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Investigators will enroll up to 20 participants from 3 Children's Hospital of Philadelphia (CHOP) primary care locations. The primary objective is to determine the whether the Sleep Well! behavioral sleep intervention is feasible to be implemented in primary care offices and acceptable to families. The direction and magnitude of change in child sleep from pre-intervention to post-intervention will also be examined.
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 the whether the Sleep Well! behavioral sleep intervention is feasible and acceptable to families. We will also examine the direction and magnitude of change in child sleep from pre-intervention to post-intervention. This is a preliminary open trial of the Sleep Well! program with pre-intervention and post-intervention 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 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 open 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 pre- to post-intervention change in child sleep.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavioral Sleep Intervention | Experimental | Parents attend 1-3 one-hour sessions at their primary care office or via telemedicine, where they receive sleep education and work with interventionists to develop strategies to help their child at bedtime. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep Well! | Behavioral | The intervention comprehensively addresses 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. Interventionists will use strategies to engage with and empower families, such as motivational interviewing and collaborative problem-solving. Session content will be reinforced via phone calls from interventionists. Families will receive intervention session appointment reminders and information about intervention content (e.g., reminders to follow a bedtime routine) via text message. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Caregiver-child Participants Who Complete All Intervention Procedures Following Enrollment (Retention Rate) | The study team will track the number of caregiver-child dyad participants who complete all intervention procedures following enrollment. | Approximately 9 months |
| Number of Caregiver-child Participants Who Complete All Assessments (Pre-intervention and Post-intervention) That Were Planned (Feasibility) | The study team will track the number of proportion of participants who complete all assessments (pre-intervention and post-intervention) that were planned. | Approximately 9 months |
| Treatment Acceptability (Strategies) | 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. Ratings are shown for proportion of caregivers agreeing or strongly agreeing with the statement that the strategies are acceptable. | 3 months |
| Cultural Humility | Caregivers will complete the Multicultural Therapy Competency Inventory- Client Version (MTCI-CV), adapted to assess perceptions of the Sleep Well! therapist's/program's cultural humility (e.g. "When we discussed my child's sleep, the Sleep Well! therapist seemed to have some understanding about my/my family's culture and background" and "When we discussed my child's sleep, the Sleep Well! therapist appreciated my expertise on my own life.") Average proportion of caregivers agreeing/strongly agreeing with statements on measure is reported. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Patterns and Problems: Sleep Problem | Caregivers will complete the Brief Child Sleep Questionnaire (BCSQ) to report on child sleep habits and the severity of any caregiver-perceived sleep problems at pretreatment and posttreatment. The BCSQ is appropriate for children ages 1.5-5 years and has shown good reliability and moderate correspondence with actigraphic recordings of child sleep. | Baseline (pre-intervention) and 3 months (post-intervention). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ariel Williamson, PhD | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34910624 | Derived | Williamson AA, Okoroji C, Cicalese O, Evans BC, Ayala A, Harvey B, Honore R, Kratchman A, Beidas RS, Fiks AG, Power TJ, Mindell JA. Sleep Well! An adapted behavioral sleep intervention implemented in urban primary care. J Clin Sleep Med. 2022 Apr 1;18(4):1153-1166. doi: 10.5664/jcsm.9822. |
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Both caregivers and children were enrolled in the study and were combined as a dyad.
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| ID | Title | Description |
|---|---|---|
| FG000 | Behavioral Sleep Intervention | Caregivers attend 1-3 one-hour sessions at their primary care office or via telemedicine, where they receive sleep education and work with interventionists to develop strategies to help their child at bedtime. Sleep Well!: The intervention comprehensively addresses 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. Interventionists will use strategies to engage with and empower families, such as motivational interviewing and collaborative problem-solving. Session content will be reinforced via phone calls from interventionists. Families will receive intervention session appointment reminders and information about intervention content (e.g., reminders to follow a bedtime routine) via text message. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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At baseline, we collected data from 15 caregiver-child dyads that initiated the intervention. Three families were lost to follow-up so post-intervention data were collected from 12 caregiver-child dyads.
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| ID | Title | Description |
|---|---|---|
| BG000 | Behavioral Sleep Intervention | Caregivers attend 1-3 one-hour sessions at their primary care office or via telemedicine, where they receive sleep education and work with interventionists to develop strategies to help their child at bedtime. Sleep Well!: The intervention comprehensively addresses 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. Interventionists will use strategies to engage with and empower families, such as motivational interviewing and collaborative problem-solving. Session content will be reinforced via phone calls from interventionists. Families will receive intervention session appointment reminders and information about intervention content (e.g., reminders to follow a bedtime routine) via text message. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Categorical age is presenting for caregiver participants in the caregiver-child dyads who participated. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Caregiver-child Participants Who Complete All Intervention Procedures Following Enrollment (Retention Rate) | The study team will track the number of caregiver-child dyad participants who complete all intervention procedures following enrollment. | Posted | Count of Participants | Participants | Approximately 9 months |
|
Through study completion; approximately 3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Behavioral Sleep Intervention | Parents attend 1-3 one-hour sessions at their primary care office or via telemedicine, where they receive sleep education and work with interventionists to develop strategies to help their child at bedtime. Sleep Well!: The intervention comprehensively addresses 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. Interventionists will use strategies to engage with and empower families, such as motivational interviewing and collaborative problem-solving. Session content will be reinforced via phone calls from interventionists. Families will receive intervention session appointment reminders and information about intervention content (e.g., reminders to follow a bedtime routine) via text message. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marsha Wallace | Children's Hospital of Philadelphia | 2155900119 | wallacem@chop.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 8, 2020 | Jul 26, 2021 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 22, 2019 | Jul 6, 2020 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D020447 | Parasomnias |
| D012892 | Sleep Deprivation |
| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D020920 | Dyssomnias |
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Caregiver-child dyads (child ages 1-5 years with a sleep problem) will be recruited from CHOP urban primary care sites.
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| Sleep Patterns and Problems: Sleep Onset Latency | Caregivers will complete the BCSQ to report on child sleep habits and the severity of any caregiver-perceived sleep problems at pretreatment and posttreatment. The BCSQ is appropriate for children ages 1.5-5 years and has shown good reliability and moderate correspondence with actigraphic recordings of child-sleep. When completing the BCSQ, caregivers are prompted to think about their child's sleep on a "typical night" over the past week (7 nights). Sleep onset latency is assessed by asking caregivers to report in minutes how long it typically takes their child to fall asleep. | 3 months |
| Sleep Patterns and Problems: Night Awakening Duration | Caregivers will complete the BCSQ to report on child sleep habits and the severity of any caregiver-perceived sleep problems at pretreatment and posttreatment. The BCSQ is appropriate for children ages 1.5-5 years and has shown good reliability and moderate correspondence with actigraphic recordings of child-sleep. | 3 months |
| Sleep Patterns and Problems: Nighttime Sleep Duration | Caregivers will complete the BCSQ to report on child sleep habits and the severity of any caregiver-perceived sleep problems at pretreatment and posttreatment. The BCSQ is appropriate for children ages 1.5-5 years and has shown good reliability and moderate correspondence with actigraphic recordings of child-sleep. | 3 months |
| Sleep Patterns and Problems: 24-hour Sleep Duration | Caregivers will complete the BCSQ to report on child sleep habits and the severity of any caregiver-perceived sleep problems at pretreatment and posttreatment. The BCSQ is appropriate for children ages 1.5-5 years and has shown good reliability and moderate correspondence with actigraphic recordings of child-sleep. | 3 months |
| Count of Participants |
| Participants |
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| Age, Continuous | Continuous age information is based on the child participant in the caregiver-child dyad. | Mean | Standard Deviation | years |
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| Sex: Female, Male | This information is for the child participants in the caregiver-child dyad. | Count of Participants | Participants |
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| Sex: Female, Male | This information is for the caregiver participant in the caregiver-child dyad. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | This information is for the child in the caregiver-child dyad. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | This information is for the caregiver in the caregiver-child dyad | Count of Participants | Participants |
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| Race (NIH/OMB) | This information is for the child in the caregiver-child dyad. | Count of Participants | Participants |
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| Race (NIH/OMB) | This information is for the caregiver in the caregiver-child dyad | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Brief Child Sleep Questionnaire- Perceived Sleep Problem | Questionnaire item for Brief Child Sleep Questionnaire that asks caregivers about the severity of a child sleep problem. A very small or no sleep problem is coded as 0, and a small to severe sleep problem is coded as 1. | Count of Participants | Participants |
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| Primary | Number of Caregiver-child Participants Who Complete All Assessments (Pre-intervention and Post-intervention) That Were Planned (Feasibility) | The study team will track the number of proportion of participants who complete all assessments (pre-intervention and post-intervention) that were planned. | Posted | Count of Participants | Participants | Approximately 9 months |
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| Primary | Treatment Acceptability (Strategies) | 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. Ratings are shown for proportion of caregivers agreeing or strongly agreeing with the statement that the strategies are acceptable. | The treatment evaluation form was administered at post-intervention only and thus data were not available for the 3 participants who did not complete the post-intervention assessment. | Posted | Number | Caregivers | 3 months |
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| Primary | Cultural Humility | Caregivers will complete the Multicultural Therapy Competency Inventory- Client Version (MTCI-CV), adapted to assess perceptions of the Sleep Well! therapist's/program's cultural humility (e.g. "When we discussed my child's sleep, the Sleep Well! therapist seemed to have some understanding about my/my family's culture and background" and "When we discussed my child's sleep, the Sleep Well! therapist appreciated my expertise on my own life.") Average proportion of caregivers agreeing/strongly agreeing with statements on measure is reported. | The treatment evaluation form was administered at post-intervention only and was added to the protocol after feedback from family partners during the trial. Thus, data were not available for the 3 participants who did not complete the post-intervention assessment and the 2 participants that completed the intervention post-assessment before this measure was added. | Posted | Count of Participants | Participants | 3 months |
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| Secondary | Sleep Patterns and Problems: Sleep Problem | Caregivers will complete the Brief Child Sleep Questionnaire (BCSQ) to report on child sleep habits and the severity of any caregiver-perceived sleep problems at pretreatment and posttreatment. The BCSQ is appropriate for children ages 1.5-5 years and has shown good reliability and moderate correspondence with actigraphic recordings of child sleep. | Analysis was for those with both pre- and post-intervention data (N = 12) | Posted | Count of Participants | Participants | Baseline (pre-intervention) and 3 months (post-intervention). |
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| Secondary | Sleep Patterns and Problems: Sleep Onset Latency | Caregivers will complete the BCSQ to report on child sleep habits and the severity of any caregiver-perceived sleep problems at pretreatment and posttreatment. The BCSQ is appropriate for children ages 1.5-5 years and has shown good reliability and moderate correspondence with actigraphic recordings of child-sleep. When completing the BCSQ, caregivers are prompted to think about their child's sleep on a "typical night" over the past week (7 nights). Sleep onset latency is assessed by asking caregivers to report in minutes how long it typically takes their child to fall asleep. | Analysis was for those with both pre- and post-intervention data (N = 12) | Posted | Mean | Standard Deviation | minutes | 3 months |
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| Secondary | Sleep Patterns and Problems: Night Awakening Duration | Caregivers will complete the BCSQ to report on child sleep habits and the severity of any caregiver-perceived sleep problems at pretreatment and posttreatment. The BCSQ is appropriate for children ages 1.5-5 years and has shown good reliability and moderate correspondence with actigraphic recordings of child-sleep. | Analysis was for those with both pre- and post-intervention data, and with a corrected version of the BCSQ that included the duration of night awakenings question (N =7) | Posted | Mean | Standard Deviation | minutes | 3 months |
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| Secondary | Sleep Patterns and Problems: Nighttime Sleep Duration | Caregivers will complete the BCSQ to report on child sleep habits and the severity of any caregiver-perceived sleep problems at pretreatment and posttreatment. The BCSQ is appropriate for children ages 1.5-5 years and has shown good reliability and moderate correspondence with actigraphic recordings of child-sleep. | Analysis was for those with both pre- and post-intervention data (N = 12) | Posted | Mean | Standard Deviation | hours | 3 months |
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| Secondary | Sleep Patterns and Problems: 24-hour Sleep Duration | Caregivers will complete the BCSQ to report on child sleep habits and the severity of any caregiver-perceived sleep problems at pretreatment and posttreatment. The BCSQ is appropriate for children ages 1.5-5 years and has shown good reliability and moderate correspondence with actigraphic recordings of child-sleep. | Analysis was for those with both pre- and post-intervention data (N = 12) | Posted | Mean | Standard Deviation | hours | 3 months |
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| 15 |
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| 15 |
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |