Sleep ProblemsPhase 1/2GNSPNCT06249217
Good Nights Sleep Program to Improve Child and Family Sleep
A Phase 1/2 study testing Good Nights Sleep Program in people with Sleep Problems and Sleep Hygiene, run by Auburn University at 1 site in United States.
Trial summary
The purpose of this study is to pilot a randomized clinical trial designed to improve the sleep environments, sleep hygiene practices, and the duration and quality of sleep of children and parents in low-income families. Read more about this study
- Who is it for?
- Ages 7 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Problems, Sleep Hygiene
- What is being tested?
- Good Nights Sleep Program
- 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
- 1 Feb 2024to 1 Oct 2024
- Phase
- Phase 1/2
- 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 7 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children be eligible for free or reduced school lunch
- parents and children can speak and read in English
Who cannot join
- diagnosed medical sleep disorder of child or parent
Trial locations and contacts
1 site in 1 country.
United States1 site
Room 266, ARTF Building, 570 Devall Drive
Auburn, Alabama, 36849
About this study
Official title: Good Nights Sleep Program: Pilot of a Randomized Clinical Trial to Improve Child and Family Sleep
The purpose of this study is to pilot a randomized clinical trial designed to improve the sleep environments, sleep hygiene practices, and the duration and quality of sleep of children and parents in low-income families. It is hypothesized that child and parent sleep (assessed through subjective reports of sleep, sleep environments, sleep hygiene practices, and objective sleep data via sleep actigraphy collected with Fitbit watches) in the intervention group will improve between Week 2 (intervention session) and Week 4 (post-intervention session) as compared to child and parent sleep in the waitlist-control group.
Read the detailed description
Children from economically disadvantaged families have shorter and poorer-quality actigraphy-derived sleep and greater subjective sleep problems compared to children from wealthier families. These sleep disparities are linked to overall health disparities that exist among socioeconomic strata as well as differences in children's psychosocial and academic development. A sleep intervention for children in socioeconomically disadvantaged families could reduce socioeconomic disparities in sleep with potential downstream effects on broader socioeconomic-based disparities in physical and mental health and academic functioning. Research on the protective functions of sleep suggest that the benefits of sleep may be even greater for children in economically disadvantaged families. Thus, improving sleep is a potentially powerful strategy to reduce health disparities.
The investigators will recruit a non-random, purposive pilot sample of 30 parent-child dyads (60 total participants) through the Alabama Extension at Auburn University Supplemental Nutrition Assistance Program - Education (SNAP-Ed) serving children from low-income families in Alabama elementary schools. Study information will be sent home to children in participating schools. The primary inclusion criterion is that children be eligible for free or reduced school lunch. Participants will be randomly assigned to waitlist-control or intervention groups. The intervention adapts established evidence-based motivational practices to change child and family sleep environments and sleep hygiene practices. At Week 0, participants will provide a comprehensive assessment of sleep environment and sleep hygiene practices and will be issued a Fitbit watch to wear for the duration of the study as baseline data. At Week 2, participants will receive information about the benefits of good sleep, feedback about their sleep environment and sleep hygiene practices based on the assessment data to implement at home, and sleep environment modification items based on participant-identified areas of need (e.g., a fan, sound machine, bedding). At Week 4, families in the intervention group will provide post-intervention assessment data and feedback on the intervention and families in the waitlist-control group can elect to receive the intervention if they choose to. Primary variables of interest are subjective reports of sleep, sleep environments, sleep hygiene practices, and objective sleep data via sleep actigraphy collected with Fitbit watches worn over the three assessment periods spaced over four weeks.
The research design is a between-subjects experiment with pre- and post-intervention assessments, also called a randomized clinical trial. This is a methodologically rigorous design with high internal validity, allowing for causal inferences about any observed effects of the intervention. Random assignment to conditions will help to ensure that the intervention or waitlist control groups are equivalent prior to the intervention and that any subsequent changes are not due to initial group differences.
Data analysis will evaluate group equivalence on sleep variables pre-intervention, group differences in sleep post-intervention, and between-group differences in change in sleep pre- to post-intervention. Consistent with best practices in data management and analysis, variables will be evaluated for patterns of missingness, normality, and outlier points as part of preliminary analysis procedures that have long been established in our lab.
Primary analyses will take into account the innovative emphasis on both children, parents, and families as units of study. Specifically, children's and parents' sleep variables are likely to be non-independent because they are in the same family and share many of the same sleep environment characteristics. Non-independence in the data due to nesting within families violates a basic assumption of the general linear model underlying many statistical analyses; not taking family nesting into account would likely result in biased and less accurate results. Similarly, repeated measures of sleep variables are likely to be non-independent within participants. In other words, repeated measures are nested within participants and participants are nested within families. Multilevel modeling (also called hierarchical linear modeling) addresses non-independent data appropriately by separating the variability in variables of interest into a within-individual level, a between-individual level, and a between-family level to arrive at the most statistically valid estimates of change in sleep variables due to the intervention.
A priori power analyses were conducted using the Monte Carlo feature in the Mplus statistical software package to determine the range of effect sizes that could be detected given the proposed sample size, alpha level (set to .05), and minimum acceptable power (set to .80). The research design generates multilevel data with 180 repeated measures of variables (three measurement occasions per individual) nested within 60 individuals who are nested within 30 families. The primary independent variable, condition (i.e., waitlist control or experimental), exists at both the individual and family levels of analysis.
At the individual level (n = 60), the study is powered to detect a small or greater effect size of approximately F ≥ .3; D ≥ .6; R2 ≥ .08. In plain language, if the intervention explains 8% or more of the between-individual differences in a measured variable, the analyses will be powered to detect that effect. At the family level (n = 30), the study is powered to detect a medium or greater effect size of approximately F ≥ .4; D ≥ .8; R2 ≥ .14. If the intervention explains 14% or more of the between-family differences in a measured variable, the analyses will be powered to detect that effect. The emphasis in this pilot project is on the practical meaningfulness of effect sizes that point to the need for larger scale replication.
- Conditions
- Sleep Problems, Sleep Hygiene
- Being tested
- Good Nights Sleep Program
- Keywords
- Sleep problems, Sleep hygiene
- Medical subject headings
- Parasomnias, Sleep Hygiene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Good Nights Sleep ProgramBehavioural
The Good Nights Sleep Program arm adapts established evidence-based motivational practices to change child and family sleep environments and sleep hygiene practices. At Week 0, participants will provide a comprehensive assessment of sleep environment and sleep hygiene practices and will be issued a Fitbit watch to wear for the duration of the study. At Week 2, participants will receive information about the benefits of good sleep, feedback about their sleep environment and sleep hygiene practices based on the Week 0 assessment data to implement at home, and sleep environment modification items based on participant-identified areas of need (e.g., a fan, sound machine, bedding). At Week 4, families in the Good Nights Sleep Program arm will provide post-intervention assessment data and feedback on the intervention and families in the Waitlist-Control arm can elect to receive the intervention if they choose to.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | At Week 0, participants will provide a comprehensive assessment of sleep environment and sleep hygiene practices and participants will be given a Fitbit watch to wear for the duration of the study. At Week 2, participants will receive information about the benefits of good sleep, feedback about their sleep environment and sleep hygiene practices based on the assessment data to implement at home, and sleep environment modification items based on participant-identified areas of need (e.g., a fan, sound machine, bedding). At Week 4, families in the intervention group will provide post-intervention assessment data and feedback on the intervention. Receives: Behavioral: Good Nights Sleep Program |
| Waitlist control | No intervention | The waitlist control group will not receive the sleep intervention at Week 2 but families in the waitlist-control group can elect to receive the intervention if they choose to after Week 4. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Actigraphic sleep measures
Objective sleep will be measured via sleep actigraphy collected on Fitbit watches.
Measured: One month total. Objective sleep measured daily.
Subjective sleep measures
Sleep quality will be measured via validated self-report surveys.
Measured: One month total. Sleep quality measured at Week 0, Week 2, and Week 4.
Secondary outcomes (2)
Sleep environments
Sleep environments will be measured via validated self-report surveys.
Measured: One month total. Sleep environments measured at Week 0, Week 2, and Week 4.
Sleep hygiene behaviors
Sleep hygiene behaviors will be measured via validated self-report surveys.
Measured: One month total. Sleep hygiene behaviors measured at Week 0, Week 2, and Week 4.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start1 Feb 2024
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep ProblemsStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The research design is a between-subjects experiment with pre- and post-intervention assessments. Random assignment to conditions will help to ensure that the intervention or waitlist control groups are equivalent prior to the intervention and that any subsequent changes are not due to initial group differences.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Auburn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Benjamin Hinnant, Auburn University
- Investigators
- James B Hinnant, Principal investigator, Auburn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06249217
- Sponsor's protocol ID
- 23-562 FB
- Acronym
- GNSP
- Status last verified
- Aug 2024
- First submitted
- 29 Jan 2024
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Publications
Gillis BT, Hinnant B, Martin-Pinon O, Neuhoff EL. Good nights sleep program: design and preliminary findings from a randomized clinical trial to improve child and parent sleep in low-income families. Front Sleep. 2026 Jun 17;5:1764378. doi: 10.3389/frsle.2026.1764378. eCollection 2026.
PubMed 42389224
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Good Nights Sleep Program: Pilot of a Randomized Clinical Trial to Improve Child and Family Sleep
- ClinicalTrials.gov ID
- NCT06249217
- Acronym / sponsor ID
- GNSP / 23-562 FB
- Conditions
- Sleep Problems, Sleep Hygiene
- Keywords
- Sleep problems, Sleep hygiene
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Auburn UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 8 Feb 2024 (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.
The purpose of this study is to pilot a randomized clinical trial designed to improve the sleep environments, sleep hygiene practices, and the duration and quality of sleep of children and parents in low-income families. It is hypothesized that child and parent sleep (assessed through subjective reports of sleep, sleep environments, sleep hygiene practices, and objective sleep data via sleep actigraphy collected with Fitbit watches) in the intervention group will improve between Week 2 (intervention session) and Week 4 (post-intervention session) as compared to child and parent sleep in the waitlist-control group.
Detailed description
Children from economically disadvantaged families have shorter and poorer-quality actigraphy-derived sleep and greater subjective sleep problems compared to children from wealthier families. These sleep disparities are linked to overall health disparities that exist among socioeconomic strata as well as differences in children's psychosocial and academic development. A sleep intervention for children in socioeconomically disadvantaged families could reduce socioeconomic disparities in sleep with potential downstream effects on broader socioeconomic-based disparities in physical and mental health and academic functioning. Research on the protective functions of sleep suggest that the benefits of sleep may be even greater for children in economically disadvantaged families. Thus, improving sleep is a potentially powerful strategy to reduce health disparities.
The investigators will recruit a non-random, purposive pilot sample of 30 parent-child dyads (60 total participants) through the Alabama Extension at Auburn University Supplemental Nutrition Assistance Program - Education (SNAP-Ed) serving children from low-income families in Alabama elementary schools. Study information will be sent home to children in participating schools. The primary inclusion criterion is that children be eligible for free or reduced school lunch. Participants will be randomly assigned to waitlist-control or intervention groups. The intervention adapts established evidence-based motivational practices to change child and family sleep environments and sleep hygiene practices. At Week 0, participants will provide a comprehensive assessment of sleep environment and sleep hygiene practices and will be issued a Fitbit watch to wear for the duration of the study as baseline data. At Week 2, participants will receive information about the benefits of good sleep, feedback about their sleep environment and sleep hygiene practices based on the assessment data to implement at home, and sleep environment modification items based on participant-identified areas of need (e.g., a fan, sound machine, bedding). At Week 4, families in the intervention group will provide post-intervention assessment data and feedback on the intervention and families in the waitlist-control group can elect to receive the intervention if they choose to. Primary variables of interest are subjective reports of sleep, sleep environments, sleep hygiene practices, and objective sleep data via sleep actigraphy collected with Fitbit watches worn over the three assessment periods spaced over four weeks.
The research design is a between-subjects experiment with pre- and post-intervention assessments, also called a randomized clinical trial. This is a methodologically rigorous design with high internal validity, allowing for causal inferences about any observed effects of the intervention. Random assignment to conditions will help to ensure that the intervention or waitlist control groups are equivalent prior to the intervention and that any subsequent changes are not due to initial group differences.
Data analysis will evaluate group equivalence on sleep variables pre-intervention, group differences in sleep post-intervention, and between-group differences in change in sleep pre- to post-intervention. Consistent with best practices in data management and analysis, variables will be evaluated for patterns of missingness, normality, and outlier points as part of preliminary analysis procedures that have long been established in our lab.
Primary analyses will take into account the innovative emphasis on both children, parents, and families as units of study. Specifically, children's and parents' sleep variables are likely to be non-independent because they are in the same family and share many of the same sleep environment characteristics. Non-independence in the data due to nesting within families violates a basic assumption of the general linear model underlying many statistical analyses; not taking family nesting into account would likely result in biased and less accurate results. Similarly, repeated measures of sleep variables are likely to be non-independent within participants. In other words, repeated measures are nested within participants and participants are nested within families. Multilevel modeling (also called hierarchical linear modeling) addresses non-independent data appropriately by separating the variability in variables of interest into a within-individual level, a between-individual level, and a between-family level to arrive at the most statistically valid estimates of change in sleep variables due to the intervention.
A priori power analyses were conducted using the Monte Carlo feature in the Mplus statistical software package to determine the range of effect sizes that could be detected given the proposed sample size, alpha level (set to .05), and minimum acceptable power (set to .80). The research design generates multilevel data with 180 repeated measures of variables (three measurement occasions per individual) nested within 60 individuals who are nested within 30 families. The primary independent variable, condition (i.e., waitlist control or experimental), exists at both the individual and family levels of analysis.
At the individual level (n = 60), the study is powered to detect a small or greater effect size of approximately F ≥ .3; D ≥ .6; R2 ≥ .08. In plain language, if the intervention explains 8% or more of the between-individual differences in a measured variable, the analyses will be powered to detect that effect. At the family level (n = 30), the study is powered to detect a medium or greater effect size of approximately F ≥ .4; D ≥ .8; R2 ≥ .14. If the intervention explains 14% or more of the between-family differences in a measured variable, the analyses will be powered to detect that effect. The emphasis in this pilot project is on the practical meaningfulness of effect sizes that point to the need for larger scale replication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The research design is a between-subjects experiment with pre- and post-intervention assessments. Random assignment to conditions will help to ensure that the intervention or waitlist control groups are equivalent prior to the intervention and that any subsequent changes are not due to initial group differences.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Good Nights Sleep ProgramAt Week 0, participants will provide a comprehensive assessment of sleep environment and sleep hygiene practices and participants will be given a Fitbit watch to wear for the duration of the study. At Week 2, participants will receive information about the benefits of good sleep, feedback about their sleep environment and sleep hygiene practices based on the assessment data to implement at home, and sleep environment modification items based on participant-identified areas of need (e.g., a fan, sound machine, bedding). At Week 4, families in the intervention group will provide post-intervention assessment data and feedback on the intervention. |
| Waitlist control | No intervention | –The waitlist control group will not receive the sleep intervention at Week 2 but families in the waitlist-control group can elect to receive the intervention if they choose to after Week 4. |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- children be eligible for free or reduced school lunch
- parents and children can speak and read in English
Key exclusion criteria (1 listed)
- diagnosed medical sleep disorder of child or parent
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 |
|---|---|---|
| Good Nights Sleep ProgramThe Good Nights Sleep Program arm adapts established evidence-based motivational practices to change child and family sleep environments and sleep hygiene practices. At Week 0, participants will provide a comprehensive assessment of sleep environment and sleep hygiene practices and will be issued a Fitbit watch to wear for the duration of the study. At Week 2, participants will receive information about the benefits of good sleep, feedback about their sleep environment and sleep hygiene practices based on the Week 0 assessment data to implement at home, and sleep environment modification items based on participant-identified areas of need (e.g., a fan, sound machine, bedding). At Week 4, families in the Good Nights Sleep Program arm will provide post-intervention assessment data and feedback on the intervention and families in the Waitlist-Control arm can elect to receive the intervention if they choose to. | Behavioural | Experimental |
Primary outcome
Actigraphic sleep measures
Time frame: One month total. Objective sleep measured daily.
Objective sleep will be measured via sleep actigraphy collected on Fitbit watches.
Subjective sleep measures
Time frame: One month total. Sleep quality measured at Week 0, Week 2, and Week 4.
Sleep quality will be measured via validated self-report surveys.
2 secondary outcomes
Sleep environments
Time frame: One month total. Sleep environments measured at Week 0, Week 2, and Week 4.
Sleep hygiene behaviors
Time frame: One month total. Sleep hygiene behaviors measured at Week 0, Week 2, and Week 4.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Derived from this study: PubMed 42389224Gillis BT, Hinnant B, Martin-Pinon O, Neuhoff EL. Good nights sleep program: design and preliminary findings from a randomized clinical trial to improve child and parent sleep in low-income families. Front Sleep. 2026 Jun 17;5:1764378. doi: 10.3389/frsle.2026.1764378. eCollection 2026.
- Individual participant dataSharing planned: Undecided. Undecided
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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.
James B Hinnant principal investigator
Auburn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Good Nights Sleep Program in people with Sleep Problems and Sleep Hygiene, run by Auburn University 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 23 Aug 2024. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Actigraphic sleep measures (time frame: One month total. Objective sleep measured daily.). 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?
On the ClinicalTrials.gov record for NCT06249217, which also lists 1 linked publication.
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 23 Aug 2024.