Sleep DisturbanceNCT05646095
A Trauma-Informed Sleep Intervention for Children in Foster Care
A study testing Bolstering Sleep and Adjustment in Foster Environments (B-SAFE) in people with Sleep Disturbance and Child Development, run by Candice A Alfano at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Sleep Disturbance, Child Development, Mental Disorder, Child
- What is being tested?
- Bolstering Sleep and Adjustment in Foster Environments (B-SAFE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2023to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Sleep and Anxiety Center of Houston
Houston, Texas, 77204
Candice Alfano, PhD., 713-743-3400, SACH@times.uh.edu
About this study
Official title: B-SAFE: A Trauma-Informed Early Intervention Targeting Sleep and Adjustment Among Children in Foster Care
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.
Read the 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.
- Conditions
- Sleep Disturbance, Child Development, Mental Disorder, Child
- Being tested
- Bolstering Sleep and Adjustment in Foster Environments (B-SAFE)
- Medical subject headings
- Parasomnias, Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bolstering Sleep and Adjustment in Foster Environments (B-SAFE)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Bolstering Sleep and Adjustment in Foster Environments (B-SAFE) | Experimental | Brief, behavioral sleep intervention for children and caregivers Receives: 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 Receives: Behavioral: Bolstering Sleep and Adjustment in Foster Environments (B-SAFE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child average total sleep time (TST)
Changes in TST will be assessed using subjective sleep logs and wrist actigraphy across one week
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: one week and 3-months follow up
Secondary outcomes (3)
Pre-Sleep Arousal Scale for Children (PSAS-C)
Difference in subjective reports of children on Pre-Sleep Arousal Scale for Children (PSAS-C) measure will be compared at baseline (week 0) and post treatment (3 months later). The raw score is calculated by summing up the 16 items in the measure with scores ranging from 16 to 80. Higher scores indicate higher states of arousal before sleep.
Measured: one week and 3-months follow up
Children's Sleep Habits Questionnaire (CSHQ)
Difference in subjective reports of parents on Children's Sleep Habits Questionnaire (CSHQ) measure will be compared at baseline (week 0) and post treatment (3 months later). The measure produces 8 subscales: bedtime resistance, sleep onset delay, sleep duration, sleep anxiety, night awakening, parasomnias sleep disordered breathing, and daytime sleepiness. The subscales are scored by summing up the score of all items' in a subscale. The total sleep disturbance score is the sum of all the subscales, with higher scores indicating more sleep disturbances.
Measured: one week and 3-months follow up
Bedtime Routines Questionnaire (BRQ)
Difference in subjective reports of parents on The Bedtime Routines Questionnaire will be compared at baseline (week 0) and post treatment (3 months later). The Bedtimes Routines Questionnaire produces 4 subscales: total reactivity, total consistency, adaptive and maladaptive activity. Each subscale is calculated by summing the items compromising the subscales. Greater scores suggest greater reactivity to changes in routine (range 5 to 25), greater routine consistency (range 10 to 50) and more frequent adaptive (range 10 to 50) and maladaptive activities (range 6 - 30).
Measured: one week and 3-months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start1 Jan 2023
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- multi-phase hybrid effectiveness-implementation trial
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Candice A Alfano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Candice A Alfano, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05646095
- Sponsor's protocol ID
- 000181698
- Status last verified
- Dec 2023
- First submitted
- 21 Feb 2022
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- B-SAFE: A Trauma-Informed Early Intervention Targeting Sleep and Adjustment Among Children in Foster Care
- ClinicalTrials.gov ID
- NCT05646095
- Acronym / sponsor ID
- 000181698
- Conditions
- Sleep Disturbance, Child Development, Mental Disorder, Child
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Candice A AlfanoUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 12 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- multi-phase hybrid effectiveness-implementation trial
| Arm | Type | Receives |
|---|---|---|
| Bolstering Sleep and Adjustment in Foster Environments (B-SAFE) | Experimental | Behavioral: Bolstering Sleep and Adjustment in Foster Environments (B-SAFE)Brief, behavioral sleep intervention for children and caregivers |
| Delayed Intervention | Active comparator | Behavioral: Bolstering Sleep and Adjustment in Foster Environments (B-SAFE)Waitlist families will be monitored for 1 month before receiving the B-SAFE intervention |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Bolstering Sleep and Adjustment in Foster Environments (B-SAFE), Delayed Intervention |
Primary outcome
Child average total sleep time (TST)
Time frame: one week and 3-months follow up
Changes in TST will be assessed using subjective sleep logs and wrist actigraphy across one week
Child average wake minutes after sleep onset (WASO)
Time frame: one week and 3-months follow up
Changes in WASO will be assessed using subjective sleep logs and wrist actigraphy across one week
Child average sleep onset latency (SOL)
Time frame: one week and 3-months follow up
Changes in SOL will be assessed using subjective sleep logs and wrist actigraphy across one week
Change in Emotional and behavioral regulation
Time frame: one week and 3-months follow up
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.
Cortisol awakening response (mcg/dL)
Time frame: one week and 3-months follow up
Changes in biological rhythms will be assessed via morning and evening salivary cortisol across two non-consecutive days during the same week
Objective sleep timing (mid sleep point)
Time frame: one week and 3-months follow up
Changes average mid sleep point across across one week based on actigraphy
3 secondary outcomes
Pre-Sleep Arousal Scale for Children (PSAS-C)
Time frame: one week and 3-months follow up
Children's Sleep Habits Questionnaire (CSHQ)
Time frame: one week and 3-months follow up
Bedtime Routines Questionnaire (BRQ)
Time frame: one week and 3-months follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bolstering Sleep and Adjustment in Foster Environments (B-SAFE) in people with Sleep Disturbance and Child Development, run by Candice A Alfano at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child average total sleep time (TST) (time frame: one week and 3-months follow up). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2023.