Training Parents by Acceptance and Commitment Therapy for Managing Childhood Asthma Care

NCT ID: NCT02405962

Last Updated: 2019-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2017-01-31

Brief Summary

The purpose of this study is to examine whether a parental training program using group-based Acceptance and Commitment Therapy for childhood asthma care, is effective in reducing the children's unplanned health care services utilization and asthmatic symptoms.

Detailed Description

One-tenth of children in worldwide are diagnosed with asthma and it is the leading cause for unplanned health care services utilization. Parents, as the primary caregivers, experience different level of psychological distress in taking care of their children with asthma. Some of them responded with avoidance-based coping, which results in poor asthma symptom management and monitoring. Acceptance and Commitment Therapy (ACT) is a contextual focused, behavioral therapy aiming at improving psychological flexibility, so that a person can be more opened up to engaging in value-driven behavior modification, thus attaining an optimal disease control. The benefits of ACT have been demonstrated on both parents and their children with chronic health conditions such as developmental disabilities, acquired brain injuries, chronic pain, cancer and mental disorders. To date, no ACT intervention has been conducted on examining its effects on training parents in managing their children with asthmatic conditions.

This is the first study aims to examine the effects of a parental training program using group-based Acceptance and Commitment Therapy (ACT) in reducing the unplanned health care services utilization and asthmatic symptoms, among children with asthma. Parents of children diagnosed with asthma will either receive one session of pediatric asthma educational talk as usual practice in the study hospital, or in addition, four sessions of group-based ACT integrated with asthma education.

If the group-based ACT is effective in reducing children's asthmatic symptoms and overall unplanned asthma-related health services utilization, it could lead to substantial health benefits in children with asthma and on parents with a reduction in psychological distress. In addition to cutting medical expenses, it could also contribute to the community health through the reduction in mortality and morbidity due to asthmatic attacks. Furthermore, information collected from this proposed study will open up an opportunity for exploring the potential of ACT-based intervention in managing other childhood chronic diseases.

Conditions

Childhood Asthma

Study Design

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

Study Groups

Control group

Parents of children with asthma will receive one session of asthma educational talk as the usual care, plus three weekly sessions of telephone calls to assess the child's asthma symptoms

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: BEHAVIORAL

One session of educational talk about pediatric asthma care, as the usual care. To ensure the equivalency of the assigned sessions between groups, after attending the talk in the first week, the parents in the Control group will receive three telephone calls, starting from the second week on a weekly basis. This arrangement can also minimize the interference of the usual care naturalistically available in the study setting.

ACT group

Parents of children with asthma will receive four sessions of group-based ACT intervention integrated with asthma education (its content will be the same as that of the Control Group).

Group Type: EXPERIMENTAL

ACT

Intervention Type: BEHAVIORAL

Four sessions of group-based ACT integrated with asthma education. Each session will compose of pediatric asthma education based on guidelines of Global Strategy for Asthma Management and Prevention Revised 2011, plus group-based Acceptance and Commitment Therapy (ACT). The goal of ACT is to enhance the psychological flexibility of the parents, enabling them to (1) become aware of their thoughts and feelings regarding their child's asthma and its management, (2) accept and adapt flexibly to challenging situations, and (3) take actions to achieve valued goals in childhood asthma management.

Interventions

ACT

Four sessions of group-based ACT integrated with asthma education. Each session will compose of pediatric asthma education based on guidelines of Global Strategy for Asthma Management and Prevention Revised 2011, plus group-based Acceptance and Commitment Therapy (ACT). The goal of ACT is to enhance the psychological flexibility of the parents, enabling them to (1) become aware of their thoughts and feelings regarding their child's asthma and its management, (2) accept and adapt flexibly to challenging situations, and (3) take actions to achieve valued goals in childhood asthma management.

Intervention Type: BEHAVIORAL

Control

One session of educational talk about pediatric asthma care, as the usual care. To ensure the equivalency of the assigned sessions between groups, after attending the talk in the first week, the parents in the Control group will receive three telephone calls, starting from the second week on a weekly basis. This arrangement can also minimize the interference of the usual care naturalistically available in the study setting.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Between 18 and 65 years old
• Fathers or mothers in each family who are primarily responsible for the daily care of their child with asthma
• Living together with the index child
• Able to communicate in Cantonese
• Hong Kong residents who plan to stay in Hong Kong for at least 6 months
• Accessible by telephone and by mail

• 3 to 12 years old with a physician's diagnosis of asthma

Exclusion Criteria

• Enrolled in another asthma research intervention study

• Enrolled in another asthma research intervention study
• Two years old or under presented with an acute wheezing attack. As symptoms at this age can be due to bronchiolitis, a viral infection, rather than asthma
• Have (1) other chronic pulmonary diseases, such as cystic fibrosis (CF), bronchopulmonary dysplasia (BPD), oxygen dependent conditions, or presence of tracheotomy; (2) other significant medical and mental morbidities, such as congenital malformation, Down's syndrome, cerebral palsy and psychomotor retardation. Both may hinder the control of asthma.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Authority, Hong Kong

OTHER_GOV

Sponsor Role: collaborator

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Yim Wah MAK, Ph.D

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yim Wah Mak, PhD

Role: PRINCIPAL_INVESTIGATOR

School of Nursing, The Hong Kong Polytechnic University

Locations

School of Nursing, The Hong Kong Polytechnic University

Hung Hom, Kowloon, Hong Kong

Ambulatory Care Clinic, Department of Paediatrics and Adolescent Medicine, Tuen Mun Hospital

Hong Kong, , Hong Kong

Pediatric asthma nurse-led clinic, Department of Paediatrics and Adolescent Medicine, Tuen Mun Hospital

Hong Kong, , Hong Kong

Countries

Hong Kong

References

Chong YY, Mak YW, Leung SP, Lam SY, Loke AY. Acceptance and Commitment Therapy for Parental Management of Childhood Asthma: An RCT. Pediatrics. 2019 Feb;143(2):e20181723. doi: 10.1542/peds.2018-1723. Epub 2019 Jan 18.

Reference Type: DERIVED

PMID: 30659063 (View on PubMed)

Other Identifiers

HSEARS20150109001

Identifier Type: -

Identifier Source: org_study_id