Maintaining Behavior Change: A 6-year Follow-up of Adolescent 'Night-owls'

Study Overview
=================
Brief Summary
-----------------
A follow-up of a cohort of participants recruited for a prior study will be conducted. In the prior study, 10-18 years olds were provided one of two treatments to improve the sleep of adolescent night-owls. The follow-up will be approximately 6-years following participation in the prior study. The goal is to establish long-term outcomes in sleep and circadian functioning, in the five health-relevant domains and in engagement in sleep health behavior.

Detailed Description
-----------------
A follow-up of a cohort of participants recruited for a prior study will be conducted. In the prior study, 10-18 years olds were provided one of two treatments to improve the sleep of adolescent night-owls. This follow-up will be conducted approximately 6-years following participation in the prior study. The participants will be 18-28 years of age. Specific Aim 1: At the 6-year follow-up, participants recruited for the prior study will be assessed for sleep and circadian functioning and functioning in five health- relevant domains. Specific Aim 2: The sample will also be assessed for their engagement in sleep health behavior. This research will advance knowledge on: (a) longer-term outcomes and (b) the role of eveningness as a mechanism contributing to poorer outcomes.

Official Title
-----------------
Maintaining Behavior Change: A 6-year Follow-up of Adolescent 'Night-owls'

Conditions
-----------------
Circadian Dysregulation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The inclusion criteria is individuals who participated in a previously-funded behavioral intervention (R01HD071065). Exclusion Criteria: N/A
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Scale of Morningness | Sum of 13-item; Mix of 4-point and 5-point response scale. Scores can range from 13 (extreme evening) to 55 (extreme morning). | 6 years | 
| Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment | Sum of 8-items rated on a 5-point response scale. Scores can range from 8 to 40 (Higher score means more Sleep Related impairment) | 6 years | 
| Patient-Reported Outcomes Measurement Information System - Sleep Disturbance | Sum of 8-items rated on a 5-point response scale. Scores can range from 8 to 40 (Higher score means more Sleep Disturbance) | 6 years | 
| Youth Self-Report Composite Score for Emotional domain | A score of Depression, Anxiety, and Stress Scale (DASS) - Sum of 21 item scale, ranging 0-3. Scores can range from 0 to 63 (Higher score means worse outcome). | 6 years | 
| Youth Self-Report Score for Cognitive Domain | (Not a scale). A composite score of the Patient-Reported Outcomes Measurement Information System -Cognitive Function and the Patient-Reported Outcomes Measurement Information System-Cognitive Function - Abilities will be used to assess functioning in the Cognitive domain | 6 years | 
| Youth Self-Report Score for Behavioral Domain | (Not a scale) A composite score of the Brief Sensation Seeking Scale, Patient-Reported Outcomes Measurement Information System -Alcohol Use, Patient-Reported Outcomes Measurement Information System-Severity of Substance Use will be used to assess functioning in the Behavioral domain | 6 years | 
| Youth Self-Report Score for Social Domain | (Not a scale) A composite score of the Patient-Reported Outcomes Measurement Information System-Companionship, Patient-Reported Outcomes Measurement Information System-Emotional Support, Patient-Reported Outcomes Measurement Information System-Social Isolation, and Patient-Reported Outcomes Measurement Information System-Ability to Participate will be used to assess functioning in the Social domain. | 6 years | 
| Youth Self-Report Score for Physical Domain | (Not a scale) A composite score of the Modifiable Activity Questionnaire and Physical Health Questionnaire will be used to assess functioning in the Social domain. | 6 years | 
| Utilization Scale | 14-item; 0-4 scale. Scores can range from 0 to 56 (Higher score means more utilization). | 6 years | 
| Self-Report Behavioral Automaticity Index integrated with the Utilization Scale | 14-item; 0-4 scale. Scores can range from 0 to 56 (Higher score means more automaticity in utilization). | 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pittsburgh Sleep Quality Index | 19-item. First four items are integer responses. The rest of the items are on a 0-3 scale. Creates 7 composite scores, with the sum of the composite scores ranging from 0 to 21. (Higher score means increased severity of difficulty in all sleep area components). | 6 years | 
| Sleep Diary | (Not a scale) Night-to-night variability in the mid-point of sleep | 6 years | 
| Actigraphy | (Not a scale) Night-to-night variability in the mid-point of sleep | 6 years | 
| Youth Ecological Momentary Assessment Composite Risk Score of Functioning - Emotional Domain | (Not a scale) Measured via Ecological Momentary Assessment | 6 years | 
| Youth Ecological Momentary Assessment Composite Risk Score of Functioning - Cognitive Domain | (Not a scale) Measured via Ecological Momentary Assessment | 6 years | 
| Youth Ecological Momentary Assessment Composite Risk Score of Functioning - Behavioral Domain | (Not a scale) Measured via Ecological Momentary Assessment | 6 years | 
| Youth Ecological Momentary Assessment Composite Risk Score of Functioning - Social Domain | (Not a scale) Measured via Ecological Momentary Assessment | 6 years | 
| Youth Ecological Momentary Assessment Composite Risk Score of Functioning - Physical Domain | (Not a scale) Measured via Ecological Momentary Assessment | 6 years | 
| Composite Sleep Health Score | Composite Sleep Health Score which is defined as the sum of scores on 6 sleep health dimensions: Regularity (Midpoint fluctuation), Satisfaction (Sleep quality question on PROMIS-SD), Alertness (Daytime sleepiness question on PROMIS-SRI), Timing (Mean midpoint), Efficiency (Sleep efficiency) and Duration (Total Sleep Time). The Sleep Health Composite was constructed such that higher score indicates better sleep health. | 6 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Risk: Emotional, Cognitive, Behavioral, Social, Physical