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Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||6 Years - 65 Years|
Inclusion criteria:The parent-child dyads should fulfil the following criteria: 1. For the child, he or she should be 6-12 years old and diagnosed with eczema by a physician as documented in the medical records. 2. For the parent, he or she should be 19-65 years; either father/mother in each family who is the primary caregiver responsible for the daily care of his/her child (e.g. the same parent who accompanied the child for follow-up appointments of the study hospital at every time), living together with the target child, able to communicate in Cantonese and accessible by telephone.
Exclusion criteria:1. Any parent and/or his/her child who are currently participating in another eczema-related intervention study, or where the child has significant medical morbidities, including congenital problems, oxygen-dependent conditions, or the presence of tracheotomy, will be excluded.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Chinese University of Hong Kong|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Yuen Yu CHONG, PhD|
|Principal Investigator Affiliation||Chinese University of Hong Kong|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Background: Eczema is the most common paediatric skin condition affecting 15-20% children worldwide and 30% of children in Hong Kong. The highly visible nature of eczema symptoms that deviate from the individual's idealized body image could compromise his/her sense of self, leading to feelings of body image disturbance. It has been reported that children may use their illness to avoid schools, experience low self-esteem, shame and guilt and even stigmatization. In addition, their parents experience high level of stress in caring for their children with eczema, can easily generate shame and guilt feelings if they perceive themselves not performing satisfactory parenting roles in safeguarding their child's health. One emerging therapeutic approach to managing body-image concern, psychological difficulties associated with self-criticism and shame is by fostering self-compassion. This study is a pilot randomized controlled trial aiming at examining the effects of a family-based eczema management programme in Hong Kong utilizing Acceptance and Commitment Therapy (ACT) to foster self-compassion of parents and their children affected by eczema. It is expected that fostering self-compassion could empower the parent-child dyads in cultivating a more loving, kind and forgiving attitude towards eczema, leading to improved motivation for self-care and better health outcomes. If found effective, the programme can improve the lives of many local families with children living with eczema through addressing their unmet psychological needs. In addition, the programme can be incorporated into current service in hospitals and community settings in Hong Kong and other Chinese communities. Aim and hypothesis to be tested: The proposed study will use a single-blinded, pilot randomized wait-list controlled trial design to determine the feasibility, acceptability and preliminary effects of a family ACT-based eczema management programme (FACT-EMP) on the health outcomes of both parent caregivers and children with eczema over 3-month post-intervention. It is hypothesized that when compared with a wait-list control group receiving standard care, the participants of the programme can show significant improvements in: 1. childhood eczema severity (primary outcome for children), 2. parental eczema management (primary outcome for parents), 3. parental depression, anxiety and stress, 4. health-related quality of life, psychological flexibility and self-compassion of both caregivers and their children with eczema immediately at immediately and 3-month post-intervention. Design: A randomized wait-list controlled trial. Participants: 62 parents and their children aged 6-12 years diagnosed with eczema. Intervention condition: The parent-child dyads will receive four weekly 2-hour sessions of FACT-EMP. In each session, a group of 7-8 parent-child dyads will receive 90 minutes of ACT, followed by 30 minutes of education related to eczema management. The dyads in the wait-list control group will be offered to receive the same intervention after the completion of all assessments of the intervention arm. Outcomes: The primary outcome for children is childhood eczema severity, while the primary outcome for parents is parental eczema management. The secondary outcomes for children are quality of life, self-compassion and psychological flexibility, while the secondary outcomes for parents are symptoms of depression, anxiety and stress, quality of life, psychological flexibility and self-compassion. The assessments of the aforementioned outcomes will be conducted at baseline, at post-intervention and at 3-month post-intervention by trained nurses/ research staff blinded to treatment allocation.
Experimental: ACT Group
One four weekly 2-hour sessions of family ACT-based eczema management programme (FACT-EMP) and routine eczema care provided by the study hospital, including medical follow-ups and nurses' consultation.
Other: Wait-list Control Group
Routine eczema care provided by the study hospital, including medical follow-ups and nurses' consultation
Behavioral: - Family Acceptance and Commitment Therapy-based Eczema Management Programme
The parent-child dyads will receive four weekly 2-hour sessions of family ACT-based eczema management programme (FACT-EMP). In each session, a group of 6-8 parent-child dyads will receive 90 minutes of ACT, followed by 30 minutes of education related to eczema management. Throughout the sessions, ACT strategies will help the dyads achieve the following therapeutic processes: To weaken the rumination cycle and "fused thoughts" related to eczema with body-image concern, shame and self-criticism for extending kindness and understanding to oneself; to build self-perspective-taking when seeing one's experience as part of the larger human experience; to strengthen their stands for their values related to self-kindness with acceptance of one's experience; and to take steps to act on values while practising kindness and compassion. Same as the waitlist control, the dyads will receive routine eczema care provided by the study hospital, including medical follow-ups and nurses' consultation.
Behavioral: - Wait-list Control Group
The parent-child dyads will receive routine eczema care provided by the study hospital, including medical follow-ups and nurses' consultation. To ensure equity of access to potentially effective treatment (i.e., family ACT-based eczema management programme), the dyads in the wait-list control group will receive the same programme after the completion of all assessments of the intervention arm.
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If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.