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A Trauma-Informed Sleep Intervention for Children in Foster Care

Primary Purpose

Sleep Disturbance, Child Development, Mental Disorder, Child

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bolstering Sleep and Adjustment in Foster Environments (B-SAFE)
Sponsored by
Candice A Alfano
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disturbance

Eligibility Criteria

6 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: All non-relative and kinship 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. Exclusion Criteria: 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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

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

    Delayed Intervention

    Arm Description

    Brief, behavioral sleep intervention for children and caregivers

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

    Outcomes

    Primary Outcome Measures

    Child average total sleep time (TST)
    Changes in TST will be assessed using subjective sleep logs and wrist actigraphy across one week
    Child average wake minutes after sleep onset (WASO)
    Changes in WASO will be assessed using subjective sleep logs and wrist actigraphy across one week
    Child average sleep onset latency (SOL)
    Changes in SOL will be assessed using subjective sleep logs and wrist actigraphy across one week
    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.
    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
    Objective sleep timing (mid sleep point)
    Changes average mid sleep point across across one week based on actigraphy

    Secondary Outcome Measures

    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.
    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.
    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).

    Full Information

    First Posted
    February 21, 2022
    Last Updated
    December 19, 2022
    Sponsor
    Candice A Alfano
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05646095
    Brief Title
    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

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 31, 2022 (Anticipated)
    Primary Completion Date
    January 31, 2025 (Anticipated)
    Study Completion Date
    January 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Candice A Alfano

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Sleep disturbances are pervasive and impairing among children 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 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 foster care. 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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Sleep Disturbance, Child Development, Mental Disorder, Child

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    multi-phase hybrid effectiveness-implementation trial
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Bolstering Sleep and Adjustment in Foster Environments (B-SAFE)
    Arm Type
    Experimental
    Arm Description
    Brief, behavioral sleep intervention for children and caregivers
    Arm Title
    Delayed Intervention
    Arm Type
    Active Comparator
    Arm Description
    Waitlist families will be monitored for 1 month before receiving the B-SAFE intervention
    Intervention Type
    Behavioral
    Intervention Name(s)
    Bolstering Sleep and Adjustment in Foster Environments (B-SAFE)
    Intervention Description
    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 Information:
    Title
    Child average total sleep time (TST)
    Description
    Changes in TST will be assessed using subjective sleep logs and wrist actigraphy across one week
    Time Frame
    one week and 3-months follow up
    Title
    Child average wake minutes after sleep onset (WASO)
    Description
    Changes in WASO will be assessed using subjective sleep logs and wrist actigraphy across one week
    Time Frame
    one week and 3-months follow up
    Title
    Child average sleep onset latency (SOL)
    Description
    Changes in SOL will be assessed using subjective sleep logs and wrist actigraphy across one week
    Time Frame
    one week and 3-months follow up
    Title
    Change in Emotional and behavioral regulation
    Description
    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.
    Time Frame
    one week and 3-months follow up
    Title
    Cortisol awakening response (mcg/dL)
    Description
    Changes in biological rhythms will be assessed via morning and evening salivary cortisol across two non-consecutive days during the same week
    Time Frame
    one week and 3-months follow up
    Title
    Objective sleep timing (mid sleep point)
    Description
    Changes average mid sleep point across across one week based on actigraphy
    Time Frame
    one week and 3-months follow up
    Secondary Outcome Measure Information:
    Title
    Pre-Sleep Arousal Scale for Children (PSAS-C)
    Description
    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.
    Time Frame
    one week and 3-months follow up
    Title
    Children's Sleep Habits Questionnaire (CSHQ)
    Description
    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.
    Time Frame
    one week and 3-months follow up
    Title
    Bedtime Routines Questionnaire (BRQ)
    Description
    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).
    Time Frame
    one week and 3-months follow up
    Other Pre-specified Outcome Measures:
    Title
    Rates of retention
    Description
    Treatment Feasibility will be assessed based on rates of retention/attrition during the study. Treatment feasibility will be assessed based on the retention during the study. The retention rate is defined as the percentage of participants who complete the study.
    Time Frame
    3-months follow up
    Title
    Rates of attrition
    Description
    Treatment feasibility will be assessed based the attrition rate during the study. The attrition rate is defined as the percentage of participants who drop out of the study.
    Time Frame
    3-months follow up
    Title
    Homework Compliance
    Description
    Treatment feasibility will be assessed based on homework compliance during treatment. Homework compliance is defined as the percentage of completed homework assignments compared to the total number of assigned homework.
    Time Frame
    one week
    Title
    Client Satisfaction Questionnaire (CSQ)
    Description
    Treatment acceptability will be accessed based on the ratings using the Client Satisfaction Questionnaire (CSQ). The CSQ is an 8-item measure scored on a 4 point Likert scale. The sum of the items produces a total score, ranging from 8 to 32. Higher scores indicate greater client satisfaction.
    Time Frame
    one week
    Title
    Parenting Stress Index -Short Form (PSI)
    Description
    Changes in parenting Stress will be assessed using the PSI. Difference in subjective reports on Parenting Stress Index -Short Form will be compared at baseline (week 0) and post treatment (3 months later). The measure produces 3 subscales: parental distress, parent- child dysfunctional interaction and difficult child. The total score is the sum of the three subscales. Higher scores indicate higher levels of stress.
    Time Frame
    one week and 3-months follow up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    10 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All non-relative and kinship 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. Exclusion Criteria: 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).

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

    A Trauma-Informed Sleep Intervention for Children in Foster Care

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