B-SAFE Program for Childhood Sleep Disorders
Trial Summary
Do I need to stop my current medications to join the trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, it excludes children with certain medical conditions that require routine care or medical treatment, so it's best to discuss your specific situation with the trial coordinators.
What data supports the idea that B-SAFE Program for Childhood Sleep Disorders is an effective treatment?
The available research shows that children in therapeutic foster care, which includes programs like B-SAFE, slept longer and had earlier bedtimes compared to those in regular foster care and low-income community settings. This suggests that the B-SAFE program is effective in improving sleep duration and bedtime routines for children in foster care. Additionally, the study highlights the importance of early intervention in enhancing sleep for foster children, supporting the effectiveness of treatments like B-SAFE.12345
What safety data exists for the B-SAFE treatment for childhood sleep disorders?
Is the B-SAFE treatment a promising treatment for childhood sleep disorders?
What is the purpose of this trial?
Sleep disturbances are pervasive and impairing among children who spend time in foster care but not a single prevention or intervention program for this fragile group targets sleep health. Poor sleep undermines effective self-regulation and stable biological rhythms, amplifying the negative impacts of early adversity/trauma on immediate and long-term functioning. Consistent with evidence that optimizing sleep is critical for trauma recovery, the investigators will adapt cognitive-behavioral treatment for pediatric insomnia for children placed in or adopted from foster care to evaluate child outcomes and target mechanism engagement and explore implementation barriers and supports.
Eligibility Criteria
This trial is for children aged 6-10 in foster care who have sleep problems at least twice a week. They must be living with their current foster family for at least one month, whether it's a non-relative or kinship placement.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Phase 1: Intervention Development
Input and feedback from FC agency partners, expert consultants, and pilot families to finalize the intervention manual, materials, and procedures
Phase 2: Randomized Controlled Trial
Conduct a randomized, controlled trial among 60 families; 30 receive B-SAFE immediately, 30 serve as waitlist controls
Follow-up
Post-treatment and follow-up assessments of child sleep health, emotional/behavioral regulation, and biological rhythms
Stakeholder Engagement
Quantitative surveys and qualitative interviews with key stakeholders to explore potential barriers and supports for larger implementation
Treatment Details
Interventions
- Bolstering Sleep and Adjustment in Foster Environments (B-SAFE)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Candice A Alfano
Lead Sponsor