Clinical trial NCT02405962: Training Parents by Acceptance and Commitment Therapy for Managing Childhood Asthma Care
Official title: Effects of a Parental Training Program Using Group-based Acceptance and Commitment Therapy for Managing Children With Asthma: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Asthma
Keywords: Acceptance and Commitment Therapy
Childhood asthma
Randomized controlled trial
Training parents
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Hospital Authority, Hong Kong
First posted: 2015-04-01
Enrollment: 168
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria for parents:

* 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

Inclusion Criteria for children:

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

Exclusion criteria for parents:

* Enrolled in another asthma research intervention study

Exclusion criteria for children:

* 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.

Primary outcomes:
measure: Child's Total Number of Emergency Department Visits Due to Asthma Attacks Over the 6 Months Post Intervention
timeFrame: 6 months after the completion of intervention
Secondary outcomes:
measure: Children's Total Number of General Outpatient Clinic Visits Due to Asthma Attacks Over the Past 6 Months
timeFrame: At 6 months after the intervention
measure: Children's Total Number of Private Practitioner's Clinic Visits Due to Asthma Attacks Over the Past 6 Months
timeFrame: At 6 months after the intervention
measure: Children's Total Number of Hospital Admissions Due to Asthma Attacks Over the Past 6 Months
timeFrame: At 6 months after the intervention
measure: Children's Number of Days of Hospital Stay Due to Asthma Attacks Over the Past 6 Months
timeFrame: At 6 months after the intervention
measure: Children's Asthma Symptoms During Daytime Per Week Over the Past 4 Weeks
timeFrame: At 6 months after the intervention
measure: Children's Asthma Symptoms During Nighttime Per Week Over the Past 4 Weeks
timeFrame: At 6 months after the intervention
measure: Children's Days of Activities Affected by Asthma Symptoms Per Week Over the Past 4 Weeks
timeFrame: At 6 months after the intervention
measure: Children's Reliever Use Due to Asthma Symptoms Per Week Over the Past 4 Weeks
timeFrame: At 6 months after the intervention
measure: Parents' Psychological Flexibility
timeFrame: At 6 months after the intervention
measure: Parents' Psychological Adjustment to Their Child's Asthma
timeFrame: At 6 months after the intervention
measure: Parents' Psychological Symptoms
timeFrame: At 6 months after the intervention
measure: Parents' Knowledge in Childhood Asthma Management
timeFrame: At 6 months after the intervention
measure: Parents' Asthma Management Self-efficacy
timeFrame: At 6 months after the intervention
measure: Parents' Quality of Life
timeFrame: At 6 months after the intervention
Other outcomes:
Locations:
city: Hung Hom
country: Hong Kong
facility: School of Nursing, The Hong Kong Polytechnic University
state: Kowloon
city: Hong Kong
country: Hong Kong
facility: Ambulatory Care Clinic, Department of Paediatrics and Adolescent Medicine, Tuen Mun Hospital
city: Hong Kong
country: Hong Kong
facility: Pediatric asthma nurse-led clinic, Department of Paediatrics and Adolescent Medicine, Tuen Mun Hospital
Study officials:
affiliation: School of Nursing, The Hong Kong Polytechnic University
name: Yim Wah Mak, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.