Clinical trial NCT04617977: Integrative Body-Mind-Spirit Intervention for Families With Children Suffering From Eczema
Official title: Interdependent Quality of Life in Parent-Child Dyads Adjusting to Eczema: Effects of a Randomized Controlled Trial of the Integrative Body-Mind-Spirit Group Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Eczema
Dermatitis, Atopic
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2020-11-05
Enrollment: 192
Sex: ALL
Minimum age (years): 6
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial aims to examine the efficacy of two integrative body-mind-spirit interventions, compared to a health education active control, in promoting adaptive emotional regulation and quality of life of children with eczema and their parent caregivers in Hong Kong. It also aims to examine the interdependent associations between children and their parent caregivers' baseline primary outcomes and the post-intervention changes in primary outcomes.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria (Children):

* age 6-12
* are diagnosed with atopic dermatitis as assessed by the doctors (ICD-10 Revision codes L20-L30)
* are able to communicate in Cantonese
* give their consent to participate in this RCT
* obtain parental consent to participate in this RCT

Inclusion Criteria (Parent caregivers):

* are the primary caregivers of the child participants
* are able to communicate in Cantonese
* give their consent to participate in this RCT

Exclusion Criteria (Children):

- are diagnosed with Autism Spectrum Disorder or Attention Deficit Hyperactivity Disorder

Exclusion Criteria (Parent caregivers):

* exhibit a history of family abuse
* present with clinically significant psychiatric morbidity such as psychosis

Primary outcomes:
measure: Changes over the measurement points in the Family Dermatology Life Quality Index
timeFrame: Baseline, post-intervention: 6 weeks after intervention initiation, 6-week follow up
measure: Changes over the measurement points in the Children's Dermatology Life Quality Index
timeFrame: Baseline, post-intervention: 6 weeks after intervention initiation, 6-week follow up
measure: Changes over the measurement points in the Cognitive Emotion Regulation Questionnaire - Short Version
timeFrame: Baseline, post-intervention: 6 weeks after intervention initiation, 6-week follow up
measure: Changes over the measurement points in the Short Version of the Cognitive Emotion Regulation Questionnaire for Spanish Kids
timeFrame: Baseline, post-intervention: 6 weeks after intervention initiation, 6-week follow up
Secondary outcomes:
measure: Changes over the measurement points in the Hospital Anxiety and Depression Scale
timeFrame: Baseline, post-intervention: 6 weeks after intervention initiation, 6-week follow up
measure: Changes over the measurement points in the Revised Child Anxiety and Depression Scale - Short Version
timeFrame: Baseline, post-intervention: 6 weeks after intervention initiation, 6-week follow up
measure: Changes over the measurement points in the Perceived Stress Scale for Children
timeFrame: Baseline, post-intervention: 6 weeks after intervention initiation, 6-week follow up
measure: Changes over the measurement points in the Perceived Stress Scale
timeFrame: Baseline, post-intervention: 6 weeks after intervention initiation, 6-week follow up
measure: Changes over the measurement points in the Parent-Child Relationship Questionnaire - Personal Relationship Subscale (Parent Form)
timeFrame: Baseline, post-intervention: 6 weeks after intervention initiation, 6-week follow up
measure: Changes over the measurement points in the Parent-Child Relationship Questionnaire - Personal Relationship Subscale (Child Form)
timeFrame: Baseline, post-intervention: 6 weeks after intervention initiation, 6-week follow up
measure: Patient-Oriented Eczema Measure for Child (Parent Form)
timeFrame: Baseline, post-intervention: 6 weeks after intervention initiation, 6-week follow up
Other outcomes:
measure: Satisfaction with Treatment Program Scale
timeFrame: Post-intervention: 6 weeks after intervention initiation
measure: Demographics
timeFrame: Baseline
measure: Childhood eczema onset age
timeFrame: Baseline
measure: Current treatment for childhood eczema
timeFrame: Baseline
measure: Cross-condition contamination check
timeFrame: Post-intervention: 6 weeks after intervention initiation
measure: Presence of other clinical co-morbidities
timeFrame: Baseline
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Social Work and Social Administration
Study officials:
affiliation: The University of Hong Kong
name: Celia Hoi-Yan Chan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hui VKY, Chan CHY, Fung YL, Chan CLW, Luk MSK. 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. BMJ Open. 2022 Mar 16;12(3):e059150. doi: 10.1136/bmjopen-2021-059150.