A Trauma-Informed Sleep Intervention for Children in Foster Care

NCT05646095 | Unknown DMC

• 1 other identifier: 000181698
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disturbance; Child Development; Mental Disorder, Child

Outcome Measures

Primary Outcomes (6)

• Child average total sleep time (TST)

  Changes in TST will be assessed using subjective sleep logs and wrist actigraphy across one week

  one week and 3-months follow up

• Child average wake minutes after sleep onset (WASO)

  Changes in WASO will be assessed using subjective sleep logs and wrist actigraphy across one week

  one week and 3-months follow up

• Child average sleep onset latency (SOL)

  Changes in SOL will be assessed using subjective sleep logs and wrist actigraphy across one week

  one week and 3-months follow up

• Change in Emotional and behavioral regulation

  Reports on the NIH Toolbox Emotion Control measure will be used to assess changes in emotional and behavioral regulation. Difference in subjective reports on the NIH Toolbox Fixed Form v2.0 - Emotion Control v2.0 Measure will be compared at baseline (week 0) and post treatment (3 months later). The raw score is calculated by summing up the 10 items in the measure. Raw scores are converted to Toolbox Age-Adjusted, Fully Adjusted and Unadjusted Scale Scores for PROs - Mean of 50, SD of 10. Higher scores are an indicative of greater emotional regulation and lower scores are indicative of lower levels of emotional regulation.

  one week and 3-months follow up

• Cortisol awakening response (mcg/dL)

  Changes in biological rhythms will be assessed via morning and evening salivary cortisol across two non-consecutive days during the same week

  one week and 3-months follow up

• Objective sleep timing (mid sleep point)

  Changes average mid sleep point across across one week based on actigraphy

  one week and 3-months follow up

Secondary Outcomes (3)

• Pre-Sleep Arousal Scale for Children (PSAS-C)

  one week and 3-months follow up

• Children's Sleep Habits Questionnaire (CSHQ)

  one week and 3-months follow up

• Bedtime Routines Questionnaire (BRQ)

  one week and 3-months follow up

Other Outcomes (5)

• Rates of retention

  3-months follow up

• Rates of attrition

  3-months follow up

• Homework Compliance

  one week

Study Arms (2)

Bolstering Sleep and Adjustment in Foster Environments (B-SAFE)

EXPERIMENTAL

Brief, behavioral sleep intervention for children and caregivers

Behavioral: Bolstering Sleep and Adjustment in Foster Environments (B-SAFE)

Delayed Intervention

ACTIVE COMPARATOR

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

Behavioral: Bolstering Sleep and Adjustment in Foster Environments (B-SAFE)

Interventions

Bolstering Sleep and Adjustment in Foster Environments (B-SAFE) BEHAVIORAL

We will adapt CBT for insomnia for children in foster care using a trauma-informed approach that considers the child's individual history, unique family environment, and child welfare policies regarding safe sleep practices.

Bolstering Sleep and Adjustment in Foster Environments (B-SAFE); Delayed Intervention

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• A caregiver or child-reported behavioral sleep problem at least twice a week.

You may not qualify if:

• 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).
• 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).
• 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.
• Foster parent and/or child who is a non-fluent English speaker.
• Current foster parent or child suicidality or self-harm behaviors (i.e., suicidal ideation, intent, and/or plan, cutting, burning, etc).

Sponsors & Collaborators

• Candice A Alfano: lead

Study Sites (1)

Sleep and Anxiety Center of Houston

Houston, Texas, 77204, United States

RECRUITING

MeSH Terms

Conditions

Parasomnias; Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: multi-phase hybrid effectiveness-implementation trial

Study Record Dates

• First Submitted: February 21, 2022
• First Posted: December 12, 2022
• Study Start: January 1, 2023
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: December 19, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)