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| ID | Type | Description | Link |
|---|---|---|---|
| K01HL146993 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleep Intervention | Other | Pre and post test of 9-week intervention |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 7 weeks |
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Inclusion Criteria:
• Blackfeet families with K-3rd grade children
Exclusion Criteria:
• Blackfeet families living off the Blackfeet Indian Reservation in Montana
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montana State University | Bozeman | Montana | 59718 | United States |
All participant data will be confidential
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Adult Participants | 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. |
| FG001 | Child Participants | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All continuous data is represented as mean and standard deviation. All categorical data is number and percent.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Adult age | There were 23 adult participants analyzed at baseline for age. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Adults sleep according to PSQI | Posted | Mean | Standard Deviation | Scores on a scale | 7 weeks |
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7 weeks.
The definition does not differ.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adult Participants | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vernon Grant | Center for American Indian and Rural Health Equity | 406-531-9310 | vernon.grant@montana.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 6, 2025 | Feb 20, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 6, 2025 | Feb 20, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 10, 2023 | Dec 4, 2024 | ICF_002.pdf |
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Pre and post test of intervention group; pilot test
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| Mean |
| Standard Deviation |
| years |
|
| Age, Continuous | Child Age | There were 23 child participants analyzed at baseline for age. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Adult Participants | There were 23 adults analyzed at baseline for gender. | Count of Participants | Participants | No |
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| Sex: Female, Male | Child Participants | There were 23 children at baseline analyzed for gender. | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Adult Participants | There were 23 adults analyzed at baseline for Race/Ethnicity | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Child Participants | There were 23 children analyzed at baseline for Race/Ethnicity | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Adult Height | Height in inches | There were 23 adults measured at baseline for height | Mean | Standard Deviation | inches |
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| Child Height | Height in inches | There were 23 children at baseline measured for height. | Mean | Standard Deviation | inches |
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| Adult Weight | Weight in pounds | There were 23 adults at baseline measured for weight | Mean | Standard Deviation | pounds |
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| Child Weight | Weight in pounds | There were 23 children measured at baseline for weight | Mean | Standard Deviation | pounds |
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| Adult Body Mass Index | weight (kg)/height (m2) | There were 23 adults measured at baseline for BMI | Mean | Standard Deviation | weight (kg)/height (m2) |
|
| Child Body Mass Index | weight (kg)/height (m2) | There were 23 children at baseline measured for BMI | Mean | Standard Deviation | weight (kg)/height (m2) |
|
| Adult Education | Adults Education by high school, some college, and college degree | There were 23 adults at baseline measured for Education. This is not applicable to children. | Count of Participants | Participants |
|
| Adult Income | Adult income by catgeory | There were 23 adults measured at baseline for income. This is not applicable to children. | Count of Participants | Participants |
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| Child Grade | Number of children per grade Kindergarten through higher | There were 23 children at baseline measured for grade. This is not applicable to adults. | Count of Participants | Participants |
|
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | Child Participants | 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. | 0 | 23 | 0 | 23 | 0 | 23 |
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