Traditional Chinese Medicine Pediatric Massage for Attention Deficit Hyperactivity Disorder Symptoms

NCT04237259 | Unknown

• 1 other identifier: TCM ped msg_ADHD
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

ADHD

Outcome Measures

Primary Outcomes (1)

• Change in The self-completed Swanson, Nolan and Pelham Parent Scale (SNAP-IV-P) - ADHD Scale

  It has 26 items that include 18 ADHD symptoms (nine inattentive, nine hyperactive or impulsive) and as specified in the DSM-5. Items are rated for frequency by the parent or teacher on a 4-point scale (0 = not at all to 3 = very much) and average ratings per item are then calculated for each subscale.

  Baseline, week 4, week 8

Secondary Outcomes (4)

• Preschool Anxiety Scale (PAS)

  Baseline, week 4, week 8

• Children's Sleep Habits Questionnaire (CSHQ)

  Baseline, week 4, week 8

• Parental Stress Scale (PSS)

  Baseline, week 4, week 8

• Clinical Global Impression (CGI)

  Baseline, week 4, week 8

Study Arms (2)

Parent-administered TCM massage group

EXPERIMENTAL

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.

Other: Parent-administered TCM pediatric massage training

Parent-child interaction group

ACTIVE COMPARATOR

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.

Other: Progressive Muscle Relaxation Exercise

Interventions

Parent-administered TCM pediatric massage training 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-administered TCM massage group

Progressive Muscle Relaxation Exercise 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.

Parent-child interaction group

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children between 3-7 years old by the time of the start of the assessment;
• 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.
• able to communicate using Mandarin;
• willing to learn the knowledge and manipulations of TCM pediatric massage for treating ADHD;
• available to take their child to hospital for treatment and conduct manipulations at home according to the study process;
• agree to give informed consent.

You may not qualify if:

• currently receiving other massage therapy;
• having other developmental disability such as autism spectrum disorders or intellectual disability;
• 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);
• having any severe illness or medical condition that the investigator deems not appropriate to receive TCM massage (e.g. bone fractures and paraplegia).
• having any severe psychiatric disorder, such as major depressive disorder;
• having difficulties to conduct massage therapy due to physical problems;
• having a score of Montreal Cognitive Assessment (MoCA) less than 22, indicating cognitive impairment (Appendix 1: Montreal Cognitive Assessment (MoCA) - Chinese Version)

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Related Publications (1)

• 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.

  PMID: 33292826 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 20, 2020
• First Posted: January 23, 2020
• Study Start: February 1, 2020
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: February 5, 2020

Record last verified: 2020-01