SleepNCT06038591
Parent Intervention to Improve Child Sleep
A study testing Sleep Tight in people with Sleep, run by University of South Carolina at 1 site in United States.
Trial summary
In this study, the investigators pilot tested a parenting intervention to improve young children's sleep in families with low income. Families were randomized to an intervention or wait-list control group. The investigators hypothesized the intervention would be feasible and acceptable to enrolled families. Read more about this study
- Who is it for?
- Ages 2 to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Sleep Tight
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2024to 28 Mar 2025
- 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 2 to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parents or primary caregivers 18 years of age or older
- Have a child 2-4 years of age
- Child's 24-hour sleep duration does not meet established recommendations based on child age
- English speaking
- Annual household income <= 200% of the Federal Poverty Line or receive assistance benefits (e.g., SNAP, WIC)
- Computer or phone access for video calls
Who cannot join
- Parent or child has a medical condition that impairs their ability to participate
- Child has a clinical sleep disorder
- Child takes medication that significantly impacts their sleep
Trial locations and contacts
1 site in 1 country.
United States1 site
South Carolina early childhood support state agencies
Columbia, South Carolina, 29204
About this study
Official title: Parenting Intervention to Improve Young Children's Sleep Among Families With Low Income
In this study, the investigators pilot tested a parenting intervention to improve young children's sleep in families with low income. Families were randomized to an intervention or wait-list control group. The investigators hypothesized the intervention would be feasible and acceptable to enrolled families.
Read the detailed description
This pilot study tested a parenting intervention to improve young children's sleep in families with low income using a randomized controlled trial (RCT) design. Parents were randomized to the intervention or wait-list control group. Intervention content was delivered in virtual sessions with a parent and interventionist. The primary aim was to examine intervention feasibility (e.g., recruitment, retention, acceptability) with a secondary goal of preliminary efficacy on intervention changes in child sleep patterns to inform a future large-scale RCT. Exploratory evidence was collected on changes in children's health behaviors (e.g., diet, screen time), and social-emotional health (e.g., behavior problems) as indicators for potential spillover effects on these domains.
- Conditions
- Sleep
- Being tested
- Sleep Tight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep TightBehavioural
The sleep intervention focuses on enhancing young children's sleep by providing parents with behavioral strategies and support. Interventionists will work with parents on establishing consistent soothing bedtime routines; behavioral regulation to manage bedtime resistance and nighttime wakings; goal setting, problem solving, and action planning; self-monitoring via daily sleep logs; and stimulus control of child's sleep environment.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Intervention | Experimental | The sleep intervention focuses on enhancing young children's sleep by providing parents with behavioral strategies and support. Interventionists will work with parents on establishing consistent soothing bedtime routines; behavioral regulation to manage bedtime resistance and nighttime wakings; goal setting, problem solving, and action planning; self-monitoring via daily sleep logs; and stimulus control of child's sleep environment. Receives: Behavioral: Sleep Tight |
| Comparison/control | No intervention | The comparison arm is a no-contact control group. Parents and children will not receive any intervention. They will be placed on a wait-list, and then offered the sleep intervention once the post-assessments are complete. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention feasibility: recruitment screening eligibility
Percent of children screened who were eligible
Measured: Through study completion, an average of 2 years
Intervention feasibility: recruitment screening enrollment
Percent of eligible children who were enrolled
Measured: Through study completion, an average of 2 years
Intervention feasibility: recruitment duration
Duration to reach the target sample
Measured: Through study completion, an average of 2 years
Intervention feasibility: Enrollment yield for each recruitment strategy
Percent of enrolled participants that were recruited via each recruitment strategy to determine the highest and lowest yielding strategies.
Measured: Through study completion, an average of 2 years
Intervention feasibility: retention attendance
Percent attendance at assessment visits
Measured: Through study completion, an average of 2 years
Intervention feasibility: retention percentage
Percent of sample retained at post-intervention
Measured: Through study completion, an average of 2 years
Intervention feasibility: retention dropout
Percent of sample that drops out or is lost to follow-up
Measured: Through study completion, an average of 2 years
Intervention feasibility: retention dropout reasons
Reasons for dropping out of the study
Measured: Through study completion, an average of 2 years
Intervention acceptability
Acceptability will be assessed in an exit survey with Likert scale items and open-ended questions about intervention likes/dislikes and suggestions for future changes. Likert scale values range 1-5. Higher numbers indicate better outcomes (e.g., more positive acceptability)
Measured: Through study completion, an average of 2 years
Secondary outcomes (8)
Process measures: Intervention attendance
Proportion of intervention sessions attended, including makeup sessions, obtained from attendance records.
Measured: Through study completion, an average of 2 years
Process measures: Content fidelity
Checklist completed by researchers for each intervention session that evaluates the extent to which the program content was addressed
Measured: Through study completion, an average of 2 years
Process measure: Implementation
Survey checklist completed by interventionists after each intervention session that assess implementation barriers
Measured: Through study completion, an average of 2 years
Child sleep: night sleep duration
Wrist-worn actigraphy devices were used to calculate child's nighttime sleep duration
Measured: Baseline (0 weeks) and post-intervention (6 weeks)
Child sleep: daytime sleep duration
Wrist-worn actigraphy devices were used to calculate child's daytime sleep duration
Measured: Baseline (0 weeks) and post-intervention (6 weeks)
Child sleep: 24-hour sleep duration
Wrist-worn actigraphy devices were used to calculate child's 24-hour sleep duration
Measured: Baseline (0 weeks) and post-intervention (6 weeks)
Child sleep: sleep quality
Wrist-worn actigraphy devices were used to calculate child's sleep quality (e.g., wake after sleep onset)
Measured: Baseline (0 weeks) and post-intervention (6 weeks)
Child sleep: sleep timing
Wrist-worn actigraphy devices were used to calculate variability in child's sleep timing
Measured: Baseline (0 weeks) and post-intervention (6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start8 Jan 2024
- Primary completion3 Jan 2025
- Study completion28 Mar 2025
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.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Temple University, National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Elizabeth Adams, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06038591
- Sponsor's protocol ID
- Pro00123879
- Other IDs
- 5P20GM130420
- Status last verified
- Apr 2025
- First submitted
- 28 Aug 2023
- Last updated
- 4 Apr 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 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parenting Intervention to Improve Young Children's Sleep Among Families With Low Income
- ClinicalTrials.gov ID
- NCT06038591
- Acronym / sponsor ID
- Pro00123879
- Conditions
- Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- Temple University, National Institute of General Medical Sciences (NIGMS)
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 3 Jan 2025 (actual)
- Study completion
- 28 Mar 2025 (actual)
- First posted
- 15 Sep 2023 (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.
In this study, the investigators pilot tested a parenting intervention to improve young children's sleep in families with low income. Families were randomized to an intervention or wait-list control group. The investigators hypothesized the intervention would be feasible and acceptable to enrolled families.
Detailed description
This pilot study tested a parenting intervention to improve young children's sleep in families with low income using a randomized controlled trial (RCT) design. Parents were randomized to the intervention or wait-list control group. Intervention content was delivered in virtual sessions with a parent and interventionist. The primary aim was to examine intervention feasibility (e.g., recruitment, retention, acceptability) with a secondary goal of preliminary efficacy on intervention changes in child sleep patterns to inform a future large-scale RCT. Exploratory evidence was collected on changes in children's health behaviors (e.g., diet, screen time), and social-emotional health (e.g., behavior problems) as indicators for potential spillover effects on these domains.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep Intervention | Experimental | Behavioral: Sleep TightThe sleep intervention focuses on enhancing young children's sleep by providing parents with behavioral strategies and support. Interventionists will work with parents on establishing consistent soothing bedtime routines; behavioral regulation to manage bedtime resistance and nighttime wakings; goal setting, problem solving, and action planning; self-monitoring via daily sleep logs; and stimulus control of child's sleep environment. |
| Comparison/control | No intervention | –The comparison arm is a no-contact control group. Parents and children will not receive any intervention. They will be placed on a wait-list, and then offered the sleep intervention once the post-assessments are complete. |
Who may qualify
- Ages
- 2 to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Parents or primary caregivers 18 years of age or older
- Have a child 2-4 years of age
- Child's 24-hour sleep duration does not meet established recommendations based on child age
- English speaking
- Annual household income <= 200% of the Federal Poverty Line or receive assistance benefits (e.g., SNAP, WIC)
Key exclusion criteria (3 listed)
- Parent or child has a medical condition that impairs their ability to participate
- Child has a clinical sleep disorder
- Child takes medication that significantly impacts their sleep
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 |
|---|---|---|
| Sleep TightThe sleep intervention focuses on enhancing young children's sleep by providing parents with behavioral strategies and support. Interventionists will work with parents on establishing consistent soothing bedtime routines; behavioral regulation to manage bedtime resistance and nighttime wakings; goal setting, problem solving, and action planning; self-monitoring via daily sleep logs; and stimulus control of child's sleep environment. | Behavioural | Sleep Intervention |
Primary outcome
Intervention feasibility: recruitment screening eligibility
Time frame: Through study completion, an average of 2 years
Percent of children screened who were eligible
Intervention feasibility: recruitment screening enrollment
Time frame: Through study completion, an average of 2 years
Percent of eligible children who were enrolled
Intervention feasibility: recruitment duration
Time frame: Through study completion, an average of 2 years
Duration to reach the target sample
Intervention feasibility: Enrollment yield for each recruitment strategy
Time frame: Through study completion, an average of 2 years
Percent of enrolled participants that were recruited via each recruitment strategy to determine the highest and lowest yielding strategies.
Intervention feasibility: retention attendance
Time frame: Through study completion, an average of 2 years
Percent attendance at assessment visits
Intervention feasibility: retention percentage
Time frame: Through study completion, an average of 2 years
Percent of sample retained at post-intervention
Intervention feasibility: retention dropout
Time frame: Through study completion, an average of 2 years
Percent of sample that drops out or is lost to follow-up
Intervention feasibility: retention dropout reasons
Time frame: Through study completion, an average of 2 years
Reasons for dropping out of the study
Intervention acceptability
Time frame: Through study completion, an average of 2 years
Acceptability will be assessed in an exit survey with Likert scale items and open-ended questions about intervention likes/dislikes and suggestions for future changes. Likert scale values range 1-5. Higher numbers indicate better outcomes (e.g., more positive acceptability)
8 secondary outcomes
Process measures: Intervention attendance
Time frame: Through study completion, an average of 2 years
Process measures: Content fidelity
Time frame: Through study completion, an average of 2 years
Process measure: Implementation
Time frame: Through study completion, an average of 2 years
Child sleep: night sleep duration
Time frame: Baseline (0 weeks) and post-intervention (6 weeks)
Child sleep: daytime sleep duration
Time frame: Baseline (0 weeks) and post-intervention (6 weeks)
Child sleep: 24-hour sleep duration
Time frame: Baseline (0 weeks) and post-intervention (6 weeks)
Child sleep: sleep quality
Time frame: Baseline (0 weeks) and post-intervention (6 weeks)
Child sleep: sleep timing
Time frame: Baseline (0 weeks) and post-intervention (6 weeks)
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 4 Apr 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Tight in people with Sleep, run by University of South Carolina 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 6 inclusion and 3 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 4 Apr 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?
Intervention feasibility: recruitment screening eligibility (time frame: Through study completion, an average of 2 years). The study lists 9 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 4 Apr 2025.