Assessing Sleep in Blackfeet Families With K-3rd Grade Children

Developing, Implementing, and Evaluating a Mixed-methods Community-based Participatory Research Sleep Intervention in Families With K-3rd Grade Children Living on the Blackfeet Indian Reservation

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.

Study Overview

• Status: Completed
• Conditions: Sleep
• Intervention / Treatment: Behavioral: Sleep intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Montana
    • Bozeman, Montana, United States, 59718
      • Montana State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Blackfeet families with K-3rd grade children

Exclusion Criteria:

• Blackfeet families living off the Blackfeet Indian Reservation in Montana

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Sleep Intervention; Pre and post test of 9-week intervention	Behavioral: Sleep 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Montana State University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2023
• Primary Completion (Actual): December 3, 2023
• Study Completion (Actual): December 3, 2023

Study Registration Dates

• First Submitted: March 29, 2022
• First Submitted That Met QC Criteria: March 29, 2022
• First Posted (Actual): April 6, 2022

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 27, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: VG032922; K01HL146993 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All participant data will be confidential

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No