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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02405962

Enrollment

168

Registered

2015-04-01

Start date

2015-01-31

Completion date

2017-01-31

Last updated

2019-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood Asthma

Keywords

Acceptance and Commitment Therapy, Childhood asthma, Randomized controlled trial, Training parents

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.

Interventions

BEHAVIORALACT

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.

BEHAVIORALControl

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

3 Years to 12 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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	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
Children's Total Number of Hospital Admissions Due to Asthma Attacks Over the Past 6 Months	At 6 months after the intervention	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
Children's Number of Days of Hospital Stay Due to Asthma Attacks Over the Past 6 Months	At 6 months after the intervention	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
Children's Asthma Symptoms During Daytime Per Week Over the Past 4 Weeks	At 6 months after the intervention	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
Children's Asthma Symptoms During Nighttime Per Week Over the Past 4 Weeks	At 6 months after the intervention	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
Children's Days of Activities Affected by Asthma Symptoms Per Week Over the Past 4 Weeks	At 6 months after the intervention	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.
Children's Total Number of General Outpatient Clinic Visits Due to Asthma Attacks Over the Past 6 Months	At 6 months after the intervention	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
Parents' Psychological Flexibility	At 6 months after the intervention	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 (α) = .84, range α = .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.
Parents' Psychological Adjustment to Their Child's Asthma	At 6 months after the intervention	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 (α in each subscale = .72 to .89) and test-retest reliabilities over a 2-week interval (r in each subscale = .83 to .86)
Parents' Psychological Symptoms	At 6 months after the intervention	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.
Parents' Knowledge in Childhood Asthma Management	At 6 months after the intervention	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.
Parents' Asthma Management Self-efficacy	At 6 months after the intervention	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 (α of each subscale = .77 to .82) and strong construct validity with the self-efficacy of children in managing asthma (r = 0.36).
Parents' Quality of Life	At 6 months after the intervention	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).
Children's Reliever Use Due to Asthma Symptoms Per Week Over the Past 4 Weeks	At 6 months after the intervention	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

Countries

Hong Kong

Participant flow

Recruitment details

This study enrolled parents of children aged 3-12 years who had been diagnosed with asthma from 2 pediatric respiratory outpatient clinics, the Ambulatory Care Centre and a nurse-led asthma clinic, in the Department of Pediatrics and Adolescent Medicine of a public hospital under the Hospital Authority in Hong Kong.

Pre-assignment details

No significant events in this study occurred after participant enrollment. All the enrolled participants who provided written consent to participate in the study were included in the study.

Participants by arm

Arm	Count
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 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.	84
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). 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.	84
Total	168

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	A participant has moved to another place	0	1
Overall Study	Lost to Follow-up	1	4

Baseline characteristics

Characteristic	Control Group	ACT Group	Total
Age, Continuous	39.07 years STANDARD_DEVIATION 6.19	37.74 years STANDARD_DEVIATION 5.55	38.40 years STANDARD_DEVIATION 5.9
Child's age	6.95 years STANDARD_DEVIATION 2.46	6.67 years STANDARD_DEVIATION 2.55	6.81 years STANDARD_DEVIATION 2.5
Child's age of diagnosis as asthma	3.61 years STANDARD_DEVIATION 1.88	3.31 years STANDARD_DEVIATION 1.7	3.46 years STANDARD_DEVIATION 1.79
Child's concurrently diagnosed with allergic rhinitis No	54 Participants	55 Participants	109 Participants
Child's concurrently diagnosed with allergic rhinitis Yes	30 Participants	29 Participants	59 Participants
Child's concurrently diagnosed with eczema No	76 Participants	74 Participants	150 Participants
Child's concurrently diagnosed with eczema Yes	8 Participants	10 Participants	18 Participants
Child's current use of inhaled corticosteroid as prophylaxis, by types Beclometasone dipropionate	46 Participants	35 Participants	81 Participants
Child's current use of inhaled corticosteroid as prophylaxis, by types Fluticasone propionate	4 Participants	1 Participants	5 Participants
Child's current use of inhaled corticosteroid as prophylaxis, by types Fluticasone propionate and Salmeterol	1 Participants	1 Participants	2 Participants
Child's current use of inhaled corticosteroid as prophylaxis, by types None	33 Participants	47 Participants	80 Participants
Child's current use of oral Montelukast as prophylaxis No	71 Participants	73 Participants	144 Participants
Child's current use of oral Montelukast as prophylaxis Yes	13 Participants	11 Participants	24 Participants
Child's gender Female	32 Participants	33 Participants	65 Participants
Child's gender Male	52 Participants	51 Participants	103 Participants
Child's total number of emergency care visit(s) due to asthma exacerbations in the past 6 months 0 times	54 Participants	49 Participants	103 Participants
Child's total number of emergency care visit(s) due to asthma exacerbations in the past 6 months 1 to 2 times	26 Participants	29 Participants	55 Participants
Child's total number of emergency care visit(s) due to asthma exacerbations in the past 6 months 3 to 4 times	3 Participants	5 Participants	8 Participants
Child's total number of emergency care visit(s) due to asthma exacerbations in the past 6 months 5 times or above	1 Participants	1 Participants	2 Participants
Child's total number of GOPC visits due to asthma exacerbations in the past 6 months 0 times	74 Participants	69 Participants	143 Participants
Child's total number of GOPC visits due to asthma exacerbations in the past 6 months 1 to 2 times	5 Participants	10 Participants	15 Participants
Child's total number of GOPC visits due to asthma exacerbations in the past 6 months 3 to 4 times	4 Participants	3 Participants	7 Participants
Child's total number of GOPC visits due to asthma exacerbations in the past 6 months 5 times or above	1 Participants	2 Participants	3 Participants
Child's total number of hospital admission(s) due to asthma exacerbation(s) in the past 6 months 0 times	67 Participants	60 Participants	127 Participants
Child's total number of hospital admission(s) due to asthma exacerbation(s) in the past 6 months 1 to 2 times	16 Participants	22 Participants	38 Participants
Child's total number of hospital admission(s) due to asthma exacerbation(s) in the past 6 months 3 to 4 times	1 Participants	2 Participants	3 Participants
Child's total number of PP clinic visits due to asthma exacerbations in the past 6 months 0 times	46 Participants	47 Participants	93 Participants
Child's total number of PP clinic visits due to asthma exacerbations in the past 6 months 1 to 2 times	26 Participants	22 Participants	48 Participants
Child's total number of PP clinic visits due to asthma exacerbations in the past 6 months 3 to 4 times	9 Participants	7 Participants	16 Participants
Child's total number of PP clinic visits due to asthma exacerbations in the past 6 months 5 times or above	3 Participants	8 Participants	11 Participants
Child's use of alternative therapy in the past 6 months, by types Herbal soup	9 Participants	8 Participants	17 Participants
Child's use of alternative therapy in the past 6 months, by types Natural moxibustion	2 Participants	2 Participants	4 Participants
Child's use of alternative therapy in the past 6 months, by types None	73 Participants	74 Participants	147 Participants
Child use 1 or more course of oral prednisolone use in the previous year due to asthma exacerbations No	40 Participants	34 Participants	74 Participants
Child use 1 or more course of oral prednisolone use in the previous year due to asthma exacerbations Yes	44 Participants	50 Participants	94 Participants
Educational attainment Primary education or below	5 Participants	4 Participants	9 Participants
Educational attainment Secondary education	65 Participants	58 Participants	123 Participants
Educational attainment Tertiary education or above	14 Participants	22 Participants	36 Participants
Employment status Full-time employed	34 Participants	29 Participants	63 Participants
Employment status Home-makers or unemployed	44 Participants	49 Participants	93 Participants
Employment status Part-time employed	6 Participants	6 Participants	12 Participants
History of asthma diagnosis At least one parent has a history of asthma	24 Participants	22 Participants	46 Participants
History of asthma diagnosis Neither parents has a history of asthma	48 Participants	51 Participants	99 Participants
History of asthma diagnosis Other family members has a history of asthma	12 Participants	11 Participants	23 Participants
Marital status Married	72 Participants	73 Participants	145 Participants
Marital status Single/ separated/ divorced/ widowed	12 Participants	11 Participants	23 Participants
Monthly household income (Hong Kong Dollars) < $ 10,000	15 Participants	10 Participants	25 Participants
Monthly household income (Hong Kong Dollars) $10,000 to $25,000	27 Participants	18 Participants	45 Participants
Monthly household income (Hong Kong Dollars) $25,001 to $50,000	37 Participants	51 Participants	88 Participants
Monthly household income (Hong Kong Dollars) >$50,000	5 Participants	5 Participants	10 Participants
Region of Enrollment Hong Kong	84 participants	84 participants	168 participants
Sex: Female, Male Female	72 Participants	76 Participants	148 Participants
Sex: Female, Male Male	12 Participants	8 Participants	20 Participants
Smoking status At least one parent is a current smoker	31 Participants	33 Participants	64 Participants
Smoking status Both parents are non-smokers	53 Participants	51 Participants	104 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 84	0 / 84
other Total, other adverse events	0 / 84	0 / 84
serious Total, serious adverse events	0 / 84	0 / 84

Outcome results

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

Time frame: 6 months after the completion of intervention

Arm	Measure	Value (MEAN)	Dispersion
Control Group	Child's Total Number of Emergency Department Visits Due to Asthma Attacks Over the 6 Months Post Intervention	0.38 Number of visits	Standard Error 0.11
ACT Group	Child's Total Number of Emergency Department Visits Due to Asthma Attacks Over the 6 Months Post Intervention	0.08 Number of visits	Standard Error 0.04

p-value: <0.0595% CI: [0.08, 0.53]Mixed Models Analysis

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