Sleep in Children Placed in Out-of-home Care

NCT07820683 | Not Yet Recruiting

• 1 other identifier: 26202_SleepFoster
• Study Type: interventional
• Target: 730
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Enuresis Nocturnal; Sleep Problems; Parasomnias

Keywords

sleep; out-of-home care; foster care; ACEs; behaviour; out-of home placement; RCT; sleep problems; trauma focused sleep intervention

Outcome Measures

Primary Outcomes (6)

• 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.

  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).

  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.

  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.

  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.

  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.

  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)

  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.

Study Arms (2)

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).

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.

Behavioral: Sleep and Adjustment in Foster care Environments (SAFE) intervention

Interventions

Sleep and Adjustment in Foster care Environments (SAFE) intervention BEHAVIORAL

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 and Adjustment in Foster care Environments (SAFE) intervention group

Sleep Education Support BEHAVIORAL

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 Education Support (SES) control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead

Related Publications (12)

• 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.

  PMID: 2748771 BACKGROUND

• Vermulst, A., Kroes, G., De Meyer, R., Nguyen, L., & Veerman, J. W. (2015). Handleiding OBVL. Praktikon.

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 11132119 BACKGROUND

• Van 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.

  PMID: 37318018 BACKGROUND

• Goodman 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.

  PMID: 9255702 BACKGROUND

• Nishiyama 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.

  PMID: 24657203 BACKGROUND

• Waumans 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.

  PMID: 20550026 BACKGROUND

• Van 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

• 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.

  PMID: 11145319 BACKGROUND

• Van 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

• 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.

  PMID: 39405652 BACKGROUND

MeSH Terms

Conditions

Parasomnias; Nocturnal Enuresis; Behavior

Interventions

Sleep; Methods

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Enuresis; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Behavioral Symptoms; Elimination Disorders

Intervention Hierarchy (Ancestors)

Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Investigative Techniques

Study Officials

• Johan Vanderfaeillie, Professor

  Vrije Universiteit Brussel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuko Junius, PhD researcher in Psychology

CONTACT

+32 478 114 717; Yuko.Junius@vub.be

Frank Van Holen, Professor

CONTACT

Frank.Van.Holen@vub.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: September 3, 2026
• First Posted: September 15, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2030
• Last Updated: September 15, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share