Integrative Body-Mind-Spirit Intervention for Families With Children Suffering From Eczema

Not Applicable

• Conditions: Dermatitis, Atopic; Eczema
• Interventions: Behavioral: Health education for parents whose children have eczema; Behavioral: I-BMS for families with children suffering from eczema

• Registration Number: NCT04617977
• Lead Sponsor: The University of Hong Kong

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-10-30
• Study First Submitted QC: 2020-10-30
• Study First Posted: 2020-11-05
• Study Start: 2021-08-23
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-26
• Last Update Posted: 2022-01-27
• Primary Completion: 2023-10-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 192

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Parent only health education active control group	Health education for parents whose children have eczema	Only parent caregivers of children with eczema will attend the six sessions. Each session consists of teaching in the first 2.5 hours and Q\&A in the final 0.5 hour. The children group will simultaneously attend a group activity class in a separate room for 3 hours.
Parent-child I-BMS intervention group	I-BMS for families with children suffering from eczema	Children with eczema and their parent caregivers will attend the six sessions simultaneously in a parallel group format. Parent caregivers will attend the parents group in the first 2.5 hours; while children will attend the children group in the first 2.5 hours. Both parents and children will later reunite in the joint group in the final 0.5 hours.
Parent only I-BMS intervention group	I-BMS for families with children suffering from eczema	Only parent caregivers of children with eczema will attend the six sessions. The content of the 2.5-hour parents group will be the same as the one in Arm 1 (Parent-child I-BMS intervention group), with an additional 0.5 hour of reflective discussion among group members. The children group will simultaneously attend a group activity class in a separate room for 3 hours.

Primary Outcome Measures

Name	Time	Method
Changes over the measurement points in the Children's Dermatology Life Quality Index	Baseline, post-intervention: 6 weeks after intervention initiation, 6-week follow up	It has 10 items. It measures the impact of atopic dermatitis on the lives of children. Scores range from 0 to 30, where a higher score represents a greater impact on the child's life.
Changes over the measurement points in the Family Dermatology Life Quality Index	Baseline, post-intervention: 6 weeks after intervention initiation, 6-week follow up	It has 10 items. It measures how much a child with atopic dermatitis affects the quality of life of their parent caregivers. Scores range from 0 to 30, where a high score represents a greater effect on the life of the parent caregiver.
Changes over the measurement points in the Cognitive Emotion Regulation Questionnaire - Short Version	Baseline, post-intervention: 6 weeks after intervention initiation, 6-week follow up	It has 18 items. It measures the specific cognitive emotion regulation strategies parent caregivers have used when caring for their children. It has nine subscales, namely, self-blame, other-blame, rumination, catastrophizing, putting into perspective, positive refocusing, positive appraisal, acceptance and planning. Subscale scores range from 2 to 10, where a higher score represents more usage of a specific cognitive emotion strategy.
Changes over the measurement points in the Short Version of the Cognitive Emotion Regulation Questionnaire for Spanish Kids	Baseline, post-intervention: 6 weeks after intervention initiation, 6-week follow up	It has 18 items. It measures the specific cognitive emotion regulation strategies children have used to cope with their illness experience. It has nine subscales, namely, self-blame, other-blame, rumination, catastrophizing, putting into perspective, positive refocusing, positive appraisal, acceptance and planning. Subscale scores range from 2 to 10, where a higher score represents more usage of a specific cognitive emotion strategy.

Secondary Outcome Measures

Name	Time	Method
Changes over the measurement points in the Hospital Anxiety and Depression Scale	Baseline, post-intervention: 6 weeks after intervention initiation, 6-week follow up	It has 14 items. It measures parent caregivers' emotional states of depression and anxiety. It has two subscales, namely, depression and anxiety. Subscale scores range from 0 to 21, where a higher score represents a higher level of depression or anxiety.
Changes over the measurement points in the Perceived Stress Scale for Children	Baseline, post-intervention: 6 weeks after intervention initiation, 6-week follow up	It has 14 items. It measures children's emotional states of stress. One item is for illustration purposes and is not scored. Scores range from 0 to 39, where a higher score represents a higher level of stress.
Changes over the measurement points in the Perceived Stress Scale	Baseline, post-intervention: 6 weeks after intervention initiation, 6-week follow up	It has 10 items. It measures parent caregivers' emotional states of stress. Scores range from 0 to 40, where a higher score represents a higher level of stress.
Changes over the measurement points in the Revised Child Anxiety and Depression Scale - Short Version	Baseline, post-intervention: 6 weeks after intervention initiation, 6-week follow up	It has 25 items. It measures children's emotional states of depression and anxiety. The depression subscale has 10 items, its scores range from 0 to 30, where a higher score represents a higher level of depression. The anxiety subscale has 15 items, its scores range from 0 to 45, where a higher score represents a higher level of anxiety.
Patient-Oriented Eczema Measure for Child (Parent Form)	Baseline, post-intervention: 6 weeks after intervention initiation, 6-week follow up	It has 7 items. It measures parent caregivers' perception of their children's eczema severity. Scores range from 0 to 28, where a higher score represents more severe eczema.
Changes over the measurement points in the Parent-Child Relationship Questionnaire - Personal Relationship Subscale (Parent Form)	Baseline, post-intervention: 6 weeks after intervention initiation, 6-week follow up	It has 10 items. It measures parent caregivers' perception of their relationship quality with their children. Scores range from 10 to 50, where a higher score represents a better parent-child relationship.
Changes over the measurement points in the Parent-Child Relationship Questionnaire - Personal Relationship Subscale (Child Form)	Baseline, post-intervention: 6 weeks after intervention initiation, 6-week follow up	It has 10 items. It measures children's perception of their relationship quality with their parent caregivers. Scores range from 10 to 50, where a higher score represents a better parent-child relationship.

Trial Locations

Locations (1)

Department of Social Work and Social Administration; 🇭🇰 Hong Kong, Hong Kong