跳至主要内容
临床试验/NCT05646095
NCT05646095招募中不适用

B-SAFE: A Trauma-Informed Early Intervention Targeting Sleep and Adjustment Among Children in Foster Care

Candice A Alfano2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
2
主要终点
Change in Emotional and behavioral regulation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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).

结局指标

主要结局

Change in Emotional and behavioral regulation

时间窗: 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.

Child average total sleep time (TST)

时间窗: 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)

时间窗: 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)

时间窗: one week and 3-months follow up

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

Cortisol awakening response (mcg/dL)

时间窗: 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)

时间窗: one week and 3-months follow up

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

次要结局

  • 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)

研究者

发起方
Candice A Alfano
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Candice A Alfano

Professor

University of Houston

研究点 (2)

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