EczemaNCT04617977
Integrative Body-Mind-Spirit Intervention for Families With Children Suffering From Eczema
A study testing I-BMS for families with children suffering from eczema and Health education for parents whose children have eczema in people with Eczema and Dermatitis, Atopic, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Eczema, Dermatitis, Atopic
- What is being tested?
- I-BMS for families with children suffering from eczema and Health education for parents whose children have eczema
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteHong Kong
- Study dates
- 23 Aug 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Department of Social Work and Social Administration
Hong Kong
Celia Hoi-Yan Chan, PhD, (852) 3917 2089, chancelia@hku.hk
Yat-Lui Fung, PhD
About this study
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
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.
Read the 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
- Being tested
- I-BMS for families with children suffering from eczema, Health education for parents whose children have eczema
- Medical subject headings
- Eczema, Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-BMS for families with children suffering from eczemaBehavioural
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.
Health education for parents whose children have eczemaBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Parent-child I-BMS intervention group | Experimental | 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. Receives: Behavioral: I-BMS for families with children suffering from eczema |
| Parent only I-BMS intervention group | Experimental | 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. Receives: Behavioral: I-BMS for families with children suffering from eczema |
| Parent only health education active control group | Active comparator | 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. Receives: Behavioral: Health education for parents whose children have eczema |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes over the measurement points in the Family Dermatology Life Quality Index
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.
Measured: Baseline, post-intervention: 6 weeks after intervention initiation, 6-week follow up
Changes over the measurement points in the Children's Dermatology Life Quality Index
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.
Measured: Baseline, post-intervention: 6 weeks after intervention initiation, 6-week follow up
Changes over the measurement points in the Cognitive Emotion Regulation Questionnaire - Short Version
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.
Measured: Baseline, post-intervention: 6 weeks after intervention initiation, 6-week follow up
Changes over the measurement points in the Short Version of the Cognitive Emotion Regulation Questionnaire for Spanish Kids
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.
Measured: Baseline, post-intervention: 6 weeks after intervention initiation, 6-week follow up
Secondary outcomes (7)
Changes over the measurement points in the Hospital Anxiety and Depression Scale
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.
Measured: Baseline, post-intervention: 6 weeks after intervention initiation, 6-week follow up
Changes over the measurement points in the Revised Child Anxiety and Depression Scale - Short Version
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.
Measured: Baseline, post-intervention: 6 weeks after intervention initiation, 6-week follow up
Changes over the measurement points in the Perceived Stress Scale for Children
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.
Measured: Baseline, post-intervention: 6 weeks after intervention initiation, 6-week follow up
Changes over the measurement points in the Perceived Stress Scale
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.
Measured: Baseline, post-intervention: 6 weeks after intervention initiation, 6-week follow up
Changes over the measurement points in the Parent-Child Relationship Questionnaire - Personal Relationship Subscale (Parent Form)
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.
Measured: Baseline, post-intervention: 6 weeks after intervention initiation, 6-week follow up
Changes over the measurement points in the Parent-Child Relationship Questionnaire - Personal Relationship Subscale (Child Form)
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.
Measured: Baseline, post-intervention: 6 weeks after intervention initiation, 6-week follow up
Patient-Oriented Eczema Measure for Child (Parent Form)
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.
Measured: Baseline, post-intervention: 6 weeks after intervention initiation, 6-week follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start23 Aug 2021
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EczemaStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Celia Hoi-Yan Chan, The University of Hong Kong
- Investigators
- Celia Hoi-Yan Chan, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04617977
- Sponsor's protocol ID
- EA2001001
- Status last verified
- Jan 2022
- First submitted
- 30 Oct 2020
- Last updated
- 27 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35296490
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04617977
- Acronym / sponsor ID
- EA2001001
- Conditions
- Eczema, Dermatitis, Atopic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 5 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Parent-child I-BMS intervention group | Experimental | Behavioral: I-BMS for families with children suffering from eczemaChildren 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 | Experimental | Behavioral: I-BMS for families with children suffering from eczemaOnly 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. |
| Parent only health education active control group | Active comparator | Behavioral: Health education for parents whose children have eczemaOnly 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. |
Who may qualify
- Ages
- 6 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| I-BMS for families with children suffering from eczemaIt 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. | Behavioural | Parent only I-BMS intervention group, Parent-child I-BMS intervention group |
| Health education for parents whose children have eczemaIt 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. | Behavioural | Parent only health education active control group |
Primary outcome
Changes over the measurement points in the Family Dermatology Life Quality Index
Time frame: 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 Children's Dermatology Life Quality Index
Time frame: 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 Cognitive Emotion Regulation Questionnaire - Short Version
Time frame: 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
Time frame: 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.
7 secondary outcomes
Changes over the measurement points in the Hospital Anxiety and Depression Scale
Time frame: Baseline, post-intervention: 6 weeks after intervention initiation, 6-week follow up
Changes over the measurement points in the Revised Child Anxiety and Depression Scale - Short Version
Time frame: Baseline, post-intervention: 6 weeks after intervention initiation, 6-week follow up
Changes over the measurement points in the Perceived Stress Scale for Children
Time frame: Baseline, post-intervention: 6 weeks after intervention initiation, 6-week follow up
Changes over the measurement points in the Perceived Stress Scale
Time frame: Baseline, post-intervention: 6 weeks after intervention initiation, 6-week follow up
Changes over the measurement points in the Parent-Child Relationship Questionnaire - Personal Relationship Subscale (Parent Form)
Time frame: Baseline, post-intervention: 6 weeks after intervention initiation, 6-week follow up
Changes over the measurement points in the Parent-Child Relationship Questionnaire - Personal Relationship Subscale (Child Form)
Time frame: Baseline, post-intervention: 6 weeks after intervention initiation, 6-week follow up
Patient-Oriented Eczema Measure for Child (Parent Form)
Time frame: Baseline, post-intervention: 6 weeks after intervention initiation, 6-week follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2022.
- Derived from this study: PubMed 35296490Hui 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Celia Hoi-Yan Chan, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I-BMS for families with children suffering from eczema and Health education for parents whose children have eczema in people with Eczema and Dermatitis, Atopic, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Celia Hoi-Yan Chan, PhD ((852) 3917 2089, chancelia@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes over the measurement points in the Family Dermatology Life Quality Index (time frame: Baseline, post-intervention: 6 weeks after intervention initiation, 6-week follow up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04617977, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2022.