Sleep
Conditions
Brief summary
This project will investigate traditional sleep routines and the current sleep environment in American Indian children to develop a culturally appropriate and novel sleep intervention to increase total sleep time for families with K-3rd grade children. The outcomes of this study will provide a comprehensive understanding of a relatively unknown behavior (sleep) in American Indians, show results from a novel sleep intervention in a high risk and underserved population, and will also contribute to the research and training development of an American Indian investigator, all defined missions of NHLBI.
Detailed description
Children sleep less now than ever before. Despite a growing body of literature in understanding child sleep patterns, sleep interventions are limited. To date, there are no sleep intervention studies that have been done in AI tribal communities. Elders and community members play a critical role in identifying culturally adaptive solutions to address problems in tribal communities. Because of the prevalence of historical trauma and mistrust of outsiders, I am uniquely positioned to do this work in my own tribal community. Preliminary data of sleep patterns showed that Blackfeet children age 2-5 and age 12-15 averaged 10.15 hours and 7.5 hours of weekday sleep. Despite this understanding, evidence-based solutions to increase TST in tribal communities are unknown. Thus, I propose to explore traditional sleep routines coupled with asking Blackfeet families about the current sleep environment in their home to develop a culturally specific sleep intervention with one child and one adult dyad. I hypothesize that the sleep intervention will increase TST (primary outcome) in the dyads. The intervention may also result in improved physical activity and diet, and decreased stress and screen time (secondary outcomes). Data will be measured at 0 and 9 weeks and then at 3 month follow-up. This hypothesis will be tested in the following specific aims: Specific Aim 1: Develop a culturally appropriate sleep intervention for Blackfeet families with K-3rd grade children using surveys, focus groups, interviews, community input, and evidence-based strategies on sleep. Specific Aim 2: Feasibility test of the 9-week sleep intervention with K-3rd grade Blackfeet families. The work proposed in these aims is designed to develop a comprehensive understanding of traditional sleep strategies and the child sleep environment to develop and pilot-test a novel culturally appropriate sleep intervention in the Blackfeet community. Developing culturally specific interventions to increase TST will address two significant gaps in the literature; understanding sleep problems in AI children and pilot-testing culturally adaptive sleep intervention strategies that will inform future research for investigators doing similar work in AI communities and provide direction for an R01 proposal that is one of the outcomes of this work.
Interventions
BEHAVIORALSleep intervention
Participants will receive a 9-week sleep intervention through text and Facebook that include traditional Blackfoot cultural components combined with scientifically validated strategies for sleep.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Montana State University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Pre and post test of intervention group; pilot test
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
• Blackfeet families with K-3rd grade children
Exclusion criteria
• Blackfeet families living off the Blackfeet Indian Reservation in Montana
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Trouble | 7 weeks | Sleep Trouble assessed by Pittsburgh Sleep Quality Index. Five questions on sleep trouble were asked on a likert scale that was treated as continuous and included four options: 0 = Not during the past month; 1 = Less than a once a week; 2 = Once or twice a week; 3 = Three or more times a week. Each step in the scale represents an equal change on a continuous scale, e.g., going from a response of 1 to 2 is considered the same as going from 3 to 4. 0 is considered better and 3 is considered worse. The mean of the five responses were used as a total score for sleep trouble for each participant. |
Countries
United States
Participant flow
Recruitment details
Recruitment was done through social media in the Blackfeet community. A total of 30 families (1 parent and 1 child) were recruited and consented. This was done summer and fall 2023.
Pre-assignment details
As mentioned above, a total of 30 families were consented in the study. However, six families did not complete baseline data collection and a total of 14 families dropped out of the study. We were able to retain 23 families (46 parent/child dyads) for the study with post-intervention data on all participants.
Participants by arm
| Arm | Count |
|---|---|
| Sleep Intervention Pre and post test of 7-week intervention
Sleep intervention: Participants will receive a 7-week sleep intervention through text and Facebook that include traditional Blackfoot cultural components combined with scientifically validated strategies for sleep. | 46 |
| Total | 46 |
Baseline characteristics
| Characteristic | Sleep Intervention |
|---|---|
| Adult Body Mass Index | 38.6 weight (kg)/height (m2) STANDARD_DEVIATION 8.2 |
| Adult Education College Degree | 9 Participants |
| Adult Education High School Diploma/GED | 6 Participants |
| Adult Education Some College/Associates Degree | 8 Participants |
| Adult Height | 66 inches STANDARD_DEVIATION 2.8 |
| Adult Income $0-$20,000 | 4 Participants |
| Adult Income $21,000-$40,000 | 7 Participants |
| Adult Income $41,000-$60,000 | 6 Participants |
| Adult Income $61,000 or more | 6 Participants |
| Adult Weight | 233.7 pounds STANDARD_DEVIATION 51.1 |
| Age, Continuous | 6.5 years STANDARD_DEVIATION 2.8 |
| Child Body Mass Index | 22.4 weight (kg)/height (m2) STANDARD_DEVIATION 5.7 |
| Child Grade 1st grade | 4 Participants |
| Child Grade Kindergarten | 7 Participants |
| Child Grade Other | 12 Participants |
| Child Height | 48.6 inches STANDARD_DEVIATION 9.9 |
| Child Weight | 75.3 pounds STANDARD_DEVIATION 41.4 |
| Race/Ethnicity, Customized Blackfeet | 23 Participants |
| Region of Enrollment United States | 46 participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 23 |
| other Total, other adverse events | 0 / 23 | 0 / 23 |
| serious Total, serious adverse events | 0 / 23 | 0 / 23 |
Outcome results
Primary
Sleep Trouble
Sleep Trouble assessed by Pittsburgh Sleep Quality Index. Five questions on sleep trouble were asked on a likert scale that was treated as continuous and included four options: 0 = Not during the past month; 1 = Less than a once a week; 2 = Once or twice a week; 3 = Three or more times a week. Each step in the scale represents an equal change on a continuous scale, e.g., going from a response of 1 to 2 is considered the same as going from 3 to 4. 0 is considered better and 3 is considered worse. The mean of the five responses were used as a total score for sleep trouble for each participant.
Time frame: 7 weeks
Population: Adults sleep according to PSQI
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sleep Intervention | Sleep Trouble | 1.32 Scores on a scale | Standard Deviation 0.53 |
Comparison: Since all participants in this pilot study received in the intervention and data was collected pre and post intervention, there was no hypothesis test. Under the assumption that the likert scale data was treated as continuous, the data was analyzed using a linear mixed model. Variables in final model were included after variable selection (details below).
Comparison: Since all participants in this pilot study received in the intervention and data was collected pre and post intervention, there was no hypothesis test. The data was analyzed using a mixed effects linear regression model. Variables in final model were included after variable selection (details below).