Pediatric tuina for the treatment of attention deficit hyperactivity disorder (ADHD) symptoms in preschool children: study protocol for a pilot randomized controlled trial.

backgroundMedication and behavior therapy are the conventional treatments for attention deficit hyperactivity disorder (ADHD), but they have limitations for preschool children. Evidence suggests that pediatric tuina, which is a modality of traditional Chinese medicine, might have beneficial effects on this condition.

objectiveTo assess the feasibility of conducting an RCT in terms of recruitment, use, and acceptability of the parent-administered pediatric tuina for ADHD symptoms in preschoolers.

methodsIt is a single-center, two-arm, parallel, open-label, pilot randomized controlled trial (RCT). Sixty children with pre-specified ADHD symptoms (hyperactivity, anxiety, and sleep disturbance) together with one of their parents will be recruited and randomized into two groups at a 1:1 ratio. Parents in the parent-administered tuina group (intervention group, n = 30) will attend an online training program to learn pediatric tuina skills for ADHD symptoms and conduct this treatment on their children at home. Parents in the parent-child interaction group (comparison group, n = 30) will attend an online training about progressive muscle relaxation exercise and do this exercise with their children at home. Additional teaching materials will be provided to the participants in both groups. Both interventions should be carried out every other day during a 2-month treatment period, with each time around 20 min. Assessment will be performed at baseline, week 4, and week 8. The primary outcome measure is the Swanson, Nolan, and Pelham parent scale; the secondary outcomes include preschool anxiety scale, children's sleep habits questionnaire, and parental stress scale. A process evaluation embedded within the outcome evaluation will be performed. Differences in the scale scores and test parameters between groups will be examined using a linear mixed-effects model. Qualitative data will be analyzed using thematic content analysis, facilitated by QSR NVivo. DISCUSSION: This study will provide evidence on the acceptability and feasibility of pediatric tuina for ADHD in preschool children. The process evaluation will help to better understand the facilitators and barriers of the intervention functioning.

trial registrationThe study was registered at ClinicalTrials.gov (Identifier: NCT04237259 ) on 14 February 2020. Protocol version: 2; date, 23 June 2020.