Randomized clinical trial of parental psychosocial stress management to improve asthma outcomes

Abstract

Objective

Because higher parental psychosocial stress is associated with worsened asthma outcomes in children, we sought to determine if a parent-focused stress management intervention would improve outcomes among their at-risk African American children.

Methods

We enrolled self-identified African American parent-child dyads (children aged 4-12 years old with persistent asthma, no co-morbidities, on Medicaid) in a prospective, single-blind, randomized clinical trial with follow-up at 3, 6, and 12 months. All children received care based on the guidelines of the National Institutes of Health. Developed with extensive local stakeholder engagement, the intervention consisted of four individual sessions with a community wellness coach (delivered over 3 months) supplemented with weekly text messaging and twice monthly group sessions (both delivered for 6 months). The main outcome was asthma symptom-free days in the prior 14 days by repeated measures at 3 and 6 months follow-up.

Results

We randomized 217 parent-child dyads and followed 196 (90.3%) for 12 months. Coaches completed 338/428 (79%) of all individual sessions. Symptom-free days increased significantly from baseline in both groups at 3, 6, and 12 months, but there were no significant differences between groups over the first 6 months. At 12 months, the intervention group sustained a significantly greater increase in symptom-free days from baseline [adjusted difference = 0.92 days, 95% confidence interval (0.04, 1.8)].

Conclusion

The intervention did not achieve its primary outcome. The efficacy of providing psychosocial stress management training to parents of at-risk African American children with persistent asthma in order to improve the children’s outcomes may be limited.

ClinicalTrials.gov

NCT02374138

Keywords:

• Asthma
• stress
• depression
• poverty
• children
• African Americans
• adherence

Acknowledgements

The authors would like to thank all of our study participants and stakeholders, especially the parents of children with asthma, for their contributions to this effort. In addition, they would like to thank Damian Waters, PhD and Erin Collins, MPH for their support in conduct of the trial; and Michael Cabana, MD, MPH, Jill S. Halterman, MD, MPH, and Rosalind J. Wright, MD for their thoughtful advice on the design, conduct, and interpretation of the trial.

Disclosure statement

The authors have no financial relationships relevant to this article to disclose. They have no conflicts of interest.

Additional information

Funding

Research reported in this article was funded by an award from the Patient-Centered Outcomes Research Institute (AS-1307–05284). The views, statements and opinions in this article are solely the responsibility of the authors and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute, its Board of Governors or Methodology Committee. The Patient-Centered Outcomes Research Institute had no role in study design; in the collection, analysis and interpretation of data; in the writing of the report; or in the decision to submit the article for publication.