Abstract
BACKGROUND: Asthma in school-age children adversely affects their daily lives and increases parental stress that may further compromise asthma management and worsen asthma control. Few interventions address both aspects simultaneously. AIM: To evaluate the feasibility, acceptability, and preliminary efficacy of an Acceptance and Commitment Therapy-based empowerment intervention for asthma management in school-age children with asthma and their parents. DESIGN: A parallel, two-arm pilot randomised controlled trial. SETTING: Three paediatric respiratory clinics in Chengdu, China. PARTICIPANTS: Children aged 6 to 12 years with asthma receiving daily controller medications and their parents. METHODS: Fifty-six parent-child dyads were randomised to either a 5-week intervention or usual asthma care. The intervention integrated Acceptance and Commitment Therapy, family empowerment strategies, and asthma education and self-management training, delivered weekly through three online parent sessions and two face-to-face parent-child sessions. Feasibility was assessed via recruitment, attrition, and intervention completion rates and acceptability through satisfaction questionnaires and focus group interviews. Preliminary efficacy was evaluated through asthma control and parental stress (primary outcomes); children's asthma self-management ability; parental symptoms of anxiety and depression; psychological flexibility; asthma knowledge; and family empowerment in asthma management (secondary outcomes), measured at baseline and immediately post-intervention. RESULTS: We achieved 61.5 % recruitment, 71.4 % intervention completion rates, and low attrition (children 3.5 %, parents 10.7 %). High satisfaction (93-100 %) and positive qualitative feedback indicated good acceptability despite challenges, including disruptions from children during online sessions and barriers to attending face-to-face sessions. The intervention group demonstrated statistically-significant improvements in asthma control, parental stress, children's self-management ability, parental asthma knowledge, and family empowerment in asthma management, compared to controls. No statistically-significant between-group differences were observed for other outcomes. CONCLUSION: We found that the intervention demonstrated feasibility, acceptability, and promising effects on asthma control, parental stress, and secondary outcomes related to asthma management. Future fully-powered trials should implement enhanced strategies to further improve intervention completion rates and optimise online learning environments to improve parental psychological outcomes and should include extended follow-up assessments to establish long-term efficacy.