NCT04237259

Traditional Chinese Medicine Pediatric Massage for Attention Deficit Hyperactivity Disorder Symptoms

Traditional Chinese Medicine (TCM) Pediatric Massage for the Treatment of Attention Deficit Hyperactivity Disorder (ADHD) Symptoms in Preschool Children: 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: 3 Years – 7 Years
• Healthy volunteers: Not accepted

Summary

This project is designed to preliminarily assess the effects and feasibility of parent-delivered TCM pediatric massage for ADHD symptoms in preschool children.

Detailed description

Objectives: To preliminarily assess the effects and feasibility of parent-delivered TCM pediatric massage for ADHD symptoms in preschool children. Hypothesis: The parent-delivered TCM pediatric massage group would have greater improvement in children's hyperactivity, anxiety, and sleep disturbance symptoms when compared to the parent-child interaction group. Design and subjects: In this pilot randomized controlled trial, 60 pair of children with pre-specified ADHD symptoms and their parent will be recruited and randomized to parent-administered TCM pediatric massage comparison group, and parent-child interaction group at a 1: 1 ratio. Interventions: Parents of subjects in the parent-administered TCM massage group (n=30) will attend 2 training sessions (5 hours in total) to learn and practice the parent-administered TCM massage for ADHD before treatment starts. The parents will be told to practice the TCM massage on their child every 2 days for 2 months. Parents in the parent-child interaction group (comparison group, n=30) will attend a 3-hour training course on line and spend extra time on interacting with their child at home. Main outcome measures: The primary outcome measure is the Swanson, Nolan and Pelham Parent Scale (SNAP-IV-P). Other outcomes include Preschool Anxiety Scale (PAS), Children's Sleep Habits Questionnaire (CSHQ), Parental Stress Scale (PSS) for parental stress, and the Clinical Global Impression (CGI). Data Analysis: Differences in the scale scores and test parameters between groups will be examined using a linear mixed-effects model. Expected results: Subjects in the parent-administered TCM massage group will have greater improvements in the ADHD symptoms compared to those in the parent-child interaction group at week 4 and week 8.

Conditions

• ADHD

Interventions

Type	Name	Description
OTHER	Parent-administered TCM pediatric massage training	Massage therapy is a kind of complementary and alternative therapy, which involves a number of techniques such as friction, pressing, rubbing, grasping, pinching, and kneading. TCM pediatric massage, also called pediatric tuina and pediatric anmo, is a special part of TCM massage system that usually use lines or surfaces rather than points as acupoints and the manipulations are different from those of TCM adult massage. From TCM perspective, the pathogenesis of ADHD is the abnormal exuberance of yang, which can be relieved by specific approaches of massage. Participants in this group will receive two TCM pediatric massage training sessions (5 hours in total, one is 3 hours, and the other is 2 hours). The protocol will be tested for feasibility at the first feasibility stage (the first 8 subjects).
OTHER	Progressive Muscle Relaxation Exercise	The principle of progressive muscle relaxation exercise is to achieve a relaxation state through relaxing our muscles. With training, we become more familiarized with the sense of relaxation so that we can voluntarily induce this sensation in the face of a stressor.

Timeline

• Start date: 2020-02-01
• Primary completion: 2020-07-31
• Completion: 2020-07-31
• First posted: 2020-01-23
• Last updated: 2020-02-05