Clinical trial NCT06007742: Parent-administered Pediatric Tuina for Improving Sleep Quality and Appetite in School-aged Children With ADHD
Official title: Parent-administered Pediatric Tuina for Improving Sleep Quality and Appetite in School-aged Children With ADHD: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ADHD
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2023-08-23
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* Inclusion criteria for the children are the following:

  1. 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)
  2. Have an internationally recognized diagnosis or documentation of ADHD
  3. Have a score of more than 39 on the Sleep Disturbance Scale for Children (SDSC)
* Inclusion criteria for the parents are the following

  1. Ability to communicate in Cantonese
  2. Willingness to learn the knowledge and manipulations of pediatric tuina for ADHD symptoms
  3. Available to visit the Hong Kong Polytechnic University to attend the course as scheduled in accordance with the trial process
  4. Sign the informed consent form

Exclusion Criteria:

* Exclusion criteria for the children are the following:

  1. Currently receiving other tuina (or massage) treatments
  2. Having other developmental disorders (e.g., autism, intellectual disability)
  3. 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)
  4. Having any severe illness or medical condition (e.g., fractures, paraplegia) that are not suitable to receive pediatric tuina
* Exclusion criteria for the parents are the following:

  1. Having any severe psychiatric disorder (e.g., major depression)
  2. Having difficulties to conduct massage therapy due to physical problems
  3. Having a score less than 22 on the Montreal Cognitive Assessment (MoCA).

Primary outcomes:
measure: Sleep Disturbance Scale for Children (SDSC) Chinese version
timeFrame: Baseline, week 4, and week 8.
Secondary outcomes:
measure: Children's Eating Behaviour Questionnaire (CEBQ) Chinese version
timeFrame: Baseline, week 4, and week 8.
measure: Conners Parent Rating Scale (CPRS) Chinese version
timeFrame: Baseline, week 4, and week 8.
measure: Child Health Questionnaire (CHQ) Chinese version
timeFrame: Baseline, week 4, and week 8.
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Hong Kong Polytechnic University
state: Hong Kong
Study officials:
References: