A Sleep Hygiene Intervention to Improve Sleep Health in Urban, Latino Middle School Children
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age11-13
SponsorRhode Island Hospital
About this trial
The main goal of this study is to evaluate the "SIESTA" intervention, a culturally and contextually tailored sleep hygiene intervention that has the potential to exert greater improvements in sleep hygiene and sleep outcomes for group that may be more vulnerable to poor sleep health.
The main question is: do SIESTA participants have improved sleep outcomes, sleep hygiene behaviors and less sleep-related impairment compared to Control Group participants?
Participants randomized to the SIESTA intervention will:
1. Attend 4 remotely administered group sleep hygiene education sessions 2. Complete along with a parent/guardian, two individualized sessions administered by a SIESTA intervention facilitator 3. Complete study survey at baseline, end of treatment, and at 4, 8 and 12 months post-intervention. 4. Wear electronic sleep watches (actigraphy) throughout the protocol to objectively measure sleep duration and quality.
Participants randomized to the Child Health Control condition will:
1. Attend 4 remotely administered group sessions covering general health topics 2. Complete along with a parent/guardian, two individualized sessions administered by a SIESTA intervention facilitator 3. Complete study survey at baseline, end of treatment, and at 4, 8 and 12 months post-intervention. 4. Wear electronic sleep watches (actigraphy) throughout the protocol to objectively measure sleep duration and quality.
A secondary goal of the study is to conduct a process evaluation to prepare for future larger scale use of the intervention in other urban school settings. This will entail assessing Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) of the program through several methods, such as by conducting in-depth interviews with research participants and their parents/guardians, as well as school staff and by looking at rates of participation in the program.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
children must be middle schoolers between 11-13 years old, live and go to school in one of the targeted school districts and sleep no more than 9 hours on an average night
Disqualifiers
Children are not eligible to take part in the study if they have a medical, psychiatric, or developmental condition and/or are taking medicine for any condition that might affect their ability to and comfort with taking part in the study.
Trial design
Design model
Parallel
Treatments tested in this trial
SIESTA
BehavioralActive condition
Sleep education and health education control
BehavioralAttention Control
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: SIESTAExperimental treatment 1 intervention
Group B: Sleep Education plus Child Health attention controlOther 1 intervention
Trial outcomes
Primary outcomes
1
Sleep Duration
Sleep Duration through actigraphy will be calculated through Time in Bed (TIB) scores. A daily diary will document sleep events (e.g., bedtime) to score actigraphic data . Children will wear the actigraph Motion Logger device for 1-2 weeks at each time point. Data will be compared to data in a family-report daily diary using standard procedures.
Time frame
Sleep duration will be assessed for 1-2 weeks at baseline, immediately after the intervention ("end of treatment") and at follow ups at 4, 8, and 12 months post intervention/control.2
Sleep Efficiency/Quality
Sleep efficiency will be estimated via actigraphy and will be calculated through % epochs of sleep between sleep start and sleep end.
Time frame
Sleep efficiency will be assessed for 1-2 weeks at baseline, end of treatment and at each 4, 8, and 12 months post intervention/control.Secondary outcomes
1
Sleep Disturbance and Sleep-related Impairment
Sleep disturbance and sleep-related impairment will be assessed by caregiver and child report by the Patient-Reported Outcomes Measurement Information System (PROMIS™) measures (Yu et al., 2011). Participants will be asked to report on the previous week. Raw scores are converted to T-scores (Mean=50, SD=10). Higher scores indicate more of the concept being measured, hence higher scores on Sleep Disturbance and Sleep Impairment indicate less optimal status on these domains, while scores lower than T=50 indicate better functioning (less sleep disturbance and sleep impairment).
Time frame
Sleep Disturbance and Sleep-related Impairment measures will be collected on each child at each of the of the 5 research assessment time points: enrollment/baseline, immediately after the intervention, and at the 4, 8 and 12 month follow up visits.Sponsors and contacts
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Rhode Island Hospital
Lead sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
University of Puerto Rico
Collaborator
Source ClinicalTrials.gov