60 Participants Needed

B-SAFE Program for Childhood Sleep Disorders

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

The provided research does not contain specific safety data for the B-SAFE treatment or its variations. The studies focus on general sleep health initiatives and interventions, but none directly evaluate the safety of the B-SAFE program.23678

Is the B-SAFE treatment a promising treatment for childhood sleep disorders?

Yes, the B-SAFE treatment is promising because it focuses on improving sleep health for children in foster care, who often face sleep challenges due to their difficult experiences. By addressing sleep issues, B-SAFE can help enhance their overall well-being and development.12349

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

A caregiver or child-reported behavioral sleep problem at least twice a week
I am a foster or adoptive parent with a child aged 6-10 who has lived with me for at least one month.

Exclusion Criteria

Current foster parent or child suicidality or self-harm behaviors (i.e., suicidal ideation, intent, and/or plan, cutting, burning, etc)
My child has significant developmental delays or intellectual disability that makes understanding or participating in treatment difficult.
Foster parent and/or child who is a non-fluent English speaker
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1: Intervention Development

Input and feedback from FC agency partners, expert consultants, and pilot families to finalize the intervention manual, materials, and procedures

1 year

Phase 2: Randomized Controlled Trial

Conduct a randomized, controlled trial among 60 families; 30 receive B-SAFE immediately, 30 serve as waitlist controls

3 months
Multiple visits for assessments

Follow-up

Post-treatment and follow-up assessments of child sleep health, emotional/behavioral regulation, and biological rhythms

3 months

Stakeholder Engagement

Quantitative surveys and qualitative interviews with key stakeholders to explore potential barriers and supports for larger implementation

1 year

Treatment Details

Interventions

  • Bolstering Sleep and Adjustment in Foster Environments (B-SAFE)
Trial Overview The study tests the B-SAFE program, which adapts cognitive-behavioral treatment to improve sleep and overall adjustment for children in foster environments. It aims to help them recover from trauma by stabilizing their sleep patterns.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Bolstering Sleep and Adjustment in Foster Environments (B-SAFE)Experimental Treatment1 Intervention
Brief, behavioral sleep intervention for children and caregivers
Group II: Delayed InterventionActive Control1 Intervention
Waitlist families will be monitored for 1 month before receiving the B-SAFE intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Candice A Alfano

Lead Sponsor

Trials
1
Recruited
60+

Findings from Research

Children in therapeutic foster care showed improved sleep patterns compared to those in regular foster care and low-income community children, indicating that therapeutic interventions can enhance sleep quality.
Despite longer sleep latency and variability in sleep duration, therapeutic foster care children had earlier bedtimes and longer total sleep time, suggesting that early interventions can positively impact sleep in at-risk populations.
Sleep disruption in young foster children.Tininenko, JR., Fisher, PA., Bruce, J., et al.[2018]
Children in the US child welfare system, particularly those in alternative care settings, face significant sleep health challenges due to trauma and adversities, which can negatively impact their overall health and development.
There is a critical need for more research and evidence-based practices to promote sleep health among these children, as current studies are limited and do not adequately inform practitioners and policymakers.
Call to action: Prioritizing sleep health among US children and youth residing in alternative care settings.Hash, JB., Alfano, CA., Owens, J., et al.[2023]
The Beds for Kids (BfK) program significantly improved maternal sleep duration by 1 hour within a week of intervention, indicating immediate benefits for mothers living in poverty.
By one month after the intervention, mothers reported improvements in their children's sleep quality and behavior, although children initially faced challenges adjusting to independent sleeping.
A multimethod evaluation of bed provision and sleep education for young children and their families living in poverty.Williamson, AA., Min, J., Fay, K., et al.[2023]

References

Sleep disruption in young foster children. [2018]
Call to action: Prioritizing sleep health among US children and youth residing in alternative care settings. [2023]
A multimethod evaluation of bed provision and sleep education for young children and their families living in poverty. [2023]
An eHealth insomnia intervention for children with neurodevelopmental disorders: Results of a usability study. [2020]
Behavioural management of sleep problems. [2019]
As easy as ABC: evaluation of safe sleep initiative on safe sleep compliance in a freestanding pediatric hospital. [2022]
Expansion of a multi-pronged safe sleep quality improvement initiative to three children's hospital campuses. [2020]
Effect of a behavioral-educational sleep intervention for first-time mothers and their infants: pilot of a controlled trial. [2022]
Impact of a Behavioral Sleep Intervention on New School Entrants' Social Emotional Functioning and Sleep: A Translational Randomized Trial. [2020]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of ServiceยทPrivacy PolicyยทCookiesยทSecurity