Clinical trial NCT04919330: Acceptance and Commitment Therapy-based Eczema Management Programme
Official title: Embodying a Compassionate Self Through Acceptance and Commitment Therapy for Parents and Children With Eczema: A Family Based Eczema Management Programme
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eczema
Keywords: Acceptance and Commitment Therapy
Eczema
Randomised Controlled Trial
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Tuen Mun Hospital
First posted: 2021-06-09
Enrollment: 78
Sex: ALL
Minimum age (years): 6
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment; repeated-measures 2-arm randomized controlled trial
Primary purpose: TREATMENT

Brief summary: This pilot randomised wait-list controlled trial aims to determine the feasibility, acceptability and preliminary effects of a Family Acceptance and Commitment Therapy-based Eczema Management Programme (FACT-EMP) on the health outcomes of both children patients and their main caregivers over a 3-month post-intervention.

Detailed description: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Child's eczema severity
timeFrame: Change from baseline to 3 months post-intervention
measure: Parent's self-efficacy of eczema management
timeFrame: Change from baseline to 3 months post-intervention
Secondary outcomes:
measure: Child's quality of life
timeFrame: Change from baseline to 3 months post-intervention
measure: Child's self-compassion
timeFrame: Change from baseline to 3 months post-intervention
measure: Child's psychological flexibility
timeFrame: Change from baseline to 3 months post-intervention
measure: Parent's symptoms of depression, anxiety and stress
timeFrame: Change from baseline to 3 months post-intervention
measure: Parent's quality of life.
timeFrame: Change from baseline to 3 months post-intervention
measure: Parent's psychological flexibility
timeFrame: Change from baseline to 3 months post-intervention
measure: Parent's self-compassion
timeFrame: Change from baseline to 3 months post-intervention
Other outcomes:
Locations:
city: Tuen Mun
country: Hong Kong
facility: Department of Paediatrics and Adolescent Medicine, Tuen Mun Hospital
state: New Territories
Study officials:
affiliation: Chinese University of Hong Kong
name: Yuen Yu CHONG, PhD
role: PRINCIPAL_INVESTIGATOR
References: