Childhood eczema is a significant pediatric health crisis in Hong Kong. It not only has
adverse psychosocial impacts on children, but also poses tremendous burden for their parent
caregivers. The interdependence of family members calls for a systemic family-based
psychosocial intervention.
An integrative body-mind-spirit (I-BMS) intervention for families with children suffering
from eczema has been developed, and its initial results are promising. Compared to the
waitlist control group, parent caregivers in the I-BSM intervention group reported
significantly more improvements in perceived stress, depression and well-being. Likewise,
children in the I-BSM intervention group reported significantly more improvements in somatic
eczema severity, generalized anxiety, social phobia and emotional regulation. It is not
clear, however, if the I-BMS intervention delivered only to the parent caregivers would be:
(1) as efficacious as the I-BMS intervention delivered to both the parent caregivers and
children, and (2) more efficacious than the health education delivered only to the parent
caregivers, in improving their emotional regulation and quality of life. This three-arm
parallel randomized controlled trial (RCT) aims to examine the efficacy of two I-BMS
interventions (one delivered to both parents and children, one delivered to parents only),
compared to a health education active control (delivered to parents only), in promoting
adaptive emotional regulation and quality of life of children with eczema and their parent
caregivers. This RCT also aims to examine the interdependent associations between children
and their parent caregivers' baseline primary outcomes and the post-intervention changes in
primary outcomes.
One hundred and ninety-two parent-child dyads will be recruited through hospitals and
non-governmental organizations in various districts in Hong Kong. Each dyad will complete an
individual pre-group screening interview. Those who meet the eligibility criteria will be
randomized in a ratio of 1:1:1 into one of the three arms, hence, each arm will have 64
parent-child dyads. Arm 1 is I-BMS intervention delivered to both children and their parent
caregivers. Arm 2 is I-BMS intervention delivered to parent caregivers only. Arm 3 is health
education delivered to parent caregivers only. Each arm consists of six weekly three-hour
sessions. A computer-generated list of random numbers will be used to perform randomization.
The primary outcomes are changes over the measurement points in quality of life and emotional
regulation. The secondary outcomes include changes over the measurement points in depression,
anxiety, stress, parent-child relationship, holistic well-being, caregiver burden, and
perceived eczema severity. Assessments will be administered at baseline, post-intervention,
and 6-week follow up. Important adverse events, if any, will be documented. Mixed factorial
ANCOVAs based on intention-to-treat principle will be conducted to examine the efficacy of
the two I-BMS interventions.
Seven hypotheses are generated. First, it is hypothesized that, after the intervention,
participants in the two I-BMS intervention groups will report significantly more improvements
in emotional regulation and quality of life than those in the health education active control
group. Second, it is hypothesized that there is no significant difference between the two
I-BMS intervention groups in terms of post-intervention improvements in emotional regulation
and quality of life. Third, it is hypothesized that the post-intervention improvements in
emotional regulation and quality of life will be maintained at 6-week follow-up for the two
I-BMS intervention groups, but not for the health education active control group. Fourth, it
is hypothesized that children's baseline quality of life is predicted by their own baseline
emotional regulation and by their parents' baseline quality of life. Fifth, it is
hypothesized that parents' baseline quality of life is predicted by their own baseline
emotional regulation and by their children's baseline quality of life. Sixth, it is
hypothesized that children's post-intervention improvements in quality of life are predicted
by their own post-intervention improvements in emotional regulation and their parents'
post-intervention improvements in quality of life. Seventh, it is hypothesized that parents'
post-intervention improvements in quality of life are predicted by their own
post-intervention improvements in emotional regulation and their children's post-intervention
improvements in quality of life.