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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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

Other trials in United States

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.

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 groups in NCT06249217
Study groupRoleWhat they receive
ExperimentalExperimentalAt 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 controlNo interventionThe 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.

  1. Actigraphic sleep measures

    Objective sleep will be measured via sleep actigraphy collected on Fitbit watches.

    Measured: One month total. Objective sleep measured daily.

  2. 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)
  1. 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.

  2. 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.

  1. First posted8 Feb 2024
  2. Study start1 Feb 2024
  3. Primary completion1 Sep 2024 (estimated)
  4. Study completion1 Oct 2024 (estimated)

Resources

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)
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

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.

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