Childhood AsthmaNCT02405962
Training Parents by Acceptance and Commitment Therapy for Managing Childhood Asthma Care
A study testing ACT in people with Childhood Asthma, run by The Hong Kong Polytechnic University at 3 sites in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Childhood Asthma
- What is being tested?
- ACT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 3 sitesHong Kong
- Study dates
- Jan 2015to Jan 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
- 3 to 12 years old with a physician's diagnosis of asthma
Who cannot join
- Enrolled in another asthma research intervention study
- 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.
Trial locations and contacts
3 sites in 1 country.
Hong Kong3 sites
Ambulatory Care Clinic, Department of Paediatrics and Adolescent Medicine, Tuen Mun Hospital
Hong Kong
Pediatric asthma nurse-led clinic, Department of Paediatrics and Adolescent Medicine, Tuen Mun Hospital
Hong Kong
School of Nursing, The Hong Kong Polytechnic University
Hung Hom, Kowloon
About this study
Official title: Effects of a Parental Training Program Using Group-based Acceptance and Commitment Therapy for Managing Children With Asthma: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Childhood Asthma
- Being tested
- ACT, Control
- Keywords
- Acceptance and Commitment Therapy, Childhood asthma, Randomized controlled trial, Training parents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACTBehavioural
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.
ControlBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Control |
| 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). Receives: Behavioral: ACT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months after the completion of intervention
Secondary outcomes (14)
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
Measured: 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
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
Measured: At 6 months after the intervention
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
Measured: At 6 months after the intervention
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
Measured: At 6 months after the intervention
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
Measured: At 6 months after the intervention
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
Measured: At 6 months after the intervention
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.
Measured: At 6 months after the intervention
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
Measured: At 6 months after the intervention
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 (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.
Measured: At 6 months after the intervention
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 (α in each subscale = .72 to .89) and test-retest reliabilities over a 2-week interval (r in each subscale = .83 to .86)
Measured: At 6 months after the intervention
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.
Measured: At 6 months after the intervention
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.
Measured: At 6 months after the intervention
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 (α of each subscale = .77 to .82) and strong construct validity with the self-efficacy of children in managing asthma (r = 0.36).
Measured: At 6 months after the intervention
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).
Measured: At 6 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2015 (estimated)
- Study startJan 2015
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Childhood AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Authority, Hong Kong
- Responsible party
- Principal investigator, Yim Wah MAK, Ph.D, The Hong Kong Polytechnic University
- Investigators
- Yim Wah Mak, PhD, Principal investigator, School of Nursing, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02405962
- Sponsor's protocol ID
- HSEARS20150109001
- Status last verified
- Jan 2019
- First submitted
- 28 Mar 2015
- Last updated
- 12 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chong YY, Mak YW, Leung SP, Lam SY, Loke AY. Acceptance and Commitment Therapy for Parental Management of Childhood Asthma: An RCT. Pediatrics. 2019 Feb;143(2):e20181723. doi: 10.1542/peds.2018-1723. Epub 2019 Jan 18.
PubMed 30659063
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Parental Training Program Using Group-based Acceptance and Commitment Therapy for Managing Children With Asthma: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02405962
- Acronym / sponsor ID
- HSEARS20150109001
- Conditions
- Childhood Asthma
- Keywords
- Acceptance and Commitment Therapy, Childhood asthma, Randomized controlled trial, Training parents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Hospital Authority, Hong Kong
- Study start
- Jan 2015 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 1 Apr 2015 (estimated)
- Results
- Posted 23 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Behavioral: ControlParents 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 |
| ACT group | Experimental | Behavioral: ACTParents 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). |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- Enrolled in another asthma research intervention study
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACTFour 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. | Behavioural | ACT group |
| ControlOne 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. | Behavioural | Control group |
Primary outcome
Child's Total Number of Emergency Department Visits Due to Asthma Attacks Over the 6 Months Post Intervention
Time frame: 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
14 secondary outcomes
Children's Total Number of General Outpatient Clinic Visits Due to Asthma Attacks Over the Past 6 Months
Time frame: 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
Time frame: At 6 months after the intervention
Children's Total Number of Hospital Admissions Due to Asthma Attacks Over the Past 6 Months
Time frame: At 6 months after the intervention
Children's Number of Days of Hospital Stay Due to Asthma Attacks Over the Past 6 Months
Time frame: At 6 months after the intervention
Children's Asthma Symptoms During Daytime Per Week Over the Past 4 Weeks
Time frame: At 6 months after the intervention
Children's Asthma Symptoms During Nighttime Per Week Over the Past 4 Weeks
Time frame: At 6 months after the intervention
Children's Days of Activities Affected by Asthma Symptoms Per Week Over the Past 4 Weeks
Time frame: At 6 months after the intervention
Children's Reliever Use Due to Asthma Symptoms Per Week Over the Past 4 Weeks
Time frame: At 6 months after the intervention
Parents' Psychological Flexibility
Time frame: At 6 months after the intervention
Parents' Psychological Adjustment to Their Child's Asthma
Time frame: At 6 months after the intervention
Parents' Psychological Symptoms
Time frame: At 6 months after the intervention
Parents' Knowledge in Childhood Asthma Management
Time frame: At 6 months after the intervention
Parents' Asthma Management Self-efficacy
Time frame: At 6 months after the intervention
Parents' Quality of Life
Time frame: At 6 months after the intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30659063Chong YY, Mak YW, Leung SP, Lam SY, Loke AY. Acceptance and Commitment Therapy for Parental Management of Childhood Asthma: An RCT. Pediatrics. 2019 Feb;143(2):e20181723. doi: 10.1542/peds.2018-1723. Epub 2019 Jan 18.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yim Wah Mak, PhD principal investigator
School of Nursing, The Hong Kong Polytechnic University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT in people with Childhood Asthma, run by The Hong Kong Polytechnic University at 3 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child's Total Number of Emergency Department Visits Due to Asthma Attacks Over the 6 Months Post Intervention (time frame: 6 months after the completion of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02405962, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2019.