Sleep ProblemsNCT07820683
Sleep in Children Placed in Out-of-home Care
A study testing Sleep and Adjustment in Foster care Environments (SAFE) intervention and Sleep Education Support in people with Sleep Problems and Parasomnias, run by Vrije Universiteit Brussel.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sleep Problems, Parasomnias, Enuresis Nocturnal
- What is being tested?
- Sleep and Adjustment in Foster care Environments (SAFE) intervention and Sleep Education Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 730 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 17Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Frank Van Holen, Professor contact
About this study
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.
Read more
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.
Read the detailed description
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:
- Based on findings from the original American Children Sleep Habits Questionnaire (CSHQ) validation study , and in the absence of Dutch percentile norms, the investigators hypothesize that approximately 23% of children in the general population will obtain a total CSHQ score of 41 or higher.
- The prevalence of sleep problems in Flemish children placed in out-of-home care is higher than the prevalence of sleep problems in the general population.
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:
- Children placed in out-of-home care experience significantly more sleep-related problems compared to children from the general population.
- Children placed in residential out-of-home care experience significantly more sleep-related problems compared to children in foster care.
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:
- What characteristics are sleep problems of Flemish children in the general population associated with?
- What characteristics are sleep problems of children placed in out-of-home care associated with?
Hypotheses:
- Sleep-related problems in 4- to 10-year-old children (across all subgroups) are positively associated with adverse childhood experiences.
- Sleep-related problems in 4- to 10-year-old children (across all subgroups) are positively associated with behavioral problems.
- Sleep-related problems in out-of-home placed children are associated with placement characteristics including factors associated with the placement such as placement duration, age at placement, contact with biological parents, etc.
- Sleep-related problems in 4- to 10-year-old (foster) children are positively associated with levels of (foster) parenting stress.
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.
- Conditions
- Sleep Problems, Parasomnias, Enuresis Nocturnal
- Being tested
- Sleep and Adjustment in Foster care Environments (SAFE) intervention, Sleep Education Support
- Keywords
- sleep, out-of-home care, foster care, ACEs, behaviour, out-of home placement, RCT, sleep problems, trauma focused sleep intervention
- Medical subject headings
- Parasomnias, Nocturnal Enuresis, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep and Adjustment in Foster care Environments (SAFE) interventionBehavioural
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.
Sleep Education SupportBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Education Support (SES) control group | Placebo comparator | 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). Receives: Behavioral: Sleep Education Support |
| Sleep and Adjustment in Foster care Environments (SAFE) intervention group | Active comparator | 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. Receives: Behavioral: Sleep and Adjustment in Foster care Environments (SAFE) intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Parents should answer this questionnaire right before participating to the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completionMar 2029 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Sleep ProblemsStudies of the same condition, open and under way.
- More trials run by Vrije Universiteit BrusselThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study 1: Sleep problems and associated factors among foster children (Component 1). Study 2: Sleep problems and associated factors among children placed in residential care settings (Component 1). Study 3: Sleep problems and associated factors among children in the general population (Component 2). Study 4: Comparative study of sleep problems among children in foster care, residential care and regular family settings (Component 2). Study 5: Randomized Controlled Trial (RCT) of a brief trauma-focused sleep intervention (Component 3). Study 1-3: Non-interventional, cross-sectional survey design. A target sample size of approximately 180 to 200 participants was set for each cross-sectional study. Study 4: Retrospective, comparative study. Study 5: RCT sleep intervention study, consisting of baseline-assessment, 3 individual intervention sessions, post-intervention assessment and follow-up assessment. The investigators aim to recruit 130 families (65 per group).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 730 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Johan Vanderfaeillie, Professor, Principal investigator, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07820683
- Sponsor's protocol ID
- 26202_SleepFoster
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
PubMed 2748771Vermulst, A., Kroes, G., De Meyer, R., Nguyen, L., & Veerman, J. W. (2015). Handleiding OBVL. Praktikon.
Megan Rech, Sirine Harmouch, Annika Myers, Jinu Kim, Anthony Cifre, Alyssa Vieira, Theo Andre, Candice Alfano, 0798 Feasibility & Acceptability of SAFE: A Brief Trauma-Informed Behavioral Sleep Intervention for Youth in Foster Care, Sleep, Volume 47, Issue Supplement_1, May 2024, Page A342, https://doi.org/10.1093/sleep/zsae067.0798
Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. doi: 10.1016/s0005-7916(00)00012-4.
PubMed 11132119Van der Feltz-Cornelis CM, de Beurs E. The 10-item Adverse Childhood Experience International Questionnaire (ACE-IQ-10): psychometric properties of the Dutch version in two clinical samples. Eur J Psychotraumatol. 2023;14(2):2216623. doi: 10.1080/20008066.2023.2216623.
PubMed 37318018Goodman R. The Strengths and Difficulties Questionnaire: a research note. J Child Psychol Psychiatry. 1997 Jul;38(5):581-6. doi: 10.1111/j.1469-7610.1997.tb01545.x.
PubMed 9255702Nishiyama T, Mizuno T, Kojima M, Suzuki S, Kitajima T, Ando KB, Kuriyama S, Nakayama M. Criterion validity of the Pittsburgh Sleep Quality Index and Epworth Sleepiness Scale for the diagnosis of sleep disorders. Sleep Med. 2014 Apr;15(4):422-9. doi: 10.1016/j.sleep.2013.12.015. Epub 2014 Feb 22.
PubMed 24657203Waumans RC, Terwee CB, Van den Berg G, Knol DL, Van Litsenburg RR, Gemke RJ. Sleep and sleep disturbance in children: Reliability and validity of the Dutch version of the Child Sleep Habits Questionnaire. Sleep. 2010 Jun;33(6):841-5. doi: 10.1093/sleep/33.6.841.
PubMed 20550026Van Holen, F., West, D., Verheyden, C., & Vanderfaeillie, J. (2026). Sleep problems of Flemish foster children according to foster parents. Developmental Child Welfare, 25161032261426458. https://doi.org/10.1177/25161032261426458
Owens JA, Spirito A, McGuinn M. The Children's Sleep Habits Questionnaire (CSHQ): psychometric properties of a survey instrument for school-aged children. Sleep. 2000 Dec 15;23(8):1043-51.
PubMed 11145319Van Holen, F., West, D., Verheyden, C., & Vanderfaeillie, J. (2026). Sleep problems of Flemish foster children according to foster parents. Developmental Child Welfare, 8(2), 89-106. https://doi.org/10.1177/25161032261426458
Alfano CA, Rech ME, Harmouch S, Gallagher MW, Zhang Y. Sleep and adjustment in foster environments for toddlers and preschoolers (SAFE-T): Initial efficacy of a trauma-informed sleep intervention for young children in foster care. Child Abuse Negl. 2024 Nov;157:107083. doi: 10.1016/j.chiabu.2024.107083. Epub 2024 Oct 13.
PubMed 39405652
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep in Children Placed in Out-of-home Care
- ClinicalTrials.gov ID
- NCT07820683
- Acronym / sponsor ID
- 26202_SleepFoster
- Conditions
- Sleep Problems, Parasomnias, Enuresis Nocturnal
- Keywords
- sleep, out-of-home care, foster care, ACEs, behaviour, out-of home placement, RCT, sleep problems
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 730 participants (estimated)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 15 Sep 2026 (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.
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.
Detailed description
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:
- Based on findings from the original American Children Sleep Habits Questionnaire (CSHQ) validation study , and in the absence of Dutch percentile norms, the investigators hypothesize that approximately 23% of children in the general population will obtain a total CSHQ score of 41 or higher.
- The prevalence of sleep problems in Flemish children placed in out-of-home care is higher than the prevalence of sleep problems in the general population.
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:
- Children placed in out-of-home care experience significantly more sleep-related problems compared to children from the general population.
- Children placed in residential out-of-home care experience significantly more sleep-related problems compared to children in foster care.
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:
- What characteristics are sleep problems of Flemish children in the general population associated with?
- What characteristics are sleep problems of children placed in out-of-home care associated with?
Hypotheses:
- Sleep-related problems in 4- to 10-year-old children (across all subgroups) are positively associated with adverse childhood experiences.
- Sleep-related problems in 4- to 10-year-old children (across all subgroups) are positively associated with behavioral problems.
- Sleep-related problems in out-of-home placed children are associated with placement characteristics including factors associated with the placement such as placement duration, age at placement, contact with biological parents, etc.
- Sleep-related problems in 4- to 10-year-old (foster) children are positively associated with levels of (foster) parenting stress.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Study 1: Sleep problems and associated factors among foster children (Component 1). Study 2: Sleep problems and associated factors among children placed in residential care settings (Component 1). Study 3: Sleep problems and associated factors among children in the general population (Component 2). Study 4: Comparative study of sleep problems among children in foster care, residential care and regular family settings (Component 2). Study 5: Randomized Controlled Trial (RCT) of a brief trauma-focused sleep intervention (Component 3). Study 1-3: Non-interventional, cross-sectional survey design. A target sample size of approximately 180 to 200 participants was set for each cross-sectional study. Study 4: Retrospective, comparative study. Study 5: RCT sleep intervention study, consisting of baseline-assessment, 3 individual intervention sessions, post-intervention assessment and follow-up assessment. The investigators aim to recruit 130 families (65 per group).
| Arm | Type | Receives |
|---|---|---|
| Sleep Education Support (SES) control group | Placebo comparator | Behavioral: Sleep Education SupportFoster 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). |
| Sleep and Adjustment in Foster care Environments (SAFE) intervention group | Active comparator | Behavioral: Sleep and Adjustment in Foster care Environments (SAFE) interventionFoster 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| Sleep and Adjustment in Foster care Environments (SAFE) interventionIn 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. | Behavioural | Sleep and Adjustment in Foster care Environments (SAFE) intervention group |
| Sleep Education SupportThe 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. | Behavioural | Sleep Education Support (SES) control group |
Primary outcome
Sleep problems children: Children's Sleep Habits Questionnaire (CSHQ)
Time frame: 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
Time frame: 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
Time frame: 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
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.
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
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.
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
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.
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.
5 secondary outcomes
Sleep problems parent: Pittsburgh Sleep Quality Index (PSQI)
Time frame: Observational studies: at baseline. RCT: at baseline, post-intervention, and follow-up.
Behavior: Strengths and Difficulties Questionnaire (SDQ)
Time frame: Observational studies: at baseline. RCT: at baseline, post-intervention, and follow-up.
Adverse Child Experiences (ACE-IQ-10)
Time frame: Observational studies: at baseline. RCT: at baseline.
Parental stress (OBVL)
Time frame: Observational studies: at baseline. RCT: at baseline, post-intervention, and follow-up.
Expectations regarding the intervention: Credibility/Expectancy Questionnaire (CEQ)
Time frame: Parents should answer this questionnaire right before participating to the intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Background: PubMed 2748771Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
- BackgroundVermulst, A., Kroes, G., De Meyer, R., Nguyen, L., & Veerman, J. W. (2015). Handleiding OBVL. Praktikon.
- BackgroundMegan Rech, Sirine Harmouch, Annika Myers, Jinu Kim, Anthony Cifre, Alyssa Vieira, Theo Andre, Candice Alfano, 0798 Feasibility & Acceptability of SAFE: A Brief Trauma-Informed Behavioral Sleep Intervention for Youth in Foster Care, Sleep, Volume 47, Issue Supplement_1, May 2024, Page A342, https://doi.org/10.1093/sleep/zsae067.0798
- Background: PubMed 11132119Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. doi: 10.1016/s0005-7916(00)00012-4.
- Background: PubMed 37318018Van der Feltz-Cornelis CM, de Beurs E. The 10-item Adverse Childhood Experience International Questionnaire (ACE-IQ-10): psychometric properties of the Dutch version in two clinical samples. Eur J Psychotraumatol. 2023;14(2):2216623. doi: 10.1080/20008066.2023.2216623.
- Background: PubMed 9255702Goodman R. The Strengths and Difficulties Questionnaire: a research note. J Child Psychol Psychiatry. 1997 Jul;38(5):581-6. doi: 10.1111/j.1469-7610.1997.tb01545.x.
- Background: PubMed 24657203Nishiyama T, Mizuno T, Kojima M, Suzuki S, Kitajima T, Ando KB, Kuriyama S, Nakayama M. Criterion validity of the Pittsburgh Sleep Quality Index and Epworth Sleepiness Scale for the diagnosis of sleep disorders. Sleep Med. 2014 Apr;15(4):422-9. doi: 10.1016/j.sleep.2013.12.015. Epub 2014 Feb 22.
- Background: PubMed 20550026Waumans RC, Terwee CB, Van den Berg G, Knol DL, Van Litsenburg RR, Gemke RJ. Sleep and sleep disturbance in children: Reliability and validity of the Dutch version of the Child Sleep Habits Questionnaire. Sleep. 2010 Jun;33(6):841-5. doi: 10.1093/sleep/33.6.841.
- BackgroundVan Holen, F., West, D., Verheyden, C., & Vanderfaeillie, J. (2026). Sleep problems of Flemish foster children according to foster parents. Developmental Child Welfare, 25161032261426458. https://doi.org/10.1177/25161032261426458
- Background: PubMed 11145319Owens JA, Spirito A, McGuinn M. The Children's Sleep Habits Questionnaire (CSHQ): psychometric properties of a survey instrument for school-aged children. Sleep. 2000 Dec 15;23(8):1043-51.
- BackgroundVan Holen, F., West, D., Verheyden, C., & Vanderfaeillie, J. (2026). Sleep problems of Flemish foster children according to foster parents. Developmental Child Welfare, 8(2), 89-106. https://doi.org/10.1177/25161032261426458
- Background: PubMed 39405652Alfano CA, Rech ME, Harmouch S, Gallagher MW, Zhang Y. Sleep and adjustment in foster environments for toddlers and preschoolers (SAFE-T): Initial efficacy of a trauma-informed sleep intervention for young children in foster care. Child Abuse Negl. 2024 Nov;157:107083. doi: 10.1016/j.chiabu.2024.107083. Epub 2024 Oct 13.
- Individual participant dataSharing planned: No
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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.
Frank Van Holen, Professor contact
Johan Vanderfaeillie, Professor principal investigator
Vrije Universiteit Brussel
Questions about this trial
What is this clinical trial studying?
A study testing Sleep and Adjustment in Foster care Environments (SAFE) intervention and Sleep Education Support in people with Sleep Problems and Parasomnias, run by Vrije Universiteit Brussel.
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 17 inclusion and 9 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: opening soon, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuko Junius, PhD researcher in Psychology (+32 478 114 717, Yuko.Junius@vub.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep problems children: Children's Sleep Habits Questionnaire (CSHQ) (time frame: RCT: screening (before baseline), baseline, post-intervention, follow-up; observational: baseline). 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?
On the ClinicalTrials.gov record for NCT07820683, which also lists 12 linked publications.
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 15 Sep 2026.