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

NCT05314712 | Completed Results

• 2 other identifiers: VG032922K01HL146993
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Sleep Intervention

OTHER

Pre and post test of 9-week intervention

Behavioral: Sleep intervention

Interventions

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.

Sleep Intervention

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Blackfeet families with K-3rd grade children

You may not qualify if:

• Blackfeet families living off the Blackfeet Indian Reservation in Montana

Sponsors & Collaborators

• Montana State University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Montana State University

Bozeman, Montana, 59718, United States

Location

Results Point of Contact

• Title: Vernon Grant
• Organization: Center for American Indian and Rural Health Equity

vernon.grant@montana.edu

406-531-9310

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Research Professor

Model Details: Pre and post test of intervention group; pilot test

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: April 6, 2022
• Study Start: August 15, 2023
• Primary Completion: December 3, 2023
• Study Completion: December 3, 2023
• Last Updated: March 30, 2025
• Results First Posted: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)