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

Childhood Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02405962
• Other study ID #: HSEARS20150109001
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: January 2017

Study information

• Verified date: January 2019
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Childhood Asthma

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
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	School of Nursing, The Hong Kong Polytechnic University	Hung Hom	Kowloon

Sponsors (2)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	Hospital Authority, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child's Total Number of Emergency Department Visits Due to Asthma Attacks Over the 6 Months Post 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	6 months after the completion of intervention
Secondary	Children's Total Number of General Outpatient Clinic Visits Due to Asthma Attacks Over the Past 6 Months	The total number of general outpatient clinic visits due to asthma attacks of children over the past 6 months by parental reports in self-administered questionnaires	At 6 months after the intervention
Secondary	Children's Total Number of Private Practitioner's Clinic Visits Due to Asthma Attacks Over the Past 6 Months	The total number of private practitioner's clinic visits due to asthma attacks of children over the past 6 months by parental reports in self-administered questionnaires	At 6 months after the intervention
Secondary	Children's Total Number of Hospital Admissions Due to Asthma Attacks Over the Past 6 Months	The total number of hospital admissions due to asthma attacks of children in either the public hospitals under the Hong Kong Hospital Authority and/or the private hospitals over the past 6 months by parental reports in self-administered questionnaires	At 6 months after the intervention
Secondary	Children's Number of Days of Hospital Stay Due to Asthma Attacks Over the Past 6 Months	The total number of days of inpatient hospital stay due to asthma attacks of children in either the public hospitals under the Hong Kong Hospital Authority and/or the private hospitals over the past 6 months by parental reports in self-administered questionnaires	At 6 months after the intervention
Secondary	Children's Asthma Symptoms During Daytime Per Week Over the Past 4 Weeks	The days per week that the child presented with asthma symptoms (either chronic coughing, wheezing, shortness of breath, or chest tightness) during the daytime over the past 4 weeks, assessed by parental reports in self-administered questionnaires	At 6 months after the intervention
Secondary	Children's Asthma Symptoms During Nighttime Per Week Over the Past 4 Weeks	The nights per week that the child was awakened due to asthma symptoms (either chronic coughing, wheezing, shortness of breath, or chest tightness) during the nighttime over the past 4 weeks, assessed by parental reports in self-administered questionnaires	At 6 months after the intervention
Secondary	Children's Days of Activities Affected by Asthma Symptoms Per Week Over the Past 4 Weeks	The days per week that the child has to slow down or discontinue his/her activities due to asthma symptoms (either chronic coughing, wheezing, shortness of breath, or chest tightness) over the past 4 weeks, assessed by parental reports in self-administered questionnaires.	At 6 months after the intervention
Secondary	Children's Reliever Use Due to Asthma Symptoms Per Week Over the Past 4 Weeks	The days per week that the child requires to use an inhaled bronchodilator to relieve asthma symptoms (either chronic coughing, wheezing, shortness of breath, or chest tightness) over the past 4 weeks, assessed by parental reports in self-administered questionnaires	At 6 months after the intervention
Secondary	Parents' Psychological Flexibility	The Acceptance and Action Questionnaire-II was used to assess the psychological flexibility of the parents.; The parents rated 7 statements on a 7-point Likert scale ranging from 1 (never true) to 7 (always true), for example: "My painful experiences and memories make it difficult for me to live a life that I would value." The possible range of the total score is 7-49 (minimum value = 7; maximum value = 49). A higher score means a worse outcome, that is the parent is more psychologically inflexible.; The Acceptance and Action Questionnaire-II possessed good internal consistencies (mean Cronbach's alpha (a) = .84, range a = .86 to .88) and test-retest reliabilities over a 3-month interval (test-retest reliability coefficient (r) = .81) and 12-month interval (r = .79), respectively.	At 6 months after the intervention
Secondary	Parents' Psychological Adjustment to Their Child's Asthma	The Parent Experience of Child Illness scale was used to capture the psychological adjustment of parents in caring for a child with asthma.; The Parent Experience of Child Illness scale contains 25 statements with 3 subscales for assessing the illness-specific psychological distress experienced by parents who have a chronically ill child, including Guilt and Worry, Unresolved Sorrow and Anger, and Long-term Uncertainty, together with 1 subscale on perceived Emotional Resources. The possible range of each of the subscale score is 0-4 (minimum value = 0; maximum value = 4). Higher scores in Guilt and Worry, Unresolved Sorrow and Anger, and Long-term Uncertainty mean worse outcomes. A higher score in Emotional Resources means a better outcome.; The Parent Experience of Child Illness scale had adequate internal consistencies (a in each subscale = .72 to .89) and test-retest reliabilities over a 2-week interval (r in each subscale = .83 to .86)	At 6 months after the intervention
Secondary	Parents' Psychological Symptoms	The Depression Anxiety Stress Scale 21 was used to evaluate the psychological symptoms of parents.; This instrument contains 21 statements with 3 subscales assessing the symptoms of depression, anxiety and stress of parents, respectively. The parents rated the degree to which each statement applied to them in the past week on a 4-point Likert scale from 0 (does not apply to me at all) to 3 (applies to me very much, or most of the time).; The subscale scores for depression, anxiety and stress subscale would be multiplied by two. The possible range for each of the subscale score is 0-42 (minimum value = 0, maximum value = 42). Higher scores mean worse outcomes. The cut-off scores indicating at least a mild level of psychological symptoms of an individual are 9 for depression; 7 for anxiety and 14 for stress, respectively.; The Cronbach's alpha for the depression, anxiety, and stress subscales in DASS-21 were 0.82, 0.88 and 0.90, respectively.	At 6 months after the intervention
Secondary	Parents' Knowledge in Childhood Asthma Management	The Asthma Knowledge Questionnaire was used to assess the knowledge level among parents in pediatric asthma management.; This instrument composes of 25 true and false statements to measure parental asthma knowledge, including symptoms, triggers, treatment and prevention (Cronbach's alpha = 0.69).; The possible range of total score is 0-25 (minimum value = 0; maximum value = 25). A higher score means a better outcome, that is the parent has better asthma knowledge.	At 6 months after the intervention
Secondary	Parents' Asthma Management Self-efficacy	The Parental Asthma Management Self-Efficacy Scale was used to assess the self-efficacy of parents in childhood asthma care.; The instrument consists of 13 questions with two subscales in assessing the self-efficacy of parents in preventing and in managing children's asthma attacks. The parents rated the strength of their beliefs in a variety of situations related to childhood asthma management on a 5-point rating scale from 1 (not at sure) to 5 (completely sure). The possible range of each of the subscale score is 1-5 (minimum value = 1, maximum value = 5). A higher score means a better outcome, that is the parent has better self-efficacy.; This instrument had satisfactory internal consistency (a of each subscale = .77 to .82) and strong construct validity with the self-efficacy of children in managing asthma (r = 0.36).	At 6 months after the intervention
Secondary	Parents' Quality of Life	The Pediatric Asthma Caregiver's Quality of Life was used to assess the quality of life of the parents in caring for a child with asthma.; This instrument is a 13-question, 7-point Likert scale measuring parental psychosocial well-being with 2 subscales, emotional function and activity limitation. The possible range of each of the subscale score is 1-7 (minimum value = 1, maximum value = 7). Higher scores in the subscales mean better outcomes, that is the parent has a better quality of life.; This instrument had stable reliabilities within the intervals of four weeks (intraclass correlation coefficient (ICC) = 0.80 to 0.85).	At 6 months after the intervention