Trial Outcomes & Findings for Training Parents by Acceptance and Commitment Therapy for Managing Childhood Asthma Care (NCT NCT02405962)

NCT ID: NCT02405962

Last Updated: 2019-02-12

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 168 participants
• Primary outcome timeframe: 6 months after the completion of intervention
• Results posted on: 2019-02-12

Participant Flow

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.

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.

Participant milestones

Measure	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.	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.
Overall Study STARTED	84	84
Overall Study Post-intervention	80	81
Overall Study 3 Months After the Intervention	80	79
Overall Study COMPLETED	83	79
Overall Study NOT COMPLETED	1	5

Reasons for withdrawal

Measure	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.	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.
Overall Study Lost to Follow-up	1	4
Overall Study A participant has moved to another place	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Control Group n=84 Participants 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.	ACT Group n=84 Participants 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.	Total n=168 Participants Total of all reporting groups
Age, Continuous	39.07 years STANDARD_DEVIATION 6.19 • n=5 Participants	37.74 years STANDARD_DEVIATION 5.55 • n=7 Participants	38.40 years STANDARD_DEVIATION 5.90 • n=5 Participants
Sex: Female, Male Female	72 Participants n=5 Participants	76 Participants n=7 Participants	148 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	8 Participants n=7 Participants	20 Participants n=5 Participants
Region of Enrollment Hong Kong	84 participants n=5 Participants	84 participants n=7 Participants	168 participants n=5 Participants
Educational attainment Primary education or below	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Educational attainment Secondary education	65 Participants n=5 Participants	58 Participants n=7 Participants	123 Participants n=5 Participants
Educational attainment Tertiary education or above	14 Participants n=5 Participants	22 Participants n=7 Participants	36 Participants n=5 Participants
Monthly household income (Hong Kong Dollars) < $ 10,000	15 Participants n=5 Participants	10 Participants n=7 Participants	25 Participants n=5 Participants
Monthly household income (Hong Kong Dollars) $10,000 to $25,000	27 Participants n=5 Participants	18 Participants n=7 Participants	45 Participants n=5 Participants
Monthly household income (Hong Kong Dollars) $25,001 to $50,000	37 Participants n=5 Participants	51 Participants n=7 Participants	88 Participants n=5 Participants
Monthly household income (Hong Kong Dollars) >$50,000	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Employment status Full-time employed	34 Participants n=5 Participants	29 Participants n=7 Participants	63 Participants n=5 Participants
Employment status Part-time employed	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Employment status Home-makers or unemployed	44 Participants n=5 Participants	49 Participants n=7 Participants	93 Participants n=5 Participants
Marital status Single/ separated/ divorced/ widowed	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Marital status Married	72 Participants n=5 Participants	73 Participants n=7 Participants	145 Participants n=5 Participants
Smoking status Both parents are non-smokers	53 Participants n=5 Participants	51 Participants n=7 Participants	104 Participants n=5 Participants
Smoking status At least one parent is a current smoker	31 Participants n=5 Participants	33 Participants n=7 Participants	64 Participants n=5 Participants
History of asthma diagnosis Neither parents has a history of asthma	48 Participants n=5 Participants	51 Participants n=7 Participants	99 Participants n=5 Participants
History of asthma diagnosis At least one parent has a history of asthma	24 Participants n=5 Participants	22 Participants n=7 Participants	46 Participants n=5 Participants
History of asthma diagnosis Other family members has a history of asthma	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Child's age	6.95 years STANDARD_DEVIATION 2.46 • n=5 Participants	6.67 years STANDARD_DEVIATION 2.55 • n=7 Participants	6.81 years STANDARD_DEVIATION 2.50 • n=5 Participants
Child's gender Male	52 Participants n=5 Participants	51 Participants n=7 Participants	103 Participants n=5 Participants
Child's gender Female	32 Participants n=5 Participants	33 Participants n=7 Participants	65 Participants n=5 Participants
Child's age of diagnosis as asthma	3.61 years STANDARD_DEVIATION 1.88 • n=5 Participants	3.31 years STANDARD_DEVIATION 1.70 • n=7 Participants	3.46 years STANDARD_DEVIATION 1.79 • n=5 Participants
Child's concurrently diagnosed with allergic rhinitis Yes	30 Participants n=5 Participants	29 Participants n=7 Participants	59 Participants n=5 Participants
Child's concurrently diagnosed with allergic rhinitis No	54 Participants n=5 Participants	55 Participants n=7 Participants	109 Participants n=5 Participants
Child's concurrently diagnosed with eczema Yes	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Child's concurrently diagnosed with eczema No	76 Participants n=5 Participants	74 Participants n=7 Participants	150 Participants n=5 Participants
Child's current use of oral Montelukast as prophylaxis Yes	13 Participants n=5 Participants	11 Participants n=7 Participants	24 Participants n=5 Participants
Child's current use of oral Montelukast as prophylaxis No	71 Participants n=5 Participants	73 Participants n=7 Participants	144 Participants n=5 Participants
Child's current use of inhaled corticosteroid as prophylaxis, by types None	33 Participants n=5 Participants	47 Participants n=7 Participants	80 Participants n=5 Participants
Child's current use of inhaled corticosteroid as prophylaxis, by types Beclometasone dipropionate	46 Participants n=5 Participants	35 Participants n=7 Participants	81 Participants n=5 Participants
Child's current use of inhaled corticosteroid as prophylaxis, by types Fluticasone propionate	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Child's current use of inhaled corticosteroid as prophylaxis, by types Fluticasone propionate and Salmeterol	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Child use 1 or more course of oral prednisolone use in the previous year due to asthma exacerbations Yes	44 Participants n=5 Participants	50 Participants n=7 Participants	94 Participants n=5 Participants
Child use 1 or more course of oral prednisolone use in the previous year due to asthma exacerbations No	40 Participants n=5 Participants	34 Participants n=7 Participants	74 Participants n=5 Participants
Child's total number of GOPC visits due to asthma exacerbations in the past 6 months 0 times	74 Participants n=5 Participants	69 Participants n=7 Participants	143 Participants n=5 Participants
Child's total number of GOPC visits due to asthma exacerbations in the past 6 months 1 to 2 times	5 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants
Child's total number of GOPC visits due to asthma exacerbations in the past 6 months 3 to 4 times	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Child's total number of GOPC visits due to asthma exacerbations in the past 6 months 5 times or above	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Child's total number of PP clinic visits due to asthma exacerbations in the past 6 months 0 times	46 Participants n=5 Participants	47 Participants n=7 Participants	93 Participants n=5 Participants
Child's total number of PP clinic visits due to asthma exacerbations in the past 6 months 1 to 2 times	26 Participants n=5 Participants	22 Participants n=7 Participants	48 Participants n=5 Participants
Child's total number of PP clinic visits due to asthma exacerbations in the past 6 months 3 to 4 times	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Child's total number of PP clinic visits due to asthma exacerbations in the past 6 months 5 times or above	3 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants
Child's total number of emergency care visit(s) due to asthma exacerbations in the past 6 months 0 times	54 Participants n=5 Participants	49 Participants n=7 Participants	103 Participants n=5 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 n=5 Participants	29 Participants n=7 Participants	55 Participants n=5 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 n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 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 n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Child's total number of hospital admission(s) due to asthma exacerbation(s) in the past 6 months 0 times	67 Participants n=5 Participants	60 Participants n=7 Participants	127 Participants n=5 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 n=5 Participants	22 Participants n=7 Participants	38 Participants n=5 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 n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Child's use of alternative therapy in the past 6 months, by types None	73 Participants n=5 Participants	74 Participants n=7 Participants	147 Participants n=5 Participants
Child's use of alternative therapy in the past 6 months, by types Herbal soup	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Child's use of alternative therapy in the past 6 months, by types Natural moxibustion	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Control Group n=84 Participants 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.	ACT Group n=84 Participants 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.
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	0.08 Number of visits Standard Error 0.04

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Control Group n=84 Participants 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.	ACT Group n=84 Participants 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.
Children's Total Number of General Outpatient Clinic Visits Due to Asthma Attacks Over the Past 6 Months	0.18 Number of visits Standard Error 0.06	0.05 Number of visits Standard Error 0.02

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Control Group n=84 Participants 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.	ACT Group n=84 Participants 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.
Children's Total Number of Private Practitioner's Clinic Visits Due to Asthma Attacks Over the Past 6 Months	0.85 Number of visits Standard Error 0.14	0.40 Number of visits Standard Error 0.09

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Control Group n=84 Participants 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.	ACT Group n=84 Participants 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.
Children's Total Number of Hospital Admissions Due to Asthma Attacks Over the Past 6 Months	0.06 Number of hospital admissions Standard Error 0.03	0.04 Number of hospital admissions Standard Error 0.02

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Control Group n=84 Participants 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.	ACT Group n=84 Participants 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.
Children's Number of Days of Hospital Stay Due to Asthma Attacks Over the Past 6 Months	3.75 Number of days of hospital stay Standard Error 0.42	3.67 Number of days of hospital stay Standard Error 0.72

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Control Group n=84 Participants 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.	ACT Group n=84 Participants 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.
Children's Asthma Symptoms During Daytime Per Week Over the Past 4 Weeks	2.30 Number of days Standard Error 0.22	0.58 Number of days Standard Error 0.15

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Control Group n=84 Participants 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.	ACT Group n=84 Participants 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.
Children's Asthma Symptoms During Nighttime Per Week Over the Past 4 Weeks	1.89 Number of nights Standard Error 0.23	0.55 Number of nights Standard Error 0.13

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Control Group n=84 Participants 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.	ACT Group n=84 Participants 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.
Children's Days of Activities Affected by Asthma Symptoms Per Week Over the Past 4 Weeks	0.84 Number of days Standard Error 0.16	0.17 Number of days Standard Error 0.07

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Control Group n=84 Participants 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.	ACT Group n=84 Participants 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.
Children's Reliever Use Due to Asthma Symptoms Per Week Over the Past 4 Weeks	1.62 Number of days Standard Error 0.22	0.59 Number of days Standard Error 0.15

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Control Group n=84 Participants 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.	ACT Group n=84 Participants 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.
Parents' Psychological Flexibility	20.40 score on a scale Standard Error 0.89	14.67 score on a scale Standard Error 0.72

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Control Group n=84 Participants 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.	ACT Group n=84 Participants 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.
Parents' Psychological Adjustment to Their Child's Asthma Guilt and worry	1.46 score on a subscale Standard Error 0.07	1.19 score on a subscale Standard Error 0.06
Parents' Psychological Adjustment to Their Child's Asthma Unresolved sorrow and anger	1.16 score on a subscale Standard Error 0.07	0.95 score on a subscale Standard Error 0.05
Parents' Psychological Adjustment to Their Child's Asthma Long-term uncertainty	1.13 score on a subscale Standard Error 0.08	0.98 score on a subscale Standard Error 0.06
Parents' Psychological Adjustment to Their Child's Asthma Perceived emotional resources	2.38 score on a subscale Standard Error 0.10	2.64 score on a subscale Standard Error 0.08

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Control Group n=84 Participants 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.	ACT Group n=84 Participants 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.
Parents' Psychological Symptoms Depressive symptoms	4.12 score on a subscale Standard Error 0.58	2.75 score on a subscale Standard Error 0.40
Parents' Psychological Symptoms Anxiety symptoms	6.10 score on a subscale Standard Error 0.65	3.80 score on a subscale Standard Error 0.42
Parents' Psychological Symptoms Stress symptoms	9.85 score on a subscale Standard Error 0.90	7.41 score on a subscale Standard Error 0.63

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Control Group n=84 Participants 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.	ACT Group n=84 Participants 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.
Parents' Knowledge in Childhood Asthma Management	18.81 score on a scale Standard Error 0.29	19.50 score on a scale Standard Error 0.27

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Control Group n=84 Participants 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.	ACT Group n=84 Participants 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.
Parents' Asthma Management Self-efficacy Attack prevention	3.89 score on a subscale Standard Error 0.07	4.10 score on a subscale Standard Error 0.07
Parents' Asthma Management Self-efficacy Attack management	3.59 score on a subscale Standard Error 0.08	3.81 score on a subscale Standard Error 0.05

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Control Group n=84 Participants 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.	ACT Group n=84 Participants 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.
Parents' Quality of Life Emotional function	5.36 score on a subscale Standard Error 0.12	5.69 score on a subscale Standard Error 0.10
Parents' Quality of Life Activity limitation	5.23 score on a subscale Standard Error 0.13	5.65 score on a subscale Standard Error 0.11

Adverse Events

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ACT Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Yim Wah Mak

The Hong Kong Polytechnic University

Phone: (852) 2766-6421

Email: yw.mak@polyu.edu.hk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place