An interventional study of Sleep and Adjustment in Foster care Environments (SAFE) intervention and Sleep Education Support in Sleep Problems, Parasomnias and Enuresis Nocturnal, sponsored by Vrije Universiteit Brussel. Not yet recruiting. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Vrije Universiteit Brussel · Not applicable, Interventional, and Supportive care
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.
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:
Hypotheses:
To investigate the differences in the prevalence and nature of sleep between groups of children with different life experiences and upbringing contexts.
Research question: Are there differences in the prevalence and nature of sleep problems between Flemish foster children, children placed in long-term residential care and children from the general population?
Hypotheses:
To evaluate the effectiveness of a brief trauma-based sleep intervention and thereby contribute to evidence-based practices that promote healthy sleep and psychological well-being in high-risk populations.
Research question: What is the effect of a brief trauma-sensitive sleep intervention in foster care? Hypothesis: Foster children who are randomized into the intervention group will experience a significant improvement in sleep health (e.g., increased total nighttime sleep and fewer sleep problems) based on caregiver reports, in comparison to foster children in the control group at both post-intervention and follow-up.
Secondary Objectives:
To identify associated individual and contextual factors, including factors associated with the placement such as placement duration, age at placement, contact with biological parents etc. linked to sleep in both children placed in out-of-home care and children from the general population.
Research questions:
Hypotheses:
To investigate the differences in associated factors of sleep between groups of children with different life experiences and upbringing contexts.
Research question: Are there differences in the associations between sleep and behavior, adverse childhood experiences and parenting stress in children placed in out-of-home care compared to children from the general population? Hypothesis: There are differences in the link between sleep and associated factors in children placed in out-of-home care compared to children from the general population.
To evaluate outcomes of a brief trauma-based sleep-intervention. Research question: What are outcomes of a trauma-focused sleep-intervention in foster children and their families? Hypothesis: A brief trauma-focused sleep intervention will result in a significant reduction of foster child behavior problems and parenting stress in the intervention group compared to the control group both at post-intervention and follow-up.
Data Collection:
The surveys of component 1 and 2 will be developed in Qualtrics and distributed to respondents via a web link and/or QR code. Data collection will be conducted anonymously. Participants may withdraw from the study at any time without consequences and without being required to provide a reason.
An a priori power analysis was conducted for all studies using G*Power 3.1 to determine the required minimum sample size. Based on previous literature, assuming a medium effect size, a target sample size of approximately 180 to 200 participants was set for each cross-sectional study (540 - 600 participants in total).
For the RCT study, assuming a medium intervention effect (Hedges' g = 0.50), α = .05, power = .80,three assessment points, and a within-subject correlation of .50, a minimum sample of approximately 120 families is required. To account for potential attrition, the investigators aim to recruit 130 families (65 per group).
Statistical Considerations and Data Analysis Cross-sectional survey studies Data will be analyzed using IBM SPSS Statistics (version 31). Prior to conducting the analyses, the dataset will be screened for missing values and outliers.Cases with substantial missing data or extreme outliers will be handled appropriately and, if necessary, excluded from further analyses. Assumptions for parametric tests (normality, homogeneity of variance, linearity) will be evaluated.
The primary objective of the cross-sectional studies is to investigate the prevalence and nature of sleep problems in Flemish children aged 4-10 years from the general population and children placed in out-of-home care.
Descriptive statistics will be used to characterize the study sample and the distribution of the study variables. Sleep problems will primarily be operationalized as the total score on the Children's Sleep Habits Questionnaire (CSHQ), with higher scores indicating more sleep-related problems. The prevalence of clinically relevant sleep problems will additionally be estimated using the recommended cut-off score of 41 on the total CSHQ score. Prevalence estimates will be reported with 95% confidence intervals. The nature of sleep problems will be described using the total CSHQ score and the scores on the CSHQ subscales, allowing for the identification of the most prevalent types of sleep difficulties.
The secondary research questions aim to identify individual, family-related, and placement-related characteristics associated with sleep problems in children from the general population and children placed in out-of-home care. Univariable analyses will initially be conducted to describe the associations between individual predictors and sleep problems. Depending on the measurement level and distribution of the variables, Pearson or Spearman correlations, independent-samples t-tests, or analyses of variance (ANOVAs) will be used.
To examine the independent associations between the hypothesized individual, family-related, and placement-related factors and sleep problems, multivariable regression analyses will subsequently be conducted. The total CSHQ score will be used as the dependent variable in linear regression models.
Candidate variables for the multivariable models will be selected a priori based on theoretical considerations, previous empirical research, and the study hypotheses, rather than solely based on statistical significance in the univariable analyses. These prespecified candidate variables will be included in the initial multivariable models. Where appropriate, backward elimination will subsequently be used to obtain a more parsimonious final model. Prespecified variables considered theoretically important or relevant potential confounders will be retained irrespective of their statistical significance.
Separate multivariable models will be considered for children from the general population and children placed in out-of-home care, given that some predictors are specific to the out-of-home care context. For children placed in out-of-home care, placement-related characteristics such as placement duration, age at placement, and contact with biological parents will additionally be examined as potential explanatory variables. Across the groups, adverse childhood experiences, behavioral problems, and (foster) parenting stress will be examined as hypothesized correlates of sleep problems.
Regression coefficients, 95% confidence intervals, and p-values will be reported. Model assumptions will be assessed before interpreting the regression results, including linearity, homoscedasticity, normality of residuals, and multicollinearity.
Comparative study Descriptive statistics will be computed to compare the different samples. ANCOVA analyses will be conducted to investigate group differences in sleep and associated factors between different respondent groups.
RCT study Baseline characteristics of participants will be summarized descriptively for each study group.
Randomization To allocate foster parents to either the control or the intervention group the investigators will use minimization, controlling for important variables such as age, gender, sleep, ACEs, kinship/non-kinship and duration of placement.
Intervention effects A repeated-measures mixed-effects model (Linear Mixed Model) will be used to examine the effects of the intervention on sleep problems, behavioral problems, and parenting stress over time. Time, condition, and the time × condition interaction will be included as fixed effects. Participants will be included as a random intercept only, to account forwithin-subject dependency across repeated measurements. Significant time × condition interactions will be followed up using simple effects analyses and pairwise comparisons.
Drop-outs Between-group ANOVAs will be conducted to compare participants who completed the study with those who did not (retained vs. non-retained participants).
Analyses will be performed according to the intention-to-treat (ITT) principle.
Missing data The linear mixed-effects model will be used as the primary approach for handling missing outcome data. This approach allows participants with incomplete repeated measurements to contribute to the analyses using the data they provided, under the assumption that data are missing at random (MAR).
The extent and patterns of missing data will be examined. Where appropriate, multiple imputation (MI) will be considered as a sensitivity analysis to assess whether the findings are robust to alternative approaches for handling missing data.
Further design considerations The design and implementation of the RCT intervention study and comparative study will be further informed by the findings of the preceding studies.
All respondents of components 1 and 2 will remain anonymous while completing the questionnaire. The collected data will be used solely for research purposes and will be treated confidentially. The informed consent form states that participants may withdraw from the study at any time without consequences and without needing to provide a reason. All data will be securely stored on a VUB Pixiu platform that is accessible only to the researchers and will be retained for a maximum period of 10 years.
Given the inclusion of potentially sensitive questions (e.g., adverse childhood experiences), contact information for professional support services will be provided at the end of the questionnaires.
104 studies on the registry are indexed under Nocturnal Enuresis; 22 are open to participants now.
This study's planned enrollment of 730 is above the median of 68 across 76 interventional studies indexed under Nocturnal Enuresis.
Browse Nocturnal Enuresis studies →Vrije Universiteit Brussel is the lead sponsor of 158 studies on the registry; 43 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
- Foster parents
Professionals residential setting
Parents in the general population
Foster parents participating in the SAFE sleep intervention
Exclusion Criteria:
- Foster parents and professionals residential setting
- Children with medical conditions requiring specific care and/or using medical equipment
Parents in the general population
Foster parents participating in the SAFE sleep intervention
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).
Behavioral: Sleep Education Support
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.
Behavioral: Sleep and Adjustment in Foster care Environments (SAFE) intervention
In the Sleep and Adjustment in Foster care Environments (SAFE) intervention group, foster parents willreceive 3 individual sessions in their own home, one week apart, 60 minutes each. Healthcare professionals with a master's degree in psychology will be trained to provide these sessions. SAFE is a brief, behavioral intervention, developed by prof. dr. Candice Alfano (Alfano et al., 2024). The intervention aims to help foster parents to provide young foster children to get the quality sleep they need to thrive. It focuses on the importance of sleep for children, how to create environments and interactions conducive to healthy sleep, and specific strategies for reducing different types of sleep problems.
The Sleep Education Support (SES) control group will be e-mailed an informational booklet about sleep in young children. Caregivers will be given the message that they can read the booklet as much as they like.
Sleep problems children: Children's Sleep Habits Questionnaire (CSHQ)
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.
Time frame: RCT: screening (before baseline), baseline, post-intervention, follow-up; observational: baseline
Sleep diary: Planned naps and Unplanned naps
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).
Time frame: Baseline, post-intervention (1 week after), and follow-up (3 months later).
Sleep diary: Sleep duration
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.
Time frame: Baseline, post-intervention (after one week), follow-up (after 3 months).
Sleep diary: Sleepiness level
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.
Time frame: 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.
Sleep diary: Sleep disturbances
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.
Time frame: 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.
Sleep diary: Bedtime activities
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.
Time frame: 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.
Sleep problems parent: Pittsburgh Sleep Quality Index (PSQI)
Sleep problems in (foster) parents will be questioned using the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a self-report 19-item questionnaire that measures sleep quality and sleep disturbances over one-month-period. The instrument contains ten questions, divided into seven subscales related to different sleep-related components. In this study, the investigators focus specifically on four aspects of parental sleep: sleep duration, use of sleep medication, daytime sleepiness, and subjective sleep quality. Sleep duration will be assessed as the number of hours of actual sleep per night and will be treated as a continuous variable. Use of sleep medication and daytime sleepiness will each be scored on a 4-point scale ranging from 0 (not during the past month) to 3 (three or more times per week). Subjective sleep quality will be scored on a 4-point scale ranging from 0 (very good) to 3 (very bad), with higher scores indicating poorer sleep quality.
Time frame: Observational studies: at baseline. RCT: at baseline, post-intervention, and follow-up.
Behavior: Strengths and Difficulties Questionnaire (SDQ)
Behavioral difficulties will be assessed using the Strengths and Difficulties Questionnaire (SDQ). The SDQ is a widely used screening instrument for children and adolescents aged 4-16 years and can be completed by caregivers, teachers, and by children themselves from the age of 11 years onward. The questionnaire contains 25 items grouped into five subscales: emotional symptoms, conduct problems, hyperactivity/inattention, peerrelationship problems, and prosocial behavior. Each subscale consists of five items rated on a three-point scale (0 = "not true", 1 = "somewhat true", 2 = "certainly true"), resulting in subscale scores ranging from 0 to 10. A total difficulties score is calculated by summing the scores of the emotional symptoms, conduct problems, hyperactivity/inattention, and peer problems subscales, yielding a total score between 0 and 40.
Time frame: Observational studies: at baseline. RCT: at baseline, post-intervention, and follow-up.
Adverse Child Experiences (ACE-IQ-10)
The ACE-IQ-10 is a dichotomous self-report measure that retrospectively assesses adverse childhood experiences (ACEs), including maltreatment (e.g., physical, emotional, and sexual abuse, and physical or emotional neglect) and family dysfunction (e.g., parental separation/divorce and household mental illness or suicide attempts). A total ACE score is obtained by summing up all items, resulting in a score between 0 and 10, with higher scores reflecting greater exposure to ACEs. The study of Van Der Feltz-Cornelis and De Beurs provides evidence on the factor structure, reliability, and validity of the Dutch version of the ACE-IQ-10. Forthe present study, the ACE-IQ-10 will be adapted to a parent/caregiver-report version.
Time frame: Observational studies: at baseline. RCT: at baseline.
Parental stress (OBVL)
The Parenting Stress Questionnaire (OBVL) assesses the extent to which parents experience burden or stress related to raising their children. This caregiver-report instrument consists of 34 items, each scored on a four-point Likert scale ranging from (1) "Not applicable" to (4) "Fully applicable." The OBVL includes five subscales. In the present study, the investigators focused on the three domains most relevant to our research objectives. The first domain, parent-child relationship problems, assesses the extent to which parents experience conflicting feelings or thoughts toward their child. The second domain, parenting problems, captures parents' perceived difficulties and insecurities regarding their parenting skills and effectiveness. The third domain, role restriction, reflects the degree to which parents experience the parenting role as limiting their personal freedom and opportunities. Higher scores indicate greater parental stress.
Time frame: Observational studies: at baseline. RCT: at baseline, post-intervention, and follow-up.
Expectations regarding the intervention: Credibility/Expectancy Questionnaire (CEQ)
Beliefs about treatment will be assessed before the start of treatment using the Credibility/Expectancy Questionnaire (CEQ). In line with previous research, selected questionnaire items were modified to ensure their relevance for the SAFE-T population. The three treatment expectancy items will be rated on a 9-point Likert scale ranging from 1 (not at all) to 9 (very much). Item scores will be summed to obtain a total treatment expectancy score ranging from 3 to 27, with higher scores indicating greater perceived credibility of the intervention and higher expectations regarding its effectiveness.
Time frame: Parents should answer this questionnaire right before participating to the intervention.
No study locations are listed for this record.
Plan to share: No
Start is estimated for Oct 2026; primary completion for Mar 2029, 29 months later.
Of 40 interventional studies with no phase under Nocturnal Enuresis, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 49. This study's planned 29 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.