Sleep, Sleep Deprivation, Sleep Disturbance
Conditions
Brief 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. 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.
Interventions
BEHAVIORALSleep 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.
BEHAVIORALSleep education
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.
Sponsors
Children's Hospital of Philadelphia
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Research assistants conducting outcome assessments will be blinded to study condition.
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
1 Years to 5 Years
Healthy volunteers
No
Inclusion criteria
1. Parental/guardian permission (informed consent) 2. Caregiver participant is the parent or legal guardian of the child subject 3. Caregiver/legal guardian is greater than or equal to 18 years of age. 4. Child between the ages of 1 and 5 years. 5. 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. 6. English-speaking.
Exclusion criteria
1. Caregiver is not parent or legal guardian of child participant. 2. 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. 3. Caregivers/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention Rate (Intervention Feasibility) | 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) | 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) | 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 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 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of Child Sleep Problems | Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline) | 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. |
| Child Sleep Problems: Bedtime Difficulties | Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline) | 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. |
| Child Sleep Patterns: Sleep Onset Latency | Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline) | 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. |
| Child Sleep Patterns: Number of Wakings Per Night | Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline) | 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. |
| Child Sleep Patterns: Duration of Wakings Per Night | Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline) | 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. |
| Child Sleep Patterns: Nighttime Sleep Duration | Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline) | 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. |
| Child Sleep Patterns: Total 24-hour Sleep Duration | Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline) | 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. |
| Child Sleep Patterns: Actigraphy Derived Nighttime Sleep Duration | 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) | 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. |
| Child Behavior Problems: Externalizing Problems | Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline) | 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. |
| Child Behavior Problems: Internalizing Problems | Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline) | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAriel Williamson, PhD
Children's Hospital of Philadelphia
Participant flow
Recruitment details
Caregiver-child dyads (child ages 1-5 years with a sleep problem) were recruited from pediatrician referrals, chart reviews, and study flyers at 3 urban (i.e., large, metropolitan) primary care sites affiliated with Children's Hospital of Philadelphia (CHOP).
Pre-assignment details
103 unique caregiver-child dyads (206 participants; 103 caregivers and 103 children) were randomly assigned to either the intervention group or enhanced usual care group immediately following consent. The number in each group shown reflects dyads and not individual caregivers and/or individual children. Of note, one dyad was enrolled, randomized, lost contact, and then re-randomized per office of research compliance feedback. Thus, 104 dyads were randomized, but only 103 were unique dyads.
Participants by arm
| Arm | Count |
|---|---|
| Sleep Well! Intervention 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.
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. | 100 |
| Enhanced Usual Care 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.
Sleep education: 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. | 94 |
| Total | 194 |
Baseline characteristics
| Characteristic | Sleep Well! Intervention | Total | Enhanced Usual Care |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 50 Participants | 97 Participants | 47 Participants |
| Age, Continuous | 2.50 years STANDARD_DEVIATION 1.18 | 2.52 years STANDARD_DEVIATION 1.24 | 2.55 years STANDARD_DEVIATION 1.32 |
| Caregiver educational attainment Greater than high school education | 30 Participants | 62 Participants | 32 Participants |
| Caregiver educational attainment High school education or less | 20 Participants | 35 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 6 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 48 Participants | 89 Participants | 41 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Family living at or below 125% of the US poverty line Living above 125% of the poverty line | 28 Participants | 58 Participants | 30 Participants |
| Family living at or below 125% of the US poverty line Living at or below 125% of the poverty line | 22 Participants | 39 Participants | 17 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 33 Participants | 67 Participants | 36 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) White | 12 Participants | 20 Participants | 8 Participants |
| Region of Enrollment United States | 100 participants | 194 participants | 94 participants |
| Sex: Female, Male Female | 48 Participants | 45 Participants | 25 Participants |
| Sex: Female, Male Male | 30 Participants | 3 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 47 | 0 / 50 | 0 / 47 |
| other Total, other adverse events | 0 / 50 | 0 / 47 | 0 / 50 | 0 / 47 |
| serious Total, serious adverse events | 0 / 50 | 0 / 47 | 0 / 50 | 0 / 47 |
Outcome results
Primary
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.
Time frame: Study duration (up to 24 weeks)
Population: The analytic sample was based on the participants that completed baseline measures (50 Sleep Well! and 47 Enhanced Usual Care participants). This is a descriptive outcome and no statistical comparisons were made.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sleep Well! Intervention | Assessment Process (Study Feasibility) | Baseline (pre-intervention) | 50 Participants |
| Sleep Well! Intervention | Assessment Process (Study Feasibility) | Time 2 (an average of 9 weeks post-baseline) | 44 Participants |
| Sleep Well! Intervention | Assessment Process (Study Feasibility) | Time 3 (an average of 15 weeks post-baseline) | 39 Participants |
| Enhanced Usual Care | Assessment Process (Study Feasibility) | Baseline (pre-intervention) | 47 Participants |
| Enhanced Usual Care | Assessment Process (Study Feasibility) | Time 2 (an average of 9 weeks post-baseline) | 43 Participants |
| Enhanced Usual Care | Assessment Process (Study Feasibility) | Time 3 (an average of 15 weeks post-baseline) | 37 Participants |
Primary
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.
Time frame: Study duration (up to 24 weeks)
Population: The analytic sample is based on the 49 caregiver-child dyads that attended at least 1 session. Of the 50 dyads that completed baseline measures, 1 dyad lost contact prior to the start of intervention and thus is not included. Results are not reported for the Enhanced Usual Care dyads, as this outcome pertains only to those who initiated the Sleep Well! intervention. This is a descriptive outcome without any statistical comparisons.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sleep Well! Intervention | Family Engagement (Sessions) | 4.58 units on a scale | Standard Deviation 0.66 |
Primary
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.
Time frame: Study duration (up to 24 weeks)
Population: The analytic sample is based on the 49 caregiver-child dyads that completed at least 1 telephone call. Of the 50 dyads that completed baseline measures, 1 dyad lost contact prior to the start of intervention and thus is not included. Results are not reported for the Enhanced Usual Care dyads, as this outcome pertains only to those who initiated the Sleep Well! intervention. This is a descriptive outcome without any statistical comparisons.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sleep Well! Intervention | Family Engagement (Telephone Calls) | 4.59 units on a scale | Standard Deviation 0.66 |
Primary
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.
Time frame: Study duration (up to 24 weeks)
Population: Percentage of caregiver-child dyads that completed all sessions of Sleep Well! of those who initiated the intervention. Results for this outcome are not reported for the Enhanced Usual Care condition, as this outcome pertains only to those who initiated the Sleep Well! intervention. This is a descriptive outcome, and no statistical comparisons were conducted.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sleep Well! Intervention | Retention Rate (Intervention Feasibility) | Completed all 3 sessions and all 3 phone calls | 46 Participants |
| Sleep Well! Intervention | Retention Rate (Intervention Feasibility) | Did not complete all 3 sessions and/or all 3 phone calls | 4 Participants |
Primary
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.
Time frame: Time 2 (an average of 9 weeks post-baseline)
Population: The analytic sample is based on the 44 intervention participants that completed Sleep Well! and time 2 (post-intervention) surveys. Of the 50 that completed baseline, 1 lost contact prior to attending any sessions, 3 lost contact during intervention, and 2 lost contact after the intervention but before post-intervention. Results are not reported for Enhanced Usual Care, as this outcome pertains to the Sleep Well! intervention. This is a descriptive outcome without any statistical comparisons.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sleep Well! Intervention | Treatment Acceptability | Strongly agree | 28 Participants |
| Sleep Well! Intervention | Treatment Acceptability | Agree | 13 Participants |
| Sleep Well! Intervention | Treatment Acceptability | Neutral | 2 Participants |
| Sleep Well! Intervention | Treatment Acceptability | Disagree | 0 Participants |
| Sleep Well! Intervention | Treatment Acceptability | Strongly disagree | 1 Participants |
Primary
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.
Time frame: Time 2 (an average of 9 weeks post-baseline)
Population: The analytic sample is based on the 44 intervention participants that completed Sleep Well! and time 2 (post-intervention) surveys. Of the 50 that completed baseline, 1 lost contact prior to attending any sessions, 3 lost contact during intervention, and 2 lost contact after the intervention but before post-intervention. Results are not reported for Enhanced Usual Care, as this outcome pertains to the Sleep Well! intervention. This is a descriptive outcome without any statistical comparisons.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sleep Well! Intervention | Treatment Acceptability: Cultural Humility | Strongly disagree | 3 Participants |
| Sleep Well! Intervention | Treatment Acceptability: Cultural Humility | Strongly agree | 36 Participants |
| Sleep Well! Intervention | Treatment Acceptability: Cultural Humility | Agree | 4 Participants |
| Sleep Well! Intervention | Treatment Acceptability: Cultural Humility | Neutral | 1 Participants |
| Sleep Well! Intervention | Treatment Acceptability: Cultural Humility | Disagree | 0 Participants |
Secondary
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.
Time frame: Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline)
Population: The analytic sample was based on the participants that completed baseline measures.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sleep Well! Intervention | Child Behavior Problems: Externalizing Problems | Baseline (pre-intervention) | 50.32 T-score | Standard Deviation 11.45 |
| Sleep Well! Intervention | Child Behavior Problems: Externalizing Problems | Time 2 (an average of 9 weeks post-baseline) | 46.41 T-score | Standard Deviation 12.09 |
| Sleep Well! Intervention | Child Behavior Problems: Externalizing Problems | Time 3 (an average of 15 weeks post-baseline) | 44.84 T-score | Standard Deviation 10.85 |
| Enhanced Usual Care | Child Behavior Problems: Externalizing Problems | Time 2 (an average of 9 weeks post-baseline) | 44.14 T-score | Standard Deviation 11.54 |
| Enhanced Usual Care | Child Behavior Problems: Externalizing Problems | Baseline (pre-intervention) | 45.68 T-score | Standard Deviation 11.43 |
| Enhanced Usual Care | Child Behavior Problems: Externalizing Problems | Time 3 (an average of 15 weeks post-baseline) | 44.47 T-score | Standard Deviation 11.52 |
p-value: 0.019t-test, 2 sided
Secondary
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.
Time frame: Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline)
Population: The analytic sample was based on the participants that completed baseline measures.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sleep Well! Intervention | Child Behavior Problems: Internalizing Problems | Baseline | 47.39 T-score | Standard Deviation 10.54 |
| Sleep Well! Intervention | Child Behavior Problems: Internalizing Problems | Time 2 (an average of 9 weeks post-baseline) | 44.20 T-score | Standard Deviation 9.49 |
| Sleep Well! Intervention | Child Behavior Problems: Internalizing Problems | Time 3 (an average of 15 weeks post-baseline) | 44.54 T-score | Standard Deviation 11.19 |
| Enhanced Usual Care | Child Behavior Problems: Internalizing Problems | Baseline | 43.20 T-score | Standard Deviation 10.23 |
| Enhanced Usual Care | Child Behavior Problems: Internalizing Problems | Time 2 (an average of 9 weeks post-baseline) | 43.05 T-score | Standard Deviation 12.46 |
| Enhanced Usual Care | Child Behavior Problems: Internalizing Problems | Time 3 (an average of 15 weeks post-baseline) | 41.37 T-score | Standard Deviation 10.86 |
p-value: 0.776t-test, 2 sided
Secondary
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 minutes across the 7 nights of actigraphy at each timepoint. Higher values indicate longer average 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)
Population: Analytic sample was based on the number of participants that completed actigraphy. Of the 50 intervention participants that initiated baseline, 11 did not complete actigraphy assessment due to losing contact or opting out of this assessment procedure. Of the 47 enhanced usual care participants that initiated baseline, 9 did not complete actigraphy assessment due to losing contact or opting out of this assessment procedure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sleep Well! Intervention | Child Sleep Patterns: Actigraphy Derived Nighttime Sleep Duration | Baseline (pre-intervention) | 556.97 Minutes per night | Standard Deviation 51.78 |
| Sleep Well! Intervention | Child Sleep Patterns: Actigraphy Derived Nighttime Sleep Duration | Time 2 (an average of 9 weeks post-baseline) | 545.45 Minutes per night | Standard Deviation 84.24 |
| Sleep Well! Intervention | Child Sleep Patterns: Actigraphy Derived Nighttime Sleep Duration | Time 3 (an average of 15 weeks post-baseline) | 571.40 Minutes per night | Standard Deviation 72.26 |
| Enhanced Usual Care | Child Sleep Patterns: Actigraphy Derived Nighttime Sleep Duration | Baseline (pre-intervention) | 559.96 Minutes per night | Standard Deviation 58.08 |
| Enhanced Usual Care | Child Sleep Patterns: Actigraphy Derived Nighttime Sleep Duration | Time 2 (an average of 9 weeks post-baseline) | 554.29 Minutes per night | Standard Deviation 76.57 |
| Enhanced Usual Care | Child Sleep Patterns: Actigraphy Derived Nighttime Sleep Duration | Time 3 (an average of 15 weeks post-baseline) | 557.69 Minutes per night | Standard Deviation 60.97 |
p-value: 0.734t-test, 2 sided
Secondary
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.
Time frame: Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline)
Population: The analytic sample is based on participants that completed the baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sleep Well! Intervention | Child Sleep Patterns: Duration of Wakings Per Night | Baseline (pre-intervention) | 106.80 Minutes | Standard Deviation 162.48 |
| Sleep Well! Intervention | Child Sleep Patterns: Duration of Wakings Per Night | Time 2 (an average of 9 weeks post-baseline) | 58.64 Minutes | Standard Deviation 109.07 |
| Sleep Well! Intervention | Child Sleep Patterns: Duration of Wakings Per Night | Time 3 (an average of 15 weeks post-baseline) | 21.38 Minutes | Standard Deviation 38.11 |
| Enhanced Usual Care | Child Sleep Patterns: Duration of Wakings Per Night | Baseline (pre-intervention) | 71.81 Minutes | Standard Deviation 113.85 |
| Enhanced Usual Care | Child Sleep Patterns: Duration of Wakings Per Night | Time 2 (an average of 9 weeks post-baseline) | 78.49 Minutes | Standard Deviation 132.51 |
| Enhanced Usual Care | Child Sleep Patterns: Duration of Wakings Per Night | Time 3 (an average of 15 weeks post-baseline) | 89.62 Minutes | Standard Deviation 175.08 |
p-value: 0.006t-test, 2 sided
Secondary
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.
Time frame: Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline)
Population: The analytic sample is based on participants that completed the baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sleep Well! Intervention | Child Sleep Patterns: Nighttime Sleep Duration | Baseline (pre-intervention) | 7.58 Hours | Standard Deviation 2.46 |
| Sleep Well! Intervention | Child Sleep Patterns: Nighttime Sleep Duration | Time 2 (an average of 9 weeks post-baseline) | 8.73 Hours | Standard Deviation 1.86 |
| Sleep Well! Intervention | Child Sleep Patterns: Nighttime Sleep Duration | Time 3 (an average of 15 weeks post-baseline) | 8.73 Hours | Standard Deviation 2.11 |
| Enhanced Usual Care | Child Sleep Patterns: Nighttime Sleep Duration | Time 2 (an average of 9 weeks post-baseline) | 8.39 Hours | Standard Deviation 2.06 |
| Enhanced Usual Care | Child Sleep Patterns: Nighttime Sleep Duration | Baseline (pre-intervention) | 7.99 Hours | Standard Deviation 2.62 |
| Enhanced Usual Care | Child Sleep Patterns: Nighttime Sleep Duration | Time 3 (an average of 15 weeks post-baseline) | 8.19 Hours | Standard Deviation 2.07 |
p-value: 0.045t-test, 2 sided
Secondary
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.
Time frame: Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline)
Population: The analytic sample is based on participants that completed the baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sleep Well! Intervention | Child Sleep Patterns: Number of Wakings Per Night | Time 3 (an average of 15 weeks post-baseline) | 1.02 Wakings | Standard Deviation 1.12 |
| Sleep Well! Intervention | Child Sleep Patterns: Number of Wakings Per Night | Baseline (pre-intervention) | 1.84 Wakings | Standard Deviation 1.54 |
| Sleep Well! Intervention | Child Sleep Patterns: Number of Wakings Per Night | Time 2 (an average of 9 weeks post-baseline) | 1.27 Wakings | Standard Deviation 1.07 |
| Enhanced Usual Care | Child Sleep Patterns: Number of Wakings Per Night | Time 2 (an average of 9 weeks post-baseline) | 1.37 Wakings | Standard Deviation 1.11 |
| Enhanced Usual Care | Child Sleep Patterns: Number of Wakings Per Night | Time 3 (an average of 15 weeks post-baseline) | 1.23 Wakings | Standard Deviation 1.06 |
| Enhanced Usual Care | Child Sleep Patterns: Number of Wakings Per Night | Baseline (pre-intervention) | 1.85 Wakings | Standard Deviation 1.16 |
p-value: 0.161t-test, 2 sided
Secondary
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.
Time frame: Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline)
Population: The analytic sample is based on participants that completed the baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sleep Well! Intervention | Child Sleep Patterns: Sleep Onset Latency | Time 3 (an average of 15 weeks post-baseline) | 29.13 Minutes | Standard Deviation 31.09 |
| Sleep Well! Intervention | Child Sleep Patterns: Sleep Onset Latency | Time 2 (an average of 9 weeks post-baseline) | 31.02 Minutes | Standard Deviation 35.35 |
| Sleep Well! Intervention | Child Sleep Patterns: Sleep Onset Latency | Baseline (pre-intervention) | 57.00 Minutes | Standard Deviation 46.24 |
| Enhanced Usual Care | Child Sleep Patterns: Sleep Onset Latency | Time 2 (an average of 9 weeks post-baseline) | 42.79 Minutes | Standard Deviation 35.78 |
| Enhanced Usual Care | Child Sleep Patterns: Sleep Onset Latency | Baseline (pre-intervention) | 52.34 Minutes | Standard Deviation 36.7 |
| Enhanced Usual Care | Child Sleep Patterns: Sleep Onset Latency | Time 3 (an average of 15 weeks post-baseline) | 38.08 Minutes | Standard Deviation 32.56 |
p-value: 0.01t-test, 2 sided
Secondary
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.
Time frame: Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline)
Population: The analytic sample is based on participants that completed the baseline assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sleep Well! Intervention | Child Sleep Patterns: Total 24-hour Sleep Duration | Time 2 (an average of 9 weeks post-baseline) | 10.61 Hours | Standard Deviation 2.81 |
| Sleep Well! Intervention | Child Sleep Patterns: Total 24-hour Sleep Duration | Time 3 (an average of 15 weeks post-baseline) | 10.29 Hours | Standard Deviation 2.42 |
| Sleep Well! Intervention | Child Sleep Patterns: Total 24-hour Sleep Duration | Baseline (pre-intervention) | 9.53 Hours | Standard Deviation 3.4 |
| Enhanced Usual Care | Child Sleep Patterns: Total 24-hour Sleep Duration | Time 2 (an average of 9 weeks post-baseline) | 10.18 Hours | Standard Deviation 2.68 |
| Enhanced Usual Care | Child Sleep Patterns: Total 24-hour Sleep Duration | Time 3 (an average of 15 weeks post-baseline) | 10.07 Hours | Standard Deviation 2.88 |
| Enhanced Usual Care | Child Sleep Patterns: Total 24-hour Sleep Duration | Baseline (pre-intervention) | 9.88 Hours | Standard Deviation 3.48 |
p-value: 0.685t-test, 2 sided
Secondary
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.
Time frame: Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline)
Population: Analysis was based on the sample that completed baseline (pre-intervention) measures.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sleep Well! Intervention | Child Sleep Problems: Bedtime Difficulties | Baseline (pre-intervention) | 41 Participants |
| Sleep Well! Intervention | Child Sleep Problems: Bedtime Difficulties | Time 2 (an average of 9 weeks post-baseline) | 18 Participants |
| Sleep Well! Intervention | Child Sleep Problems: Bedtime Difficulties | Time 3 (an average of 15 weeks post-baseline) | 14 Participants |
| Enhanced Usual Care | Child Sleep Problems: Bedtime Difficulties | Baseline (pre-intervention) | 36 Participants |
| Enhanced Usual Care | Child Sleep Problems: Bedtime Difficulties | Time 2 (an average of 9 weeks post-baseline) | 30 Participants |
| Enhanced Usual Care | Child Sleep Problems: Bedtime Difficulties | Time 3 (an average of 15 weeks post-baseline) | 22 Participants |
p-value: 0.032t-test, 2 sided
Secondary
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.
Time frame: Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline)
Population: Analysis was based on the sample that completed baseline (pre-intervention) measures.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sleep Well! Intervention | Severity of Child Sleep Problems | Baseline (pre-intervention) | 45 Participants |
| Sleep Well! Intervention | Severity of Child Sleep Problems | Time 2 (an average of 9 weeks post-baseline) | 20 Participants |
| Sleep Well! Intervention | Severity of Child Sleep Problems | Time 3 (an average of 15 weeks post-baseline) | 13 Participants |
| Enhanced Usual Care | Severity of Child Sleep Problems | Baseline (pre-intervention) | 38 Participants |
| Enhanced Usual Care | Severity of Child Sleep Problems | Time 2 (an average of 9 weeks post-baseline) | 33 Participants |
| Enhanced Usual Care | Severity of Child Sleep Problems | Time 3 (an average of 15 weeks post-baseline) | 21 Participants |
p-value: 0.026t-test, 2 sided