Trial Outcomes & Findings for Behavioral Sleep Intervention in Urban Primary Care: Aim 3 (NCT NCT04473222)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

104 participants

Primary outcome timeframe

Study duration (up to 24 weeks)

Results posted on

2025-02-05

Participant Flow

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).

104 caregiver-child dyads 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.

Participant milestones

Participant milestones
Measure	Sleep Well! Intervention Caregiver-child dyads 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.	Enhanced Usual Care The enhanced usual care condition will occur between 6 and 8 weeks. At randomization to this condition, caregiver-child dyads will be provided with an evidence-based sleep guidelines for young children from the CHOP Parent Family Education manual. Caregiver-child dyads 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.
Overall Study STARTED	52	52
Overall Study Baseline	50	47
Overall Study Time 2/Post-intervention	44	43
Overall Study COMPLETED	39	37
Overall Study NOT COMPLETED	13	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Sleep Well! Intervention Caregiver-child dyads 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.	Enhanced Usual Care The enhanced usual care condition will occur between 6 and 8 weeks. At randomization to this condition, caregiver-child dyads will be provided with an evidence-based sleep guidelines for young children from the CHOP Parent Family Education manual. Caregiver-child dyads 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.
Overall Study Lost to Follow-up	13	13
Overall Study Withdrawal by Subject	0	1
Overall Study Participant partially completed baseline surveys, then lost contact, then re-consented	0	1

Baseline Characteristics

This information is for the caregiver participants only in the caregiver-child dyad. Caregivers reported their age by responding to a categorical question with age group brackets.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Sleep Well! Intervention n=50 Participants 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.	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.
Retention Rate (Intervention Feasibility) Completed all 3 sessions and all 3 phone calls	46 Participants	—
Retention Rate (Intervention Feasibility) Did not complete all 3 sessions and/or all 3 phone calls	4 Participants	—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Sleep Well! Intervention n=49 Participants 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.	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.
Family Engagement (Sessions)	4.58 units on a scale Standard Deviation 0.66	—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Sleep Well! Intervention n=49 Participants 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.	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.
Family Engagement (Telephone Calls)	4.59 units on a scale Standard Deviation 0.66	—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Sleep Well! Intervention n=44 Participants 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.	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.
Treatment Acceptability Strongly agree	28 Participants	—
Treatment Acceptability Agree	13 Participants	—
Treatment Acceptability Neutral	2 Participants	—
Treatment Acceptability Disagree	0 Participants	—
Treatment Acceptability Strongly disagree	1 Participants	—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Sleep Well! Intervention n=44 Participants 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.	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.
Treatment Acceptability: Cultural Humility Strongly agree	36 Participants	—
Treatment Acceptability: Cultural Humility Agree	4 Participants	—
Treatment Acceptability: Cultural Humility Neutral	1 Participants	—
Treatment Acceptability: Cultural Humility Disagree	0 Participants	—
Treatment Acceptability: Cultural Humility Strongly disagree	3 Participants	—

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Sleep Well! Intervention n=50 Participants 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.	Enhanced Usual Care n=47 Participants 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.
Assessment Process (Study Feasibility) Baseline (pre-intervention)	50 Participants	47 Participants
Assessment Process (Study Feasibility) Time 2 (an average of 9 weeks post-baseline)	44 Participants	43 Participants
Assessment Process (Study Feasibility) Time 3 (an average of 15 weeks post-baseline)	39 Participants	37 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Sleep Well! Intervention n=50 Participants 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.	Enhanced Usual Care n=47 Participants 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.
Severity of Child Sleep Problems Baseline (pre-intervention)	45 Participants	38 Participants
Severity of Child Sleep Problems Time 2 (an average of 9 weeks post-baseline)	20 Participants	33 Participants
Severity of Child Sleep Problems Time 3 (an average of 15 weeks post-baseline)	13 Participants	21 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Sleep Well! Intervention n=50 Participants 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.	Enhanced Usual Care n=47 Participants 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.
Child Sleep Problems: Bedtime Difficulties Baseline (pre-intervention)	41 Participants	36 Participants
Child Sleep Problems: Bedtime Difficulties Time 2 (an average of 9 weeks post-baseline)	18 Participants	30 Participants
Child Sleep Problems: Bedtime Difficulties Time 3 (an average of 15 weeks post-baseline)	14 Participants	22 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Sleep Well! Intervention n=50 Participants 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.	Enhanced Usual Care n=47 Participants 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.
Child Sleep Patterns: Sleep Onset Latency Baseline (pre-intervention)	57.00 Minutes Standard Deviation 46.24	52.34 Minutes Standard Deviation 36.70
Child Sleep Patterns: Sleep Onset Latency Time 2 (an average of 9 weeks post-baseline)	31.02 Minutes Standard Deviation 35.35	42.79 Minutes Standard Deviation 35.78
Child Sleep Patterns: Sleep Onset Latency Time 3 (an average of 15 weeks post-baseline)	29.13 Minutes Standard Deviation 31.09	38.08 Minutes Standard Deviation 32.56

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Sleep Well! Intervention n=50 Participants 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.	Enhanced Usual Care n=47 Participants 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.
Child Sleep Patterns: Number of Wakings Per Night Baseline (pre-intervention)	1.84 Wakings Standard Deviation 1.54	1.85 Wakings Standard Deviation 1.16
Child Sleep Patterns: Number of Wakings Per Night Time 2 (an average of 9 weeks post-baseline)	1.27 Wakings Standard Deviation 1.07	1.37 Wakings Standard Deviation 1.11
Child Sleep Patterns: Number of Wakings Per Night Time 3 (an average of 15 weeks post-baseline)	1.02 Wakings Standard Deviation 1.12	1.23 Wakings Standard Deviation 1.06

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Sleep Well! Intervention n=50 Participants 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.	Enhanced Usual Care n=47 Participants 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.
Child Sleep Patterns: Duration of Wakings Per Night Baseline (pre-intervention)	106.80 Minutes Standard Deviation 162.48	71.81 Minutes Standard Deviation 113.85
Child Sleep Patterns: Duration of Wakings Per Night Time 2 (an average of 9 weeks post-baseline)	58.64 Minutes Standard Deviation 109.07	78.49 Minutes Standard Deviation 132.51
Child Sleep Patterns: Duration of Wakings Per Night Time 3 (an average of 15 weeks post-baseline)	21.38 Minutes Standard Deviation 38.11	89.62 Minutes Standard Deviation 175.08

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Sleep Well! Intervention n=50 Participants 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.	Enhanced Usual Care n=47 Participants 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.
Child Sleep Patterns: Nighttime Sleep Duration Time 2 (an average of 9 weeks post-baseline)	8.73 Hours Standard Deviation 1.86	8.39 Hours Standard Deviation 2.06
Child Sleep Patterns: Nighttime Sleep Duration Baseline (pre-intervention)	7.58 Hours Standard Deviation 2.46	7.99 Hours Standard Deviation 2.62
Child Sleep Patterns: Nighttime Sleep Duration Time 3 (an average of 15 weeks post-baseline)	8.73 Hours Standard Deviation 2.11	8.19 Hours Standard Deviation 2.07

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Sleep Well! Intervention n=50 Participants 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.	Enhanced Usual Care n=47 Participants 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.
Child Sleep Patterns: Total 24-hour Sleep Duration Baseline (pre-intervention)	9.53 Hours Standard Deviation 3.40	9.88 Hours Standard Deviation 3.48
Child Sleep Patterns: Total 24-hour Sleep Duration Time 2 (an average of 9 weeks post-baseline)	10.61 Hours Standard Deviation 2.81	10.18 Hours Standard Deviation 2.68
Child Sleep Patterns: Total 24-hour Sleep Duration Time 3 (an average of 15 weeks post-baseline)	10.29 Hours Standard Deviation 2.42	10.07 Hours Standard Deviation 2.88

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Sleep Well! Intervention n=39 Participants 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.	Enhanced Usual Care n=38 Participants 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.
Child Sleep Patterns: Actigraphy Derived Nighttime Sleep Duration Baseline (pre-intervention)	556.97 Minutes per night Standard Deviation 51.78	559.96 Minutes per night Standard Deviation 58.08
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	554.29 Minutes per night Standard Deviation 76.57
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	557.69 Minutes per night Standard Deviation 60.97

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Sleep Well! Intervention n=50 Participants 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.	Enhanced Usual Care n=47 Participants 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.
Child Behavior Problems: Externalizing Problems Baseline (pre-intervention)	50.32 T-score Standard Deviation 11.45	45.68 T-score Standard Deviation 11.43
Child Behavior Problems: Externalizing Problems Time 2 (an average of 9 weeks post-baseline)	46.41 T-score Standard Deviation 12.09	44.14 T-score Standard Deviation 11.54
Child Behavior Problems: Externalizing Problems Time 3 (an average of 15 weeks post-baseline)	44.84 T-score Standard Deviation 10.85	44.47 T-score Standard Deviation 11.52

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Sleep Well! Intervention n=50 Participants 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.	Enhanced Usual Care n=47 Participants 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.
Child Behavior Problems: Internalizing Problems Baseline	47.39 T-score Standard Deviation 10.54	43.20 T-score Standard Deviation 10.23
Child Behavior Problems: Internalizing Problems Time 2 (an average of 9 weeks post-baseline)	44.20 T-score Standard Deviation 9.49	43.05 T-score Standard Deviation 12.46
Child Behavior Problems: Internalizing Problems Time 3 (an average of 15 weeks post-baseline)	44.54 T-score Standard Deviation 11.19	41.37 T-score Standard Deviation 10.86

Adverse Events

Sleep Well! Intervention Child Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Enhanced Usual Care Child Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sleep Well! Intervention Caregiver Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Enhanced Usual Care Caregiver Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ariel Williamson

University of Oregon

Phone: 971-352-4004

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Sleep Well! Intervention n=100 Participants 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.	Enhanced Usual Care n=94 Participants 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.	Total n=194 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=50 Participants • This information is for the caregiver participants only in the caregiver-child dyad. Caregivers reported their age by responding to a categorical question with age group brackets.	0 Participants n=47 Participants • This information is for the caregiver participants only in the caregiver-child dyad. Caregivers reported their age by responding to a categorical question with age group brackets.	0 Participants n=97 Participants • This information is for the caregiver participants only in the caregiver-child dyad. Caregivers reported their age by responding to a categorical question with age group brackets.
Age, Categorical Between 18 and 65 years	50 Participants n=50 Participants • This information is for the caregiver participants only in the caregiver-child dyad. Caregivers reported their age by responding to a categorical question with age group brackets.	47 Participants n=47 Participants • This information is for the caregiver participants only in the caregiver-child dyad. Caregivers reported their age by responding to a categorical question with age group brackets.	97 Participants n=97 Participants • This information is for the caregiver participants only in the caregiver-child dyad. Caregivers reported their age by responding to a categorical question with age group brackets.
Age, Categorical >=65 years	0 Participants n=50 Participants • This information is for the caregiver participants only in the caregiver-child dyad. Caregivers reported their age by responding to a categorical question with age group brackets.	0 Participants n=47 Participants • This information is for the caregiver participants only in the caregiver-child dyad. Caregivers reported their age by responding to a categorical question with age group brackets.	0 Participants n=97 Participants • This information is for the caregiver participants only in the caregiver-child dyad. Caregivers reported their age by responding to a categorical question with age group brackets.
Age, Continuous	2.50 years STANDARD_DEVIATION 1.18 • n=50 Participants • This information is for the child participants in the caregiver-child dyad. Age in years for the participating child was drawn from their medical record.	2.55 years STANDARD_DEVIATION 1.32 • n=47 Participants • This information is for the child participants in the caregiver-child dyad. Age in years for the participating child was drawn from their medical record.	2.52 years STANDARD_DEVIATION 1.24 • n=97 Participants • This information is for the child participants in the caregiver-child dyad. Age in years for the participating child was drawn from their medical record.
Sex: Female, Male Female	48 Participants n=50 Participants • This information is for the caregiver participants in the caregiver-child dyad. Caregivers reported their sex by responding to categorical survey question.	46 Participants n=47 Participants • This information is for the caregiver participants in the caregiver-child dyad. Caregivers reported their sex by responding to categorical survey question.	94 Participants n=97 Participants • This information is for the caregiver participants in the caregiver-child dyad. Caregivers reported their sex by responding to categorical survey question.
Sex: Female, Male Male	2 Participants n=50 Participants • This information is for the caregiver participants in the caregiver-child dyad. Caregivers reported their sex by responding to categorical survey question.	1 Participants n=47 Participants • This information is for the caregiver participants in the caregiver-child dyad. Caregivers reported their sex by responding to categorical survey question.	3 Participants n=97 Participants • This information is for the caregiver participants in the caregiver-child dyad. Caregivers reported their sex by responding to categorical survey question.
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=50 Participants • This information is for the caregiver participants in the caregiver-child dyad. Caregivers responded to a categorical item to report their ethnic background.	4 Participants n=47 Participants • This information is for the caregiver participants in the caregiver-child dyad. Caregivers responded to a categorical item to report their ethnic background.	6 Participants n=97 Participants • This information is for the caregiver participants in the caregiver-child dyad. Caregivers responded to a categorical item to report their ethnic background.
Ethnicity (NIH/OMB) Not Hispanic or Latino	48 Participants n=50 Participants • This information is for the caregiver participants in the caregiver-child dyad. Caregivers responded to a categorical item to report their ethnic background.	43 Participants n=47 Participants • This information is for the caregiver participants in the caregiver-child dyad. Caregivers responded to a categorical item to report their ethnic background.	91 Participants n=97 Participants • This information is for the caregiver participants in the caregiver-child dyad. Caregivers responded to a categorical item to report their ethnic background.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=50 Participants • This information is for the caregiver participants in the caregiver-child dyad. Caregivers responded to a categorical item to report their ethnic background.	0 Participants n=47 Participants • This information is for the caregiver participants in the caregiver-child dyad. Caregivers responded to a categorical item to report their ethnic background.	0 Participants n=97 Participants • This information is for the caregiver participants in the caregiver-child dyad. Caregivers responded to a categorical item to report their ethnic background.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=50 Participants • This information is for the caregiver participants in the caregiver-child dyad. Caregivers responded to a categorical item to report their racial background.	0 Participants n=47 Participants • This information is for the caregiver participants in the caregiver-child dyad. Caregivers responded to a categorical item to report their racial background.	0 Participants n=97 Participants • This information is for the caregiver participants in the caregiver-child dyad. Caregivers responded to a categorical item to report their racial background.
Race (NIH/OMB) Asian	2 Participants n=50 Participants • This information is for the caregiver participants in the caregiver-child dyad. Caregivers responded to a categorical item to report their racial background.	1 Participants n=47 Participants • This information is for the caregiver participants in the caregiver-child dyad. Caregivers responded to a categorical item to report their racial background.	3 Participants n=97 Participants • This information is for the caregiver participants in the caregiver-child dyad. Caregivers responded to a categorical item to report their racial background.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=50 Participants • This information is for the caregiver participants in the caregiver-child dyad. Caregivers responded to a categorical item to report their racial background.	1 Participants n=47 Participants • This information is for the caregiver participants in the caregiver-child dyad. Caregivers responded to a categorical item to report their racial background.	1 Participants n=97 Participants • This information is for the caregiver participants in the caregiver-child dyad. Caregivers responded to a categorical item to report their racial background.
Race (NIH/OMB) Black or African American	32 Participants n=50 Participants • This information is for the caregiver participants in the caregiver-child dyad. Caregivers responded to a categorical item to report their racial background.	35 Participants n=47 Participants • This information is for the caregiver participants in the caregiver-child dyad. Caregivers responded to a categorical item to report their racial background.	67 Participants n=97 Participants • This information is for the caregiver participants in the caregiver-child dyad. Caregivers responded to a categorical item to report their racial background.
Race (NIH/OMB) White	12 Participants n=50 Participants • This information is for the caregiver participants in the caregiver-child dyad. Caregivers responded to a categorical item to report their racial background.	8 Participants n=47 Participants • This information is for the caregiver participants in the caregiver-child dyad. Caregivers responded to a categorical item to report their racial background.	20 Participants n=97 Participants • This information is for the caregiver participants in the caregiver-child dyad. Caregivers responded to a categorical item to report their racial background.
Race (NIH/OMB) More than one race	0 Participants n=50 Participants • This information is for the caregiver participants in the caregiver-child dyad. Caregivers responded to a categorical item to report their racial background.	0 Participants n=47 Participants • This information is for the caregiver participants in the caregiver-child dyad. Caregivers responded to a categorical item to report their racial background.	0 Participants n=97 Participants • This information is for the caregiver participants in the caregiver-child dyad. Caregivers responded to a categorical item to report their racial background.
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=50 Participants • This information is for the caregiver participants in the caregiver-child dyad. Caregivers responded to a categorical item to report their racial background.	2 Participants n=47 Participants • This information is for the caregiver participants in the caregiver-child dyad. Caregivers responded to a categorical item to report their racial background.	6 Participants n=97 Participants • This information is for the caregiver participants in the caregiver-child dyad. Caregivers responded to a categorical item to report their racial background.
Region of Enrollment United States	100 participants n=100 Participants	94 participants n=94 Participants	194 participants n=194 Participants
Caregiver educational attainment Greater than high school education	30 Participants n=50 Participants • This information is for the caregiver participants in the caregiver-child dyad. Caregivers reported on their highest level of educational attainment, which was dichotomized to reflect education of high school or less and education of more than high school.	32 Participants n=47 Participants • This information is for the caregiver participants in the caregiver-child dyad. Caregivers reported on their highest level of educational attainment, which was dichotomized to reflect education of high school or less and education of more than high school.	62 Participants n=97 Participants • This information is for the caregiver participants in the caregiver-child dyad. Caregivers reported on their highest level of educational attainment, which was dichotomized to reflect education of high school or less and education of more than high school.
Caregiver educational attainment High school education or less	20 Participants n=50 Participants • This information is for the caregiver participants in the caregiver-child dyad. Caregivers reported on their highest level of educational attainment, which was dichotomized to reflect education of high school or less and education of more than high school.	15 Participants n=47 Participants • This information is for the caregiver participants in the caregiver-child dyad. Caregivers reported on their highest level of educational attainment, which was dichotomized to reflect education of high school or less and education of more than high school.	35 Participants n=97 Participants • This information is for the caregiver participants in the caregiver-child dyad. Caregivers reported on their highest level of educational attainment, which was dichotomized to reflect education of high school or less and education of more than high school.
Family living at or below 125% of the US poverty line Living at or below 125% of the poverty line	22 Participants n=50 Participants • This information reflects the caregiver within the caregiver-child dyad. Caregivers reported on their family size and household income, which were used to determine whether families were living at 125% or below the US federal poverty line, according to US guidelines.	17 Participants n=47 Participants • This information reflects the caregiver within the caregiver-child dyad. Caregivers reported on their family size and household income, which were used to determine whether families were living at 125% or below the US federal poverty line, according to US guidelines.	39 Participants n=97 Participants • This information reflects the caregiver within the caregiver-child dyad. Caregivers reported on their family size and household income, which were used to determine whether families were living at 125% or below the US federal poverty line, according to US guidelines.
Family living at or below 125% of the US poverty line Living above 125% of the poverty line	28 Participants n=50 Participants • This information reflects the caregiver within the caregiver-child dyad. Caregivers reported on their family size and household income, which were used to determine whether families were living at 125% or below the US federal poverty line, according to US guidelines.	30 Participants n=47 Participants • This information reflects the caregiver within the caregiver-child dyad. Caregivers reported on their family size and household income, which were used to determine whether families were living at 125% or below the US federal poverty line, according to US guidelines.	58 Participants n=97 Participants • This information reflects the caregiver within the caregiver-child dyad. Caregivers reported on their family size and household income, which were used to determine whether families were living at 125% or below the US federal poverty line, according to US guidelines.