The present protocol has been registered within ClinicalTrials.gov (Identifier: NCT04237259) and is being reported in accordance with the reporting guidance provided in the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement  (see checklist in Additional file 1). The final study report will be prepared in accordance with the reporting guidance provided in the CONSORT extension for reporting pilot randomized controlled trials [34, 35].
This study is a single-center, two-arm, parallel, open-label, pilot randomized controlled trial. Participants (parent-child pairs) will be distributed into the intervention group and the control group at a 1:1 ratio. Parents in the intervention group (n=30) will receive a training of parent-administered pediatric tuina and perform manipulations on their child. Parents in the active control group (n=30) will be given an online training session about the skills of interacting with their children and a progressive muscle relaxation exercise. Treatments as usual (TAU) of the preschoolers in both groups will not be intervened during the treatment period.
This study includes a feasibility phase, which is expected to be the first two months of data collection treatment period with around eight parent-child pairs. The feasibility stage is designed to preliminary test the logistics of the intervention delivery, and to undertake an early evaluation of the study design of the whole pilot trial.
The treatment period will be 8 weeks. Outcomes will be measured at 3 time points: baseline, week 4, and week 8. A CONsolidated Standards of Reporting Trials (CONSORT) flow diagram demonstrates the procedure of the trial, including the recruitment, allocation, intervention (Figure 2). A Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) diagram shows the schedule of enrollment, intervention, and assessment (Table 1).
Table 1 SPIRIT diagram
Participants will be recruited at Shandong University of Traditional Chinese Medicine Affiliated Hospital, which is a tertiary A hospital with a pediatric tuina clinic center and a pediatric tuina teaching base. The hospital is located in Jinan city, Shandong Province, China.
Subjects and Recruitment Methods
This study will recruit 60 preschool children with ADHD symptoms (hyperactivity, anxiety, and sleep disorders) together with their parents. The methods of recruitment are as follows:
- Flyers and posters in the affiliated hospitals of the university;
- Advertisement through mass media, including newspaper, and radio;
- Poster through social media, including WeChat, Weibo.
Children and their parents who are interested in participating will be screened according to the eligibility criteria via an online meeting. The researcher who is responsible for recruitment will explain the procedure of the study to the subjects’ parents. Parents will be required to sign the informed consent before participating in this study if they are eligible.
There are few published guidance concerning how large the sample size a pilot study should be. “Rule of 12” for continuous variables recommends that at least 12 participants for pilot studies with the primary focus of estimating average values and variability for planning larger subsequent studies. This size is practical for most early-stage researchers within a single center while still providing valued preliminary information . It has been proposed that a sample size ranged from 10 to 40 each group is sufficient to assess the adequacy in providing a precise estimate of the between-group effect size. Assuming a 25% dropout rate, the total sample size will be 60 (n=30 in the intervention group, n=30 in the active control group). A sample size of at least 30 participants each group will help to yield a confidence interval whose lower limits can help define the range of plausible values for subsequent power analysis . Such a sample size is considered to be sufficient to provide the preliminary data required to test the feasibility, acceptability, and effects of parent-administered pediatric tuina for preschool children and assess the study design to provide instructive information and guidance to the further fully power study.
Inclusion criteria for the children are:
- children between 3-7 years old by the start of the assessment;
- having a score equal to or higher than the borderline cutoff of the Swanson, Nolan and Pelham Parent Rating Scale (SNAP) , indicating the children had moderate ADHD symptoms.
Children with ADHD symptoms of hyperactivity, anxiety, or sleep disturbance will be recruited in this study. We will not restrict the children to have a formal medical certificate since children are usually assessed and diagnosed by professionals after 7 years old, hence, their hyperactivity, anxiety, and sleep disturbance symptoms have not yet received a diagnosis. We will consider these children according to the inclusion criteria.
Inclusion criteria for parents are:
- able to communicate using Mandarin;
- willing to learn the knowledge and manipulations of pediatric tuina for ADHD symptoms;
- available to take their children to the designated hospital for pattern identification and conduct manipulations at home according to the study process;
- agree to give informed consent.
Exclusion criteria for children are:
- currently receiving other massage therapies;
- having other developmental disability (e.g. autism spectrum disorders, intellectual disability);
- having acute infection diseases (e.g. scarlet fever, chickenpox), 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 that the investigator deems not appropriate to receive pediatric tuina (e.g. bone fractures, paraplegia).
Exclusion criteria for parents are:
- having any severe psychiatric disorder (e.g. major depressive disorder);
- having difficulties to conduct massage therapy due to physical problems;
- unable to imitate the manipulations in the videos provided to test the cognitive and learning abilities.
Withdrawal criteria for children are:
- occurring of severe adverse events;
- commencement of other pharmacological or psychological therapies for ADHD symptoms during the treatment period.
- receiving a major surgical intervention that leads to unsuitability for receiving pediatric tuina.
Withdrawal criterion for parents is:
- withdrawal of consent.
Participant Recruitment Procedure
A total number of 60 children aged 3-7 years will be recruited with one of their parents in this study. Figure 2 shows the recruitment procedure and based on the CONSORT guidelines. A research coordinator will be responsible for obtaining written informed consent and face-to-face screening. Detailed procedures are the following:
- Recruitment and preliminary screening
The study will be promoted via posters, emails, and phone messages. Contact methods of a research coordinator will be provided. Parents who intend to participate in the study are required to contact the research coordinator via telephone call or WeChat for preliminary screening. Potentially eligible subjects who meet the preliminary criteria will be invited to further procedures.
- Informed consent and screening
Potentially eligible participants will receive an interview online. A research coordinator will explain the study to the parents and obtain the written informed consent. Further assessments will be conducted based on inclusion eligibility criteria. Parents will be required to imitate two manipulations in a video that provided by the research coordinator, and they will be excluded if they fail to do imitation. Personal information about participants will be collected. A case report form (CRF) will be performed by the research coordinator.
- Assigning a study schedule
The research coordinator will assign the baseline assessment, intervention, and follow-up schedule to the eligible participants.
Sequence Generation and Allocation
Children with their parents will be randomly divided into the intervention group or the active control group after the completion of baseline assessments. Block randomization will be carried out using MS Excel with a random block size of 4 to 8 at a 1:1 ratio. The allocation code will be enclosed in sequentially numbered opaque envelopes and kept by a coordinator and will dispense a code to each participant upon confirmation of completion of baseline assessment by the research coordinator. The research coordinator will be blind to the study arms, and the PI will not involve in the post-baseline data collection.
Due to the nature of the intervention (pediatric tuina) and the active control intervention (parent-child interaction training), it is impossible to blind the practitioners and the subjects. Therefore, they will not be blinded. However, parents might have questions when filling the rating scales. If they have any problems, they can inquire the research outcome assessors. For those outcome assessors who are in charge of guiding the parents to fill the questionnaires and collecting data, they will be blinded.
Intervention group: parent-administered pediatric tuina
Children in the intervention group will receive parent-administered pediatric tuina during the treatment period. Figure 3 presents the intervention implementation procedure. The parents will attend an online training program (2 training sessions, 5 hours in total) to gain the knowledge and basic manipulations of pediatric tuina on ADHD symptoms in preschoolers. Contents of the training sessions will cover the manipulations and acupoints that are commonly used in for treating ADHD. The instructor will, inspect their practice, and make feedback to them if there is any deviation. At the end of the training sessions, to assess the parents' mastery of the contents and techniques, the parents will be asked to conduct the manipulations in the prescription (see additional file 3) in front of the TCM practitioner via online video chat, or take a video of the manipulations in the prescription and submit it to the TCM practitioner for an assessment. Parents who have passed the assessment could the start conducting the intervention at home, while for who have not passed, they will be asked to receive the training for one more time until they could appropriately conduct the manipulations. Then they will deliver the tuina on their child at home in the following 2 months according to the tuina-prescriptions formulated by the TCM practitioner. The tuina-prescriptions will comprise the acupoints selected, the corresponding manipulation, conduction frequency, times of each manipulation, and other necessary information. The parents will be told to deliver pediatric tuina therapy on their children every other day, with 20-30 minutes each day. A logbook will be used for recording (see additional file 4). Videos of the manipulation techniques and relevant teaching materials will be provided to the parents via social media.
Active control group: parent-child interaction training
Parents in this group will receive a parent-child interaction training program which includes progressive muscle relaxation exercise training for children and a health education booklet of ADHD and coping skills. The parents in this group will have to complete an online training session of progressive muscle relaxation exercise , which aims to help children reach a relaxation state by relaxing their muscles when facing stresses. The health education booklet covers the background knowledge of ADHD, suggestions, and examples of coping skills (e.g. coping skills for reaction to stress and conflict with children) and interaction skill training for parents (e.g. behavior management, self-regulation, improving organization, improving relationship, and use of encouragement) . All the training contents are recommended by the Department of Health, the government of the Hong Kong Special Administrative Region. The training serves as an early intervention, with the emphasis on modifying the improper parenting methods and enhancing the positive parent-child interaction when the children are still at their preschool stage. Parents will be asked to complete an online written test after they have viewed the online training and teaching materials. They will be asked to spend at least 20 minutes every other day during the treatment period on doing progressive muscle relaxation exercises with their child and record their practice on a logbook (see additional file 5).
During the study period, the children’s ongoing treatment, such as medications, behavioral therapies, and other services such as mental health service and parents-supporting activities will not be intervened in both groups. Information on their TAU will be recorded, and they will be asked not to start new treatment targeting ADHD symptoms during the study period. For subjects in both groups, they will be considered to have completed the program (completers) if they have attended the training lessons and performed the treatment at home for at least 3 days per week during the 8-week intervention period.
The manipulations selected are gentle and safe for preschoolers. It is unlikely that pediatric tuina leads to severe adverse events. Any pain or discomfort, if any, during the intervention, are transient and will not bring to serious sequela. If participants withdraw during the treatment period, their reasons of withdrawal and adverse events will be recorded. They will be followed-up until the adverse events resolved.
For parents in both groups, a consultation will be available for clarification or helps during the treatment period through WeChat. We propose to use a combined approach that we will instruct the parents to perform the tuina intervention every other day and at least 3 times per week. Parents are required to record their massage practice on a logbook during the treatment period, and a researcher will remind them of carrying out the interventions two times a week. To encourage the subjects to complete the treatment, we will provide them with the intervention of the other group as a reward if they have completed the allocated treatment. During the whole process of intervention delivery and data collection, relevant information, international news, scientific research achievements, and other useful resources will be shared with the subjects, and those subjects who finish the whole process of the study will receive the resources 2 or 3 times a week until six months after the end point of trial. A process evaluation will be carried out to better adjust the intervention acceptability and feasibility .