Sleep in Children Placed in Out-of-home Care
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 730
- 主要终点
- Sleep problems children: Children's Sleep Habits Questionnaire (CSHQ)
研究概览
简要总结
This project aims to contribute to the existing literature on sleep in children placed in out-of-home care by addressing current gaps and integrating the investigation of sleep and associated risk factors, including adverse childhood experiences, behavioral problems, parenting stress, and placement characteristics.
First, the investigators will examine sleep problems and associated factors in three cross-sectional survey samples of 4- to 10-year-old children in (1) foster care, (2) residential care, and (3) the general population.
Subsequently, a comparative analysis will assess differences in sleep and related characteristics across these three groups.
In addition, this project will evaluate a trauma-informed sleep intervention for foster families with 2- to 5-year-old children through a randomized controlled trial, with the aim of improving sleep quality and related psychosocial outcomes within foster families.
详细描述
Primary Objectives:
To investigate the prevalence and nature of sleep problems in 4- to 10-year-old children in both out-of-home care (long-term residential and foster care) and regular family settings.
Research questions:
- What is the prevalence and nature of sleep problems in Flemish children from the general population?
- What is the prevalence and nature of sleep problems in Flemish children placed in outof-home care?
Hypotheses:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Foster parents
- •Dutch speaking foster parents
- •Of 4- to 10-year-old children
- •In long-term foster care
- •Child is placed for at least 6 months
- •Professionals residential setting
- •Dutch speaking professionals working in residential care
- •Of 4- to 10-year-old children
- •In long-term residential care
- •Child lives in the residential care setting for at least 6 months
- •Residential caregiver works at least 6 months in the residential care setting
- •Parents in the general population
- •Dutch speaking parents
- •Of 4- to 10-year-old children
- •Foster parents participating in the SAFE sleep intervention
- •Dutch speaking foster parents
- •Of 2- to 5-year-old children
排除标准
- •- Foster parents and professionals residential setting
- •- Children with medical conditions requiring specific care and/or using medical equipment
- •Parents in the general population
- •Of children with medical conditions requiring specific care and/or using medical equipment
- •Foster and adoptive parents
- •Foster parents participating in the SAFE sleep intervention
- •Children with medical conditions requiring specific care and/or use medical equipment
- •Children with confirmed or suspected sleep apnea
- •Foster parents going through a divorce at the moment of participation
研究组 & 干预措施
Sleep Education Support (SES) control group
Foster parents of children scoring > 41 on the total score of theCSHQ will be eligible for inclusion in the RCT and will be asked to complete the baseline assessment. After completion of the baseline assessment, foster parents will be randomized to either the intervention group or the control group. Foster parents assigned to the control group will receive a booklet containing (psycho-educational) information on sleep and sleep health. After completion of the followup assessment (at least four months after the baseline assessment) and if foster children still score > 41 on the CSHQ they are offered the intervention (although not in the context of the research).
干预措施: Sleep Education Support (Behavioral)
Sleep and Adjustment in Foster care Environments (SAFE) intervention group
Foster parents of children scoring > 41 on the total score of theCSHQ will be eligible for inclusion in the RCT and will be asked to complete the baseline assessment. After completion of the baseline assessment, foster parents will be randomized to either the intervention group or the control group. Foster parents of children scoring ≤ 41 on the CSHQ, or children meeting any of the exclusion criteria (e.g., medical conditions affecting sleep, age above 5 years), will be excluded from the RCT sample.
After randomization, participants allocated to the experimental group will receive the intervention of three sessions.
干预措施: Sleep and Adjustment in Foster care Environments (SAFE) intervention (Behavioral)
结局指标
主要结局
Sleep problems children: Children's Sleep Habits Questionnaire (CSHQ)
时间窗: RCT: screening (before baseline), baseline, post-intervention, follow-up; observational: baseline
Sleep problems in foster children will be assessed using the Dutch version of the Children's Sleep Habits Questionnaire (CSHQ). The CSHQ is a validated caregiver-report questionnaire that assesses 4- to 10-year-old children's average sleep behaviour during the previous "typical" week. The questionnaire consists of 33 items divided across eight subscales reflecting different domains of sleep problems: bedtime resistance, sleep onset delay, sleep duration, sleep anxiety, night awakenings, parasomnias, sleep-disordered breathing, and daytime sleepiness. Items are rated on a threepoint scale: "usually", "sometimes", or "rarely". Total scores range from 33 to 99. Higher total scores indicate greater sleep difficulties. In a pilot study among Flemish foster children, the CSHQ demonstrated good internal consistency (α = .77), comparable to that reported in the original validation study and other research.
Sleep diary: Planned naps and Unplanned naps
时间窗: Baseline, post-intervention (1 week after), and follow-up (3 months later).
Foster parents will be asked to register the number of planned and unplanned naps for a period of 7 consecutive days. Participants will have to specify: number of (un)planned naps and duration (from - to).
Sleep diary: Sleep duration
时间窗: Baseline, post-intervention (after one week), follow-up (after 3 months).
Participants will be asked to report on the sleep duration of their child for a period of seven consecutive days. Sleep duration will be measured with the following variables: Time in bed (hour + minutes) Time awake in the morning (hour + minutes) Sleep onset latency (minutes) Awakenings (number + minutes) Total sleep duration = Time awake in the morning - time in bed - sleep onset latency - awakenings.
Sleep diary: Sleepiness level
时间窗: Foster parents will have to report the sleepiness level of their children, right after awakening, for a period of seven consecutive days. At baseline, post-intervention, and follow-up.
The following options are given: * Awake and alert * Mostly awake * A little sleepy * Sleepy * Too sleepy to stay awake Sleepiness level will be rated on a scale from 0 to 5, with higher scores indicating greater sleepiness.
Sleep diary: Sleep disturbances
时间窗: Participants will be asked to complete this question every morning for a period of seven consecutive days. This will be asked on 3 time-points: at baseline, post-intervention, and follow-up.
Participants will be asked to indicate whether their foster child experienced any of the following sleep disturbances during the past night: * bad dreams or nightmares * environmental noise * bedwetting * sleepwalking or night terrors * other Each sleep disturbance will be coded as a binary variable (0 = no, 1 = yes). The prevalence of each sleep disturbance will be reported separately.
Sleep diary: Bedtime activities
时间窗: Participants will be asked to complete this question every evening for a period of seven consecutive days. This will be asked on 3 time-points: at baseline, post-intervention, and follow-up.
Participants will be asked to indicate whether they did any of the following activities together with their foster child before going to sleep: * watching tv/ a movie * reading a book * playing games * cuddling/ lying close to each other * talking about the day * other: \_\_\_ Each bedtime activity will be coded as a binary variable (0 = no, 1 = yes). The prevalence of each bedtime activity will be reported separately.
次要结局
- Sleep problems parent: Pittsburgh Sleep Quality Index (PSQI)(Observational studies: at baseline. RCT: at baseline, post-intervention, and follow-up.)
- Behavior: Strengths and Difficulties Questionnaire (SDQ)(Observational studies: at baseline. RCT: at baseline, post-intervention, and follow-up.)
- Adverse Child Experiences (ACE-IQ-10)(Observational studies: at baseline. RCT: at baseline.)
- Parental stress (OBVL)(Observational studies: at baseline. RCT: at baseline, post-intervention, and follow-up.)
- Expectations regarding the intervention: Credibility/Expectancy Questionnaire (CEQ)(Parents should answer this questionnaire right before participating to the intervention.)