Sleep DisturbanceNCT04473222
Behavioral Sleep Intervention in Urban Primary Care: Aim 3
A study testing Sleep Well! and Sleep education in people with Sleep Disturbance and Sleep Deprivation, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
Investigators will enroll up to 120 parent-child dyads from Children's Hospital of Philadelphia (CHOP) urban primary care clinics. The primary objective of this randomized clinical trial is to determine the whether the Sleep Well! behavioral sleep intervention is feasible and acceptable to families. Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Sleep Disturbance, Sleep Deprivation, Sleep
- What is being tested?
- Sleep Well! and Sleep education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2020to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 1 year to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parental/guardian permission (informed consent)
- Caregiver participant is the parent or legal guardian of the child subject
- Caregiver/legal guardian is greater than or equal to 18 years of age.
- Child between the ages of 1 and 5 years.
- Presence of caregiver-reported child sleep problem determined by a Brief Child Sleep Questionnaire item included in an eligibility screening questionnaire or child meets American Academy of Sleep Medicine diagnostic criteria for either pediatric insomnia or insufficient sleep, assessed through an eligibility screening questionnaire.
- English-speaking.
Who cannot join
- Caregiver is not parent or legal guardian of child participant.
- Presence of a child neurodevelopmental (e.g., autism spectrum disorder; Trisomy 21) or chronic medical (e.g., sickle cell disease, cancer) concern in which the disorder or treatment of the disorder impact sleep.
- Caregivers/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Implementing Evidence-based Behavioral Sleep Intervention in Urban Primary Care: Aim 3
Investigators will enroll up to 120 parent-child dyads from Children's Hospital of Philadelphia (CHOP) urban primary care clinics. The primary objective of this randomized clinical trial is to determine the whether the Sleep Well! behavioral sleep intervention is feasible and acceptable to families. The investigators will also examine the direction and magnitude in any change in child sleep and child behavior.
Read the detailed description
Behavioral sleep problems such as insomnia and insufficient sleep are common in toddlers and preschoolers and disproportionately impact lower socioeconomic status (SES) children. Despite a robust evidence base, behavioral sleep interventions are rarely tested with lower-SES children or in primary care, an accessible service delivery setting. The primary objective of this study is to determine whether the Sleep Well! behavioral sleep intervention is feasible and acceptable to families. The investigators will also examine the direction and magnitude of change in child sleep and behavior from pre-intervention to post-intervention and follow-up. This is a randomized controlled trial of the Sleep Well! program with pre-intervention, post-intervention, and follow-up assessments. Caregiver-child dyads (child ages 1-5 years with a sleep problem) will be recruited from CHOP urban primary care sites.
Sleep Well! is a brief, behavioral sleep intervention for toddlers and preschoolers who have a caregiver-reported behavioral sleep problem or who are not getting enough sleep. The intervention includes evidence-based behavioral sleep approaches and strategies to engage and empower families. The primary outcomes for this pilot trial are feasibility (number of caregivers recruited, engaged, and retained in intervention; participant intervention attendance rate) and caregiver acceptability, assessed via a questionnaire and qualitative post-intervention interview. Secondary outcomes are the direction and magnitude in any change in child sleep. Tertiary outcomes are the direction and magnitude in change in child behavior. Assessments occur at pre-intervention, post-intervention, and follow-up.
- Conditions
- Sleep Disturbance, Sleep Deprivation, Sleep
- Being tested
- Sleep Well!, Sleep education
- Medical subject headings
- Parasomnias, Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Well!Behavioural
Sleep Well! is a brief, behavioral sleep intervention. The intervention was originally comprised of healthy sleep advice and tested in the context of a sleep health education campaign for impoverished children. Based on preliminary research regarding the need for sleep intervention in primary care, Investigators have expanded the intervention to more comprehensively address poor sleep health behaviors (e.g., use of electronics at bedtime; inconsistent and variable sleep schedules; lack of a bedtime routine) as well as insomnia (difficulty falling and staying asleep; the need for caregiver presence at bedtime) and insufficient sleep in toddlers and preschoolers who are living in disadvantaged contexts. Intervention components are based on effective pediatric behavioral sleep treatments.
Sleep educationBehavioural
Sleep education for caregivers of toddlers and preschoolers is provided via a Parent Family Education handout available to families and clinicians in the CHOP primary care network. The handout contains evidence-based advice about healthy sleep in early childhood.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Well! Intervention | Experimental | Participants in this condition will begin the Sleep Well! intervention after initiating baseline, daily diary, and actigraph procedures. Sleep Well! will be provided over approximately 6-8 weeks and will include 3 sessions. Intervention sessions will typically last about an hour, but session length may vary. Receives: Behavioral: Sleep Well! |
| Enhanced Usual Care | Other | The enhanced usual care condition will occur between 6 and 8 weeks. At randomization to this condition, participants will be provided with an evidence-based sleep guidelines for young children from the CHOP Parent Family Education manual. Participants in this condition will also be able to consult with their primary care physician for management of child sleep. Consistent with usual care in the CHOP system, the primary care physician may manage the sleep concern or choose to make a referral to the CHOP sleep center or to other behavioral health services internal or external to the CHOP system. Of note, the CHOP Parent Family Education handouts provide contact information for the CHOP Sleep Center and direct readers to follow-up with their primary care provider for further guidance. Receives: Behavioral: Sleep education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention Rate (Intervention Feasibility)
The study team will track the number of caregiver-child dyad participants assigned to the Sleep Well! condition who complete the intervention as a measure of retention, or intervention feasibility. The retention rate reported is for those who completed all sessions and phone calls for the Sleep Well! intervention.
Measured: Study duration (up to 24 weeks)
Family Engagement (Sessions)
For families randomized to the intervention condition, study interventionists will rate family engagement during telehealth sessions using a one-item 5-point Likert scale ranging from 1 (not engaged) to 5 (very good engagement), with higher scores representing better engagement. The outcome reported is the average rating of telehealth session engagement across sessions 1, 2, and 3.
Measured: Study duration (up to 24 weeks)
Family Engagement (Telephone Calls)
For families randomized to the intervention condition, study interventionists will rate family engagement during telephone calls using a one-item 5-point Likert scale ranging from 1 (not engaged) to 5 (very good engagement), with higher scores representing better engagement. The outcome reported is the average rating of telehealth session engagement across all completed telephone calls.
Measured: Study duration (up to 24 weeks)
Treatment Acceptability
Caregivers will complete the Treatment Evaluation Inventory-Short Form, a widely used measure of treatment acceptability that has been adapted for the purposes of the Sleep Well! intervention. For this reported outcome, caregivers responded to the statement "I found these strategies to be an acceptable way of dealing with my child's sleep" on a 5-point Likert scale ranging from 1 "strongly disagree" to 5 "strongly agree," with higher scores reflecting stronger acceptability.
Measured: Time 2 (an average of 9 weeks post-baseline)
Treatment Acceptability: Cultural Humility
Caregivers will complete the Multicultural Therapy Competency Inventory- Client Version, adapted for the current study, to assess participants' perceptions of the Sleep Well! therapist's cultural humility during the intervention. Caregivers in the intervention condition responded to the statement "When we discussed my child's sleep, my Sleep Well! therapist was accepting of my family's values and beliefs," on a 5-point Likert scale ranging from 1 "strongly disagree" to 5 "strongly agree." Higher ratings indicate greater perceived cultural humility.
Measured: Time 2 (an average of 9 weeks post-baseline)
Assessment Process (Study Feasibility)
The study team will keep records of the number of planned assessments that are completed (i.e., the entire assessment was completed) as a measure of study feasibility.
Measured: Study duration (up to 24 weeks)
Secondary outcomes (10)
Severity of Child Sleep Problems
Caregivers will complete a Brief Child Sleep Questionnaire item to report on the severity of any caregiver-perceived sleep problems at pre-intervention, post-intervention, and follow-up. Caregivers reported on the severity of child sleep problems on a 5-point Likert scale; responses were then dichotomized as in prior research such that 0= no to very small sleep problem and 1= small, moderate, or serious sleep problem. Higher scores indicate worse sleep problems.
Measured: Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline)
Child Sleep Problems: Bedtime Difficulties
Caregivers will complete a Brief Child Sleep Questionnaire item to report on the severity of child bedtime difficulties at pre-intervention, post-intervention, and follow-up. Caregivers reported on the severity of bedtime difficulties on a 5-point Likert scale; responses were then dichotomized as in prior research such that 0= easy to somewhat easy bedtime and 1= somewhat difficult, difficult, or very difficult at bedtime. Higher scores indicate greater bedtime difficulties.
Measured: Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline)
Child Sleep Patterns: Sleep Onset Latency
Caregivers will complete the Brief Child Sleep Questionnaire (BCSQ) to report on child sleep habits (sleep time, total sleep duration, night wakings, aspects of the sleep environment, etc.) at pre-intervention, post-intervention, and follow-up. The BCSQ is appropriate for children ages 1-5 years and has shown good reliability and moderate correspondence with actigraphic recordings of child-sleep. Caregivers responded to a BCSQ question regarding the time the child took to fall asleep in minutes after lights out. Higher values indicate a longer period of time to fall asleep in minutes.
Measured: Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline)
Child Sleep Patterns: Number of Wakings Per Night
Caregivers will complete the Brief Child Sleep Questionnaire (BCSQ) to report on child sleep habits (sleep time, total sleep duration, night wakings, aspects of the sleep environment, etc.) at pre-intervention, post-intervention, and follow-up. The BCSQ is appropriate for children ages 1-5 years and has shown good reliability and moderate correspondence with actigraphic recordings of child-sleep. Caregivers responded to a BCSQ question regarding the number of times their child woke during the night. Higher values indicate more frequent wakings per night.
Measured: Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline)
Child Sleep Patterns: Duration of Wakings Per Night
Caregivers will complete the Brief Child Sleep Questionnaire (BCSQ) to report on child sleep habits (sleep time, total sleep duration, night wakings, aspects of the sleep environment, etc.) at pre-intervention, post-intervention, and follow-up. The BCSQ is appropriate for children ages 1-5 years and has shown good reliability and moderate correspondence with actigraphic recordings of child-sleep. Caregivers responded to a BCSQ question regarding the total time in minutes their child was awake during the night. Higher values indicate longer night wakings in minutes.
Measured: Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline)
Child Sleep Patterns: Nighttime Sleep Duration
Caregivers will complete the Brief Child Sleep Questionnaire (BCSQ) to report on child sleep habits (sleep time, total sleep duration, night wakings, aspects of the sleep environment, etc.) at pre-intervention, post-intervention, and follow-up. The BCSQ is appropriate for children ages 1-5 years and has shown good reliability and moderate correspondence with actigraphic recordings of child-sleep. Caregivers responded to a BCSQ question regarding the total time their child slept overnight in hours. Higher values indicate longer nighttime sleep duration in hours.
Measured: Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline)
Child Sleep Patterns: Total 24-hour Sleep Duration
Caregivers will complete the Brief Child Sleep Questionnaire (BCSQ) to report on child sleep habits (sleep time, total sleep duration, night wakings, aspects of the sleep environment, etc.) at pre-intervention, post-intervention, and follow-up. The BCSQ is appropriate for children ages 1-5 years and has shown good reliability and moderate correspondence with actigraphic recordings of child-sleep. Caregivers responded to a BCSQ question regarding the total time their child slept overnight, and a BCSQ question regarding the total time their child slept during the day for naps. Responses to these two items were summed to estimate total (24-hour) sleep duration in hours. Higher values indicate longer total sleep duration in hours.
Measured: Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline)
Child Sleep Patterns: Actigraphy Derived Nighttime Sleep Duration
Caregivers will have their child wear an actigraph to obtain estimates of sleep onset, sleep offset, and sleep duration at pre-intervention, post-intervention, and follow-up. Nighttime sleep duration in minutes is obtained from scoring sleep onset and sleep offset in combination with caregiver-reported nightly sleep diaries of bed and wake times. Nighttime sleep duration is expressed as the average sleep duration in hours across the 7 nights of actigraphy at each timepoint. Higher values indicate longer average nighttime sleep duration.
Measured: 7 days at Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline)
Child Behavior Problems: Externalizing Problems
Caregivers will complete the Child Behavioral Checklist (CBCL) for ages 1.5-5 years to report on child internalizing and externalizing concerns at Baseline, Time 2 (post-intervention), and Time 3 (follow-up). The CBCL has shown strong reliability and validity in large validation studies and is a widely used measure of child behavior. The Externalizing T-score is generated from caregiver-rated raw items that are summed and converted to T-scores based on CBCL normative data. Higher T-scores indicate greater externalizing problems. 50 indicates the population mean with a standard deviation of 10. A T-score of 65-69.9 indicates elevated concerns and a T-score of 70 and above indicates clinically significant concerns.
Measured: Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline)
Child Behavior Problems: Internalizing Problems
Caregivers will complete the Child Behavioral Checklist (CBCL) for ages 1.5-5 years to report on child internalizing and externalizing concerns at Baseline, Time 2 (post-intervention), and Time 3 (follow-up). The CBCL has shown strong reliability and validity in large validation studies and is a widely used measure of child behavior. The Internalizing T-score is generated from caregiver-rated raw items that are summed and converted to T-scores based on CBCL normative data. Higher T-scores indicate greater internalizing problems. 50 indicates the population mean with a standard deviation of 10. A T-score of 65-69.9 indicates elevated concerns and a T-score of 70 and above indicates clinically significant concerns.
Measured: Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start16 Oct 2020
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Caregiver-child dyads (child ages 1-5 years with a sleep problem) will be recruited from CHOP urban primary care sites and randomly assigned either to the intervention or to an enhanced usual care condition (sleep education handout).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Ariel Williamson, PhD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04473222
- Sponsor's protocol ID
- 20-017788
- Other IDs
- 5K23HD094905-02
- Status last verified
- Feb 2026
- First submitted
- 13 Jul 2020
- Last updated
- 16 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Meltzer LJ, Mindell JA. Systematic review and meta-analysis of behavioral interventions for pediatric insomnia. J Pediatr Psychol. 2014 Sep;39(8):932-48. doi: 10.1093/jpepsy/jsu041. Epub 2014 Jun 19.
PubMed 24947271Mindell JA, Williamson AA. Benefits of a bedtime routine in young children: Sleep, development, and beyond. Sleep Med Rev. 2018 Aug;40:93-108. doi: 10.1016/j.smrv.2017.10.007. Epub 2017 Nov 6.
PubMed 29195725Quach J, Gold L, Arnup S, Sia KL, Wake M, Hiscock H. Sleep well--be well study: improving school transition by improving child sleep: a translational randomised trial. BMJ Open. 2013 Oct 28;3(10):e004009. doi: 10.1136/bmjopen-2013-004009.
PubMed 24165031Allen SL, Howlett MD, Coulombe JA, Corkum PV. ABCs of SLEEPING: A review of the evidence behind pediatric sleep practice recommendations. Sleep Med Rev. 2016 Oct;29:1-14. doi: 10.1016/j.smrv.2015.08.006. Epub 2015 Sep 1.
PubMed 26551999Williamson AA, Milaniak I, Watson B, Cicalese O, Fiks AG, Power TJ, Barg FK, Beidas RS, Mindell JA, Rendle KA. Early Childhood Sleep Intervention in Urban Primary Care: Caregiver and Clinician Perspectives. J Pediatr Psychol. 2020 Sep 1;45(8):933-945. doi: 10.1093/jpepsy/jsaa024.
PubMed 32430496Mindell JA, Sedmak R, Boyle JT, Butler R, Williamson AA. Sleep Well!: A Pilot Study of an Education Campaign to Improve Sleep of Socioeconomically Disadvantaged Children. J Clin Sleep Med. 2016 Dec 15;12(12):1593-1599. doi: 10.5664/jcsm.6338.
PubMed 27655459
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Evidence-based Behavioral Sleep Intervention in Urban Primary Care: Aim 3
- ClinicalTrials.gov ID
- NCT04473222
- Acronym / sponsor ID
- 20-017788
- Conditions
- Sleep Disturbance, Sleep Deprivation, Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 16 Oct 2020 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 16 Jul 2020 (actual)
- Results
- Posted 5 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigators will enroll up to 120 parent-child dyads from Children's Hospital of Philadelphia (CHOP) urban primary care clinics. The primary objective of this randomized clinical trial is to determine the whether the Sleep Well! behavioral sleep intervention is feasible and acceptable to families. The investigators will also examine the direction and magnitude in any change in child sleep and child behavior.
Detailed description
Behavioral sleep problems such as insomnia and insufficient sleep are common in toddlers and preschoolers and disproportionately impact lower socioeconomic status (SES) children. Despite a robust evidence base, behavioral sleep interventions are rarely tested with lower-SES children or in primary care, an accessible service delivery setting. The primary objective of this study is to determine whether the Sleep Well! behavioral sleep intervention is feasible and acceptable to families. The investigators will also examine the direction and magnitude of change in child sleep and behavior from pre-intervention to post-intervention and follow-up. This is a randomized controlled trial of the Sleep Well! program with pre-intervention, post-intervention, and follow-up assessments. Caregiver-child dyads (child ages 1-5 years with a sleep problem) will be recruited from CHOP urban primary care sites.
Sleep Well! is a brief, behavioral sleep intervention for toddlers and preschoolers who have a caregiver-reported behavioral sleep problem or who are not getting enough sleep. The intervention includes evidence-based behavioral sleep approaches and strategies to engage and empower families. The primary outcomes for this pilot trial are feasibility (number of caregivers recruited, engaged, and retained in intervention; participant intervention attendance rate) and caregiver acceptability, assessed via a questionnaire and qualitative post-intervention interview. Secondary outcomes are the direction and magnitude in any change in child sleep. Tertiary outcomes are the direction and magnitude in change in child behavior. Assessments occur at pre-intervention, post-intervention, and follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Caregiver-child dyads (child ages 1-5 years with a sleep problem) will be recruited from CHOP urban primary care sites and randomly assigned either to the intervention or to an enhanced usual care condition (sleep education handout).
| Arm | Type | Receives |
|---|---|---|
| Sleep Well! Intervention | Experimental | Behavioral: Sleep Well!Participants in this condition will begin the Sleep Well! intervention after initiating baseline, daily diary, and actigraph procedures. Sleep Well! will be provided over approximately 6-8 weeks and will include 3 sessions. Intervention sessions will typically last about an hour, but session length may vary. |
| Enhanced Usual Care | Other | Behavioral: Sleep educationThe enhanced usual care condition will occur between 6 and 8 weeks. At randomization to this condition, participants will be provided with an evidence-based sleep guidelines for young children from the CHOP Parent Family Education manual. Participants in this condition will also be able to consult with their primary care physician for management of child sleep. Consistent with usual care in the CHOP system, the primary care physician may manage the sleep concern or choose to make a referral to the CHOP sleep center or to other behavioral health services internal or external to the CHOP system. Of note, the CHOP Parent Family Education handouts provide contact information for the CHOP Sleep Center and direct readers to follow-up with their primary care provider for further guidance. |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Parental/guardian permission (informed consent)
- Caregiver participant is the parent or legal guardian of the child subject
- Caregiver/legal guardian is greater than or equal to 18 years of age.
- Child between the ages of 1 and 5 years.
- Presence of caregiver-reported child sleep problem determined by a Brief Child Sleep Questionnaire item included in an eligibility screening questionnaire or child meets American Academy of Sleep Medicine diagnostic criteria for either pediatric insomnia or insufficient sleep, assessed through an eligibility screening questionnaire.
Key exclusion criteria (3 listed)
- Caregiver is not parent or legal guardian of child participant.
- Presence of a child neurodevelopmental (e.g., autism spectrum disorder; Trisomy 21) or chronic medical (e.g., sickle cell disease, cancer) concern in which the disorder or treatment of the disorder impact sleep.
- Caregivers/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
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 Well!Sleep Well! is a brief, behavioral sleep intervention. The intervention was originally comprised of healthy sleep advice and tested in the context of a sleep health education campaign for impoverished children. Based on preliminary research regarding the need for sleep intervention in primary care, Investigators have expanded the intervention to more comprehensively address poor sleep health behaviors (e.g., use of electronics at bedtime; inconsistent and variable sleep schedules; lack of a bedtime routine) as well as insomnia (difficulty falling and staying asleep; the need for caregiver presence at bedtime) and insufficient sleep in toddlers and preschoolers who are living in disadvantaged contexts. Intervention components are based on effective pediatric behavioral sleep treatments. | Behavioural | Sleep Well! Intervention |
| Sleep educationSleep education for caregivers of toddlers and preschoolers is provided via a Parent Family Education handout available to families and clinicians in the CHOP primary care network. The handout contains evidence-based advice about healthy sleep in early childhood. | Behavioural | Enhanced Usual Care |
Primary outcome
Retention Rate (Intervention Feasibility)
Time frame: Study duration (up to 24 weeks)
The study team will track the number of caregiver-child dyad participants assigned to the Sleep Well! condition who complete the intervention as a measure of retention, or intervention feasibility. The retention rate reported is for those who completed all sessions and phone calls for the Sleep Well! intervention.
Family Engagement (Sessions)
Time frame: Study duration (up to 24 weeks)
For families randomized to the intervention condition, study interventionists will rate family engagement during telehealth sessions using a one-item 5-point Likert scale ranging from 1 (not engaged) to 5 (very good engagement), with higher scores representing better engagement. The outcome reported is the average rating of telehealth session engagement across sessions 1, 2, and 3.
Family Engagement (Telephone Calls)
Time frame: Study duration (up to 24 weeks)
For families randomized to the intervention condition, study interventionists will rate family engagement during telephone calls using a one-item 5-point Likert scale ranging from 1 (not engaged) to 5 (very good engagement), with higher scores representing better engagement. The outcome reported is the average rating of telehealth session engagement across all completed telephone calls.
Treatment Acceptability
Time frame: Time 2 (an average of 9 weeks post-baseline)
Caregivers will complete the Treatment Evaluation Inventory-Short Form, a widely used measure of treatment acceptability that has been adapted for the purposes of the Sleep Well! intervention. For this reported outcome, caregivers responded to the statement "I found these strategies to be an acceptable way of dealing with my child's sleep" on a 5-point Likert scale ranging from 1 "strongly disagree" to 5 "strongly agree," with higher scores reflecting stronger acceptability.
Treatment Acceptability: Cultural Humility
Time frame: Time 2 (an average of 9 weeks post-baseline)
Caregivers will complete the Multicultural Therapy Competency Inventory- Client Version, adapted for the current study, to assess participants' perceptions of the Sleep Well! therapist's cultural humility during the intervention. Caregivers in the intervention condition responded to the statement "When we discussed my child's sleep, my Sleep Well! therapist was accepting of my family's values and beliefs," on a 5-point Likert scale ranging from 1 "strongly disagree" to 5 "strongly agree." Higher ratings indicate greater perceived cultural humility.
Assessment Process (Study Feasibility)
Time frame: Study duration (up to 24 weeks)
The study team will keep records of the number of planned assessments that are completed (i.e., the entire assessment was completed) as a measure of study feasibility.
10 secondary outcomes
Severity of Child Sleep Problems
Time frame: Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline)
Child Sleep Problems: Bedtime Difficulties
Time frame: Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline)
Child Sleep Patterns: Sleep Onset Latency
Time frame: Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline)
Child Sleep Patterns: Number of Wakings Per Night
Time frame: Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline)
Child Sleep Patterns: Duration of Wakings Per Night
Time frame: Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline)
Child Sleep Patterns: Nighttime Sleep Duration
Time frame: Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline)
Child Sleep Patterns: Total 24-hour Sleep Duration
Time frame: Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline)
Child Sleep Patterns: Actigraphy Derived Nighttime Sleep Duration
Time frame: 7 days at Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline)
Child Behavior Problems: Externalizing Problems
Time frame: Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline)
Child Behavior Problems: Internalizing Problems
Time frame: Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24947271Meltzer LJ, Mindell JA. Systematic review and meta-analysis of behavioral interventions for pediatric insomnia. J Pediatr Psychol. 2014 Sep;39(8):932-48. doi: 10.1093/jpepsy/jsu041. Epub 2014 Jun 19.
- Background: PubMed 29195725Mindell JA, Williamson AA. Benefits of a bedtime routine in young children: Sleep, development, and beyond. Sleep Med Rev. 2018 Aug;40:93-108. doi: 10.1016/j.smrv.2017.10.007. Epub 2017 Nov 6.
- Background: PubMed 24165031Quach J, Gold L, Arnup S, Sia KL, Wake M, Hiscock H. Sleep well--be well study: improving school transition by improving child sleep: a translational randomised trial. BMJ Open. 2013 Oct 28;3(10):e004009. doi: 10.1136/bmjopen-2013-004009.
- Background: PubMed 26551999Allen SL, Howlett MD, Coulombe JA, Corkum PV. ABCs of SLEEPING: A review of the evidence behind pediatric sleep practice recommendations. Sleep Med Rev. 2016 Oct;29:1-14. doi: 10.1016/j.smrv.2015.08.006. Epub 2015 Sep 1.
- Background: PubMed 32430496Williamson AA, Milaniak I, Watson B, Cicalese O, Fiks AG, Power TJ, Barg FK, Beidas RS, Mindell JA, Rendle KA. Early Childhood Sleep Intervention in Urban Primary Care: Caregiver and Clinician Perspectives. J Pediatr Psychol. 2020 Sep 1;45(8):933-945. doi: 10.1093/jpepsy/jsaa024.
- Background: PubMed 27655459Mindell JA, Sedmak R, Boyle JT, Butler R, Williamson AA. Sleep Well!: A Pilot Study of an Education Campaign to Improve Sleep of Socioeconomically Disadvantaged Children. J Clin Sleep Med. 2016 Dec 15;12(12):1593-1599. doi: 10.5664/jcsm.6338.
- Created by the Pediatric Sleep Council, babysleep.com provides comprehensive and expert-based information on baby and toddler sleep that is freely available to the public.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Sleep Disturbance
Not yet recruitingObservational study
Registry of Central Sleep Apnea Patients Undergoing remedē System Implant
Central Sleep Apnea (Diagnosis), Central Sleep Apnea Syndrome
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Not yet recruiting
HALO Clarity™ Cranial Alternating Current Stimulation Therapy for Adults With Moderate-to-Severe Insomnia
Moderate to Severe Insomnia
Enrolling by invitation
Recreational Badminton, Sleep and Melatonin
Sedentary Behavior
Active, not recruitingPhase 3
A Trial of TAK-861 for the Treatment of Narcolepsy With Cataplexy
Narcolepsy Type 1 (NT1), Narcolepsy With Cataplexy
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. This study is not recruiting at the moment.
Ariel Williamson, PhD principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Well! and Sleep education in people with Sleep Disturbance and Sleep Deprivation, run by Children's Hospital of Philadelphia at 1 site in United States.
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 6 inclusion and 3 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: finished, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Yes. Results are posted in the registry (first posted 5 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention Rate (Intervention Feasibility) (time frame: Study duration (up to 24 weeks)). 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 NCT04473222, which also lists 6 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 16 Mar 2026.