Trial Outcomes & Findings for Implementing Behavioral Sleep Intervention in Urban Primary Care (NCT NCT04046341)

Last Updated: 2021-10-08

Results Overview

The study team will track the number of caregiver-child dyad participants who complete all intervention procedures following enrollment.

Recruitment status

COMPLETED

Study phase

Target enrollment

15 participants

Primary outcome timeframe

Approximately 9 months

Results posted on

2021-10-08

Participant Flow

Both caregivers and children were enrolled in the study and were combined as a dyad.

Participant milestones

Participant milestones
Measure	Behavioral Sleep Intervention Caregivers attend 1-3 one-hour sessions at their primary care office or via telemedicine, where they receive sleep education and work with interventionists to develop strategies to help their child at bedtime. Sleep Well!: The intervention comprehensively addresses poor sleep health behaviors (e.g., use of electronics at bedtime; inconsistent and variable sleep schedules; lack of a bedtime routine) as well as insomnia (difficulty falling and staying asleep; the need for caregiver presence at bedtime) and insufficient sleep in toddlers and preschoolers. Interventionists will use strategies to engage with and empower families, such as motivational interviewing and collaborative problem-solving. Session content will be reinforced via phone calls from interventionists. Families will receive intervention session appointment reminders and information about intervention content (e.g., reminders to follow a bedtime routine) via text message.
Overall Study STARTED	15
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Behavioral Sleep Intervention Caregivers attend 1-3 one-hour sessions at their primary care office or via telemedicine, where they receive sleep education and work with interventionists to develop strategies to help their child at bedtime. Sleep Well!: The intervention comprehensively addresses poor sleep health behaviors (e.g., use of electronics at bedtime; inconsistent and variable sleep schedules; lack of a bedtime routine) as well as insomnia (difficulty falling and staying asleep; the need for caregiver presence at bedtime) and insufficient sleep in toddlers and preschoolers. Interventionists will use strategies to engage with and empower families, such as motivational interviewing and collaborative problem-solving. Session content will be reinforced via phone calls from interventionists. Families will receive intervention session appointment reminders and information about intervention content (e.g., reminders to follow a bedtime routine) via text message.
Overall Study Lost to Follow-up	2
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Implementing Behavioral Sleep Intervention in Urban Primary Care

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Behavioral Sleep Intervention n=15 Participants Caregivers attend 1-3 one-hour sessions at their primary care office or via telemedicine, where they receive sleep education and work with interventionists to develop strategies to help their child at bedtime. Sleep Well!: The intervention comprehensively addresses poor sleep health behaviors (e.g., use of electronics at bedtime; inconsistent and variable sleep schedules; lack of a bedtime routine) as well as insomnia (difficulty falling and staying asleep; the need for caregiver presence at bedtime) and insufficient sleep in toddlers and preschoolers. Interventionists will use strategies to engage with and empower families, such as motivational interviewing and collaborative problem-solving. Session content will be reinforced via phone calls from interventionists. Families will receive intervention session appointment reminders and information about intervention content (e.g., reminders to follow a bedtime routine) via text message.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	3.00 years STANDARD_DEVIATION 1.36 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	12 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants
Brief Child Sleep Questionnaire- Perceived Sleep Problem Caregiver-perceived sleep problem	15 Participants n=5 Participants
Brief Child Sleep Questionnaire- Perceived Sleep Problem No caregiver-perceived sleep problem	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Approximately 9 months

The study team will track the number of caregiver-child dyad participants who complete all intervention procedures following enrollment.

Outcome measures

Outcome measures
Measure	Behavioral Sleep Intervention n=15 Participants Parents attend 1-3 one-hour sessions at their primary care office or via telemedicine, where they receive sleep education and work with interventionists to develop strategies to help their child at bedtime. Sleep Well!: The intervention comprehensively addresses poor sleep health behaviors (e.g., use of electronics at bedtime; inconsistent and variable sleep schedules; lack of a bedtime routine) as well as insomnia (difficulty falling and staying asleep; the need for caregiver presence at bedtime) and insufficient sleep in toddlers and preschoolers. Interventionists will use strategies to engage with and empower families, such as motivational interviewing and collaborative problem-solving. Session content will be reinforced via phone calls from interventionists. Families will receive intervention session appointment reminders and information about intervention content (e.g., reminders to follow a bedtime routine) via text message.
Number of Caregiver-child Participants Who Complete All Intervention Procedures Following Enrollment (Retention Rate) Retained in intervention	13 Participants
Number of Caregiver-child Participants Who Complete All Intervention Procedures Following Enrollment (Retention Rate) Attrition from intervention	2 Participants

PRIMARY outcome

Timeframe: Approximately 9 months

The study team will track the number of proportion of participants who complete all assessments (pre-intervention and post-intervention) that were planned.

Outcome measures

Outcome measures
Measure	Behavioral Sleep Intervention n=15 Participants Parents attend 1-3 one-hour sessions at their primary care office or via telemedicine, where they receive sleep education and work with interventionists to develop strategies to help their child at bedtime. Sleep Well!: The intervention comprehensively addresses poor sleep health behaviors (e.g., use of electronics at bedtime; inconsistent and variable sleep schedules; lack of a bedtime routine) as well as insomnia (difficulty falling and staying asleep; the need for caregiver presence at bedtime) and insufficient sleep in toddlers and preschoolers. Interventionists will use strategies to engage with and empower families, such as motivational interviewing and collaborative problem-solving. Session content will be reinforced via phone calls from interventionists. Families will receive intervention session appointment reminders and information about intervention content (e.g., reminders to follow a bedtime routine) via text message.
Number of Caregiver-child Participants Who Complete All Assessments (Pre-intervention and Post-intervention) That Were Planned (Feasibility) All assessments completed	12 Participants
Number of Caregiver-child Participants Who Complete All Assessments (Pre-intervention and Post-intervention) That Were Planned (Feasibility) Post-intervention assessment not completed	3 Participants

PRIMARY outcome

Timeframe: 3 months

Population: The treatment evaluation form was administered at post-intervention only and thus data were not available for the 3 participants who did not complete the post-intervention assessment.

Caregivers will complete the Treatment Evaluation Inventory-Short Form, a widely used measure of treatment acceptability that has been adapted for the purposes of the Sleep Well! intervention. Ratings are shown for proportion of caregivers agreeing or strongly agreeing with the statement that the strategies are acceptable.

Outcome measures

Outcome measures
Measure	Behavioral Sleep Intervention n=12 Participants Parents attend 1-3 one-hour sessions at their primary care office or via telemedicine, where they receive sleep education and work with interventionists to develop strategies to help their child at bedtime. Sleep Well!: The intervention comprehensively addresses poor sleep health behaviors (e.g., use of electronics at bedtime; inconsistent and variable sleep schedules; lack of a bedtime routine) as well as insomnia (difficulty falling and staying asleep; the need for caregiver presence at bedtime) and insufficient sleep in toddlers and preschoolers. Interventionists will use strategies to engage with and empower families, such as motivational interviewing and collaborative problem-solving. Session content will be reinforced via phone calls from interventionists. Families will receive intervention session appointment reminders and information about intervention content (e.g., reminders to follow a bedtime routine) via text message.
Treatment Acceptability (Strategies)	12 Caregivers

PRIMARY outcome

Timeframe: 3 months

Population: The treatment evaluation form was administered at post-intervention only and was added to the protocol after feedback from family partners during the trial. Thus, data were not available for the 3 participants who did not complete the post-intervention assessment and the 2 participants that completed the intervention post-assessment before this measure was added.

Caregivers will complete the Multicultural Therapy Competency Inventory- Client Version (MTCI-CV), adapted to assess perceptions of the Sleep Well! therapist's/program's cultural humility (e.g. "When we discussed my child's sleep, the Sleep Well! therapist seemed to have some understanding about my/my family's culture and background" and "When we discussed my child's sleep, the Sleep Well! therapist appreciated my expertise on my own life.") Average proportion of caregivers agreeing/strongly agreeing with statements on measure is reported.

Outcome measures

Outcome measures
Measure	Behavioral Sleep Intervention n=10 Participants Parents attend 1-3 one-hour sessions at their primary care office or via telemedicine, where they receive sleep education and work with interventionists to develop strategies to help their child at bedtime. Sleep Well!: The intervention comprehensively addresses poor sleep health behaviors (e.g., use of electronics at bedtime; inconsistent and variable sleep schedules; lack of a bedtime routine) as well as insomnia (difficulty falling and staying asleep; the need for caregiver presence at bedtime) and insufficient sleep in toddlers and preschoolers. Interventionists will use strategies to engage with and empower families, such as motivational interviewing and collaborative problem-solving. Session content will be reinforced via phone calls from interventionists. Families will receive intervention session appointment reminders and information about intervention content (e.g., reminders to follow a bedtime routine) via text message.
Cultural Humility Agree/strongly agree	9 Participants
Cultural Humility Neutral	1 Participants
Cultural Humility Disagree/strongly disagree	0 Participants

SECONDARY outcome

Timeframe: Baseline (pre-intervention) and 3 months (post-intervention).

Population: Analysis was for those with both pre- and post-intervention data (N = 12)

Caregivers will complete the Brief Child Sleep Questionnaire (BCSQ) to report on child sleep habits and the severity of any caregiver-perceived sleep problems at pretreatment and posttreatment. The BCSQ is appropriate for children ages 1.5-5 years and has shown good reliability and moderate correspondence with actigraphic recordings of child sleep.

Outcome measures

Outcome measures
Measure	Behavioral Sleep Intervention n=12 Participants Parents attend 1-3 one-hour sessions at their primary care office or via telemedicine, where they receive sleep education and work with interventionists to develop strategies to help their child at bedtime. Sleep Well!: The intervention comprehensively addresses poor sleep health behaviors (e.g., use of electronics at bedtime; inconsistent and variable sleep schedules; lack of a bedtime routine) as well as insomnia (difficulty falling and staying asleep; the need for caregiver presence at bedtime) and insufficient sleep in toddlers and preschoolers. Interventionists will use strategies to engage with and empower families, such as motivational interviewing and collaborative problem-solving. Session content will be reinforced via phone calls from interventionists. Families will receive intervention session appointment reminders and information about intervention content (e.g., reminders to follow a bedtime routine) via text message.
Sleep Patterns and Problems: Sleep Problem Reduction from sleep problem at pre to no sleep problem at post	8 Participants
Sleep Patterns and Problems: Sleep Problem Sleep problem at both pre and post	4 Participants

SECONDARY outcome

Timeframe: 3 months

Population: Analysis was for those with both pre- and post-intervention data (N = 12)

Caregivers will complete the BCSQ to report on child sleep habits and the severity of any caregiver-perceived sleep problems at pretreatment and posttreatment. The BCSQ is appropriate for children ages 1.5-5 years and has shown good reliability and moderate correspondence with actigraphic recordings of child-sleep. When completing the BCSQ, caregivers are prompted to think about their child's sleep on a "typical night" over the past week (7 nights). Sleep onset latency is assessed by asking caregivers to report in minutes how long it typically takes their child to fall asleep.

Outcome measures

Outcome measures
Measure	Behavioral Sleep Intervention n=12 Participants Parents attend 1-3 one-hour sessions at their primary care office or via telemedicine, where they receive sleep education and work with interventionists to develop strategies to help their child at bedtime. Sleep Well!: The intervention comprehensively addresses poor sleep health behaviors (e.g., use of electronics at bedtime; inconsistent and variable sleep schedules; lack of a bedtime routine) as well as insomnia (difficulty falling and staying asleep; the need for caregiver presence at bedtime) and insufficient sleep in toddlers and preschoolers. Interventionists will use strategies to engage with and empower families, such as motivational interviewing and collaborative problem-solving. Session content will be reinforced via phone calls from interventionists. Families will receive intervention session appointment reminders and information about intervention content (e.g., reminders to follow a bedtime routine) via text message.
Sleep Patterns and Problems: Sleep Onset Latency Pre-intervention	69.00 minutes Standard Deviation 50.41
Sleep Patterns and Problems: Sleep Onset Latency Post-intervention	25.83 minutes Standard Deviation 10.62

SECONDARY outcome

Timeframe: 3 months

Population: Analysis was for those with both pre- and post-intervention data, and with a corrected version of the BCSQ that included the duration of night awakenings question (N =7)

Outcome measures

Outcome measures
Measure	Behavioral Sleep Intervention n=7 Participants Parents attend 1-3 one-hour sessions at their primary care office or via telemedicine, where they receive sleep education and work with interventionists to develop strategies to help their child at bedtime. Sleep Well!: The intervention comprehensively addresses poor sleep health behaviors (e.g., use of electronics at bedtime; inconsistent and variable sleep schedules; lack of a bedtime routine) as well as insomnia (difficulty falling and staying asleep; the need for caregiver presence at bedtime) and insufficient sleep in toddlers and preschoolers. Interventionists will use strategies to engage with and empower families, such as motivational interviewing and collaborative problem-solving. Session content will be reinforced via phone calls from interventionists. Families will receive intervention session appointment reminders and information about intervention content (e.g., reminders to follow a bedtime routine) via text message.
Sleep Patterns and Problems: Night Awakening Duration Pre-intervention	131.25 minutes Standard Deviation 121.55
Sleep Patterns and Problems: Night Awakening Duration Post-intervention	27.50 minutes Standard Deviation 58.56

SECONDARY outcome

Timeframe: 3 months

Population: Analysis was for those with both pre- and post-intervention data (N = 12)

Outcome measures

Outcome measures
Measure	Behavioral Sleep Intervention n=12 Participants Parents attend 1-3 one-hour sessions at their primary care office or via telemedicine, where they receive sleep education and work with interventionists to develop strategies to help their child at bedtime. Sleep Well!: The intervention comprehensively addresses poor sleep health behaviors (e.g., use of electronics at bedtime; inconsistent and variable sleep schedules; lack of a bedtime routine) as well as insomnia (difficulty falling and staying asleep; the need for caregiver presence at bedtime) and insufficient sleep in toddlers and preschoolers. Interventionists will use strategies to engage with and empower families, such as motivational interviewing and collaborative problem-solving. Session content will be reinforced via phone calls from interventionists. Families will receive intervention session appointment reminders and information about intervention content (e.g., reminders to follow a bedtime routine) via text message.
Sleep Patterns and Problems: Nighttime Sleep Duration Pre-intervention	6.63 hours Standard Deviation 1.99
Sleep Patterns and Problems: Nighttime Sleep Duration Post-intervention	9.21 hours Standard Deviation 1.21

SECONDARY outcome

Timeframe: 3 months

Population: Analysis was for those with both pre- and post-intervention data (N = 12)

Outcome measures

Outcome measures
Measure	Behavioral Sleep Intervention n=12 Participants Parents attend 1-3 one-hour sessions at their primary care office or via telemedicine, where they receive sleep education and work with interventionists to develop strategies to help their child at bedtime. Sleep Well!: The intervention comprehensively addresses poor sleep health behaviors (e.g., use of electronics at bedtime; inconsistent and variable sleep schedules; lack of a bedtime routine) as well as insomnia (difficulty falling and staying asleep; the need for caregiver presence at bedtime) and insufficient sleep in toddlers and preschoolers. Interventionists will use strategies to engage with and empower families, such as motivational interviewing and collaborative problem-solving. Session content will be reinforced via phone calls from interventionists. Families will receive intervention session appointment reminders and information about intervention content (e.g., reminders to follow a bedtime routine) via text message.
Sleep Patterns and Problems: 24-hour Sleep Duration Pre-intervention	8.71 hours Standard Deviation 3.28
Sleep Patterns and Problems: 24-hour Sleep Duration Post-intervention	9.98 hours Standard Deviation 1.03

Adverse Events

Behavioral Sleep Intervention

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

Marsha Wallace

Children's Hospital of Philadelphia

Phone: 2155900119

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place