Sleep, Sleep Deprivation, Sleep Disturbance
Conditions
Keywords
Difficulty falling asleep, Difficulty staying asleep, Not getting enough sleep
Brief summary
Investigators will enroll up to 20 participants from 3 Children's Hospital of Philadelphia (CHOP) primary care locations. The primary objective is to determine the whether the Sleep Well! behavioral sleep intervention is feasible to be implemented in primary care offices and acceptable to families. The direction and magnitude of change in child sleep from pre-intervention to post-intervention will also be examined.
Detailed description
Behavioral sleep problems such as insomnia and insufficient sleep are common in toddlers and preschoolers and disproportionately impact lower socioeconomic status (SES) children. Despite a robust evidence base, behavioral sleep interventions are rarely tested with lower-SES children or in primary care, an accessible service delivery setting. The primary objective of this study is to determine the whether the Sleep Well! behavioral sleep intervention is feasible and acceptable to families. We will also examine the direction and magnitude of change in child sleep from pre-intervention to post-intervention. This is a preliminary open trial of the Sleep Well! program with pre-intervention and post-intervention assessments.Caregiver-child dyads (child ages 1-5 years with a sleep problem) will be recruited from CHOP urban primary care sites. Sleep Well! is a brief, behavioral sleep intervention for toddlers and preschoolers who have a caregiver-reported sleep problem or who are not getting enough sleep. The intervention includes evidence-based behavioral sleep approaches and strategies to engage and empower families. The primary outcomes for this open trial are feasibility (number of caregivers recruited, engaged, and retained in intervention; participant intervention attendance rate) and caregiver acceptability, assessed via a questionnaire and qualitative post-intervention interview. Secondary outcomes are the direction and magnitude in any pre- to post-intervention change in child sleep.
Interventions
BEHAVIORALSleep 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.
Sponsors
Children's Hospital of Philadelphia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Caregiver-child dyads (child ages 1-5 years with a sleep problem) will be recruited from CHOP urban primary care sites.
Eligibility
Sex/Gender
ALL
Age
12 Months to 5 Years
Healthy volunteers
No
Inclusion criteria
* Caregiver participant is the parent or legal guardian of the child subject. * Caregiver/legal guardian 18 years of age. * Child between the ages of 1 and 5 years. * Presence of caregiver-reported child sleep problem determined by a Brief Child Sleep Questionnaire item, included in an eligibility screening questionnaire or child meets American Academy of Sleep Medicine diagnostic criteria for either pediatric insomnia or insufficient sleep, assessed through an eligibility screening questionnaire. * English-speaking.
Exclusion criteria
* Caregiver is not parent or legal guardian of child participant. * Presence of a diagnosed child neurodevelopmental (e.g., autism spectrum disorder; Trisomy 21) or chronic medical condition (e.g., sickle cell disease, cancer) in which the disorder or treatment of the disorder impact sleep. * Caregivers/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Caregiver-child Participants Who Complete All Intervention Procedures Following Enrollment (Retention Rate) | Approximately 9 months | The study team will track the number of caregiver-child dyad participants who complete all intervention procedures following enrollment. |
| Number of Caregiver-child Participants Who Complete All Assessments (Pre-intervention and Post-intervention) That Were Planned (Feasibility) | 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. |
| Treatment Acceptability (Strategies) | 3 months | 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. |
| Cultural Humility | 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Patterns and Problems: Sleep Problem | Baseline (pre-intervention) and 3 months (post-intervention). | 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. |
| Sleep Patterns and Problems: 24-hour Sleep Duration | 3 months | 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. |
| Sleep Patterns and Problems: Sleep Onset Latency | 3 months | 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. |
| Sleep Patterns and Problems: Night Awakening Duration | 3 months | 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. |
| Sleep Patterns and Problems: Nighttime Sleep Duration | 3 months | 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. |
Countries
United States
Participant flow
Pre-assignment details
Both caregivers and children were enrolled in the study and were combined as a dyad.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Behavioral Sleep Intervention |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants |
| Age, Continuous | 3.00 years STANDARD_DEVIATION 1.36 |
| Brief Child Sleep Questionnaire- Perceived Sleep Problem Caregiver-perceived sleep problem | 15 Participants |
| Brief Child Sleep Questionnaire- Perceived Sleep Problem No caregiver-perceived sleep problem | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 15 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
Cultural Humility
Caregivers will complete the Multicultural Therapy Competency Inventory- Client Version (MTCI-CV), adapted to assess perceptions of the Sleep Well! therapist's/program's cultural humility (e.g. When we discussed my child's sleep, the Sleep Well! therapist seemed to have some understanding about my/my family's culture and background and When we discussed my child's sleep, the Sleep Well! therapist appreciated my expertise on my own life.) Average proportion of caregivers agreeing/strongly agreeing with statements on measure is reported.
Time frame: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Behavioral Sleep Intervention | Cultural Humility | Agree/strongly agree | 9 Participants |
| Behavioral Sleep Intervention | Cultural Humility | Neutral | 1 Participants |
| Behavioral Sleep Intervention | Cultural Humility | Disagree/strongly disagree | 0 Participants |
Primary
Number of Caregiver-child Participants Who Complete All Assessments (Pre-intervention and Post-intervention) That Were Planned (Feasibility)
The study team will track the number of proportion of participants who complete all assessments (pre-intervention and post-intervention) that were planned.
Time frame: Approximately 9 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Behavioral Sleep Intervention | Number of Caregiver-child Participants Who Complete All Assessments (Pre-intervention and Post-intervention) That Were Planned (Feasibility) | All assessments completed | 12 Participants |
| Behavioral Sleep Intervention | 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
Number of Caregiver-child Participants Who Complete All Intervention Procedures Following Enrollment (Retention Rate)
The study team will track the number of caregiver-child dyad participants who complete all intervention procedures following enrollment.
Time frame: Approximately 9 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Behavioral Sleep Intervention | Number of Caregiver-child Participants Who Complete All Intervention Procedures Following Enrollment (Retention Rate) | Retained in intervention | 13 Participants |
| Behavioral Sleep Intervention | Number of Caregiver-child Participants Who Complete All Intervention Procedures Following Enrollment (Retention Rate) | Attrition from intervention | 2 Participants |
Primary
Treatment Acceptability (Strategies)
Caregivers will complete the Treatment Evaluation Inventory-Short Form, a widely used measure of treatment acceptability that has been adapted for the purposes of the Sleep Well! intervention. Ratings are shown for proportion of caregivers agreeing or strongly agreeing with the statement that the strategies are acceptable.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Behavioral Sleep Intervention | Treatment Acceptability (Strategies) | 12 Caregivers |
Secondary
Sleep Patterns and Problems: 24-hour Sleep Duration
Caregivers will complete the BCSQ to report on child sleep habits and the severity of any caregiver-perceived sleep problems at pretreatment and posttreatment. The BCSQ is appropriate for children ages 1.5-5 years and has shown good reliability and moderate correspondence with actigraphic recordings of child-sleep.
Time frame: 3 months
Population: Analysis was for those with both pre- and post-intervention data (N = 12)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Behavioral Sleep Intervention | Sleep Patterns and Problems: 24-hour Sleep Duration | Pre-intervention | 8.71 hours | Standard Deviation 3.28 |
| Behavioral Sleep Intervention | Sleep Patterns and Problems: 24-hour Sleep Duration | Post-intervention | 9.98 hours | Standard Deviation 1.03 |
p-value: 0.209t-test, 2 sided
Secondary
Sleep Patterns and Problems: Night Awakening Duration
Caregivers will complete the BCSQ to report on child sleep habits and the severity of any caregiver-perceived sleep problems at pretreatment and posttreatment. The BCSQ is appropriate for children ages 1.5-5 years and has shown good reliability and moderate correspondence with actigraphic recordings of child-sleep.
Time frame: 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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Behavioral Sleep Intervention | Sleep Patterns and Problems: Night Awakening Duration | Pre-intervention | 131.25 minutes | Standard Deviation 121.55 |
| Behavioral Sleep Intervention | Sleep Patterns and Problems: Night Awakening Duration | Post-intervention | 27.50 minutes | Standard Deviation 58.56 |
p-value: 0.013t-test, 2 sided
Secondary
Sleep Patterns and Problems: Nighttime Sleep Duration
Caregivers will complete the BCSQ to report on child sleep habits and the severity of any caregiver-perceived sleep problems at pretreatment and posttreatment. The BCSQ is appropriate for children ages 1.5-5 years and has shown good reliability and moderate correspondence with actigraphic recordings of child-sleep.
Time frame: 3 months
Population: Analysis was for those with both pre- and post-intervention data (N = 12)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Behavioral Sleep Intervention | Sleep Patterns and Problems: Nighttime Sleep Duration | Pre-intervention | 6.63 hours | Standard Deviation 1.99 |
| Behavioral Sleep Intervention | Sleep Patterns and Problems: Nighttime Sleep Duration | Post-intervention | 9.21 hours | Standard Deviation 1.21 |
p-value: 0.001t-test, 2 sided
Secondary
Sleep Patterns and Problems: Sleep Onset Latency
Caregivers will complete the BCSQ to report on child sleep habits and the severity of any caregiver-perceived sleep problems at pretreatment and posttreatment. The BCSQ is appropriate for children ages 1.5-5 years and has shown good reliability and moderate correspondence with actigraphic recordings of child-sleep. When completing the BCSQ, caregivers are prompted to think about their child's sleep on a typical night over the past week (7 nights). Sleep onset latency is assessed by asking caregivers to report in minutes how long it typically takes their child to fall asleep.
Time frame: 3 months
Population: Analysis was for those with both pre- and post-intervention data (N = 12)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Behavioral Sleep Intervention | Sleep Patterns and Problems: Sleep Onset Latency | Pre-intervention | 69.00 minutes | Standard Deviation 50.41 |
| Behavioral Sleep Intervention | Sleep Patterns and Problems: Sleep Onset Latency | Post-intervention | 25.83 minutes | Standard Deviation 10.62 |
p-value: 0.014t-test, 2 sided
Secondary
Sleep Patterns and Problems: Sleep Problem
Caregivers will complete the Brief Child Sleep Questionnaire (BCSQ) to report on child sleep habits and the severity of any caregiver-perceived sleep problems at pretreatment and posttreatment. The BCSQ is appropriate for children ages 1.5-5 years and has shown good reliability and moderate correspondence with actigraphic recordings of child sleep.
Time frame: Baseline (pre-intervention) and 3 months (post-intervention).
Population: Analysis was for those with both pre- and post-intervention data (N = 12)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Behavioral Sleep Intervention | Sleep Patterns and Problems: Sleep Problem | Reduction from sleep problem at pre to no sleep problem at post | 8 Participants |
| Behavioral Sleep Intervention | Sleep Patterns and Problems: Sleep Problem | Sleep problem at both pre and post | 4 Participants |
p-value: 0.008McNemar