A sleep intervention for children in foster care
B-SAFE: A Trauma-Informed Early Intervention Targeting Sleep and Adjustment Among Children in Foster Care
This study is testing a sleep program for children in foster care to see if it can help them sleep better and improve their overall well-being.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 6 Years to 10 Years |
| Sex | All |
| Sponsor | University of Houston Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05646095 on ClinicalTrials.gov |
What this trial studies
This intervention focuses on addressing sleep disturbances among children in foster care, who often experience significant developmental and mental health challenges. The program adapts cognitive-behavioral therapy for pediatric insomnia specifically for school-aged children in foster care or those adopted from it. By utilizing a trauma-informed approach, the study aims to evaluate child outcomes and identify barriers to implementation while promoting better sleep health. The intervention is designed to prevent negative outcomes associated with poor sleep and enhance self-regulation in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates are children aged 6 to 10 years in non-relative foster, kinship, or adoptive families who exhibit behavioral sleep problems.
Not a fit: Children who are medically fragile or have significant developmental delays may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could significantly improve sleep quality and overall well-being for children in foster care.
How similar studies have performed: While there is limited research specifically targeting sleep in this population, similar interventions for sleep disturbances in children have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. All non-relative foster, kinship and adoptive foster families with a child between the ages 6 and 10 years who have been in the home for one month. 2. A caregiver or child-reported behavioral sleep problem at least twice a week. Exclusion Criteria: 1. Children who are considered 'medically fragile' or with serious medical issues/conditions requiring routine care, supervision/monitoring and/or regular use of equipment (e.g., paralysis, tracheostomy, blindness, cerebral palsy). We will not exclude children with non-serious medical conditions that are well-managed (e.g., asthma, diabetes, HIV). 2. Children with significant developmental delays or intellectual disability who would have difficulty comprehending and/or engaging in treatment. Consistent with practices in community settings, the study team will consider the reliability of child responses during the initial assessment to identify children who meet this criterion (rather than standardized test scores). 3. Children with a confirmed or suspected medical sleep disorder requiring medical treatment (e.g., obstructive sleep apnea, narcolepsy). We will immediately refer these children for services as necessary. 4. Foster parent and/or child who is a non-fluent English speaker. 5. Current foster parent or child suicidality or self-harm behaviors (i.e., suicidal ideation, intent, and/or plan, cutting, burning, etc).
Where this trial is running
Houston, Texas
- Sleep and Anxiety Center of Houston — Houston, Texas, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.