Sleeping Healthy/Living Healthy Development

Sleep Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04484649
• Other study ID #: AAAS9595
• Status: Completed
• Phase: N/A
• Start date: October 12, 2021
• Est. completion date: June 7, 2022

Study information

• Verified date: July 2022
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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) 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: June 7, 2022
• Est. primary completion date: June 7, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psychological Stress
• Sleep
• Stress, Psychological

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Sleep duration (in hours) (past 2 weeks)	Measured using actigraphy. Confirmation of time sleeping using consensus sleep diary, a 9-item diary developed through expert and patient collaboration, and Item 4 (How many hours of actual sleep do you get at night?) from the Pittsburgh Sleep Quality Index (PSQI), an 19-item self report on sleep quality and duration.	Up to 2.5 months from the end of the intervention
Primary	Sleep fragmentation - sleep efficiency (%) (past month)	Represented as a proportion. 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. Confirmation of the numerator (time sleeping) and the denominator (time in bed), will be confirmed using the consensus sleep diary, a 9-item diary developed through expert and patient collaboration. Confirmation of sleep efficiency will also use the sleep efficiency component of the Pittsburgh Sleep Quality Index (PSQI). The sleep efficiency component of the PSQI incorporates information from Questions 1, 3, and 4: # hours slept-question 4. # hours in bed-calculated from responses to questions 1 and 3.	Up to 2.5 months from the end of the intervention
Primary	Sleep fragmentation - number of sleep disruptions (past month)	Sleep Disruptions: measured using actigraphy. Confirmation of sleep disruptions using self-report in the Consensus Sleep Diary, a 9-item diary and the Pittsburgh Sleep Quality Index (PSQI) sleep disturbance component. The PSQI sleep disturbance component (Question 5) assesses how often during the past month the respondent has had trouble sleeping due to (Wake up in the middle of the night or early morning; Have to get up to use the bathroom; Cannot breathe comfortably; Cough or snore loudly; Feel too cold; Feel too hot; Have bad dreams; Have pain; or Other reason(s)). Sleep disturbance component scores on the PSQI can range from 0 to 27, with 27 representing more sleep fragmentation (and therefore, worse quality sleep).	Up to 2.5 months from the end of the intervention
Secondary	Score on Pittsburgh Sleep Quality Index (PSQI)	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.	Up to 2.5 months from the end of the intervention
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.	Up to 2.5 months from the end of the intervention
Secondary	Score on the PROMIS Psychological Stress Experiences Survey	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.	Up to 2.5 months from the end of the intervention
Secondary	Score on the Adolescent Sleep Hygiene Scale (ASHS)	Sleep hygiene behaviors will be measured using the ASHS, a self-reported 32-item questionnaire designed to assess theoretically-based sleep hygiene domains thought to influence the sleep quality and quantity of youth aged = 12 years: physiological; cognitive; emotional; sleep environment; sleep stability; substance use; daytime sleep; and having a bedtime routine. Using a six-point ordinal rating scale ranging from 1 = never to 6 = always, adolescents indicate how often each item occurred during the past month. All but one of the items are reverse-coded, with higher scores indicating better sleep hygiene. The score is an average (range of 1 to 6) of all of the sub-scale scores with higher scores indicating better sleep hygiene.	Up to 2.5 months from the end of the intervention
Secondary	8.Score on the PROMIS Pediatric Anxiety Short Form 8a v2.0	Anxiety will be measured using the 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.	Up to 2.5 months from the end of the intervention
Secondary	Score on the PROMIS Pediatric Sleep-Related Impairment Short Form 8a v1.0	Subjective sleep-related impairment will be measured using the 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.	Up to 2.5 months from the end of the intervention
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.	Up to 2.5 months from the end of the intervention