ADHDNCT06007742
Parent-administered Pediatric Tuina for Improving Sleep Quality and Appetite in School-aged Children With ADHD
A study testing parent-administered pediatric tuina in people with ADHD, run by The Hong Kong Polytechnic University at 1 site in China.
Trial summary
Title: Parent-administered pediatric tuina for improving sleep quality and appetite in school-aged children with ADHD: a pilot randomized controlled trial Background: Pediatric tuina has been used and explored by many researchers and clinicians as a topical complementary and alternative treatment for ADHD, which can… Read more about this study
- Who is it for?
- Ages 6 to 8 years
- Conditions the study is for
- ADHD
- What is being tested?
- parent-administered pediatric tuina
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2023to 30 Nov 2024
- 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 6 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children: Aged 6-8 years old by the start of the assessment (according to the Hong Kong Education Bureau, 6 years old is considered suitable for primary school education)
- Have an internationally recognized diagnosis or documentation of ADHD
- Have a score of more than 39 on the Sleep Disturbance Scale for Children (SDSC)
- Ability to communicate in Cantonese
- Willingness to learn the knowledge and manipulations of pediatric tuina for ADHD symptoms
- Available to visit the Hong Kong Polytechnic University to attend the course as scheduled in accordance with the trial process
- Sign the informed consent form
Who cannot join
- Currently receiving other tuina (or massage) treatments
- Having other developmental disorders (e.g., autism, intellectual disability)
- Having acute infectious diseases (e.g., scarlet fever, chicken pox, etc.), hemorrhagic diseases (e.g., bleeding, local places of various kinds of malignant tumor), or dermatological problems (e.g., scald, severe skin lesion, skin infections)
- Having any severe illness or medical condition (e.g., fractures, paraplegia) that are not suitable to receive pediatric tuina
- Having any severe psychiatric disorder (e.g., major depression)
- Having difficulties to conduct massage therapy due to physical problems
- Having a score less than 22 on the Montreal Cognitive Assessment (MoCA).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hong Kong Polytechnic University
Hong Kong, Hong Kong, 000000
Shucheng CHEN, +85267653381, cara-sc.chen@polyu.edu.hk
About this study
Official title: Parent-administered Pediatric Tuina for Improving Sleep Quality and Appetite in School-aged Children With ADHD: a Pilot Randomized Controlled Trial
Title: Parent-administered pediatric tuina for improving sleep quality and appetite in school-aged children with ADHD: a pilot randomized controlled trial
Background: Pediatric tuina has been used and explored by many researchers and clinicians as a topical complementary and alternative treatment for ADHD, which can compensate for some of the shortcomings of medications and behavioural therapies, such as the side effects of medications and the financial stress of long-term behavioural therapies. Pediatric tuina can also grasp the golden stage of young children and improve their symptoms in time on the basis of TCM pattern identification and holistic concepts. We once conducted a focus group interview on 15 parents to understand the effects of parent-administered pediatric tuina on ADHD symptoms, and all parents reported that parent-administered pediatric tuina significantly improved the child's sleep quality, eating habits, and parent-child relationship within a short period of time after receiving the intervention.
Read more
Objective: This study aims to assess the preliminary effects, feasibility, and safety of parent-administered pediatric tuina for attention deficit hyperactivity disorder (ADHD) symptoms in school-aged children.
Methods: This project is a three-arm, parallel, open-label, pilot RCT. Sixty participants were randomized into three groups at a 1:1:1 ratio. Parents in the parent-administered tuina group (n = 20) will attend a face-to-face training program on pediatric tuina for ADHD and conduct this intervention on their children at home. Parents in the parent-child interaction group (n = 20) will attend face-to-face training about parent-child interactive exercises and carry them out with their children at home. Both interventions will be carried out every other day during a two-month intervention period, with each manipulation for at least 25-30 min. Participants in the waitlist group (n=20) will not receive both interventions during the intervention period. Outcomes will be assessed at baseline, week 4, and week 8. The primary outcome measure was the Sleep Disturbance Scale for Children; the secondary outcomes included Children's Eating Behaviour Questionnaire, Conners Parent Rating Scale, and Child Health Questionnaire. A process evaluation will be embedded within the outcome evaluation. Descriptive statistics for sociodemographic variables and clinical variables will be presented. Data will be presented as mean and standard deviation. The feasibility outcomes will be presented as percentages. The rating scale scores between the intervention groups and the control group in week 4 and week 8 will be compared using a linear mixed-effects model. Recorded interviews will be transcribed verbatim and analyzed using content analysis. Depending on the topic and purpose of the study, the interview was categorized into words or sentences with the help of the qualitative research tool Nvivo.
- Conditions
- ADHD
- Being tested
- parent-administered pediatric tuina
- 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 pediatric tuinaOther
Also called parent-child interactive exercise
Parents in intervention group will participate in a pediatric tuina course to improve eating and sleep symptoms of ADHD, followed by an 8-week treatment period for the children. The course will take place at the Hong Kong Polytechnic University campus and will consist of 2 sessions of approximately 2 hours each. The course content will be taught by a registered TCM practitioner.
. Parents assigned to this group will participate in a Parent-Child Exercise for ADHD program, which will complete with their children in the next 8 weeks. The program will take place at the Hong Kong Polytechnic University campus and will consist of 2 sessions of approximately 2 hours each. The content will be taught by a registered physiotherapist.
The two intervention groups are manipulated every other day for 25-30 minutes each. A total number of interventions equal to or greater than 24 is considered a completed intervention.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group: parent-administered pediatric tuina (n=20) | Experimental | Not described Receives: Other: parent-administered pediatric tuina |
| Active control group: parent-child interactive exercise (n=20) | Active comparator | Not described Receives: Other: parent-administered pediatric tuina |
| Control group: usual care (n=20) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Disturbance Scale for Children (SDSC) Chinese version
The SDSC is a 26-item scale used to evaluate specific sleep disturbance in children. The scale is divided into 6 dimensions, representing 6 types of sleep disturbance: disorders of initiating and maintaining sleep, sleep breathing disorders, disorders of arousal, sleep-wake transition disorders, disorders of excessive somnolence, and sleep hyperhydrosis. Each item is scored on a 5-point Likert scale from 1-5. The higher the total score, the more serious the sleep disturbance is, and a total score of more than 39 is considered to be a sleep disturbance.
Measured: Baseline, week 4, and week 8.
Secondary outcomes (3)
Children's Eating Behaviour Questionnaire (CEBQ) Chinese version
The Child Eating Behavior Questionnaire (CEBQ) is a 35-item parent-report questionnaire assessing eating style in children. Eating style is assessed on eight scales: food responsiveness (4 items), enjoyment of food (4 items), emotional overeating (4 items), desire to drink (3 items), satiety responsiveness (5 items), slowness in eating (4 items), and emotional undereating (4 items), and fussiness (7 items). Informants rate the frequency of their child's behaviors and experiences on a 5-point scale: 1 = never, 2 = rarely, 3 = sometimes, 4 = often, 5 = always.
Measured: Baseline, week 4, and week 8.
Conners Parent Rating Scale (CPRS) Chinese version
The CPRS is used to assess ADHD in children aged 3-17 years. It assesses the child's behaviour problems, attention deficit disorder, and hyperactivity through the parent's perspective. The scale identifies behavioural problems, learning problems, psychosomatic problems, impulsivity-hyperactivity, and anxiety problems. Each item is rated on a four-point scale: 0-3. The higher the average score, the more significant the problem, and above 1.5, the more likely ADHD is present.
Measured: Baseline, week 4, and week 8.
Child Health Questionnaire (CHQ) Chinese version
The parent-reported CHQ is used to assess the healthy quality of life in children and adolescents aged 5 to 18 years, measuring 14 unique physical and psychological concepts. A 28-item version is used for this study, divided into two subscales: physical and psychosocial, which included 14 basic dimensions.
Measured: Baseline, week 4, and 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 Aug 2023
- Study start15 Oct 2023
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06007742
- Sponsor's protocol ID
- PT_ADHD_AS
- Status last verified
- Aug 2023
- First submitted
- 17 Aug 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parent-administered Pediatric Tuina for Improving Sleep Quality and Appetite in School-aged Children With ADHD: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06007742
- Acronym / sponsor ID
- PT_ADHD_AS
- 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
- 15 Oct 2023 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 23 Aug 2023 (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.
Title: Parent-administered pediatric tuina for improving sleep quality and appetite in school-aged children with ADHD: a pilot randomized controlled trial
Background: Pediatric tuina has been used and explored by many researchers and clinicians as a topical complementary and alternative treatment for ADHD, which can compensate for some of the shortcomings of medications and behavioural therapies, such as the side effects of medications and the financial stress of long-term behavioural therapies. Pediatric tuina can also grasp the golden stage of young children and improve their symptoms in time on the basis of TCM pattern identification and holistic concepts. We once conducted a focus group interview on 15 parents to understand the effects of parent-administered pediatric tuina on ADHD symptoms, and all parents reported that parent-administered pediatric tuina significantly improved the child's sleep quality, eating habits, and parent-child relationship within a short period of time after receiving the intervention.
Objective: This study aims to assess the preliminary effects, feasibility, and safety of parent-administered pediatric tuina for attention deficit hyperactivity disorder (ADHD) symptoms in school-aged children.
Methods: This project is a three-arm, parallel, open-label, pilot RCT. Sixty participants were randomized into three groups at a 1:1:1 ratio. Parents in the parent-administered tuina group (n = 20) will attend a face-to-face training program on pediatric tuina for ADHD and conduct this intervention on their children at home. Parents in the parent-child interaction group (n = 20) will attend face-to-face training about parent-child interactive exercises and carry them out with their children at home. Both interventions will be carried out every other day during a two-month intervention period, with each manipulation for at least 25-30 min. Participants in the waitlist group (n=20) will not receive both interventions during the intervention period. Outcomes will be assessed at baseline, week 4, and week 8. The primary outcome measure was the Sleep Disturbance Scale for Children; the secondary outcomes included Children's Eating Behaviour Questionnaire, Conners Parent Rating Scale, and Child Health Questionnaire. A process evaluation will be embedded within the outcome evaluation. Descriptive statistics for sociodemographic variables and clinical variables will be presented. Data will be presented as mean and standard deviation. The feasibility outcomes will be presented as percentages. The rating scale scores between the intervention groups and the control group in week 4 and week 8 will be compared using a linear mixed-effects model. Recorded interviews will be transcribed verbatim and analyzed using content analysis. Depending on the topic and purpose of the study, the interview was categorized into words or sentences with the help of the qualitative research tool Nvivo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention group: parent-administered pediatric tuina (n=20) | Experimental | Other: parent-administered pediatric tuina |
| Active control group: parent-child interactive exercise (n=20) | Active comparator | Other: parent-administered pediatric tuina |
| Control group: usual care (n=20) | No intervention | – |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
Key exclusion criteria (7 listed)
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 pediatric tuinaAlso: parent-child interactive exerciseParents in intervention group will participate in a pediatric tuina course to improve eating and sleep symptoms of ADHD, followed by an 8-week treatment period for the children. The course will take place at the Hong Kong Polytechnic University campus and will consist of 2 sessions of approximately 2 hours each. The course content will be taught by a registered TCM practitioner. . Parents assigned to this group will participate in a Parent-Child Exercise for ADHD program, which will complete with their children in the next 8 weeks. The program will take place at the Hong Kong Polytechnic University campus and will consist of 2 sessions of approximately 2 hours each. The content will be taught by a registered physiotherapist. The two intervention groups are manipulated every other day for 25-30 minutes each. A total number of interventions equal to or greater than 24 is considered a completed intervention. | Other | Active control group: parent-child interactive exercise (n=20), Intervention group: parent-administered pediatric tuina (n=20) |
Primary outcome
Sleep Disturbance Scale for Children (SDSC) Chinese version
Time frame: Baseline, week 4, and week 8.
The SDSC is a 26-item scale used to evaluate specific sleep disturbance in children. The scale is divided into 6 dimensions, representing 6 types of sleep disturbance: disorders of initiating and maintaining sleep, sleep breathing disorders, disorders of arousal, sleep-wake transition disorders, disorders of excessive somnolence, and sleep hyperhydrosis. Each item is scored on a 5-point Likert scale from 1-5. The higher the total score, the more serious the sleep disturbance is, and a total score of more than 39 is considered to be a sleep disturbance.
3 secondary outcomes
Children's Eating Behaviour Questionnaire (CEBQ) Chinese version
Time frame: Baseline, week 4, and week 8.
Conners Parent Rating Scale (CPRS) Chinese version
Time frame: Baseline, week 4, and week 8.
Child Health Questionnaire (CHQ) Chinese version
Time frame: Baseline, week 4, and week 8.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing parent-administered pediatric tuina in people with ADHD, run by The Hong Kong Polytechnic University at 1 site in China.
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 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Cara CHEN (27661371, cara-sc.chen@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Disturbance Scale for Children (SDSC) Chinese version (time frame: Baseline, week 4, and week 8.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2024.