Clinical trial NCT04237259: Traditional Chinese Medicine Pediatric Massage for Attention Deficit Hyperactivity Disorder Symptoms
Official title: Traditional Chinese Medicine (TCM) Pediatric Massage for the Treatment of Attention Deficit Hyperactivity Disorder (ADHD) Symptoms in Preschool Children: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ADHD
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2020-01-23
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

Inclusion criteria for the children are:

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.

The children with ADHD symptoms of hyperactivity, anxiety, or inattention will be recruited in this study. The rationale for not restricting the study to children with formal diagnosis is that many children are first assessed by professionals after 7 years old, and therefore many children with severe hyperactivity, anxiety, and sleep disturbance symptoms have not yet received a diagnosis. For these children, they together with their parents should be considered according to the inclusion criteria.

Inclusion criteria for parents are:

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:

Exclusion criteria for children are:

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).

Exclusion criteria for parents are:

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)

Primary outcomes:
measure: Change in The self-completed Swanson, Nolan and Pelham Parent Scale (SNAP-IV-P) - ADHD Scale
timeFrame: Baseline, week 4, week 8
Secondary outcomes:
measure: Preschool Anxiety Scale (PAS)
timeFrame: Baseline, week 4, week 8
measure: Children's Sleep Habits Questionnaire (CSHQ)
timeFrame: Baseline, week 4, week 8
measure: Parental Stress Scale (PSS)
timeFrame: Baseline, week 4, week 8
measure: Clinical Global Impression (CGI)
timeFrame: Baseline, week 4, week 8
Other outcomes:
Locations:
Study officials:
References:
citation: 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.