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Sleeping Healthy/Living Healthy Development

Development and Pilot Testing of Sleeping Healthy/Living Healthy, a Comprehensive Sleep Intervention for Adolescents in Urban School Based Health Center (SBHCs): Phase II or Randomized Pilot Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04484649
Enrollment
61
Registered
2020-07-23
Start date
2021-10-12
Completion date
2022-06-07
Last updated
2024-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychological Stress, Sleep

Brief summary

This pilot study will: (1) develop Sleeping Healthy/Living Healthy, a school-based health center (SBHC) intervention that combines MBIH and sleep hygiene strategies to improve sleep quality in urban adolescents with poor sleep quality; (2) evaluate the feasibility and acceptability of intervention procedures; and (3) assess the preliminary intervention effects on sleep quality in urban adolescents. This study includes a development phase and a pilot individually-randomized group treatment (IRGT) phase. In Year 1, the investigators will develop the novel integrated intervention using an iterative participatory design process. In Year 2, the investigators will conduct an IRGT trial with 60 adolescents with insufficient sleep recruited from two SBHCs in New York City. Adolescents will be randomized 1:1 to receive the intervention or an attention control of equal intensity and duration. Process evaluation interviews guided by a rigorous fidelity framework with adolescents and with SBHC providers and personnel will be conducted to obtain feedback regarding intervention procedures.

Detailed description

Poor sleep quality, which contributes to impaired functioning, is elevated in urban, ethnic/racial minority adolescents due, in part, to poor sleep hygiene. Despite successful sleep hygiene interventions in younger children, none focus on adolescents, a group with unique developmental needs. Urban adolescents face unique contextual stressors, which may contribute to ineffective use of sleep hygiene behaviors. Mind-body integrative (MBIH) approaches (e.g. yoga, meditation) improve sleep quality in adults, but are rarely applied to adolescents. MBIH has been shown to reduce stress among adolescents. Taken together, this suggests that integrating MBIH with sleep hygiene strategies has the potential for a synergistic effect on improving sleep quality, yet no interventions concurrently use MBIH and sleep hygiene with adolescents.

Interventions

BEHAVIORALSleeping 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.

BEHAVIORALAttention 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.

Sponsors

Columbia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
Yes

Inclusion criteria

* Age 13.0 -17.9; * Grade 9 - 11; * Currently enrolled as a patient in one of the participating SBHCs; and * Report sleep duration \< 8 hours (below the minimally recommended number of hours of sleep for this age group through the following questions: What time do you: a) usually fall asleep on weekdays and b) usually wake up on weekdays?).

Exclusion criteria

* Report of prior diagnosis of a sleep disorder, such as sleep disordered breathing, restless leg syndrome, or periodic limb movement; * Significant developmental delay and/or severe psychiatric or medical conditions that preclude completion of study procedures or confound analyses; or * Not capable of communicating (reading, speaking, writing) in English.

Design outcomes

Primary

MeasureTime frameDescription
Average Sleep Duration (Past 2 Weeks)Baseline (Day 0)Measured using actigraphy. Measured in minutes.
Sleep Fragmentation - Sleep Efficiency (%) (Past Month)Baseline (Day 0)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.
Sleep Fragmentation - Number of Sleep Disruptions (Past Month)Baseline (Day 0)Number of sleep disruptions (number of times awakened) per night (mean, in past month): measured using actigraphy.

Secondary

MeasureTime frameDescription
Score on the PROMIS Pediatric Anxiety Short Form 8a v2.0 - T-ScoreBaseline (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.
Score on the PROMIS Pediatric Anxiety Short Form 8a v2.0 - T ScoreImmediate 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.
Score on Pittsburgh Sleep Quality Index (PSQI Global Score)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.
Score on MAAS-A (Mindfulness Attention Awareness Scale - Adolescents)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.
Score on the PROMIS Pediatric Sleep-Related Impairment Short Form 8a v1.0 - T ScoreBaseline (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)
Score on the Perceived Stress Scale (PSS)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.
Score on the PROMIS Psychological Stress Experiences Survey - T ScoreBaseline (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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
30
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.
31
Total61

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDid not submit actigraphy post interc\vention64
Overall StudyLost to Follow-up21

Baseline characteristics

CharacteristicTotalControlIntervention
Age, Customized
14 years
6 years3 years3 years
Age, Customized
15 years
19 years8 years11 years
Age, Customized
16 years
21 years10 years11 years
Age, Customized
17 years
15 years9 years6 years
Ethnicity (NIH/OMB)
Hispanic or Latino
51 Participants24 Participants27 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
10 Participants6 Participants4 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
4 Participants3 Participants1 Participants
Race (NIH/OMB)
Black or African American
15 Participants7 Participants8 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
42 Participants20 Participants22 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Region of Enrollment
United States
61 participants30 participants31 participants
Sex/Gender, Customized
Female
40 Participants20 Participants20 Participants
Sex/Gender, Customized
Male
20 Participants10 Participants10 Participants
Sex/Gender, Customized
Preferred not to answer
1 Participants0 Participants1 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 310 / 30
other
Total, other adverse events
0 / 310 / 30
serious
Total, serious adverse events
0 / 310 / 30

Outcome results

Primary

Average Sleep Duration (Past 2 Weeks)

Measured in actigraphy. Measured in minutes.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
ControlAverage Sleep Duration (Past 2 Weeks)408.5679825 minutesStandard Deviation 35.9948487
InterventionAverage Sleep Duration (Past 2 Weeks)395.8340439 minutesStandard Deviation 50.3787645
Primary

Average Sleep Duration (Past 2 Weeks)

Measured using actigraphy. Measured in minutes.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
ControlAverage Sleep Duration (Past 2 Weeks)404.2418126 minutesStandard Deviation 41.4605752
InterventionAverage Sleep Duration (Past 2 Weeks)394.9457195 minutesStandard Deviation 54.7797086
Primary

Average Sleep Duration (Past 2 Weeks)

Measured with actigraphy. Measured in minutes.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
ControlAverage Sleep Duration (Past 2 Weeks)419.5089676 minutesStandard Deviation 57.970601
InterventionAverage Sleep Duration (Past 2 Weeks)399.1041454 minutesStandard Deviation 49.9715607
Primary

Sleep Fragmentation - Number of Sleep Disruptions (Past Month)

Number of sleep disruptions (number of times awakened) per night (mean, in past month): measured using actigraphy.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
ControlSleep Fragmentation - Number of Sleep Disruptions (Past Month)33.7649958 number of times awakenedStandard Deviation 10.3250768
InterventionSleep Fragmentation - Number of Sleep Disruptions (Past Month)32.9682422 number of times awakenedStandard Deviation 10.0477777
Primary

Sleep Fragmentation - Number of Sleep Disruptions (Past Month)

Number of sleep disruptions (number of times awakened) per night (mean, in past month): measured using actigraphy.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
ControlSleep Fragmentation - Number of Sleep Disruptions (Past Month)33.6921279 number of times awakenedStandard Deviation 9.9379062
InterventionSleep Fragmentation - Number of Sleep Disruptions (Past Month)35.9452319 number of times awakenedStandard Deviation 11.2391805
Primary

Sleep Fragmentation - Number of Sleep Disruptions (Past Month)

Number of sleep disruptions (number of times awakened) per night (mean, in past month): measured using actigraphy.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
ControlSleep Fragmentation - Number of Sleep Disruptions (Past Month)32.3090725 number of times awakenedStandard Deviation 7.3284517
InterventionSleep Fragmentation - Number of Sleep Disruptions (Past Month)36.1768219 number of times awakenedStandard Deviation 8.5199704
Primary

Sleep Fragmentation - Sleep Efficiency (%) (Past Month)

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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
ControlSleep Fragmentation - Sleep Efficiency (%) (Past Month)89.2803736 percentage of sleep efficiencyStandard Deviation 3.1858765
InterventionSleep Fragmentation - Sleep Efficiency (%) (Past Month)88.4959747 percentage of sleep efficiencyStandard Deviation 3.6605489
Primary

Sleep Fragmentation - Sleep Efficiency (%) (Past Month)

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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
ControlSleep Fragmentation - Sleep Efficiency (%) (Past Month)88.7501893 percentage of sleep efficiencyStandard Deviation 3.2706091
InterventionSleep Fragmentation - Sleep Efficiency (%) (Past Month)87.1876309 percentage of sleep efficiencyStandard Deviation 3.9030391
Primary

Sleep Fragmentation - Sleep Efficiency (%) (Past Month)

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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
ControlSleep Fragmentation - Sleep Efficiency (%) (Past Month)88.5538488 percentage of sleep efficiencyStandard Deviation 6.4652919
InterventionSleep Fragmentation - Sleep Efficiency (%) (Past Month)87.8333318 percentage of sleep efficiencyStandard Deviation 4.1461175
Secondary

Score on MAAS-A (Mindfulness Attention Awareness Scale - Adolescents)

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.

Time frame: Follow-up (up to 2.5 months)

ArmMeasureValue (MEAN)Dispersion
ControlScore on MAAS-A (Mindfulness Attention Awareness Scale - Adolescents)4.05 score on a scaleStandard Error 1.11
InterventionScore on MAAS-A (Mindfulness Attention Awareness Scale - Adolescents)4.45 score on a scaleStandard Error 1.05
Secondary

Score on MAAS-A (Mindfulness Attention Awareness Scale - Adolescents)

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.

Time frame: Baseline (Day 0)

ArmMeasureValue (MEAN)Dispersion
ControlScore on MAAS-A (Mindfulness Attention Awareness Scale - Adolescents)3.73 score on a scaleStandard Error 1.1
InterventionScore on MAAS-A (Mindfulness Attention Awareness Scale - Adolescents)3.70 score on a scaleStandard Error 1.12
Secondary

Score on MAAS-A (Mindfulness Attention Awareness Scale - Adolescents)

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.

Time frame: Immediate Post (up to 7 weeks after baseline)

ArmMeasureValue (MEAN)Dispersion
ControlScore on MAAS-A (Mindfulness Attention Awareness Scale - Adolescents)4.04 score on a scaleStandard Error 1.11
InterventionScore on MAAS-A (Mindfulness Attention Awareness Scale - Adolescents)4.23 score on a scaleStandard Error 0.92
Secondary

Score on Pittsburgh Sleep Quality Index (PSQI Global Score)

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.

Time frame: Follow-up (up to 2.5 months)

ArmMeasureValue (MEAN)Dispersion
ControlScore on Pittsburgh Sleep Quality Index (PSQI Global Score)6.07 global score on a scaleStandard Error 2.02
InterventionScore on Pittsburgh Sleep Quality Index (PSQI Global Score)4.59 global score on a scaleStandard Error 2.44
Secondary

Score on Pittsburgh Sleep Quality Index (PSQI Global Score)

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.

Time frame: Immediate Post (up to 7 weeks after baseline)

ArmMeasureValue (MEAN)Dispersion
ControlScore on Pittsburgh Sleep Quality Index (PSQI Global Score)6.44 global score on a scaleStandard Error 3.06
InterventionScore on Pittsburgh Sleep Quality Index (PSQI Global Score)5.07 global score on a scaleStandard Error 2.24
Secondary

Score on Pittsburgh Sleep Quality Index (PSQI Global Score)

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.

Time frame: Baseline (Day 0)

ArmMeasureValue (MEAN)Dispersion
ControlScore on Pittsburgh Sleep Quality Index (PSQI Global Score)7.73 global score on a scaleStandard Error 2.9
InterventionScore on Pittsburgh Sleep Quality Index (PSQI Global Score)8.48 global score on a scaleStandard Error 2.98
Secondary

Score on the Perceived Stress Scale (PSS)

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.

Time frame: Baseline (Day 0)

ArmMeasureValue (MEAN)Dispersion
ControlScore on the Perceived Stress Scale (PSS)28.50 score on a scaleStandard Error 5.26
InterventionScore on the Perceived Stress Scale (PSS)29.07 score on a scaleStandard Error 6.11
Secondary

Score on the Perceived Stress Scale (PSS)

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.

Time frame: Immediate Post (up to 7 weeks after baseline)

ArmMeasureValue (MEAN)Dispersion
ControlScore on the Perceived Stress Scale (PSS)29.04 score on a scaleStandard Error 6.23
InterventionScore on the Perceived Stress Scale (PSS)27.11 score on a scaleStandard Error 5.61
Secondary

Score on the Perceived Stress Scale (PSS)

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.

Time frame: Follow-up (up to 2.5 months)

ArmMeasureValue (MEAN)Dispersion
ControlScore on the Perceived Stress Scale (PSS)28.64 score on a scaleStandard Error 6.71
InterventionScore on the Perceived Stress Scale (PSS)26.07 score on a scaleStandard Error 6.14
Secondary

Score on the PROMIS Pediatric Anxiety Short Form 8a v2.0 - T Score

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.

Time frame: Immediate Post (up to 7 weeks after baseline)

ArmMeasureValue (MEAN)Dispersion
ControlScore on the PROMIS Pediatric Anxiety Short Form 8a v2.0 - T Score50.15 PROMIS T-score on a scaleStandard Error 9.26
InterventionScore on the PROMIS Pediatric Anxiety Short Form 8a v2.0 - T Score50.17 PROMIS T-score on a scaleStandard Error 8.88
Secondary

Score on the PROMIS Pediatric Anxiety Short Form 8a v2.0 - T Score

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.

Time frame: Follow-up (up to 2.5 months)

ArmMeasureValue (MEAN)Dispersion
ControlScore on the PROMIS Pediatric Anxiety Short Form 8a v2.0 - T Score51.79 PROMIS T-score on a scaleStandard Error 7.89
InterventionScore on the PROMIS Pediatric Anxiety Short Form 8a v2.0 - T Score51.48 PROMIS T-score on a scaleStandard Error 11.02
Secondary

Score on the PROMIS Pediatric Anxiety Short Form 8a v2.0 - T-Score

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.

Time frame: Baseline (Day 0)

ArmMeasureValue (MEAN)Dispersion
ControlScore on the PROMIS Pediatric Anxiety Short Form 8a v2.0 - T-Score52.82 PROMIS T-score on a scaleStandard Error 7.79
InterventionScore on the PROMIS Pediatric Anxiety Short Form 8a v2.0 - T-Score53.63 PROMIS T-score on a scaleStandard Error 12.13
Secondary

Score on the PROMIS Pediatric Sleep-Related Impairment Short Form 8a v1.0 - T Score

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.

Time frame: Immediate Post (up to 7 weeks after baseline)

ArmMeasureValue (MEAN)Dispersion
ControlScore on the PROMIS Pediatric Sleep-Related Impairment Short Form 8a v1.0 - T Score60.08 PROMIS T-score on a scaleStandard Error 8.01
InterventionScore on the PROMIS Pediatric Sleep-Related Impairment Short Form 8a v1.0 - T Score55.09 PROMIS T-score on a scaleStandard Error 7.65
Secondary

Score on the PROMIS Pediatric Sleep-Related Impairment Short Form 8a v1.0 - T Score

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)

Time frame: Baseline (Day 0)

ArmMeasureValue (MEAN)Dispersion
ControlScore on the PROMIS Pediatric Sleep-Related Impairment Short Form 8a v1.0 - T Score61.71 PROMIS T-score on a scaleStandard Error 7.78
InterventionScore on the PROMIS Pediatric Sleep-Related Impairment Short Form 8a v1.0 - T Score91.43 PROMIS T-score on a scaleStandard Error 168.67
Secondary

Score on the PROMIS Pediatric Sleep-Related Impairment Short Form 8a v1.0 - T Score

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.

Time frame: Follow-up (up to 2.5 months)

ArmMeasureValue (MEAN)Dispersion
ControlScore on the PROMIS Pediatric Sleep-Related Impairment Short Form 8a v1.0 - T Score59.68 PROMIS T-score on a scaleStandard Error 7.9
InterventionScore on the PROMIS Pediatric Sleep-Related Impairment Short Form 8a v1.0 - T Score53.22 PROMIS T-score on a scaleStandard Error 10.32
Secondary

Score on the PROMIS Psychological Stress Experiences Survey - T Score

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.

Time frame: Follow-up (up to 2.5 months)

ArmMeasureValue (MEAN)Dispersion
ControlScore on the PROMIS Psychological Stress Experiences Survey - T Score59.15 PROMIS T-score on a scaleStandard Error 8.36
InterventionScore on the PROMIS Psychological Stress Experiences Survey - T Score57.83 PROMIS T-score on a scaleStandard Error 11.82
Secondary

Score on the PROMIS Psychological Stress Experiences Survey - T Score

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.

Time frame: Immediate Post (up to 7 weeks after baseline)

ArmMeasureValue (MEAN)Dispersion
ControlScore on the PROMIS Psychological Stress Experiences Survey - T Score58.70 PROMIS T-score on a scaleStandard Error 9.45
InterventionScore on the PROMIS Psychological Stress Experiences Survey - T Score57.46 PROMIS T-score on a scaleStandard Error 7.97
Secondary

Score on the PROMIS Psychological Stress Experiences Survey - T Score

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.

Time frame: Baseline (Day 0)

ArmMeasureValue (MEAN)Dispersion
ControlScore on the PROMIS Psychological Stress Experiences Survey - T Score61.74 PROMIS T-score on a scaleStandard Error 8.68
InterventionScore on the PROMIS Psychological Stress Experiences Survey - T Score62.12 PROMIS T-score on a scaleStandard Error 9.98

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026