Efficacy of the integrative Body-Mind-Spirit group intervention for improving quality of life in parent-child dyads adjusting to atopic dermatitis: protocol for a randomised controlled trial.

Introduction: Atopic dermatitis (AD) is the most common childhood inflammatory skin problem affecting 15%-30% of children. Although AD adversely impacts the psychosocial well-being of children and their parent caregivers, parents' psychosocial well-being is seldom mentioned in most non-pharmacological education programmes. A family-based psychosocial intervention, Integrative Body-Mind-Spirit (I-BMS) intervention, is examined. This study compares the efficacy of two versions of the I-BMS intervention (one delivered to both parents and children; one delivered to parents only) with a health education active control (delivered to parents only) in promoting adaptive emotional regulation and quality of life of children with AD and their parent caregivers.

Methods And Analysis: This is a three-arm, with equal randomisation, parallel randomised controlled trial. 192 parent-child dyads will be recruited through hospitals and non-governmental organisations in Hong Kong. Each dyad will complete an individual pre-group screening interview. Eligible dyads will be randomised in a ratio of 1:1:1 into one of the three arms. Each arm consists of six weekly sessions. A computer-generated list of random numbers will be used to perform randomisation. The primary outcomes are quality of life and emotional regulation. Assessments are administered at baseline, post-intervention and 6-week follow-up. Mixed factorial Analysis of Covariance (ANCOVAs) based on intention-to-treat principle will be conducted to examine the efficacy of the two I-BMS interventions. Structural equation modelling will be conducted to examine the parent-child interdependent effects of intervention.

Ethics And Dissemination: Ethics approval was obtained from the Human Research Ethics Committee of the University of Hong Kong (EA2001001) and the Institutional Review Board of the Hospital Authority of Hong Kong (UW 21-400, KC/KE-20-0360/FR-2, NTEC-2021-0408). Consent will be sought from participating parents and children. Parental consent for child participants will also be obtained. Findings will be presented in peer-reviewed journals and at conferences in medical dermatology, paediatrics and social work.

Trial Registration Number: ClinicalTrials.gov Registry (NCT04617977).