SleepNCT04484649
Sleeping Healthy/Living Healthy Development
A study testing Sleeping Healthy/Living Healthy in people with Sleep and Psychological Stress, run by Columbia University at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Psychological Stress
- What is being tested?
- Sleeping Healthy/Living Healthy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2021to 7 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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?).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Sleep, Psychological Stress
- Being tested
- Sleeping Healthy/Living Healthy, Attention Control
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleeping Healthy/Living HealthyBehavioural
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.
Attention ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Sleeping Healthy/Living Healthy Receives: Behavioral: Sleeping Healthy/Living Healthy |
| Control | Active comparator | Attention Control Receives: Behavioral: Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Sleep Duration (Past 2 Weeks)
Measured using actigraphy. Measured in minutes.
Measured: Baseline (Day 0)
Average Sleep Duration (Past 2 Weeks)
Measured with actigraphy. Measured in minutes.
Measured: Immediate Post (up to 7 weeks after baseline)
Average Sleep Duration (Past 2 Weeks)
Measured in actigraphy. Measured in minutes.
Measured: Follow-up (up to 2.5 months)
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.
Measured: Baseline (Day 0)
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.
Measured: Immediate Post (up to 7 weeks after baseline)
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.
Measured: Follow-up (up to 2.5 months)
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.
Measured: Baseline (Day 0)
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.
Measured: Immediate Post (up to 7 weeks after baseline)
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.
Measured: Follow-up (up to 2.5 months)
Secondary outcomes (18)
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.
Measured: Baseline (Day 0)
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.
Measured: Immediate Post (up to 7 weeks after baseline)
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.
Measured: Follow-up (up to 2.5 months)
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.
Measured: Baseline (Day 0)
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.
Measured: Immediate Post (up to 7 weeks after baseline)
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.
Measured: Follow-up (up to 2.5 months)
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.
Measured: Baseline (Day 0)
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.
Measured: Immediate Post (up to 7 weeks after baseline)
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.
Measured: Follow-up (up to 2.5 months)
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.
Measured: Baseline (Day 0)
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.
Measured: Immediate Post (up to 7 weeks after baseline)
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.
Measured: Follow-up (up to 2.5 months)
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)
Measured: Baseline (Day 0)
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.
Measured: Immediate Post (up to 7 weeks after baseline)
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.
Measured: Follow-up (up to 2.5 months)
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.
Measured: Baseline (Day 0)
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.
Measured: Immediate Post (up to 7 weeks after baseline)
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.
Measured: Follow-up (up to 2.5 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start12 Oct 2021
- Primary completion7 Jun 2022
- Study completion7 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samantha Garbers-Adams, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04484649
- Sponsor's protocol ID
- AAAS9595
- Status last verified
- May 2024
- First submitted
- 21 Jul 2020
- Last updated
- 20 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04484649
- Acronym / sponsor ID
- AAAS9595
- Conditions
- Sleep, Psychological Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- 7 Jun 2022 (actual)
- Study completion
- 7 Jun 2022 (actual)
- First posted
- 23 Jul 2020 (actual)
- Results
- Posted 20 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Sleeping Healthy/Living HealthySleeping Healthy/Living Healthy |
| Control | Active comparator | Behavioral: Attention ControlAttention Control |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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?).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleeping Healthy/Living HealthySleeping 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. | Behavioural | Intervention |
| Attention ControlThe 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. | Behavioural | Control |
Primary outcome
Average Sleep Duration (Past 2 Weeks)
Time frame: Baseline (Day 0)
Measured using actigraphy. Measured in minutes.
Average Sleep Duration (Past 2 Weeks)
Time frame: Immediate Post (up to 7 weeks after baseline)
Measured with actigraphy. Measured in minutes.
Average Sleep Duration (Past 2 Weeks)
Time frame: Follow-up (up to 2.5 months)
Measured in actigraphy. Measured in minutes.
Sleep Fragmentation - Sleep Efficiency (%) (Past Month)
Time frame: 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 - Sleep Efficiency (%) (Past Month)
Time frame: Immediate Post (up to 7 weeks after baseline)
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 - Sleep Efficiency (%) (Past Month)
Time frame: Follow-up (up to 2.5 months)
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)
Time frame: Baseline (Day 0)
Number of sleep disruptions (number of times awakened) per night (mean, in past month): measured using actigraphy.
Sleep Fragmentation - Number of Sleep Disruptions (Past Month)
Time frame: Immediate Post (up to 7 weeks after baseline)
Number of sleep disruptions (number of times awakened) per night (mean, in past month): measured using actigraphy.
Sleep Fragmentation - Number of Sleep Disruptions (Past Month)
Time frame: Follow-up (up to 2.5 months)
Number of sleep disruptions (number of times awakened) per night (mean, in past month): measured using actigraphy.
18 secondary outcomes
Score on Pittsburgh Sleep Quality Index (PSQI Global Score)
Time frame: Baseline (Day 0)
Score on Pittsburgh Sleep Quality Index (PSQI Global Score)
Time frame: Immediate Post (up to 7 weeks after baseline)
Score on Pittsburgh Sleep Quality Index (PSQI Global Score)
Time frame: Follow-up (up to 2.5 months)
Score on the Perceived Stress Scale (PSS)
Time frame: Baseline (Day 0)
Score on the Perceived Stress Scale (PSS)
Time frame: Immediate Post (up to 7 weeks after baseline)
Score on the Perceived Stress Scale (PSS)
Time frame: Follow-up (up to 2.5 months)
Score on the PROMIS Psychological Stress Experiences Survey - T Score
Time frame: Baseline (Day 0)
Score on the PROMIS Psychological Stress Experiences Survey - T Score
Time frame: Immediate Post (up to 7 weeks after baseline)
Score on the PROMIS Psychological Stress Experiences Survey - T Score
Time frame: Follow-up (up to 2.5 months)
Score on the PROMIS Pediatric Anxiety Short Form 8a v2.0 - T-Score
Time frame: Baseline (Day 0)
Score on the PROMIS Pediatric Anxiety Short Form 8a v2.0 - T Score
Time frame: Immediate Post (up to 7 weeks after baseline)
Score on the PROMIS Pediatric Anxiety Short Form 8a v2.0 - T Score
Time frame: Follow-up (up to 2.5 months)
Score on the PROMIS Pediatric Sleep-Related Impairment Short Form 8a v1.0 - T Score
Time frame: Baseline (Day 0)
Score on the PROMIS Pediatric Sleep-Related Impairment Short Form 8a v1.0 - T Score
Time frame: Immediate Post (up to 7 weeks after baseline)
Score on the PROMIS Pediatric Sleep-Related Impairment Short Form 8a v1.0 - T Score
Time frame: Follow-up (up to 2.5 months)
Score on MAAS-A (Mindfulness Attention Awareness Scale - Adolescents)
Time frame: Baseline (Day 0)
Score on MAAS-A (Mindfulness Attention Awareness Scale - Adolescents)
Time frame: Immediate Post (up to 7 weeks after baseline)
Score on MAAS-A (Mindfulness Attention Awareness Scale - Adolescents)
Time frame: Follow-up (up to 2.5 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Juvenile; Scoliosis, Scoliosis Idiopathic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samantha Garbers-Adams, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleeping Healthy/Living Healthy in people with Sleep and Psychological Stress, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Sleep Duration (Past 2 Weeks) (time frame: Baseline (Day 0)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2024.