the lack of large-scale evidence-based medical studies.

This study aims to compare the efficacy of Tuina and conventional treatment in children with ASD. Eligible children will be randomly assigned to either the pediatric Tuina plus conventional treatment group or to the conventional treatment alone group based on a random table at a ratio of 1:1. The effectiveness of the Tuina intervention for ASD will be evaluated by a third-party organization. The pre- and post-intervention scores on the Childhood Autism Rating Scale comprised the primary outcome, whereas pre- and post-intervention scores on the Autism Treatment Evaluation Checklist were the secondary outcomes to assess improvement in symptoms.

Baseline values of the participants will be determined at the time of registration. Outcomes will be evaluated after the 30th treatment session. The follow-up period will last for 6 months after treatment. This study will evaluate the effectiveness and safety of Tuina in the treatment of ASD.

The results of this study could provide reliable evidence to improve the management of patients with ASD. Chinese Clinical Trial Registry (CHICTR), ChiCTR2000040452 . Registered on 28 November 2020.