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

NCT ID: NCT04617977

Last Updated: 2022-01-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-23
• Study Completion Date: 2023-12-31

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.

Conditions

Eczema; Dermatitis, Atopic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Parent-child I-BMS intervention group

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.

Group Type: EXPERIMENTAL

I-BMS for families with children suffering from eczema

Intervention Type: BEHAVIORAL

It is a strength-based, family system approach to aid empowerment of individuals. It focuses on the interplay between physical and emotional well-being, the spiritual transformation of adverse life experiences, and the acceptance of adversity through reflection on the philosophical concepts of forgiveness and letting go. It integrates Western therapeutic techniques and Eastern philosophies to develop spiritual transformation through suffering and pain under a meaning-oriented framework. It consists of six three-hour consecutive weekly sessions: (1) awareness of body-mind connection; (2) regulation of emotion; (3) acknowledgement of the gains and losses in the caregiving or illness experience; (4) appreciation of self and others; (5) cultivation of acceptance; and (6) meaning reconstruction of caregiving or illness experience.

Parent only I-BMS intervention group

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.

Group Type: EXPERIMENTAL

I-BMS for families with children suffering from eczema

Intervention Type: BEHAVIORAL

It is a strength-based, family system approach to aid empowerment of individuals. It focuses on the interplay between physical and emotional well-being, the spiritual transformation of adverse life experiences, and the acceptance of adversity through reflection on the philosophical concepts of forgiveness and letting go. It integrates Western therapeutic techniques and Eastern philosophies to develop spiritual transformation through suffering and pain under a meaning-oriented framework. It consists of six three-hour consecutive weekly sessions: (1) awareness of body-mind connection; (2) regulation of emotion; (3) acknowledgement of the gains and losses in the caregiving or illness experience; (4) appreciation of self and others; (5) cultivation of acceptance; and (6) meaning reconstruction of caregiving or illness experience.

Parent only health education active control group

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.

Group Type: ACTIVE_COMPARATOR

Health education for parents whose children have eczema

Intervention Type: BEHAVIORAL

It focuses on practical eczema management. It serves as a control for group effect between conditions. It consists of six three-hour sessions: (1) information about the physiology of eczema and its health impact; (2) recognition and avoidance of trigger factors and daily skin care; (3) dealing with itching and scratching; (4) stage-related treatment of symptoms and unconventional therapies; (5) general child nutrition, food allergies in eczema, and different forms of diets; and (6) self-management plan and problems in integrating into daily routine.

Interventions

I-BMS for families with children suffering from eczema

It is a strength-based, family system approach to aid empowerment of individuals. It focuses on the interplay between physical and emotional well-being, the spiritual transformation of adverse life experiences, and the acceptance of adversity through reflection on the philosophical concepts of forgiveness and letting go. It integrates Western therapeutic techniques and Eastern philosophies to develop spiritual transformation through suffering and pain under a meaning-oriented framework. It consists of six three-hour consecutive weekly sessions: (1) awareness of body-mind connection; (2) regulation of emotion; (3) acknowledgement of the gains and losses in the caregiving or illness experience; (4) appreciation of self and others; (5) cultivation of acceptance; and (6) meaning reconstruction of caregiving or illness experience.

Intervention Type: BEHAVIORAL

Health education for parents whose children have eczema

It focuses on practical eczema management. It serves as a control for group effect between conditions. It consists of six three-hour sessions: (1) information about the physiology of eczema and its health impact; (2) recognition and avoidance of trigger factors and daily skin care; (3) dealing with itching and scratching; (4) stage-related treatment of symptoms and unconventional therapies; (5) general child nutrition, food allergies in eczema, and different forms of diets; and (6) self-management plan and problems in integrating into daily routine.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

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

Exclusion Criteria

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

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Dr. Celia Hoi-Yan Chan

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Celia Hoi-Yan Chan, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

Department of Social Work and Social Administration

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Celia Hoi-Yan Chan, PhD

Role: CONTACT

chancelia@hku.hk

(852) 3917 2089

YL Fung, PhD

Role: CONTACT

yl.fung28@hku.hk

(852) 3917 1160

Facility Contacts

Celia Hoi-Yan Chan, PhD

Role: primary

chancelia@hku.hk

(852) 3917 2089

References

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.

Reference Type: DERIVED

PMID: 35296490 (View on PubMed)

Other Identifiers

EA2001001

Identifier Type: -

Identifier Source: org_study_id