B-SAFE: A Trauma-Informed Early Intervention Targeting Sleep and Adjustment Among Children in Foster Care - PROJECT SUMMARY Children in foster care (FC) evidence poorer developmental, physical and mental health outcomes than even the poorest children in the U.S. and unmet need in this fragile group is extraordinarily high. Of the small number of early intervention programs demonstrated as effective for this population, most are directed at infants and young children. However, more than half of the children entering FC each year are older than 5 years, a time when capacity for and expectations of self-regulation are greater, but history of maltreatment/trauma is likely more extensive. Sleep disturbance is one of the most well-recognized consequences and enduring sequela of early adversity/trauma that creates a feedback loop through which arousal/anxiety is amplified, self-regulation is undermined, and biological rhythms are altered. Mounting evidence reveals the presence of significant sleep disruption among a majority of children in FC, which is closely associated with elevated mental health problems. Sleep disturbances are often worst in the initial weeks/months of a new foster placement. Early intervention programs targeting sleep might therefore prevent a cascade of associated negative outcomes. Our research team, with unique expertise in pediatric sleep, childhood maltreatment, attachment, and the delivery of foster care interventions, will use a trauma-informed framework to adapt cognitive-behavioral therapy for pediatric insomnia for school-aged children recently placed in a new foster home. Aligning with the goals of RFA-MH-18-706, we propose a 3-year, multi-phase study to finalize and test a brief, home-based early intervention program, called Bolstering Sleep and Adjustment in Foster Environments (B-SAFE). B-SAFE's target mechanisms are informed and supported by a wealth of research showing reductions in children's nighttime anxiety/arousal and greater parental support around bedtime/sleep routines to correspond with improvements in children's sleep, emotional and behavioral health. Phase 1 will include input and feedback from our FC agency partners, expert consultants, and several pilot families in order to finalize the B- SAFE manual, materials, and procedures. In Phase 2, we will conduct a randomized, controlled trial among N=60 new families; 30 will start the B-SAFE program within the first month of a new child placement, and 30 will serve as waitlist (WL) controls. Several months later (Phase 3), WL families will complete the B-SAFE program for comparison with the experimental group to inform optimal intervention timing. Feasibility and child-based outcomes including sleep health, emotional/behavioral regulation, and biological rhythms will be examined via objective and subjective measures, and target engagement will be confirmed. In addition to supporting a larger effectiveness trial, findings will directly inform dissemination efforts including training practitioners, alternative delivery settings, and potential adaptation for other trauma-exposed child populations, for whom evidence-based sleep interventions do not exist.
