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

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.