NCT06007742

Parent-administered Pediatric Tuina for Improving Sleep Quality and Appetite in School-aged Children With ADHD

Parent-administered Pediatric Tuina for Improving Sleep Quality and Appetite in School-aged Children With ADHD: a Pilot Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: The Hong Kong Polytechnic University · Academic / Other
• Sex: All
• Age: 6 Years – 8 Years
• Healthy volunteers: Not accepted

Summary

Title: Parent-administered pediatric tuina for improving sleep quality and appetite in school-aged children with ADHD: a pilot randomized controlled trial Background: Pediatric tuina has been used and explored by many researchers and clinicians as a topical complementary and alternative treatment for ADHD, which can compensate for some of the shortcomings of medications and behavioural therapies, such as the side effects of medications and the financial stress of long-term behavioural therapies. Pediatric tuina can also grasp the golden stage of young children and improve their symptoms in time on the basis of TCM pattern identification and holistic concepts. We once conducted a focus group interview on 15 parents to understand the effects of parent-administered pediatric tuina on ADHD symptoms, and all parents reported that parent-administered pediatric tuina significantly improved the child's sleep quality, eating habits, and parent-child relationship within a short period of time after receiving the intervention. Objective: This study aims to assess the preliminary effects, feasibility, and safety of parent-administered pediatric tuina for attention deficit hyperactivity disorder (ADHD) symptoms in school-aged children. Methods: This project is a three-arm, parallel, open-label, pilot RCT. Sixty participants were randomized into three groups at a 1:1:1 ratio. Parents in the parent-administered tuina group (n = 20) will attend a face-to-face training program on pediatric tuina for ADHD and conduct this intervention on their children at home. Parents in the parent-child interaction group (n = 20) will attend face-to-face training about parent-child interactive exercises and carry them out with their children at home. Both interventions will be carried out every other day during a two-month intervention period, with each manipulation for at least 25-30 min. Participants in the waitlist group (n=20) will not receive both interventions during the intervention period. Outcomes will be assessed at baseline, week 4, and week 8. The primary outcome measure was the Sleep Disturbance Scale for Children; the secondary outcomes included Children's Eating Behaviour Questionnaire, Conners Parent Rating Scale, and Child Health Questionnaire. A process evaluation will be embedded within the outcome evaluation. Descriptive statistics for sociodemographic variables and clinical variables will be presented. Data will be presented as mean and standard deviation. The feasibility outcomes will be presented as percentages. The rating scale scores between the intervention groups and the control group in week 4 and week 8 will be compared using a linear mixed-effects model. Recorded interviews will be transcribed verbatim and analyzed using content analysis. Depending on the topic and purpose of the study, the interview was categorized into words or sentences with the help of the qualitative research tool Nvivo.

Conditions

• ADHD

Interventions

Type	Name	Description
OTHER	parent-administered pediatric tuina	Parents in intervention group will participate in a pediatric tuina course to improve eating and sleep symptoms of ADHD, followed by an 8-week treatment period for the children. The course will take place at the Hong Kong Polytechnic University campus and will consist of 2 sessions of approximately 2 hours each. The course content will be taught by a registered TCM practitioner. . Parents assigned to this group will participate in a Parent-Child Exercise for ADHD program, which will complete with their children in the next 8 weeks. The program will take place at the Hong Kong Polytechnic University campus and will consist of 2 sessions of approximately 2 hours each. The content will be taught by a registered physiotherapist. The two intervention groups are manipulated every other day for 25-30 minutes each. A total number of interventions equal to or greater than 24 is considered a completed intervention.

Timeline

• Start date: 2023-10-15
• Primary completion: 2024-09-30
• Completion: 2024-11-30
• First posted: 2023-08-23
• Last updated: 2024-02-28

Locations

1 site across 1 country: China