Clinical trial NCT05646095: A Trauma-Informed Sleep Intervention for Children in Foster Care
Official title: B-SAFE: A Trauma-Informed Early Intervention Targeting Sleep and Adjustment Among Children in Foster Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep Disturbance
Child Development
Mental Disorder, Child
Lead sponsor: University of Houston
Sponsor class: OTHER
First posted: 2022-12-12
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: multi-phase hybrid effectiveness-implementation trial
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Children in foster care (FC) evidence poorer developmental, physical and mental health outcomes than even the poorest children in the U.S. and unmet need in this fragile group is extraordinarily high. Of the small number of early intervention programs demonstrated as effective for this population, most are directed at infants and young children. However, more than half of the children entering FC each year are older than 5 years, a time when capacity for and expectations of self-regulation are greater, but history of maltreatment/trauma is often more extensive.

Sleep disturbance is one of the most well-recognized consequences and enduring sequela of early adversity/trauma that creates a feedback loop through which arousal/anxiety is amplified, self-regulation is undermined, and biological rhythms are altered. Mounting evidence reveals behavioral sleep problems to be prevalent among a majority of children in FC and closely associated with elevated mental health problems. Early intervention programs targeting sleep might therefore prevent a cascade of negative outcomes and serve to reduce placement disruption risk.

The research team, with unique expertise in pediatric sleep, childhood maltreatment, attachment, and the delivery of foster care interventions, will use a trauma-informed framework to adapt cognitive-behavioral therapy for pediatric insomnia for school-aged children in and adopted from FC. A 3-year, multi-phase hybrid effectiveness-implementation trial will: a) determine whether the intervention, Bolstering Sleep and Adjustment in Foster Environments (B-SAFE) has measurable effects on the sleep, emotional and behavioral health of children (6 to 10 years) in or adopted from foster care; and b) engage stakeholders early in the implementation process to ensure alignment of the B-SAFE program with child welfare resources and family needs. B-SAFE's target mechanisms are informed by research showing reductions in children's nighttime anxiety/arousal and increased parental support around bedtime/sleep routines to correspond with better child sleep, emotional and behavioral health. Phase 1 will include input and feedback from FC agency partners in the local community, expert consultants, and pilot families in order to finalize the intervention manual, materials, and procedures. In Phase 2, the investigators will conduct a randomized, controlled trial among N=60 new families; 30 will receive the B-SAFE right away and 30 will serve as waitlist (WL) controls. Post treatment and follow up assessments of child sleep health, emotional/behavioral regulation, and biological rhythms will be examined via objective and subjective measures. In the last year of the project, the investigators will conduct quantitative surveys and qualitative interviews with key stakeholders to explore potential barriers to and available supports/resources for a larger implementation trial.

Eligibility 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).

Primary outcomes:
measure: Child average total sleep time (TST)
timeFrame: one week and 3-months follow up
measure: Child average wake minutes after sleep onset (WASO)
timeFrame: one week and 3-months follow up
measure: Child average sleep onset latency (SOL)
timeFrame: one week and 3-months follow up
measure: Change in Emotional and behavioral regulation
timeFrame: one week and 3-months follow up
measure: Cortisol awakening response (mcg/dL)
timeFrame: one week and 3-months follow up
measure: Objective sleep timing (mid sleep point)
timeFrame: one week and 3-months follow up
Secondary outcomes:
measure: Pre-Sleep Arousal Scale for Children (PSAS-C)
timeFrame: one week and 3-months follow up
measure: Children's Sleep Habits Questionnaire (CSHQ)
timeFrame: one week and 3-months follow up
measure: Bedtime Routines Questionnaire (BRQ)
timeFrame: one week and 3-months follow up
Other outcomes:
measure: Rates of retention
timeFrame: 3-months follow up
measure: Rates of attrition
timeFrame: 3-months follow up
measure: Homework Compliance
timeFrame: one week
measure: Client Satisfaction Questionnaire (CSQ)
timeFrame: one week
measure: Parenting Stress Index -Short Form (PSI)
timeFrame: one week and 3-months follow up
Locations:
city: Houston
country: United States
facility: Sleep and Anxiety Center of Houston
state: Texas
Study officials:
References: