Trial Outcomes & Findings for Sleeping Healthy/Living Healthy Development (NCT NCT04484649)
NCT ID: NCT04484649
Last Updated: 2024-09-20
Results Overview
Measured using actigraphy. Measured in minutes.
COMPLETED
NA
61 participants
Baseline (Day 0)
2024-09-20
Participant Flow
Participant milestones
| Measure |
Control
Attention Control
Attention Control: The Attention Control Intervention condition will meet the requirements for a comparison treatment for testing behavioral interventions - equivalent in contact time, credible and interesting, and exert limited treatment effects.
In the same number of sessions and format as the Sleeping Healthy/Living Healthy intervention (anticipated to be two group and two one-on-one sessions delivered once per week by SBHC providers and health educators), the study will teach participants about sleep and other health topics relevant to adolescents (e.g., nutrition, injury prevention) devoid of the MBIH elements in our integrated intervention.
|
Intervention
Sleeping Healthy/Living Healthy
Sleeping Healthy/Living Healthy: Sleeping Healthy/Living Healthy will be a school based health center (SBHC)-based intervention integrating mind-body integrative health (MBIH) and sleep hygiene strategies to improve sleep quality in urban adolescents. The Sleeping Healthy/Living Healthy intervention content and format will be determined in a Development Phase 1. The investigator anticipates the intervention will consist of two group and two one-on-one sessions. The intervention will be grounded in social-cognitive theory and use motivational interviewing to support MBIH and sleep hygiene strategies. Sessions will be delivered once per week by SBHC providers and health educators.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
31
|
|
Overall Study
COMPLETED
|
22
|
26
|
|
Overall Study
NOT COMPLETED
|
8
|
5
|
Reasons for withdrawal
| Measure |
Control
Attention Control
Attention Control: The Attention Control Intervention condition will meet the requirements for a comparison treatment for testing behavioral interventions - equivalent in contact time, credible and interesting, and exert limited treatment effects.
In the same number of sessions and format as the Sleeping Healthy/Living Healthy intervention (anticipated to be two group and two one-on-one sessions delivered once per week by SBHC providers and health educators), the study will teach participants about sleep and other health topics relevant to adolescents (e.g., nutrition, injury prevention) devoid of the MBIH elements in our integrated intervention.
|
Intervention
Sleeping Healthy/Living Healthy
Sleeping Healthy/Living Healthy: Sleeping Healthy/Living Healthy will be a school based health center (SBHC)-based intervention integrating mind-body integrative health (MBIH) and sleep hygiene strategies to improve sleep quality in urban adolescents. The Sleeping Healthy/Living Healthy intervention content and format will be determined in a Development Phase 1. The investigator anticipates the intervention will consist of two group and two one-on-one sessions. The intervention will be grounded in social-cognitive theory and use motivational interviewing to support MBIH and sleep hygiene strategies. Sessions will be delivered once per week by SBHC providers and health educators.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Did not submit actigraphy post interc\vention
|
6
|
4
|
Baseline Characteristics
Sleeping Healthy/Living Healthy Development
Baseline characteristics by cohort
| Measure |
Control
n=30 Participants
Attention Control
Attention Control: The Attention Control Intervention condition will meet the requirements for a comparison treatment for testing behavioral interventions - equivalent in contact time, credible and interesting, and exert limited treatment effects.
In the same number of sessions and format as the Sleeping Healthy/Living Healthy intervention (anticipated to be two group and two one-on-one sessions delivered once per week by SBHC providers and health educators), the study will teach participants about sleep and other health topics relevant to adolescents (e.g., nutrition, injury prevention) devoid of the MBIH elements in our integrated intervention.
|
Intervention
n=31 Participants
Sleeping Healthy/Living Healthy
Sleeping Healthy/Living Healthy: Sleeping Healthy/Living Healthy will be a school based health center (SBHC)-based intervention integrating mind-body integrative health (MBIH) and sleep hygiene strategies to improve sleep quality in urban adolescents. The Sleeping Healthy/Living Healthy intervention content and format will be determined in a Development Phase 1. The investigator anticipates the intervention will consist of two group and two one-on-one sessions. The intervention will be grounded in social-cognitive theory and use motivational interviewing to support MBIH and sleep hygiene strategies. Sessions will be delivered once per week by SBHC providers and health educators.
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
14 years
|
3 years
n=5 Participants
|
3 years
n=7 Participants
|
6 years
n=5 Participants
|
|
Age, Customized
15 years
|
8 years
n=5 Participants
|
11 years
n=7 Participants
|
19 years
n=5 Participants
|
|
Age, Customized
16 years
|
10 years
n=5 Participants
|
11 years
n=7 Participants
|
21 years
n=5 Participants
|
|
Age, Customized
17 years
|
9 years
n=5 Participants
|
6 years
n=7 Participants
|
15 years
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Preferred not to answer
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
24 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
31 participants
n=7 Participants
|
61 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 0)Population: Only 27 out of 30 Control and 27 out of 31 Intervention participants completed the actigraphy and were included in the analysis.
Measured using actigraphy. Measured in minutes.
Outcome measures
| Measure |
Control
n=27 Participants
Attention Control
Attention Control: The Attention Control Intervention condition will meet the requirements for a comparison treatment for testing behavioral interventions - equivalent in contact time, credible and interesting, and exert limited treatment effects.
In the same number of sessions and format as the Sleeping Healthy/Living Healthy intervention (anticipated to be two group and two one-on-one sessions delivered once per week by SBHC providers and health educators), the study will teach participants about sleep and other health topics relevant to adolescents (e.g., nutrition, injury prevention) devoid of the MBIH elements in our integrated intervention.
|
Intervention
n=27 Participants
Sleeping Healthy/Living Healthy
Sleeping Healthy/Living Healthy: Sleeping Healthy/Living Healthy will be a school based health center (SBHC)-based intervention integrating mind-body integrative health (MBIH) and sleep hygiene strategies to improve sleep quality in urban adolescents. The Sleeping Healthy/Living Healthy intervention content and format will be determined in a Development Phase 1. The investigator anticipates the intervention will consist of two group and two one-on-one sessions. The intervention will be grounded in social-cognitive theory and use motivational interviewing to support MBIH and sleep hygiene strategies. Sessions will be delivered once per week by SBHC providers and health educators.
|
|---|---|---|
|
Average Sleep Duration (Past 2 Weeks)
|
404.2418126 minutes
Standard Deviation 41.4605752
|
394.9457195 minutes
Standard Deviation 54.7797086
|
PRIMARY outcome
Timeframe: Immediate Post (up to 7 weeks after baseline)Population: Only 18 out of 30 Control and 24 out of 31 Intervention participants completed the actigraphy and were included in the analysis.
Measured with actigraphy. Measured in minutes.
Outcome measures
| Measure |
Control
n=18 Participants
Attention Control
Attention Control: The Attention Control Intervention condition will meet the requirements for a comparison treatment for testing behavioral interventions - equivalent in contact time, credible and interesting, and exert limited treatment effects.
In the same number of sessions and format as the Sleeping Healthy/Living Healthy intervention (anticipated to be two group and two one-on-one sessions delivered once per week by SBHC providers and health educators), the study will teach participants about sleep and other health topics relevant to adolescents (e.g., nutrition, injury prevention) devoid of the MBIH elements in our integrated intervention.
|
Intervention
n=24 Participants
Sleeping Healthy/Living Healthy
Sleeping Healthy/Living Healthy: Sleeping Healthy/Living Healthy will be a school based health center (SBHC)-based intervention integrating mind-body integrative health (MBIH) and sleep hygiene strategies to improve sleep quality in urban adolescents. The Sleeping Healthy/Living Healthy intervention content and format will be determined in a Development Phase 1. The investigator anticipates the intervention will consist of two group and two one-on-one sessions. The intervention will be grounded in social-cognitive theory and use motivational interviewing to support MBIH and sleep hygiene strategies. Sessions will be delivered once per week by SBHC providers and health educators.
|
|---|---|---|
|
Average Sleep Duration (Past 2 Weeks)
|
419.5089676 minutes
Standard Deviation 57.9706010
|
399.1041454 minutes
Standard Deviation 49.9715607
|
PRIMARY outcome
Timeframe: Follow-up (up to 2.5 months)Population: Only 19 out of 30 Control and 18 out of 31 Intervention participants completed the actigraphy and were included in the analysis.
Measured in actigraphy. Measured in minutes.
Outcome measures
| Measure |
Control
n=19 Participants
Attention Control
Attention Control: The Attention Control Intervention condition will meet the requirements for a comparison treatment for testing behavioral interventions - equivalent in contact time, credible and interesting, and exert limited treatment effects.
In the same number of sessions and format as the Sleeping Healthy/Living Healthy intervention (anticipated to be two group and two one-on-one sessions delivered once per week by SBHC providers and health educators), the study will teach participants about sleep and other health topics relevant to adolescents (e.g., nutrition, injury prevention) devoid of the MBIH elements in our integrated intervention.
|
Intervention
n=18 Participants
Sleeping Healthy/Living Healthy
Sleeping Healthy/Living Healthy: Sleeping Healthy/Living Healthy will be a school based health center (SBHC)-based intervention integrating mind-body integrative health (MBIH) and sleep hygiene strategies to improve sleep quality in urban adolescents. The Sleeping Healthy/Living Healthy intervention content and format will be determined in a Development Phase 1. The investigator anticipates the intervention will consist of two group and two one-on-one sessions. The intervention will be grounded in social-cognitive theory and use motivational interviewing to support MBIH and sleep hygiene strategies. Sessions will be delivered once per week by SBHC providers and health educators.
|
|---|---|---|
|
Average Sleep Duration (Past 2 Weeks)
|
408.5679825 minutes
Standard Deviation 35.9948487
|
395.8340439 minutes
Standard Deviation 50.3787645
|
PRIMARY outcome
Timeframe: Baseline (Day 0)Population: Only 27 out of 30 Control and 27 out of 31 Intervention participants completed the actigraphy and were included in the analysis.
Represented as a percentage. Sleep efficiency = (# hours slept/# hours in bed) X 100% Sleep efficiency can range from 0-100%, with higher sleep efficiency representing better sleep. The numerator and denominator will be measured through actigraphy.
Outcome measures
| Measure |
Control
n=27 Participants
Attention Control
Attention Control: The Attention Control Intervention condition will meet the requirements for a comparison treatment for testing behavioral interventions - equivalent in contact time, credible and interesting, and exert limited treatment effects.
In the same number of sessions and format as the Sleeping Healthy/Living Healthy intervention (anticipated to be two group and two one-on-one sessions delivered once per week by SBHC providers and health educators), the study will teach participants about sleep and other health topics relevant to adolescents (e.g., nutrition, injury prevention) devoid of the MBIH elements in our integrated intervention.
|
Intervention
n=27 Participants
Sleeping Healthy/Living Healthy
Sleeping Healthy/Living Healthy: Sleeping Healthy/Living Healthy will be a school based health center (SBHC)-based intervention integrating mind-body integrative health (MBIH) and sleep hygiene strategies to improve sleep quality in urban adolescents. The Sleeping Healthy/Living Healthy intervention content and format will be determined in a Development Phase 1. The investigator anticipates the intervention will consist of two group and two one-on-one sessions. The intervention will be grounded in social-cognitive theory and use motivational interviewing to support MBIH and sleep hygiene strategies. Sessions will be delivered once per week by SBHC providers and health educators.
|
|---|---|---|
|
Sleep Fragmentation - Sleep Efficiency (%) (Past Month)
|
88.7501893 percentage of sleep efficiency
Standard Deviation 3.2706091
|
87.1876309 percentage of sleep efficiency
Standard Deviation 3.9030391
|
PRIMARY outcome
Timeframe: Immediate Post (up to 7 weeks after baseline)Population: Only 18 out of 30 Control and 24 out of 31 Intervention participants completed the actigraphy and were included in the analysis.
Represented as a percentage. Sleep efficiency = (# hours slept/# hours in bed) X 100% Sleep efficiency can range from 0-100%, with higher sleep efficiency representing better sleep. The numerator and denominator will be measured through actigraphy.
Outcome measures
| Measure |
Control
n=18 Participants
Attention Control
Attention Control: The Attention Control Intervention condition will meet the requirements for a comparison treatment for testing behavioral interventions - equivalent in contact time, credible and interesting, and exert limited treatment effects.
In the same number of sessions and format as the Sleeping Healthy/Living Healthy intervention (anticipated to be two group and two one-on-one sessions delivered once per week by SBHC providers and health educators), the study will teach participants about sleep and other health topics relevant to adolescents (e.g., nutrition, injury prevention) devoid of the MBIH elements in our integrated intervention.
|
Intervention
n=24 Participants
Sleeping Healthy/Living Healthy
Sleeping Healthy/Living Healthy: Sleeping Healthy/Living Healthy will be a school based health center (SBHC)-based intervention integrating mind-body integrative health (MBIH) and sleep hygiene strategies to improve sleep quality in urban adolescents. The Sleeping Healthy/Living Healthy intervention content and format will be determined in a Development Phase 1. The investigator anticipates the intervention will consist of two group and two one-on-one sessions. The intervention will be grounded in social-cognitive theory and use motivational interviewing to support MBIH and sleep hygiene strategies. Sessions will be delivered once per week by SBHC providers and health educators.
|
|---|---|---|
|
Sleep Fragmentation - Sleep Efficiency (%) (Past Month)
|
88.5538488 percentage of sleep efficiency
Standard Deviation 6.4652919
|
87.8333318 percentage of sleep efficiency
Standard Deviation 4.1461175
|
PRIMARY outcome
Timeframe: Follow-up (up to 2.5 months)Population: Only 19 out of 30 Control and 18 out of 31 Intervention participants completed the actigraphy and were included in the analysis.
Represented as a percentage. Sleep efficiency = (# hours slept/# hours in bed) X 100% Sleep efficiency can range from 0-100%, with higher sleep efficiency representing better sleep. The numerator and denominator will be measured through actigraphy.
Outcome measures
| Measure |
Control
n=19 Participants
Attention Control
Attention Control: The Attention Control Intervention condition will meet the requirements for a comparison treatment for testing behavioral interventions - equivalent in contact time, credible and interesting, and exert limited treatment effects.
In the same number of sessions and format as the Sleeping Healthy/Living Healthy intervention (anticipated to be two group and two one-on-one sessions delivered once per week by SBHC providers and health educators), the study will teach participants about sleep and other health topics relevant to adolescents (e.g., nutrition, injury prevention) devoid of the MBIH elements in our integrated intervention.
|
Intervention
n=18 Participants
Sleeping Healthy/Living Healthy
Sleeping Healthy/Living Healthy: Sleeping Healthy/Living Healthy will be a school based health center (SBHC)-based intervention integrating mind-body integrative health (MBIH) and sleep hygiene strategies to improve sleep quality in urban adolescents. The Sleeping Healthy/Living Healthy intervention content and format will be determined in a Development Phase 1. The investigator anticipates the intervention will consist of two group and two one-on-one sessions. The intervention will be grounded in social-cognitive theory and use motivational interviewing to support MBIH and sleep hygiene strategies. Sessions will be delivered once per week by SBHC providers and health educators.
|
|---|---|---|
|
Sleep Fragmentation - Sleep Efficiency (%) (Past Month)
|
89.2803736 percentage of sleep efficiency
Standard Deviation 3.1858765
|
88.4959747 percentage of sleep efficiency
Standard Deviation 3.6605489
|
PRIMARY outcome
Timeframe: Baseline (Day 0)Population: Only 27 out of 30 Control and 27 out of 31 Intervention participants completed the actigraphy and were included in the analysis.
Number of sleep disruptions (number of times awakened) per night (mean, in past month): measured using actigraphy.
Outcome measures
| Measure |
Control
n=27 Participants
Attention Control
Attention Control: The Attention Control Intervention condition will meet the requirements for a comparison treatment for testing behavioral interventions - equivalent in contact time, credible and interesting, and exert limited treatment effects.
In the same number of sessions and format as the Sleeping Healthy/Living Healthy intervention (anticipated to be two group and two one-on-one sessions delivered once per week by SBHC providers and health educators), the study will teach participants about sleep and other health topics relevant to adolescents (e.g., nutrition, injury prevention) devoid of the MBIH elements in our integrated intervention.
|
Intervention
n=27 Participants
Sleeping Healthy/Living Healthy
Sleeping Healthy/Living Healthy: Sleeping Healthy/Living Healthy will be a school based health center (SBHC)-based intervention integrating mind-body integrative health (MBIH) and sleep hygiene strategies to improve sleep quality in urban adolescents. The Sleeping Healthy/Living Healthy intervention content and format will be determined in a Development Phase 1. The investigator anticipates the intervention will consist of two group and two one-on-one sessions. The intervention will be grounded in social-cognitive theory and use motivational interviewing to support MBIH and sleep hygiene strategies. Sessions will be delivered once per week by SBHC providers and health educators.
|
|---|---|---|
|
Sleep Fragmentation - Number of Sleep Disruptions (Past Month)
|
32.3090725 number of times awakened
Standard Deviation 7.3284517
|
36.1768219 number of times awakened
Standard Deviation 8.5199704
|
PRIMARY outcome
Timeframe: Immediate Post (up to 7 weeks after baseline)Population: Only 18 out of 30 Control and 24 out of 31 Intervention participants completed the actigraphy and were included in the analysis.
Number of sleep disruptions (number of times awakened) per night (mean, in past month): measured using actigraphy.
Outcome measures
| Measure |
Control
n=18 Participants
Attention Control
Attention Control: The Attention Control Intervention condition will meet the requirements for a comparison treatment for testing behavioral interventions - equivalent in contact time, credible and interesting, and exert limited treatment effects.
In the same number of sessions and format as the Sleeping Healthy/Living Healthy intervention (anticipated to be two group and two one-on-one sessions delivered once per week by SBHC providers and health educators), the study will teach participants about sleep and other health topics relevant to adolescents (e.g., nutrition, injury prevention) devoid of the MBIH elements in our integrated intervention.
|
Intervention
n=24 Participants
Sleeping Healthy/Living Healthy
Sleeping Healthy/Living Healthy: Sleeping Healthy/Living Healthy will be a school based health center (SBHC)-based intervention integrating mind-body integrative health (MBIH) and sleep hygiene strategies to improve sleep quality in urban adolescents. The Sleeping Healthy/Living Healthy intervention content and format will be determined in a Development Phase 1. The investigator anticipates the intervention will consist of two group and two one-on-one sessions. The intervention will be grounded in social-cognitive theory and use motivational interviewing to support MBIH and sleep hygiene strategies. Sessions will be delivered once per week by SBHC providers and health educators.
|
|---|---|---|
|
Sleep Fragmentation - Number of Sleep Disruptions (Past Month)
|
33.6921279 number of times awakened
Standard Deviation 9.9379062
|
35.9452319 number of times awakened
Standard Deviation 11.2391805
|
PRIMARY outcome
Timeframe: Follow-up (up to 2.5 months)Population: Only 19 out of 30 Control and 18 out of 31 Intervention participants completed the actigraphy and were included in the analysis.
Number of sleep disruptions (number of times awakened) per night (mean, in past month): measured using actigraphy.
Outcome measures
| Measure |
Control
n=19 Participants
Attention Control
Attention Control: The Attention Control Intervention condition will meet the requirements for a comparison treatment for testing behavioral interventions - equivalent in contact time, credible and interesting, and exert limited treatment effects.
In the same number of sessions and format as the Sleeping Healthy/Living Healthy intervention (anticipated to be two group and two one-on-one sessions delivered once per week by SBHC providers and health educators), the study will teach participants about sleep and other health topics relevant to adolescents (e.g., nutrition, injury prevention) devoid of the MBIH elements in our integrated intervention.
|
Intervention
n=18 Participants
Sleeping Healthy/Living Healthy
Sleeping Healthy/Living Healthy: Sleeping Healthy/Living Healthy will be a school based health center (SBHC)-based intervention integrating mind-body integrative health (MBIH) and sleep hygiene strategies to improve sleep quality in urban adolescents. The Sleeping Healthy/Living Healthy intervention content and format will be determined in a Development Phase 1. The investigator anticipates the intervention will consist of two group and two one-on-one sessions. The intervention will be grounded in social-cognitive theory and use motivational interviewing to support MBIH and sleep hygiene strategies. Sessions will be delivered once per week by SBHC providers and health educators.
|
|---|---|---|
|
Sleep Fragmentation - Number of Sleep Disruptions (Past Month)
|
33.7649958 number of times awakened
Standard Deviation 10.3250768
|
32.9682422 number of times awakened
Standard Deviation 10.0477777
|
SECONDARY outcome
Timeframe: Baseline (Day 0)Subjective sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI), which contains 19 self-rated questions. The 19 self-rated items are combined to form seven "component" scores, each of which has a range of 0-3 points. The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Outcome measures
| Measure |
Control
n=30 Participants
Attention Control
Attention Control: The Attention Control Intervention condition will meet the requirements for a comparison treatment for testing behavioral interventions - equivalent in contact time, credible and interesting, and exert limited treatment effects.
In the same number of sessions and format as the Sleeping Healthy/Living Healthy intervention (anticipated to be two group and two one-on-one sessions delivered once per week by SBHC providers and health educators), the study will teach participants about sleep and other health topics relevant to adolescents (e.g., nutrition, injury prevention) devoid of the MBIH elements in our integrated intervention.
|
Intervention
n=31 Participants
Sleeping Healthy/Living Healthy
Sleeping Healthy/Living Healthy: Sleeping Healthy/Living Healthy will be a school based health center (SBHC)-based intervention integrating mind-body integrative health (MBIH) and sleep hygiene strategies to improve sleep quality in urban adolescents. The Sleeping Healthy/Living Healthy intervention content and format will be determined in a Development Phase 1. The investigator anticipates the intervention will consist of two group and two one-on-one sessions. The intervention will be grounded in social-cognitive theory and use motivational interviewing to support MBIH and sleep hygiene strategies. Sessions will be delivered once per week by SBHC providers and health educators.
|
|---|---|---|
|
Score on Pittsburgh Sleep Quality Index (PSQI Global Score)
|
7.73 global score on a scale
Standard Error 2.90
|
8.48 global score on a scale
Standard Error 2.98
|
SECONDARY outcome
Timeframe: Immediate Post (up to 7 weeks after baseline)Subjective sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI), which contains 19 self-rated questions. The 19 self-rated items are combined to form seven "component" scores, each of which has a range of 0-3 points. The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Outcome measures
| Measure |
Control
n=30 Participants
Attention Control
Attention Control: The Attention Control Intervention condition will meet the requirements for a comparison treatment for testing behavioral interventions - equivalent in contact time, credible and interesting, and exert limited treatment effects.
In the same number of sessions and format as the Sleeping Healthy/Living Healthy intervention (anticipated to be two group and two one-on-one sessions delivered once per week by SBHC providers and health educators), the study will teach participants about sleep and other health topics relevant to adolescents (e.g., nutrition, injury prevention) devoid of the MBIH elements in our integrated intervention.
|
Intervention
n=31 Participants
Sleeping Healthy/Living Healthy
Sleeping Healthy/Living Healthy: Sleeping Healthy/Living Healthy will be a school based health center (SBHC)-based intervention integrating mind-body integrative health (MBIH) and sleep hygiene strategies to improve sleep quality in urban adolescents. The Sleeping Healthy/Living Healthy intervention content and format will be determined in a Development Phase 1. The investigator anticipates the intervention will consist of two group and two one-on-one sessions. The intervention will be grounded in social-cognitive theory and use motivational interviewing to support MBIH and sleep hygiene strategies. Sessions will be delivered once per week by SBHC providers and health educators.
|
|---|---|---|
|
Score on Pittsburgh Sleep Quality Index (PSQI Global Score)
|
6.44 global score on a scale
Standard Error 3.06
|
5.07 global score on a scale
Standard Error 2.24
|
SECONDARY outcome
Timeframe: Follow-up (up to 2.5 months)Subjective sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI), which contains 19 self-rated questions. The 19 self-rated items are combined to form seven "component" scores, each of which has a range of 0-3 points. The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Outcome measures
| Measure |
Control
n=30 Participants
Attention Control
Attention Control: The Attention Control Intervention condition will meet the requirements for a comparison treatment for testing behavioral interventions - equivalent in contact time, credible and interesting, and exert limited treatment effects.
In the same number of sessions and format as the Sleeping Healthy/Living Healthy intervention (anticipated to be two group and two one-on-one sessions delivered once per week by SBHC providers and health educators), the study will teach participants about sleep and other health topics relevant to adolescents (e.g., nutrition, injury prevention) devoid of the MBIH elements in our integrated intervention.
|
Intervention
n=31 Participants
Sleeping Healthy/Living Healthy
Sleeping Healthy/Living Healthy: Sleeping Healthy/Living Healthy will be a school based health center (SBHC)-based intervention integrating mind-body integrative health (MBIH) and sleep hygiene strategies to improve sleep quality in urban adolescents. The Sleeping Healthy/Living Healthy intervention content and format will be determined in a Development Phase 1. The investigator anticipates the intervention will consist of two group and two one-on-one sessions. The intervention will be grounded in social-cognitive theory and use motivational interviewing to support MBIH and sleep hygiene strategies. Sessions will be delivered once per week by SBHC providers and health educators.
|
|---|---|---|
|
Score on Pittsburgh Sleep Quality Index (PSQI Global Score)
|
6.07 global score on a scale
Standard Error 2.02
|
4.59 global score on a scale
Standard Error 2.44
|
SECONDARY outcome
Timeframe: Baseline (Day 0)Stress will be measured using Perceived Stress Scale (past month). The PSS has 10 items, completed using self-report. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress; scores ranging from 14-26 would be considered moderate stress; scores ranging from 27-40 would be considered high perceived stress.
Outcome measures
| Measure |
Control
n=30 Participants
Attention Control
Attention Control: The Attention Control Intervention condition will meet the requirements for a comparison treatment for testing behavioral interventions - equivalent in contact time, credible and interesting, and exert limited treatment effects.
In the same number of sessions and format as the Sleeping Healthy/Living Healthy intervention (anticipated to be two group and two one-on-one sessions delivered once per week by SBHC providers and health educators), the study will teach participants about sleep and other health topics relevant to adolescents (e.g., nutrition, injury prevention) devoid of the MBIH elements in our integrated intervention.
|
Intervention
n=31 Participants
Sleeping Healthy/Living Healthy
Sleeping Healthy/Living Healthy: Sleeping Healthy/Living Healthy will be a school based health center (SBHC)-based intervention integrating mind-body integrative health (MBIH) and sleep hygiene strategies to improve sleep quality in urban adolescents. The Sleeping Healthy/Living Healthy intervention content and format will be determined in a Development Phase 1. The investigator anticipates the intervention will consist of two group and two one-on-one sessions. The intervention will be grounded in social-cognitive theory and use motivational interviewing to support MBIH and sleep hygiene strategies. Sessions will be delivered once per week by SBHC providers and health educators.
|
|---|---|---|
|
Score on the Perceived Stress Scale (PSS)
|
28.50 score on a scale
Standard Error 5.26
|
29.07 score on a scale
Standard Error 6.11
|
SECONDARY outcome
Timeframe: Immediate Post (up to 7 weeks after baseline)Stress will be measured using Perceived Stress Scale (past month). The PSS has 10 items, completed using self-report. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress; scores ranging from 14-26 would be considered moderate stress; scores ranging from 27-40 would be considered high perceived stress.
Outcome measures
| Measure |
Control
n=30 Participants
Attention Control
Attention Control: The Attention Control Intervention condition will meet the requirements for a comparison treatment for testing behavioral interventions - equivalent in contact time, credible and interesting, and exert limited treatment effects.
In the same number of sessions and format as the Sleeping Healthy/Living Healthy intervention (anticipated to be two group and two one-on-one sessions delivered once per week by SBHC providers and health educators), the study will teach participants about sleep and other health topics relevant to adolescents (e.g., nutrition, injury prevention) devoid of the MBIH elements in our integrated intervention.
|
Intervention
n=31 Participants
Sleeping Healthy/Living Healthy
Sleeping Healthy/Living Healthy: Sleeping Healthy/Living Healthy will be a school based health center (SBHC)-based intervention integrating mind-body integrative health (MBIH) and sleep hygiene strategies to improve sleep quality in urban adolescents. The Sleeping Healthy/Living Healthy intervention content and format will be determined in a Development Phase 1. The investigator anticipates the intervention will consist of two group and two one-on-one sessions. The intervention will be grounded in social-cognitive theory and use motivational interviewing to support MBIH and sleep hygiene strategies. Sessions will be delivered once per week by SBHC providers and health educators.
|
|---|---|---|
|
Score on the Perceived Stress Scale (PSS)
|
29.04 score on a scale
Standard Error 6.23
|
27.11 score on a scale
Standard Error 5.61
|
SECONDARY outcome
Timeframe: Follow-up (up to 2.5 months)Stress will be measured using Perceived Stress Scale (past month). The PSS has 10 items, completed using self-report. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress; scores ranging from 14-26 would be considered moderate stress; scores ranging from 27-40 would be considered high perceived stress.
Outcome measures
| Measure |
Control
n=30 Participants
Attention Control
Attention Control: The Attention Control Intervention condition will meet the requirements for a comparison treatment for testing behavioral interventions - equivalent in contact time, credible and interesting, and exert limited treatment effects.
In the same number of sessions and format as the Sleeping Healthy/Living Healthy intervention (anticipated to be two group and two one-on-one sessions delivered once per week by SBHC providers and health educators), the study will teach participants about sleep and other health topics relevant to adolescents (e.g., nutrition, injury prevention) devoid of the MBIH elements in our integrated intervention.
|
Intervention
n=31 Participants
Sleeping Healthy/Living Healthy
Sleeping Healthy/Living Healthy: Sleeping Healthy/Living Healthy will be a school based health center (SBHC)-based intervention integrating mind-body integrative health (MBIH) and sleep hygiene strategies to improve sleep quality in urban adolescents. The Sleeping Healthy/Living Healthy intervention content and format will be determined in a Development Phase 1. The investigator anticipates the intervention will consist of two group and two one-on-one sessions. The intervention will be grounded in social-cognitive theory and use motivational interviewing to support MBIH and sleep hygiene strategies. Sessions will be delivered once per week by SBHC providers and health educators.
|
|---|---|---|
|
Score on the Perceived Stress Scale (PSS)
|
28.64 score on a scale
Standard Error 6.71
|
26.07 score on a scale
Standard Error 6.14
|
SECONDARY outcome
Timeframe: Baseline (Day 0)Stress will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Psychological Stress Experiences Ped Short Form (SF) v1.0 (past 7 days), an 8-item self report. For PROMIS instruments, a score of 50 is the average for the United States general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population. A higher PROMIS T-score represents more of the concept being measured. For the Psychological Stress Experiences, a T-score of 60 is one standard deviation (SD) worse than average.
Outcome measures
| Measure |
Control
n=30 Participants
Attention Control
Attention Control: The Attention Control Intervention condition will meet the requirements for a comparison treatment for testing behavioral interventions - equivalent in contact time, credible and interesting, and exert limited treatment effects.
In the same number of sessions and format as the Sleeping Healthy/Living Healthy intervention (anticipated to be two group and two one-on-one sessions delivered once per week by SBHC providers and health educators), the study will teach participants about sleep and other health topics relevant to adolescents (e.g., nutrition, injury prevention) devoid of the MBIH elements in our integrated intervention.
|
Intervention
n=31 Participants
Sleeping Healthy/Living Healthy
Sleeping Healthy/Living Healthy: Sleeping Healthy/Living Healthy will be a school based health center (SBHC)-based intervention integrating mind-body integrative health (MBIH) and sleep hygiene strategies to improve sleep quality in urban adolescents. The Sleeping Healthy/Living Healthy intervention content and format will be determined in a Development Phase 1. The investigator anticipates the intervention will consist of two group and two one-on-one sessions. The intervention will be grounded in social-cognitive theory and use motivational interviewing to support MBIH and sleep hygiene strategies. Sessions will be delivered once per week by SBHC providers and health educators.
|
|---|---|---|
|
Score on the PROMIS Psychological Stress Experiences Survey - T Score
|
61.74 PROMIS T-score on a scale
Standard Error 8.68
|
62.12 PROMIS T-score on a scale
Standard Error 9.98
|
SECONDARY outcome
Timeframe: Immediate Post (up to 7 weeks after baseline)Stress will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Psychological Stress Experiences Ped Short Form (SF) v1.0 (past 7 days), an 8-item self report. For PROMIS instruments, a score of 50 is the average for the United States general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population. A higher PROMIS T-score represents more of the concept being measured. For the Psychological Stress Experiences, a T-score of 60 is one standard deviation (SD) worse than average.
Outcome measures
| Measure |
Control
n=30 Participants
Attention Control
Attention Control: The Attention Control Intervention condition will meet the requirements for a comparison treatment for testing behavioral interventions - equivalent in contact time, credible and interesting, and exert limited treatment effects.
In the same number of sessions and format as the Sleeping Healthy/Living Healthy intervention (anticipated to be two group and two one-on-one sessions delivered once per week by SBHC providers and health educators), the study will teach participants about sleep and other health topics relevant to adolescents (e.g., nutrition, injury prevention) devoid of the MBIH elements in our integrated intervention.
|
Intervention
n=31 Participants
Sleeping Healthy/Living Healthy
Sleeping Healthy/Living Healthy: Sleeping Healthy/Living Healthy will be a school based health center (SBHC)-based intervention integrating mind-body integrative health (MBIH) and sleep hygiene strategies to improve sleep quality in urban adolescents. The Sleeping Healthy/Living Healthy intervention content and format will be determined in a Development Phase 1. The investigator anticipates the intervention will consist of two group and two one-on-one sessions. The intervention will be grounded in social-cognitive theory and use motivational interviewing to support MBIH and sleep hygiene strategies. Sessions will be delivered once per week by SBHC providers and health educators.
|
|---|---|---|
|
Score on the PROMIS Psychological Stress Experiences Survey - T Score
|
58.70 PROMIS T-score on a scale
Standard Error 9.45
|
57.46 PROMIS T-score on a scale
Standard Error 7.97
|
SECONDARY outcome
Timeframe: Follow-up (up to 2.5 months)Stress will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Psychological Stress Experiences Ped Short Form (SF) v1.0 (past 7 days), an 8-item self report. For PROMIS instruments, a score of 50 is the average for the United States general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population. A higher PROMIS T-score represents more of the concept being measured. For the Psychological Stress Experiences, a T-score of 60 is one standard deviation (SD) worse than average.
Outcome measures
| Measure |
Control
n=30 Participants
Attention Control
Attention Control: The Attention Control Intervention condition will meet the requirements for a comparison treatment for testing behavioral interventions - equivalent in contact time, credible and interesting, and exert limited treatment effects.
In the same number of sessions and format as the Sleeping Healthy/Living Healthy intervention (anticipated to be two group and two one-on-one sessions delivered once per week by SBHC providers and health educators), the study will teach participants about sleep and other health topics relevant to adolescents (e.g., nutrition, injury prevention) devoid of the MBIH elements in our integrated intervention.
|
Intervention
n=31 Participants
Sleeping Healthy/Living Healthy
Sleeping Healthy/Living Healthy: Sleeping Healthy/Living Healthy will be a school based health center (SBHC)-based intervention integrating mind-body integrative health (MBIH) and sleep hygiene strategies to improve sleep quality in urban adolescents. The Sleeping Healthy/Living Healthy intervention content and format will be determined in a Development Phase 1. The investigator anticipates the intervention will consist of two group and two one-on-one sessions. The intervention will be grounded in social-cognitive theory and use motivational interviewing to support MBIH and sleep hygiene strategies. Sessions will be delivered once per week by SBHC providers and health educators.
|
|---|---|---|
|
Score on the PROMIS Psychological Stress Experiences Survey - T Score
|
59.15 PROMIS T-score on a scale
Standard Error 8.36
|
57.83 PROMIS T-score on a scale
Standard Error 11.82
|
SECONDARY outcome
Timeframe: Baseline (Day 0)Anxiety will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Anxiety Short Form 8a v2.0, an 8-item questionnaire assessing self-reported fear, anxious misery, and hyperarousal. Using a five-point frequency scale, ranging from 1 (never) to 5 (almost always), adolescents indicate how frequently or infrequently they felt various dimensions of anxiety (e.g., nervous, scared, worried) in the past 7 days. PROMIS instruments are scored using item-level calibrations. For PROMIS instruments, a T-score of 50 is the average for the United States general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population. A higher PROMIS T-score represents more of the concept being measured. For the Pediatric Anxiety, a T-score of 60 is one standard deviation (SD) worse than average.
Outcome measures
| Measure |
Control
n=30 Participants
Attention Control
Attention Control: The Attention Control Intervention condition will meet the requirements for a comparison treatment for testing behavioral interventions - equivalent in contact time, credible and interesting, and exert limited treatment effects.
In the same number of sessions and format as the Sleeping Healthy/Living Healthy intervention (anticipated to be two group and two one-on-one sessions delivered once per week by SBHC providers and health educators), the study will teach participants about sleep and other health topics relevant to adolescents (e.g., nutrition, injury prevention) devoid of the MBIH elements in our integrated intervention.
|
Intervention
n=31 Participants
Sleeping Healthy/Living Healthy
Sleeping Healthy/Living Healthy: Sleeping Healthy/Living Healthy will be a school based health center (SBHC)-based intervention integrating mind-body integrative health (MBIH) and sleep hygiene strategies to improve sleep quality in urban adolescents. The Sleeping Healthy/Living Healthy intervention content and format will be determined in a Development Phase 1. The investigator anticipates the intervention will consist of two group and two one-on-one sessions. The intervention will be grounded in social-cognitive theory and use motivational interviewing to support MBIH and sleep hygiene strategies. Sessions will be delivered once per week by SBHC providers and health educators.
|
|---|---|---|
|
Score on the PROMIS Pediatric Anxiety Short Form 8a v2.0 - T-Score
|
52.82 PROMIS T-score on a scale
Standard Error 7.79
|
53.63 PROMIS T-score on a scale
Standard Error 12.13
|
SECONDARY outcome
Timeframe: Immediate Post (up to 7 weeks after baseline)Anxiety will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Anxiety Short Form 8a v2.0, an 8-item questionnaire assessing self-reported fear, anxious misery, and hyperarousal. Using a five-point frequency scale, ranging from 1 (never) to 5 (almost always), adolescents indicate how frequently or infrequently they felt various dimensions of anxiety (e.g., nervous, scared, worried) in the past 7 days. PROMIS instruments are scored using item-level calibrations. For PROMIS instruments, a T-score of 50 is the average for the United States general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population. A higher PROMIS T-score represents more of the concept being measured. For the Pediatric Anxiety, a T-score of 60 is one standard deviation (SD) worse than average.
Outcome measures
| Measure |
Control
n=30 Participants
Attention Control
Attention Control: The Attention Control Intervention condition will meet the requirements for a comparison treatment for testing behavioral interventions - equivalent in contact time, credible and interesting, and exert limited treatment effects.
In the same number of sessions and format as the Sleeping Healthy/Living Healthy intervention (anticipated to be two group and two one-on-one sessions delivered once per week by SBHC providers and health educators), the study will teach participants about sleep and other health topics relevant to adolescents (e.g., nutrition, injury prevention) devoid of the MBIH elements in our integrated intervention.
|
Intervention
n=31 Participants
Sleeping Healthy/Living Healthy
Sleeping Healthy/Living Healthy: Sleeping Healthy/Living Healthy will be a school based health center (SBHC)-based intervention integrating mind-body integrative health (MBIH) and sleep hygiene strategies to improve sleep quality in urban adolescents. The Sleeping Healthy/Living Healthy intervention content and format will be determined in a Development Phase 1. The investigator anticipates the intervention will consist of two group and two one-on-one sessions. The intervention will be grounded in social-cognitive theory and use motivational interviewing to support MBIH and sleep hygiene strategies. Sessions will be delivered once per week by SBHC providers and health educators.
|
|---|---|---|
|
Score on the PROMIS Pediatric Anxiety Short Form 8a v2.0 - T Score
|
50.15 PROMIS T-score on a scale
Standard Error 9.26
|
50.17 PROMIS T-score on a scale
Standard Error 8.88
|
SECONDARY outcome
Timeframe: Follow-up (up to 2.5 months)Anxiety will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Anxiety Short Form 8a v2.0, an 8-item questionnaire assessing self-reported fear, anxious misery, and hyperarousal. Using a five-point frequency scale, ranging from 1 (never) to 5 (almost always), adolescents indicate how frequently or infrequently they felt various dimensions of anxiety (e.g., nervous, scared, worried) in the past 7 days. PROMIS instruments are scored using item-level calibrations. For PROMIS instruments, a T-score of 50 is the average for the United States general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population. A higher PROMIS T-score represents more of the concept being measured. For the Pediatric Anxiety, a T-score of 60 is one standard deviation (SD) worse than average.
Outcome measures
| Measure |
Control
n=30 Participants
Attention Control
Attention Control: The Attention Control Intervention condition will meet the requirements for a comparison treatment for testing behavioral interventions - equivalent in contact time, credible and interesting, and exert limited treatment effects.
In the same number of sessions and format as the Sleeping Healthy/Living Healthy intervention (anticipated to be two group and two one-on-one sessions delivered once per week by SBHC providers and health educators), the study will teach participants about sleep and other health topics relevant to adolescents (e.g., nutrition, injury prevention) devoid of the MBIH elements in our integrated intervention.
|
Intervention
n=31 Participants
Sleeping Healthy/Living Healthy
Sleeping Healthy/Living Healthy: Sleeping Healthy/Living Healthy will be a school based health center (SBHC)-based intervention integrating mind-body integrative health (MBIH) and sleep hygiene strategies to improve sleep quality in urban adolescents. The Sleeping Healthy/Living Healthy intervention content and format will be determined in a Development Phase 1. The investigator anticipates the intervention will consist of two group and two one-on-one sessions. The intervention will be grounded in social-cognitive theory and use motivational interviewing to support MBIH and sleep hygiene strategies. Sessions will be delivered once per week by SBHC providers and health educators.
|
|---|---|---|
|
Score on the PROMIS Pediatric Anxiety Short Form 8a v2.0 - T Score
|
51.79 PROMIS T-score on a scale
Standard Error 7.89
|
51.48 PROMIS T-score on a scale
Standard Error 11.02
|
SECONDARY outcome
Timeframe: Baseline (Day 0)Subjective sleep-related impairment will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Sleep-Related Impairment Short Form 8a v1.0, an 8-item questionnaire focusing on self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours, and perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. Adolescents rate various aspects of their sleep over the past 7 days on a 5-point frequency scale ranging from 1 (never) to 5 (always). PROMIS instruments are scored using item-level calibrations. For PROMIS instruments, a T-score of 50 is the average for the United States general population with a standard deviation of 10. A higher PROMIS T-score represents more of the concept being measured. For the Pediatric Sleep-Related Impairment, a T-score of 60 is one standard deviation (SD)
Outcome measures
| Measure |
Control
n=30 Participants
Attention Control
Attention Control: The Attention Control Intervention condition will meet the requirements for a comparison treatment for testing behavioral interventions - equivalent in contact time, credible and interesting, and exert limited treatment effects.
In the same number of sessions and format as the Sleeping Healthy/Living Healthy intervention (anticipated to be two group and two one-on-one sessions delivered once per week by SBHC providers and health educators), the study will teach participants about sleep and other health topics relevant to adolescents (e.g., nutrition, injury prevention) devoid of the MBIH elements in our integrated intervention.
|
Intervention
n=31 Participants
Sleeping Healthy/Living Healthy
Sleeping Healthy/Living Healthy: Sleeping Healthy/Living Healthy will be a school based health center (SBHC)-based intervention integrating mind-body integrative health (MBIH) and sleep hygiene strategies to improve sleep quality in urban adolescents. The Sleeping Healthy/Living Healthy intervention content and format will be determined in a Development Phase 1. The investigator anticipates the intervention will consist of two group and two one-on-one sessions. The intervention will be grounded in social-cognitive theory and use motivational interviewing to support MBIH and sleep hygiene strategies. Sessions will be delivered once per week by SBHC providers and health educators.
|
|---|---|---|
|
Score on the PROMIS Pediatric Sleep-Related Impairment Short Form 8a v1.0 - T Score
|
61.71 PROMIS T-score on a scale
Standard Error 7.78
|
91.43 PROMIS T-score on a scale
Standard Error 168.67
|
SECONDARY outcome
Timeframe: Immediate Post (up to 7 weeks after baseline)Subjective sleep-related impairment will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Sleep-Related Impairment Short Form 8a v1.0, an 8-item questionnaire focusing on self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours, and perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. Adolescents rate various aspects of their sleep over the past 7 days on a 5-point frequency scale ranging from 1 (never) to 5 (always). PROMIS instruments are scored using item-level calibrations. For PROMIS instruments, a T-score of 50 is the average for the United States general population with a standard deviation of 10. A higher PROMIS T-score represents more of the concept being measured. For the Pediatric Sleep-Related Impairment, a T-score of 60 is one standard deviation (SD) worse than average.
Outcome measures
| Measure |
Control
n=30 Participants
Attention Control
Attention Control: The Attention Control Intervention condition will meet the requirements for a comparison treatment for testing behavioral interventions - equivalent in contact time, credible and interesting, and exert limited treatment effects.
In the same number of sessions and format as the Sleeping Healthy/Living Healthy intervention (anticipated to be two group and two one-on-one sessions delivered once per week by SBHC providers and health educators), the study will teach participants about sleep and other health topics relevant to adolescents (e.g., nutrition, injury prevention) devoid of the MBIH elements in our integrated intervention.
|
Intervention
n=31 Participants
Sleeping Healthy/Living Healthy
Sleeping Healthy/Living Healthy: Sleeping Healthy/Living Healthy will be a school based health center (SBHC)-based intervention integrating mind-body integrative health (MBIH) and sleep hygiene strategies to improve sleep quality in urban adolescents. The Sleeping Healthy/Living Healthy intervention content and format will be determined in a Development Phase 1. The investigator anticipates the intervention will consist of two group and two one-on-one sessions. The intervention will be grounded in social-cognitive theory and use motivational interviewing to support MBIH and sleep hygiene strategies. Sessions will be delivered once per week by SBHC providers and health educators.
|
|---|---|---|
|
Score on the PROMIS Pediatric Sleep-Related Impairment Short Form 8a v1.0 - T Score
|
60.08 PROMIS T-score on a scale
Standard Error 8.01
|
55.09 PROMIS T-score on a scale
Standard Error 7.65
|
SECONDARY outcome
Timeframe: Follow-up (up to 2.5 months)Subjective sleep-related impairment will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Sleep-Related Impairment Short Form 8a v1.0, an 8-item questionnaire focusing on self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours, and perceived functional impairments during wakefulness associated with sleep problems or impaired alertness. Adolescents rate various aspects of their sleep over the past 7 days on a 5-point frequency scale ranging from 1 (never) to 5 (always). PROMIS instruments are scored using item-level calibrations. For PROMIS instruments, a T-score of 50 is the average for the United States general population with a standard deviation of 10. A higher PROMIS T-score represents more of the concept being measured. For the Pediatric Sleep-Related Impairment, a T-score of 60 is one standard deviation (SD) worse than average.
Outcome measures
| Measure |
Control
n=30 Participants
Attention Control
Attention Control: The Attention Control Intervention condition will meet the requirements for a comparison treatment for testing behavioral interventions - equivalent in contact time, credible and interesting, and exert limited treatment effects.
In the same number of sessions and format as the Sleeping Healthy/Living Healthy intervention (anticipated to be two group and two one-on-one sessions delivered once per week by SBHC providers and health educators), the study will teach participants about sleep and other health topics relevant to adolescents (e.g., nutrition, injury prevention) devoid of the MBIH elements in our integrated intervention.
|
Intervention
n=31 Participants
Sleeping Healthy/Living Healthy
Sleeping Healthy/Living Healthy: Sleeping Healthy/Living Healthy will be a school based health center (SBHC)-based intervention integrating mind-body integrative health (MBIH) and sleep hygiene strategies to improve sleep quality in urban adolescents. The Sleeping Healthy/Living Healthy intervention content and format will be determined in a Development Phase 1. The investigator anticipates the intervention will consist of two group and two one-on-one sessions. The intervention will be grounded in social-cognitive theory and use motivational interviewing to support MBIH and sleep hygiene strategies. Sessions will be delivered once per week by SBHC providers and health educators.
|
|---|---|---|
|
Score on the PROMIS Pediatric Sleep-Related Impairment Short Form 8a v1.0 - T Score
|
59.68 PROMIS T-score on a scale
Standard Error 7.90
|
53.22 PROMIS T-score on a scale
Standard Error 10.32
|
SECONDARY outcome
Timeframe: Baseline (Day 0)Mindfulness will be measured using the MAAS-A, a self-reported 14-item questionnaire that measures the level of mindfulness, defined as "a receptive state of attention that, informed by an awareness of present experience, simply observes what is taking place." The MAAS-A is an adapted adolescent version of the validated Mindful Attention Awareness Scale (MAAS), which was developed for use with adult populations and considers mindfulness to be a one-dimensional construct. Using a six-point scale, ranging from 1 (almost always) to 6 (almost never), adolescents indicate how frequently or infrequently they currently have each experience. The score is the mean of the 14 items with higher scores reflecting higher trait mindfulness.
Outcome measures
| Measure |
Control
n=30 Participants
Attention Control
Attention Control: The Attention Control Intervention condition will meet the requirements for a comparison treatment for testing behavioral interventions - equivalent in contact time, credible and interesting, and exert limited treatment effects.
In the same number of sessions and format as the Sleeping Healthy/Living Healthy intervention (anticipated to be two group and two one-on-one sessions delivered once per week by SBHC providers and health educators), the study will teach participants about sleep and other health topics relevant to adolescents (e.g., nutrition, injury prevention) devoid of the MBIH elements in our integrated intervention.
|
Intervention
n=31 Participants
Sleeping Healthy/Living Healthy
Sleeping Healthy/Living Healthy: Sleeping Healthy/Living Healthy will be a school based health center (SBHC)-based intervention integrating mind-body integrative health (MBIH) and sleep hygiene strategies to improve sleep quality in urban adolescents. The Sleeping Healthy/Living Healthy intervention content and format will be determined in a Development Phase 1. The investigator anticipates the intervention will consist of two group and two one-on-one sessions. The intervention will be grounded in social-cognitive theory and use motivational interviewing to support MBIH and sleep hygiene strategies. Sessions will be delivered once per week by SBHC providers and health educators.
|
|---|---|---|
|
Score on MAAS-A (Mindfulness Attention Awareness Scale - Adolescents)
|
3.73 score on a scale
Standard Error 1.10
|
3.70 score on a scale
Standard Error 1.12
|
SECONDARY outcome
Timeframe: Immediate Post (up to 7 weeks after baseline)Mindfulness will be measured using the MAAS-A, a self-reported 14-item questionnaire that measures the level of mindfulness, defined as "a receptive state of attention that, informed by an awareness of present experience, simply observes what is taking place." The MAAS-A is an adapted adolescent version of the validated Mindful Attention Awareness Scale (MAAS), which was developed for use with adult populations and considers mindfulness to be a one-dimensional construct. Using a six-point scale, ranging from 1 (almost always) to 6 (almost never), adolescents indicate how frequently or infrequently they currently have each experience. The score is the mean of the 14 items with higher scores reflecting higher trait mindfulness.
Outcome measures
| Measure |
Control
n=30 Participants
Attention Control
Attention Control: The Attention Control Intervention condition will meet the requirements for a comparison treatment for testing behavioral interventions - equivalent in contact time, credible and interesting, and exert limited treatment effects.
In the same number of sessions and format as the Sleeping Healthy/Living Healthy intervention (anticipated to be two group and two one-on-one sessions delivered once per week by SBHC providers and health educators), the study will teach participants about sleep and other health topics relevant to adolescents (e.g., nutrition, injury prevention) devoid of the MBIH elements in our integrated intervention.
|
Intervention
n=31 Participants
Sleeping Healthy/Living Healthy
Sleeping Healthy/Living Healthy: Sleeping Healthy/Living Healthy will be a school based health center (SBHC)-based intervention integrating mind-body integrative health (MBIH) and sleep hygiene strategies to improve sleep quality in urban adolescents. The Sleeping Healthy/Living Healthy intervention content and format will be determined in a Development Phase 1. The investigator anticipates the intervention will consist of two group and two one-on-one sessions. The intervention will be grounded in social-cognitive theory and use motivational interviewing to support MBIH and sleep hygiene strategies. Sessions will be delivered once per week by SBHC providers and health educators.
|
|---|---|---|
|
Score on MAAS-A (Mindfulness Attention Awareness Scale - Adolescents)
|
4.04 score on a scale
Standard Error 1.11
|
4.23 score on a scale
Standard Error 0.92
|
SECONDARY outcome
Timeframe: Follow-up (up to 2.5 months)Mindfulness will be measured using the MAAS-A, a self-reported 14-item questionnaire that measures the level of mindfulness, defined as "a receptive state of attention that, informed by an awareness of present experience, simply observes what is taking place." The MAAS-A is an adapted adolescent version of the validated Mindful Attention Awareness Scale (MAAS), which was developed for use with adult populations and considers mindfulness to be a one-dimensional construct. Using a six-point scale, ranging from 1 (almost always) to 6 (almost never), adolescents indicate how frequently or infrequently they currently have each experience. The score is the mean of the 14 items with higher scores reflecting higher trait mindfulness.
Outcome measures
| Measure |
Control
n=30 Participants
Attention Control
Attention Control: The Attention Control Intervention condition will meet the requirements for a comparison treatment for testing behavioral interventions - equivalent in contact time, credible and interesting, and exert limited treatment effects.
In the same number of sessions and format as the Sleeping Healthy/Living Healthy intervention (anticipated to be two group and two one-on-one sessions delivered once per week by SBHC providers and health educators), the study will teach participants about sleep and other health topics relevant to adolescents (e.g., nutrition, injury prevention) devoid of the MBIH elements in our integrated intervention.
|
Intervention
n=31 Participants
Sleeping Healthy/Living Healthy
Sleeping Healthy/Living Healthy: Sleeping Healthy/Living Healthy will be a school based health center (SBHC)-based intervention integrating mind-body integrative health (MBIH) and sleep hygiene strategies to improve sleep quality in urban adolescents. The Sleeping Healthy/Living Healthy intervention content and format will be determined in a Development Phase 1. The investigator anticipates the intervention will consist of two group and two one-on-one sessions. The intervention will be grounded in social-cognitive theory and use motivational interviewing to support MBIH and sleep hygiene strategies. Sessions will be delivered once per week by SBHC providers and health educators.
|
|---|---|---|
|
Score on MAAS-A (Mindfulness Attention Awareness Scale - Adolescents)
|
4.05 score on a scale
Standard Error 1.11
|
4.45 score on a scale
Standard Error 1.05
|
Adverse Events
Intervention
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Samantha Garbers-Adams, PhD
Columbia University Irving Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place