ADHDNCT04237259
Traditional Chinese Medicine Pediatric Massage for Attention Deficit Hyperactivity Disorder Symptoms
A study testing Parent-administered TCM pediatric massage training and Progressive Muscle Relaxation Exercise in people with ADHD, run by The Hong Kong Polytechnic University.
Trial summary
This project is designed to preliminarily assess the effects and feasibility of parent-delivered TCM pediatric massage for ADHD symptoms in preschool children. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- ADHD
- What is being tested?
- Parent-administered TCM pediatric massage training and Progressive Muscle Relaxation Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2020to 31 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
- 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.
- 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.
Who cannot join
- 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)
About this study
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
This project is designed to preliminarily assess the effects and feasibility of parent-delivered TCM pediatric massage for ADHD symptoms in preschool children.
Read the 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
- Being tested
- Parent-administered TCM pediatric massage training, Progressive Muscle Relaxation Exercise
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent-administered TCM pediatric massage trainingOther
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).
Progressive Muscle Relaxation ExerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Progressive Muscle Relaxation Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, week 4, week 8
Secondary outcomes (4)
Preschool Anxiety Scale (PAS)
The PAS-SC is a 34-item parent-rated scale, which assesses anxiety symptoms in young children across six subscales: panic attack and agoraphobia, separation anxiety, physical injury fears, social phobia, obsessive compulsive, generalized anxiety disorder/overanxious disorder.
Measured: Baseline, week 4, week 8
Children's Sleep Habits Questionnaire (CSHQ)
CSHQ is a retrospective, 33- item parent questionnaire that has been used in a number of studies to examine sleep behaviour in young children.
Measured: Baseline, week 4, week 8
Parental Stress Scale (PSS)
PSS is a measure of "individual differences in the level of stress associated with raising children'', which consists of 18 items on the perception of parental stress and uses a Likert style rating scale.
Measured: Baseline, week 4, week 8
Clinical Global Impression (CGI)
The CGI is usually used as a standard primary measure in studies investigating the efficacy of pharmacological treatments for psychiatric conditions such as depression, social anxiety disorder, panic disorder and bipolar disorder.
Measured: Baseline, week 4, week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start1 Feb 2020 (estimated)
- Primary completion31 Jul 2020 (estimated)
- Study completion31 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YEUNG Wing Fai, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04237259
- Sponsor's protocol ID
- TCM ped msg_ADHD
- Status last verified
- Jan 2020
- First submitted
- 20 Jan 2020
- Last updated
- 5 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33292826
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04237259
- Acronym / sponsor ID
- TCM ped msg_ADHD
- Conditions
- ADHD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (estimated)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 31 Jul 2020 (estimated)
- First posted
- 23 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parent-administered TCM massage group | Experimental | Other: Parent-administered TCM pediatric massage trainingParents 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. |
| Parent-child interaction group | Active comparator | Other: Progressive Muscle Relaxation ExerciseParents 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. |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
- 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.
- able to communicate using Mandarin;
- willing to learn the knowledge and manipulations of TCM pediatric massage for treating ADHD;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parent-administered TCM pediatric massage trainingMassage 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 | Parent-administered TCM massage group |
| Progressive Muscle Relaxation ExerciseThe 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. | Other | Parent-child interaction group |
Primary outcome
Change in The self-completed Swanson, Nolan and Pelham Parent Scale (SNAP-IV-P) - ADHD Scale
Time frame: Baseline, week 4, week 8
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.
4 secondary outcomes
Preschool Anxiety Scale (PAS)
Time frame: Baseline, week 4, week 8
Children's Sleep Habits Questionnaire (CSHQ)
Time frame: Baseline, week 4, week 8
Parental Stress Scale (PSS)
Time frame: Baseline, week 4, week 8
Clinical Global Impression (CGI)
Time frame: Baseline, week 4, week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Derived from this study: PubMed 33292826Chen 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Parent-administered TCM pediatric massage training and Progressive Muscle Relaxation Exercise in people with ADHD, run by The Hong Kong Polytechnic University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in The self-completed Swanson, Nolan and Pelham Parent Scale (SNAP-IV-P) - ADHD Scale (time frame: Baseline, week 4, week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04237259, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.