Trial Outcomes & Findings for Assessing Sleep in Blackfeet Families With K-3rd Grade Children (NCT NCT05314712)
NCT ID: NCT05314712
Last Updated: 2025-03-30
Results Overview
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.
COMPLETED
NA
60 participants
7 weeks
2025-03-30
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
23
|
23
|
|
Overall Study
NOT COMPLETED
|
7
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
There were 23 adult participants analyzed at baseline for age.
Baseline characteristics by cohort
| Measure |
Sleep Intervention
n=46 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.
|
|---|---|
|
Age, Continuous
|
6.5 years
STANDARD_DEVIATION 2.8 • n=23 Participants • There were 23 child participants analyzed at baseline for age.
|
|
Sex: Female, Male
Female
|
12 Participants
n=23 Participants • There were 23 children at baseline analyzed for gender.
|
|
Sex: Female, Male
Male
|
11 Participants
n=23 Participants • There were 23 children at baseline analyzed for gender.
|
|
Race/Ethnicity, Customized
Blackfeet
|
23 Participants
n=23 Participants • There were 23 children analyzed at baseline for Race/Ethnicity
|
|
Region of Enrollment
United States
|
46 participants
n=46 Participants
|
|
Adult Height
|
66 inches
STANDARD_DEVIATION 2.8 • n=23 Participants • There were 23 adults measured at baseline for height
|
|
Child Height
|
48.6 inches
STANDARD_DEVIATION 9.9 • n=23 Participants • There were 23 children at baseline measured for height.
|
|
Adult Weight
|
233.7 pounds
STANDARD_DEVIATION 51.1 • n=23 Participants • There were 23 adults at baseline measured for weight
|
|
Child Weight
|
75.3 pounds
STANDARD_DEVIATION 41.4 • n=23 Participants • There were 23 children measured at baseline for weight
|
|
Adult Body Mass Index
|
38.6 weight (kg)/height (m2)
STANDARD_DEVIATION 8.2 • n=23 Participants • There were 23 adults measured at baseline for BMI
|
|
Child Body Mass Index
|
22.4 weight (kg)/height (m2)
STANDARD_DEVIATION 5.7 • n=23 Participants • There were 23 children at baseline measured for BMI
|
|
Adult Education
High School Diploma/GED
|
6 Participants
n=23 Participants • There were 23 adults at baseline measured for Education. This is not applicable to children.
|
|
Adult Education
Some College/Associates Degree
|
8 Participants
n=23 Participants • There were 23 adults at baseline measured for Education. This is not applicable to children.
|
|
Adult Education
College Degree
|
9 Participants
n=23 Participants • There were 23 adults at baseline measured for Education. This is not applicable to children.
|
|
Adult Income
$0-$20,000
|
4 Participants
n=23 Participants • There were 23 adults measured at baseline for income. This is not applicable to children.
|
|
Adult Income
$21,000-$40,000
|
7 Participants
n=23 Participants • There were 23 adults measured at baseline for income. This is not applicable to children.
|
|
Adult Income
$41,000-$60,000
|
6 Participants
n=23 Participants • There were 23 adults measured at baseline for income. This is not applicable to children.
|
|
Adult Income
$61,000 or more
|
6 Participants
n=23 Participants • There were 23 adults measured at baseline for income. This is not applicable to children.
|
|
Child Grade
Kindergarten
|
7 Participants
n=23 Participants • There were 23 children at baseline measured for grade. This is not applicable to adults.
|
|
Child Grade
1st grade
|
4 Participants
n=23 Participants • There were 23 children at baseline measured for grade. This is not applicable to adults.
|
|
Child Grade
Other
|
12 Participants
n=23 Participants • There were 23 children at baseline measured for grade. This is not applicable to adults.
|
PRIMARY outcome
Timeframe: 7 weeksPopulation: Adults sleep according to PSQI
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.
Outcome measures
| Measure |
Sleep Intervention
n=23 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.
|
|---|---|
|
Sleep Trouble
|
1.32 Scores on a scale
Standard Deviation 0.53
|
Adverse Events
Adult Participants
Child Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Vernon Grant
Center for American Indian and Rural Health Equity
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place