SleepNCT04592172
Impact of Bedtime Routines on Sleep and Development in Toddlers
A study testing Bedtime Routine Education in people with Sleep and Sleep Disturbance, run by Saint Joseph's University, Philadelphia at 1 site in United States.
Trial summary
Investigators will recruit up to 100 families (children aged 12.0 to 14.9 months and their primary caregivers) at their scheduled 12-month well child care infant visit at Temple Pediatric Care. Read more about this study
- Who is it for?
- Ages 12 to 15 months
- Conditions the study is for
- Sleep, Sleep Disturbance, Child Development
- What is being tested?
- Bedtime Routine Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2020to 4 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 15 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Presenting to a well child visit
- Child between 12.0 to 14.9 months of age
- English-speaking
- Caregiver is legal guardian of infant
- Caregiver is primary caregiver of infant
Who cannot join
- Non-English speaking
- Absence of primary caregiver at both the 12-month and 15-month well-child visit
Trial locations and contacts
1 site in 1 country.
About this study
Investigators will recruit up to 100 families (children aged 12.0 to 14.9 months and their primary caregivers) at their scheduled 12-month well child care infant visit at Temple Pediatric Care. The purpose of this randomized controlled trial is to examine the impact of implementation of a bedtime routine program, Connect, Calm, \& Comfort: 3 Cs for Bedtime ZZZs, to promote better sleep and improve developmental outcomes in toddlers from primarily low-income families.
Read the detailed description
A bedtime routine is a key factor in the promotion of not only healthy sleep, but also potentially of broad development and wellbeing in early childhood. A bedtime routine, in and of itself, embodies the characteristics of nurturing care and early child stimulation especially for at-risk children. It is consistent with the Lancet Early Childhood Series Steering Committee emphasizing the need for nurturing care, which includes adequate health, nutrition, security and safety, responsive caregiving, and early learning opportunities, to help young children (ages 0-5 years) reach their full developmental potential, and to build a strong foundation for subsequent development, health, and wellbeing. Common, adaptive components of a bedtime routine can contribute to an array of positive developmental outcomes beyond improved sleep, inclusive of language development, literacy, child emotional and behavioral regulation, parent-child attachment, and family functioning, among other outcomes. Although studies have been conducted on the relationship between bedtime routines and sleep, there have been few studies looking at bedtime routines and other developmental outcomes.
- Conditions
- Sleep, Sleep Disturbance, Child Development
- Being tested
- Bedtime Routine Education
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bedtime Routine EducationBehavioural
The intervention aims to promote healthy sleep and improved developmental outcomes in infants. Individualized bedtime routine education, including such activities as a bath, teeth-brushing, reading stories, singing songs, and cuddling will be implemented by research assistants at the 12-month well-child visit. Reinforcement of the bedtime routine education will be implemented at the 15-month visit. Each individualized bedtime routine will incorporate 3-5 steps and a bedtime routine chart depicting those steps will be created and provided to the families. Families will receive materials for their bedtime routines, including a CuddleBright kit, 1-2 additional bedtime books, toothbrush/toothpaste , and the created bedtime chart. On top of that, families will also receive a children's book provided by Reach Out and Read through the study period.
| Study group | Role | What they receive |
|---|---|---|
| Bedtime Routine Education | Experimental | 50 families will be randomly assigned to receive the bedtime routine intervention, 3 Cs for Bedtime ZZZs delivered by research assistants at the 12-month and 15-month well-child visits, in additional to receiving usual clinical care. The intervention will take approximately 30-45 minutes to implement at each study visit. Research assistants will be trained and supervised by board-certified Behavioral Sleep Medicine providers. This intervention focuses on developing an individualized bedtime routine, including such activities as a bath, teeth-brushing, reading stories, singing songs, and cuddling, based on parent's preferences. Families will receive appropriate materials for their bedtime routine, including a CuddleBright kit, bedtime books, toothbrush/toothpaste, and the created bedtime chart to take home. Receives: Behavioral: Bedtime Routine Education |
| Control group | No intervention | 50 families will be randomly assigned to control group (usual care). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sleep outcomes - bedtime routines
At the 12-month, 15-month, and 24-month visits, caregivers will report on bedtime routine frequency (the number of nights their child followed the same bedtime routine) from the well-validated and widely used Brief Infant Sleep Questionnaire-Revised (Short Form) (BISQ-R).
Measured: 12-month, 15-month, and 24-month visits
Sleep outcomes - patterns and problems
At 15-month and 24-month visits, caregivers will complete the well-validated and widely used Brief Infant Sleep Questionnaire-Revised (Short Form) (BISQ-R) to report on toddler sleep over the last two weeks. The BISQ-R contains items related to the child sleep environment (e.g., sleep space, location, and arrangement) and patterns (e.g., bedtime, sleep onset latency, night awakening frequency and duration, wake time). Items also assess caregiver-perceived child sleep problems (e.g., overall sleep problem severity, bedtime resistance severity).
Measured: 15-month and 24-month visits
Secondary outcomes (4)
Socio-emotional outcomes
The Brief Infant-Toddler Social and Emotional Assessment (BITSEA) is a screener derived from the longer ITSEA. It is a parent questionnaire that assesses the social-emotional development of children ranging in age from 12 to 36 months. Caregivers will rate each statement that best describes the child's behavior in the past month, with scores ranging from 0 to 84. Higher scores denote possible social-emotional/ behavioral concerns.
Measured: 15-month and 24-month visits
Parent stress
The Parenting Stress Index (PSI) Short form is a 36-items reliable measure to assess total parenting stress with high internal consistency. It consists of three subscales: parental distress, parent-child dysfunctional interaction, and difficult child. Statements on this measure are rated on a 5-point Likert scale from strongly agree to strongly disagree, with scores ranging from 36 to 180. Higher scores denote higher level of stress in parent-child relationship.
Measured: 15-month and 24-month visits
Treatment acceptability
Caregivers randomized to the bedtime routine education arm will complete the treatment acceptability/bedtime routine evaluation form. Caregivers will rate 7 statements related to the perceived helpfulness/efficacy and acceptability of the intervention using a 5-point Likert scale from strongly disagree to strongly agree, with total scores ranging from 0 to 35. Higher scores indicate higher perceived helpfulness and acceptability of the intervention.
Measured: 15-month and 24-month visits
Treatment feasibility
The study team will track the number of treatment sessions completed (maximum = 2, 1 session at 12-month visit and 1 session at 15-month visit) for caregivers randomized to the bedtime routine education arm.
Measured: 12-month and 15-month visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start20 Nov 2020
- Primary completion4 Nov 2022
- Study completion4 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 100 caregiver-infant dyads (infants ages 12.0 to 14.9 months) will be recruited from Temple Pediatric Care Outpatient Pediatric office with follow-up visits at approximately 15 and 24 months of age.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Joseph's University, Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Temple University, Simms/Mann Family Foundation, CuddleBright Cares, Johnson & Johnson Consumer Inc. (J&JCI)
- Responsible party
- Sponsor
- Investigators
- Megan Heere, MD, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04592172
- Sponsor's protocol ID
- 2020-02
- Status last verified
- Nov 2022
- First submitted
- 4 Sep 2020
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Bedtime Routines on Sleep and Development in Toddlers
- ClinicalTrials.gov ID
- NCT04592172
- Acronym / sponsor ID
- 2020-02
- Conditions
- Sleep, Sleep Disturbance, Child Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Saint Joseph's University, PhiladelphiaUniversity, hospital or other
- Collaborators
- Temple University, Simms/Mann Family Foundation, CuddleBright Cares, Johnson & Johnson Consumer Inc. (J&JCI)
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 4 Nov 2022 (actual)
- Study completion
- 4 Nov 2022 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigators will recruit up to 100 families (children aged 12.0 to 14.9 months and their primary caregivers) at their scheduled 12-month well child care infant visit at Temple Pediatric Care. The purpose of this randomized controlled trial is to examine the impact of implementation of a bedtime routine program, Connect, Calm, \& Comfort: 3 Cs for Bedtime ZZZs, to promote better sleep and improve developmental outcomes in toddlers from primarily low-income families.
Detailed description
A bedtime routine is a key factor in the promotion of not only healthy sleep, but also potentially of broad development and wellbeing in early childhood. A bedtime routine, in and of itself, embodies the characteristics of nurturing care and early child stimulation especially for at-risk children. It is consistent with the Lancet Early Childhood Series Steering Committee emphasizing the need for nurturing care, which includes adequate health, nutrition, security and safety, responsive caregiving, and early learning opportunities, to help young children (ages 0-5 years) reach their full developmental potential, and to build a strong foundation for subsequent development, health, and wellbeing. Common, adaptive components of a bedtime routine can contribute to an array of positive developmental outcomes beyond improved sleep, inclusive of language development, literacy, child emotional and behavioral regulation, parent-child attachment, and family functioning, among other outcomes. Although studies have been conducted on the relationship between bedtime routines and sleep, there have been few studies looking at bedtime routines and other developmental outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 100 caregiver-infant dyads (infants ages 12.0 to 14.9 months) will be recruited from Temple Pediatric Care Outpatient Pediatric office with follow-up visits at approximately 15 and 24 months of age.
| Arm | Type | Receives |
|---|---|---|
| Bedtime Routine Education | Experimental | Behavioral: Bedtime Routine Education50 families will be randomly assigned to receive the bedtime routine intervention, 3 Cs for Bedtime ZZZs delivered by research assistants at the 12-month and 15-month well-child visits, in additional to receiving usual clinical care. The intervention will take approximately 30-45 minutes to implement at each study visit. Research assistants will be trained and supervised by board-certified Behavioral Sleep Medicine providers. This intervention focuses on developing an individualized bedtime routine, including such activities as a bath, teeth-brushing, reading stories, singing songs, and cuddling, based on parent's preferences. Families will receive appropriate materials for their bedtime routine, including a CuddleBright kit, bedtime books, toothbrush/toothpaste, and the created bedtime chart to take home. |
| Control group | No intervention | –50 families will be randomly assigned to control group (usual care). |
Who may qualify
- Ages
- 12 to 15 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Presenting to a well child visit
- Child between 12.0 to 14.9 months of age
- English-speaking
- Caregiver is legal guardian of infant
- Caregiver is primary caregiver of infant
Key exclusion criteria (2 listed)
- Non-English speaking
- Absence of primary caregiver at both the 12-month and 15-month well-child visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bedtime Routine EducationThe intervention aims to promote healthy sleep and improved developmental outcomes in infants. Individualized bedtime routine education, including such activities as a bath, teeth-brushing, reading stories, singing songs, and cuddling will be implemented by research assistants at the 12-month well-child visit. Reinforcement of the bedtime routine education will be implemented at the 15-month visit. Each individualized bedtime routine will incorporate 3-5 steps and a bedtime routine chart depicting those steps will be created and provided to the families. Families will receive materials for their bedtime routines, including a CuddleBright kit, 1-2 additional bedtime books, toothbrush/toothpaste , and the created bedtime chart. On top of that, families will also receive a children's book provided by Reach Out and Read through the study period. | Behavioural | Bedtime Routine Education |
Primary outcome
Change in sleep outcomes - bedtime routines
Time frame: 12-month, 15-month, and 24-month visits
At the 12-month, 15-month, and 24-month visits, caregivers will report on bedtime routine frequency (the number of nights their child followed the same bedtime routine) from the well-validated and widely used Brief Infant Sleep Questionnaire-Revised (Short Form) (BISQ-R).
Sleep outcomes - patterns and problems
Time frame: 15-month and 24-month visits
At 15-month and 24-month visits, caregivers will complete the well-validated and widely used Brief Infant Sleep Questionnaire-Revised (Short Form) (BISQ-R) to report on toddler sleep over the last two weeks. The BISQ-R contains items related to the child sleep environment (e.g., sleep space, location, and arrangement) and patterns (e.g., bedtime, sleep onset latency, night awakening frequency and duration, wake time). Items also assess caregiver-perceived child sleep problems (e.g., overall sleep problem severity, bedtime resistance severity).
4 secondary outcomes
Socio-emotional outcomes
Time frame: 15-month and 24-month visits
Parent stress
Time frame: 15-month and 24-month visits
Treatment acceptability
Time frame: 15-month and 24-month visits
Treatment feasibility
Time frame: 12-month and 15-month visits
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Megan Heere, MD principal investigator
Temple University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bedtime Routine Education in people with Sleep and Sleep Disturbance, run by Saint Joseph's University, Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sleep outcomes - bedtime routines (time frame: 12-month, 15-month, and 24-month visits). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.