跳至主要内容
临床试验/NCT02405962
NCT02405962已完成不适用

Effects of a Parental Training Program Using Group-based Acceptance and Commitment Therapy for Managing Children With Asthma: a Randomized Controlled Trial

The Hong Kong Polytechnic University3 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2015年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
168
试验地点
3
主要终点
Child's Total Number of Emergency Department Visits Due to Asthma Attacks Over the 6 Months Post Intervention

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
3 Years 至 12 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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.

研究组 & 干预措施

Control group

Placebo Comparator

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

干预措施: Control (Behavioral)

ACT group

Experimental

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).

干预措施: ACT (Behavioral)

结局指标

主要结局

Child's Total Number of Emergency Department Visits Due to Asthma Attacks Over the 6 Months Post Intervention

时间窗: 6 months after the completion of intervention

Parental report of the total number of emergency department visits due to asthma attacks of a child in either a / public hospital(s) of the Hong Kong Hospital Authority and/or a private hospital(s) over 6 months post intervention

次要结局

  • Children's Days of Activities Affected by Asthma Symptoms Per Week Over the Past 4 Weeks(At 6 months after the intervention)
  • Parents' Psychological Adjustment to Their Child's Asthma(At 6 months after the intervention)
  • Children's Total Number of General Outpatient Clinic Visits Due to Asthma Attacks Over the Past 6 Months(At 6 months after the intervention)
  • Children's Total Number of Private Practitioner's Clinic Visits Due to Asthma Attacks Over the Past 6 Months(At 6 months after the intervention)
  • Children's Total Number of Hospital Admissions Due to Asthma Attacks Over the Past 6 Months(At 6 months after the intervention)
  • Children's Number of Days of Hospital Stay Due to Asthma Attacks Over the Past 6 Months(At 6 months after the intervention)
  • Children's Asthma Symptoms During Daytime Per Week Over the Past 4 Weeks(At 6 months after the intervention)
  • Parents' Psychological Symptoms(At 6 months after the intervention)
  • Children's Asthma Symptoms During Nighttime Per Week Over the Past 4 Weeks(At 6 months after the intervention)
  • Children's Reliever Use Due to Asthma Symptoms Per Week Over the Past 4 Weeks(At 6 months after the intervention)
  • Parents' Asthma Management Self-efficacy(At 6 months after the intervention)
  • Parents' Psychological Flexibility(At 6 months after the intervention)
  • Parents' Knowledge in Childhood Asthma Management(At 6 months after the intervention)
  • Parents' Quality of Life(At 6 months after the intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yim Wah MAK, Ph.D

Associate Professor

The Hong Kong Polytechnic University

研究点 (3)

Loading locations...

相似试验