| Author: | Chen, Shucheng |
| Title: | Pediatric tuina for attention deficit/hyperactivity disorder symptoms in preschool children : a pilot randomized controlled trial embedded with a process evaluation |
| Advisors: | Yeung, Wing Fai (SN) Suen, Kwai Ping Lorna (SN) |
| Degree: | Ph.D. |
| Year: | 2022 |
| Subject: | Attention-deficit-disordered children -- Alternative treatment Massage for children -- Therapeutic use Hong Kong Polytechnic University -- Dissertations |
| Department: | School of Nursing |
| Pages: | xxv, 410 pages : color illustrations |
| Language: | English |
| Abstract: | Background Medication and behavioral therapy are the conventional treatments for attention deficit hyperactivity disorder (ADHD), but they have limitations for preschool children. Pediatric tuina is a modality of traditional Chinese medicine (TCM) that can be administered by parents after proper training. The beneficial effects of parent-administered pediatric tuina on ADHD have been reported in previous studies. However, no rigorously designed randomized controlled trials (RCTs) have examined the effects of pediatric tuina on ADHD in preschool children. Objective This study aimed to assess the feasibility and preliminary effects of parent-administered pediatric tuina for ADHD symptoms in preschoolers. Methods This work was a two-arm, parallel, open-label, pilot RCT. Sixty-four participants were randomized into two groups at a 1:1 ratio. Parents in the parent-administered tuina group (intervention group, n = 32) attended an online training program to learn pediatric tuina skills for ADHD symptoms and conduct this treatment on their children at home based on individualized prescriptions formulated by the TCM practitioners. Parents in the parent-child interaction group (comparison group, n = 32) attended an online training about progressive muscle relaxation exercise and carried out parent-child interactive physical activities with their children at home. Additional teaching materials were provided to the participants in both groups by express mail. Both interventions were carried out at home by the parents every other day during a two-month intervention period, with each manipulation lasting for at least 20 min. Feasibility outcomes included recruitment rate, consent rate, adherence to the intervention, completion of study assessments, and adverse event. Patient-centered outcome evaluations were performed at baseline, week 4, and week 8. The primary outcome measure was the Swanson, Nolan, and Pelham parent scale (SNAP); the secondary outcomes included preschool anxiety scale, children's sleep habits questionnaire, and parental stress scale. A process evaluation embedded within the outcome evaluation was performed, which included a self-report questionnaire on parents, research personal, focus group interviews on parents, and parent logbook. For quantitative data, differences in the scale scores and test parameters between groups were examined using a generalized linear mixed-effects model (GLMM); means (standard deviation) were calculated to analyze the quantitative data of process evaluation. For qualitative data, the transcripts of focus group interviews were analyzed by template analysis; tables were formulated to summarize the key points from parents' self-report questionnaires. Results Findings showed that the study design and intervention were feasible in assessing all the five feasibility outcomes at the feasibility stage. Refinements of the study in the following period included (1) improving online recruitment methods, (2) prolonging the time for informed consent sheet explanation, (3) adjusting the parent logbook collecting method, (4) improving TCM pattern identification methods, (5) refining control intervention, and (6) adjusting patient-centered outcomes. For the pilot RCT, 64 children with pre-specified ADHD symptoms (hyperactivity, anxiety, and sleep disturbance) together with one of their caregivers were recruited from May to September 2020. The recruitment rate of this project was 12.8 per month. The consent rate was 98.5%. Good adherence was shown from the parent logbook. Four participants dropped out from the study, with a high retention rate of both outcome evaluation (93.8%) and process evaluation, namely, parents' self-report questionnaire (67.2%), willing to attend focus group interview (59.3%), and parent logbook (95.3%). No severe adverse event was reported. For the SNAP total score, the primary outcome, both groups showed improvement with moderate within-group effect size (Cohen's d > 0.5, all p <0.001), and the between-group effect size was minimal (dppc2<0.2, p > 0.05). In the parent-administered pediatric tuina group, significant within-group improvements were observed in the SNAP inattention subscale and SNAP hyperactivity/impulsivity subset at weeks 4 and 8 (all Cohen's d > 0.5, all p <0.001). In the parent-child interaction training group, significant within-group improvements were noted in all the three subscales (inattention, hyperactivity/impulsivity, and total scale) at weeks 4 and 8 (all Cohen's d > 0.5, all p <0.001). The between-group differences in the improvement of all SNAP subscales were minimal, with effect sizes smaller than 0.2 (all p > 0.05). Minimal within-group effects and between-group effects were observed in other secondary outcomes. Perceived improvements on children's appetite and sleep quality, parental anxiety, and parent-child relationship were observed from the qualitative data. Conclusions The study design was feasible. Implementation of parent-administered pediatric tuina was feasible, acceptable, and safe for the participants based on the findings. Parent-administered pediatric tuina had small to moderate effects on improving core symptoms of ADHD in children, but the effects were small compared with parent-child interaction. Perceived improvements on children's appetite and sleep quality were observed. Further RCTs with larger sample size must be conducted in the future. Significance This study is the first to examine the effects of pediatric tuina administered by parents on ADHD using both outcome evaluation and process evaluation. It combined pediatric tuina with parent-administered interventions and online setting, and the feasibility was supported by the findings. This study provides preliminary evidence of a safe and economic intervention that can be delivered conveniently, not limited by time and place, for children with ADHD and their parents. Researchers are given insight into the effects of pediatric tuina on parent-delivered and online settings in future research. |
| Rights: | All rights reserved |
| Access: | open access |
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