Acceptance and Commitment Therapy-based Eczema Management Programme

NCT04919330 | Completed DMC

• 1 other identifier: RG2019/2020_A_7
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Eczema

Keywords

Acceptance and Commitment Therapy; Eczema; Randomised Controlled Trial

Outcome Measures

Primary Outcomes (2)

• Child's eczema severity

  The Severity scoring of atopic dermatitis (SCORAD) will be used to assess the severity of childhood eczema, including the extent and intensity of the disease, and the degree of itching and sleep disturbance (Rehal et al., 2011).

  Change from baseline to 3 months post-intervention

• Parent's self-efficacy of eczema management

  The 29-item Chinese Version of Parental Self-Efficacy with Eczema Care Index (PASECI; Cheng et al., 2020) will be adopted to assess the parents' self-efficacy for performing eczema management tasks, managing the child's symptoms and behavior. The PASECI is arranged in 4 subscales: Managing Medication, Managing Eczema and Symptoms, Communicating with Health Professionals, and Managing Personal Challenges. Each item is scored on an 11-point Linkert scale, ranging from 0 (Cannot do at all) to 10 (Highly certain can do it). The scores of PASECI are gained by adding items up. The higher the PASECI score, the greater the parental self-efficacy in respective scales. The PASECI possessed high internal consistency (α=.97), test-retest reliability (ICC =.93-.99), and acceptable convergent validity in the Hong Kong population.

  Change from baseline to 3 months post-intervention

Secondary Outcomes (7)

• Child's quality of life

  Change from baseline to 3 months post-intervention

• Child's self-compassion

  Change from baseline to 3 months post-intervention

• Child's psychological flexibility

  Change from baseline to 3 months post-intervention

• Parent's symptoms of depression, anxiety and stress

  Change from baseline to 3 months post-intervention

• Parent's quality of life.

  Change from baseline to 3 months post-intervention

Study Arms (2)

ACT Group

EXPERIMENTAL

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.

Behavioral: Family Acceptance and Commitment Therapy-based Eczema Management Programme

Wait-list Control Group

OTHER

Routine eczema care provided by the study hospital, including medical follow-ups and nurses' consultation

Behavioral: Wait-list Control Group

Interventions

Family Acceptance and Commitment Therapy-based Eczema Management Programme BEHAVIORAL

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.

ACT Group

Wait-list Control Group BEHAVIORAL

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.

Wait-list Control Group

Eligibility Criteria

• Age: 6 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The parent-child dyads should fulfil the following criteria:
• 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.
• 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Tuen Mun Hospital: collaborator

Study Sites (1)

Department of Paediatrics and Adolescent Medicine, Tuen Mun Hospital

Tuenmen, New Territories, Hong Kong

Location

Related Publications (1)

• Chong YY, Chien WT, Mou HY, Leung SP, Wong OY, Lam SY. Acceptance and Commitment Therapy Eczema Management Program for Children With Eczema: A Pilot Randomised Controlled Trial. Clin Exp Allergy. 2025 Aug;55(8):701-715. doi: 10.1111/cea.70003. Epub 2025 Feb 3.

  PMID: 39900107 DERIVED

MeSH Terms

Conditions

Eczema

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Study Officials

• Yuen Yu CHONG, PhD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Outcome assessors and researchers (and health care staff of the study hospital) are blind to the group assignment and intervention undertaken and concealed to the participant list.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Parallel Assignment; repeated-measures 2-arm randomized controlled trial

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: June 9, 2021
• Study Start: July 3, 2021
• Primary Completion: June 30, 2023
• Study Completion: September 30, 2023
• Last Updated: July 12, 2024

Record last verified: 2024-07

Locations

HK (1)