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

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to help children in foster care sleep better by adapting a cognitive-behavioral treatment for pediatric insomnia. Good sleep is crucial for children recovering from trauma, as it aids in self-control and maintaining stable routines. Families first receive either a brief sleep intervention or are monitored for a month before starting the Bolstering Sleep and Adjustment in Foster Environments (B-SAFE) program. Ideal participants include foster, kinship, or adoptive families with a child aged 6-10 who experiences sleep problems at least twice a week. As an unphased trial, this study offers families the chance to contribute to innovative research that could enhance sleep and overall well-being for children in foster care.

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 prior data suggests that the B-SAFE program is safe for children in foster care?

Research shows that sleep programs like B-SAFE have been well-received by children in foster care. Earlier studies on a similar program, SAFE-T, showed good results in improving sleep for young children in similar situations. Importantly, these studies reported no major negative side effects or safety issues. This suggests that the B-SAFE program is likely safe for children, focusing on better sleep and adjustment without harmful effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the B-SAFE program because it offers a tailored, behavioral approach to improving sleep for children in foster care. Unlike typical treatments for childhood sleep disorders, which often involve medication or generalized sleep hygiene education, B-SAFE provides a specific intervention designed for both children and their caregivers. This method focuses on fostering better sleep habits and adjustments within the unique context of foster environments, potentially leading to more sustainable and effective outcomes.

What evidence suggests that the B-SAFE program is effective for childhood sleep disorders?

Research has shown that the B-SAFE program, which participants in this trial may receive, could improve sleep for children in foster care. A similar program, SAFE-T, produced positive results in helping children with a history of trauma sleep better. This approach focuses on altering sleep routines and environments to meet the needs of children who have faced early challenges. By improving sleep, these programs aim to help children manage their emotions and function better overall. Early results suggest these methods effectively address sleep problems in this vulnerable group. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05646095

A Trauma-Informed Sleep Intervention for Children in ... A 3-year, multi-phase hybrid effectiveness-implementation trial will: a) determine whether the intervention, Bolstering Sleep and Adjustment in Foster ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39405652/

Initial efficacy of a trauma-informed sleep intervention for ... Conclusions: Findings suggest SAFE-T to be a promising intervention for improving sleep health among children currently or previously placed in foster care.

3. bradleycobre.org bradleycobre.org/wp-content/uploads/2024/11/Alfano-CA.-Sleep-and-adjustment-in-foster-environments-for-toddlers-and-preschoolers-SAFE-T.pdf

Initial efficacy of a trauma-informed sleep The current study is the first to examine the efficacy of Sleep and Adjustment in Foster Environments for Toddlers and Preschoolers. (SAFE-T) ...

4. srcd.onlinelibrary.wiley.com srcd.onlinelibrary.wiley.com/doi/full/10.1002/sop2.70001

Prioritizing sleep health in foster care: Trauma‐informed ... In this report, we discuss research that demonstrates the importance of sleep for addressing child welfare goals, emphasizing the lack of state ...

5. ctv.veeva.com ctv.veeva.com/study/a-trauma-informed-sleep-intervention-for-children-in-foster-care

A Trauma-Informed Sleep Intervention for Children in Foster ... A 3-year, multi-phase hybrid effectiveness-implementation trial will: a) determine whether the intervention, Bolstering Sleep and Adjustment in ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0145213424004733

Initial efficacy of a trauma-informed sleep intervention for ... Findings suggest SAFE-T to be a promising intervention for improving sleep health among children currently or previously placed in foster care.

7. researchgate.net researchgate.net/publication/384969291_Sleep_and_adjustment_in_foster_environments_for_toddlers_and_preschoolers_SAFE-T_Initial_efficacy_of_a_trauma-informed_sleep_intervention_for_young_children_in_foster_care

Sleep and adjustment in foster environments for toddlers ... At both post-intervention and 3-month follow-up, children in the SAFE-T group only evidenced meaningful improvements in multiple sleep outcomes, including ...