Results Summary
What was the research about?
Asthma is a common illness in children that can make it hard to breathe. African-American children have more hospital visits and die at higher rates from asthma than white children. High stress levels in parents of children with asthma can increase symptoms, such as wheezing, and related problems for children.
In this study, the research team wanted to see if helping African-American parents manage stress could increase the number of days their children had no asthma symptoms. The team compared children of parents who took part in a stress management program with children of parents who weren’t in the program. All children in the study received usual asthma care that included three months of services to help coordinate care.
What were the results?
After six months, children in both groups had more days without asthma symptoms. The two groups had a similar increase in days without symptoms.
However, at 12 months, children whose parents took part in the stress management program had a greater increase in days without symptoms compared with children whose parents weren’t in the program.
Who was in the study?
The study included 217 parent-child pairs from Washington, DC. All children and parents were African American. Children had asthma, were ages 4 to 12, and had public insurance. The average age of children was 7, and 61 percent were boys. The average age of parents was 38, and 92 percent were women.
What did the research team do?
The research team assigned parents by chance to either take part in the six-month stress management program or not. The stress management program had three main parts:
- One-on-one sessions with a wellness coach. In the first three months of the program, parents met with a trained wellness coach four times in person or by phone. During these sessions, the wellness coach taught parents ways to handle stress.
- Group sessions. Parents could go to group sessions with other parents twice a month. Group sessions reviewed information from the one-on-one sessions and offered time for parents to talk with each other.
- Text or phone messages. The research team sent parents weekly text messages about stress management. The text messages had information from the sessions and links to more information. Parents who couldn’t get text messages got the same information by phone.
Parents in the stress management program also had access to a website for the program.
All children in the study received usual asthma care. With this care, parents learned how to treat their children’s asthma and manage their children’s care.
The research team interviewed parents when the study started and again 6 and 12 months later.
Parents of children with asthma, doctors, social workers, and experts in asthma and stress management gave input to the research team during the study.
What were the limits of the study?
This study included children who were African American and had public insurance. Results may differ for children with other backgrounds.
Future research could test the program with more people and follow up for longer than 12 months.
How can people use the results?
Health clinics treating children with asthma can use these results when considering ways to support children with asthma and their parents.
| How this project fits under PCORI’s Research Priorities PCORI identified asthma in African American and Hispanic/Latino populations as an important research topic. Patients, clinicians, and others wanted to learn how to encourage care that follows national asthma guidelines and improves patient-centered outcomes for African American and Hispanic/Latino populations. In 2013, PCORI launched an initiative on Treatment Options for African Americans and Hispanics/Latinos with Uncontrolled Asthma. The initiative funded this research project and others. |
Professional Abstract
Objective
To compare the effectiveness of a parent-focused stress management intervention plus usual care with usual care alone on symptom-free days (SFDs) among African-American children with asthma
Study Design
| Design Elements | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 217 dyads of African-American children ages 4–12 with persistent asthma and public insurance and their parents |
| Interventions/ Comparators |
|
| Outcomes |
Primary: child SFDs in the prior 14 days at 6 months Secondary: child SFDs in the prior 14 days at 12 months, change in asthma SFDs from baseline at 6 and 12 months |
| Timeframe | 6-month follow-up for primary outcome |
This randomized controlled trial compared a stress management intervention for parents of children with asthma plus usual care with usual care alone. The primary outcome was SFDs in the prior 14 days at 6 months. An SFD is a 24-hour period with no signs or symptoms of asthma.
All children in the study received usual asthma care consistent with National Institutes of Health (NIH) guidelines, supplemented by three months of limited care-coordination services to address barriers to care. Researchers randomly assigned parents to either receive the stress management intervention or not. The stress management intervention, called Breathe with Ease: A Unique Approach to Managing Stress (BEAMS), had three main components:
- One-on-one wellness coaching sessions. Parents could attend four one-on-one sessions over three months with a trained wellness coach either in person or by phone. Sessions covered various stress management topics. Coaches were members of the local community.
- Group sessions. Parents could also attend group sessions two times each month for six months. These sessions included time for discussion among the parents.
- Text or phone messages. Parents received weekly text messages about stress management during the same six-month period. Text messages reinforced the core curriculum and included links to more resources. Parents who could not get text messages received the same information by phone.
Parents in the BEAMS group also had access to a BEAMS program website.
The study included 217 parent-child dyads who were African American and from Washington, DC. All children in the study had persistent asthma, were ages 4–12, and had public insurance. The children’s average age was 7, and 61% were male. Parents’ average age was 38, and 92% were female.
Researchers interviewed parents at baseline and again 6 and 12 months after randomization to review patient-reported outcomes.
Parents of children with asthma, community-based clinicians and service providers, and experts in asthma and stress management gave input throughout the study.
Results
At 6 and 12 months, the number of asthma SFDs had improved from baseline for children in both groups. The two groups did not differ significantly at 6 months. However, at 12 months, children in the BEAMS group had a significantly greater increase from baseline in SFDs compared with children in the usual care group (2.3±4.4 vs. 1.5±4.9, difference=0.92, p=0.04).
Limitations
Study participants were African-American children with public insurance and their parents; results may differ for other populations.
Conclusions and Relevance
Children of parents who took part in BEAMS had significantly greater improvements in SFDs at 12 months compared with children of parents who did not participate in BEAMS.
Future Research Needs
Future research could test BEAMS with a larger sample and extend the follow-up beyond 12 months.
| How this project fits under PCORI’s Research Priorities PCORI identified asthma in African American and Hispanic/Latino populations as an important research topic. Patients, clinicians, and others wanted to learn how to encourage care that follows national asthma guidelines and improves patient-centered outcomes for African American and Hispanic/Latino populations. In 2013, PCORI launched an initiative on Treatment Options for African Americans and Hispanics/Latinos with Uncontrolled Asthma. The initiative funded this research project and others. |
Final Research Report
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Peer-Review Summary
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
Peer reviewers commented, and the researchers made changes or provided responses. The comments and responses included the following:
- The reviewers noted that the researchers did not find any benefit from the intervention based on the planned analyses. Positive findings were based on exploratory analyses comparing the experimental group to its baseline scores. The researchers acknowledged this and the need to be clear about the negative primary outcome. They revised the text.
- Reviewers said the absence of a theoretical framework made it difficult to interpret the results of the study. The researchers said that given the lack of understanding about how parental stress affects child asthma outcomes, they reasoned that the mechanism may be complex. They focused their efforts on building parental self-efficacy to manage stress. The researchers also added a figure to illustrate their conceptual model.
- The reviewers noted that several planned analyses, based on the study protocol, were not completed. These included a per-protocol analysis and a comparison to a historical control. The researchers acknowledged that they wanted to include these analyses but did not have the resources to do so. They did add an analysis of intervention fidelity to the final report.