Traditional Chinese Medicine Pediatric Massage for Attention Deficit Hyperactivity Disorder Symptoms

NCT ID: NCT04237259

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-01
• Study Completion Date: 2020-07-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Parent-administered TCM massage group

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.

Group Type: EXPERIMENTAL

Parent-administered TCM pediatric massage training

Intervention Type: OTHER

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).

Parent-child interaction group

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.

Group Type: ACTIVE_COMPARATOR

Progressive Muscle Relaxation Exercise

Intervention Type: OTHER

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.

Interventions

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).

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. children between 3-7 years old by the time of the start of the assessment;

2. having a score equal to or higher than the borderline cutoff of the Strengths and Weaknesses of ADHD Symptoms and Normal Behaviors Rating Scale (SWAN), indicating the children had moderate ADHD symptoms.

1. able to communicate using Mandarin;

2. willing to learn the knowledge and manipulations of TCM pediatric massage for treating ADHD;

3. available to take their child to hospital for treatment and conduct manipulations at home according to the study process;

4. agree to give informed consent.

Exclusion Criteria

1. currently receiving other massage therapy;

2. having other developmental disability such as autism spectrum disorders or intellectual disability;

3. having acute infection diseases (such as scarlet fever, chickenpox), hemorrhagic diseases (like bleeding, local places of various kinds of malignant tumor), or dermatological problems (e.g. scald, severe skin lesion, or skin infections);

4. having any severe illness or medical condition that the investigator deems not appropriate to receive TCM massage (e.g. bone fractures and paraplegia).

1. having any severe psychiatric disorder, such as major depressive disorder;

2. having difficulties to conduct massage therapy due to physical problems;

3. having a score of Montreal Cognitive Assessment (MoCA) less than 22, indicating cognitive impairment (Appendix 1: Montreal Cognitive Assessment (MoCA) - Chinese Version)

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

YEUNG Wing Fai

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Chen SC, Yu J, Suen LK, Sun Y, Pang YZ, Wang DD, Zhao WX, Yeung WF. Pediatric tuina for the treatment of attention deficit hyperactivity disorder (ADHD) symptoms in preschool children: study protocol for a pilot randomized controlled trial. Pilot Feasibility Stud. 2020 Nov 5;6(1):169. doi: 10.1186/s40814-020-00704-z.

Reference Type: DERIVED

PMID: 33292826 (View on PubMed)

Other Identifiers

TCM ped msg_ADHD

Identifier Type: -

Identifier Source: org_study_id