B-SAFE Program for Childhood Sleep Disorders

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Candice A Alfano

Disqualifiers: Medically fragile, Developmental delays, Sleep disorders, Non-fluent English, Suicidality, others

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

Compensation: Varies

Number of Visits: Unknown

60 Participants Needed

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. ^{1 2 3 4 5}

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. ^{2 3 6 7 8}

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. ^{1 2 3 4 9}

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

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

Group I: Bolstering Sleep and Adjustment in Foster Environments (B-SAFE) Experimental Treatment 1 Intervention

Brief, behavioral sleep intervention for children and caregivers

Group II: Delayed Intervention Active Control 1 Intervention

Waitlist families will be monitored for 1 month before receiving the B-SAFE intervention

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Parents of children with neurodevelopmental disorders found the Better Nights, Better Days (BNBD) online intervention to be usable, acceptable, and feasible for addressing insomnia, based on feedback from 20 caregivers.

The study highlighted the need for specific modifications to adapt the BNBD program for children with neurodevelopmental disorders, supporting a flexible approach to treating sleep issues in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An eHealth insomnia intervention for children with neurodevelopmental disorders: Results of a usability study. Tan-MacNeill, KM., Smith, IM., Weiss, SK., et al.[2020]

A study of 19 children with sleep disorders showed an impressive 84% success rate using behavioral management techniques, which was sustained at a 6-month follow-up.

Successful treatment outcomes were linked to factors such as the absence of marital discord and the involvement of both parents in the treatment sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioural management of sleep problems. Jones, DP., Verduyn, CM.[2019]

A quality improvement program at a pediatric hospital significantly increased adherence to safe sleep recommendations, with overall compliance rising from 3% to 34% after the intervention, particularly in safe sleep environments (from 3% to 38%).

The study found that while crib cards were intended to promote safe sleep practices, their presence did not significantly affect compliance, suggesting that the auditing process and tracking boards were more effective in improving adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

As easy as ABC: evaluation of safe sleep initiative on safe sleep compliance in a freestanding pediatric hospital. Leong, T., Billaud, M., Agarwal, M., et al.[2022]

A quality improvement initiative at three children's hospitals significantly increased overall compliance with the American Academy of Pediatrics' safe sleep recommendations from 4.4% to 32.5%, indicating a successful intervention.

The initiative notably improved the percentage of infants sleeping in a safe sleep environment from 5.9% to 39.8%, although there was no significant change in sleep position/location compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expansion of a multi-pronged safe sleep quality improvement initiative to three children's hospital campuses. Leong, T., Roome, K., Miller, T., et al.[2020]

The study involved 40 first-time mothers, with those receiving a behavioral-educational sleep intervention reporting significantly greater improvements in their nocturnal sleep duration compared to the control group.

Both groups experienced increased sleep duration and quality over time, but the intervention group also reported enhanced confidence in managing their infant's sleep, indicating the intervention's positive impact on maternal perceptions and sleep management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a behavioral-educational sleep intervention for first-time mothers and their infants: pilot of a controlled trial. Sweeney, BM., Signal, TL., Babbage, DR.[2022]

A brief behavioral sleep intervention for 334 children with sleep problems led to significant improvements in sleep quality and reduced sleep issues at 6 months, but did not enhance social-emotional functioning.

While parents reported fewer symptoms of depression after the intervention, these benefits diminished by 12 months, suggesting that longer or more intensive interventions may be needed for sustained effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a Behavioral Sleep Intervention on New School Entrants' Social Emotional Functioning and Sleep: A Translational Randomized Trial. Hiscock, H., Quach, J., Paton, K., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Sleep disruption in young foster children. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Call to action: Prioritizing sleep health among US children and youth residing in alternative care settings. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

A multimethod evaluation of bed provision and sleep education for young children and their families living in poverty. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

An eHealth insomnia intervention for children with neurodevelopmental disorders: Results of a usability study. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Behavioural management of sleep problems. [2019]

6. England pubmed.ncbi.nlm.nih.gov

As easy as ABC: evaluation of safe sleep initiative on safe sleep compliance in a freestanding pediatric hospital. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Expansion of a multi-pronged safe sleep quality improvement initiative to three children's hospital campuses. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Effect of a behavioral-educational sleep intervention for first-time mothers and their infants: pilot of a controlled trial. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Impact of a Behavioral Sleep Intervention on New School Entrants' Social Emotional Functioning and Sleep: A Translational Randomized Trial. [2020]