Recruiting

Sleep Intervention

Sponsor:

Candice A Alfano

Code:

NCT05646095

Conditions

Sleep Disturbance

Child Development

Mental Disorder, Child

Eligibility Criteria

Sex: All

Age: 6 - 10

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Study ID

NCT05646095

Start date

Jan 1, 2023

Status verified date

Dec, 2023

Completion date

Jan 31, 2025

Anticipated

Primary completion date

Jan 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 10

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Brief, behavioral sleep intervention for children and caregivers

active comparator: Delayed Intervention

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

Interventions

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

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.

Primary outcome measure

  • Child average total sleep time (TST) [ Time Frame: one week and 3-months follow up ]
  • Child average wake minutes after sleep onset (WASO) [ Time Frame: one week and 3-months follow up ]
  • Child average sleep onset latency (SOL) [ Time Frame: one week and 3-months follow up ]
  • Change in Emotional and behavioral regulation [ Time Frame: one week and 3-months follow up ]
  • Cortisol awakening response (mcg/dL) [ Time Frame: one week and 3-months follow up ]
  • Objective sleep timing (mid sleep point) [ Time Frame: one week and 3-months follow up ]

Central Contacts and Locations

Locations

Sleep and Anxiety Center of Houston

Recruiting

Houston, Texas, United States, 77204

Contacts

Candice Alfano, PhD.

713-743-3400SACH@times.uh.edu

More Information

Sponsor

Candice A Alfano

Last update posted

Dec 19, 2023

Last verified

Dec, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Candice A Alfano on 2023-12-19.