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

The University of Hong Kong (HKU)

Status: Unknown

Conditions: Dermatitis, Atopic; Eczema

Treatments: Behavioral: Health education for parents whose children have eczema; Behavioral: I-BMS for families with children suffering from eczema

Study type: Interventional

Funder types: Other

Identifiers

NCT04617977

EA2001001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 192 estimated patients

Sex: All

Ages: 6 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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192 participants in 3 patient groups

Parent-child I-BMS intervention group

Experimental group

Description:

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.

Treatment:

Behavioral: I-BMS for families with children suffering from eczema

Parent only I-BMS intervention group

Experimental group

Description:

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.

Treatment:

Behavioral: I-BMS for families with children suffering from eczema

Parent only health education active control group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Health education for parents whose children have eczema