Circadian Dysregulation Clinical Trial
Official title:
Maintaining Behavior Change: A 6-year Follow-up of Adolescent 'Night-owls'
Verified date | October 2022 |
Source | University of California, Berkeley |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 108 |
Est. completion date | October 5, 2022 |
Est. primary completion date | October 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - The inclusion criteria is individuals who participated in a previously-funded behavioral intervention (R01HD071065). Exclusion Criteria: - N/A |
Country | Name | City | State |
---|---|---|---|
United States | University of California, Berkeley | Berkeley | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Berkeley |
United States,
Harvey AG, Hein K, Dolsen MR, Dong L, Rabe-Hesketh S, Gumport NB, Kanady J, Wyatt JK, Hinshaw SP, Silk JS, Smith RL, Thompson MA, Zannone N, Blum DJ. Modifying the Impact of Eveningness Chronotype ("Night-Owls") in Youth: A Randomized Controlled Trial. J Am Acad Child Adolesc Psychiatry. 2018 Oct;57(10):742-754. doi: 10.1016/j.jaac.2018.04.020. Epub 2018 Aug 15. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in Composite Scale of Morningness (CSM) | Sum of 13-item; Mix of 4-point and 5-point response scale. Scores can range from 13 (extreme evening) to 55 (extreme morning). | Baseline and at 6 years | |
Other | Change in 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) | Baseline and at 6 years | |
Other | Change in 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) | Baseline and at 6 years | |
Other | Change in 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). | Baseline and at 6 years | |
Other | Change in Patient-Reported Outcomes Measurement Information System -Cognitive Function | Sum of 6-item; 5-point response scale. Scores can range from 6 to 30 (Higher score means higher cognitive function ). | Baseline and at 6 years | |
Other | Change in Patient-Reported Outcomes Measurement Information System-Cognitive Function - Abilities | Sum of 6-item; 5-point response scale. Scores can range from 6 to 30 (Higher score means higher cognitive function and abilities). | Baseline and at 6 years | |
Other | Change in Brief Sensation Seeking Scale | 8-item; 5-point response scale; Scores can range from 8 to 40 (Higher score means higher sensation seeking). | Baseline and at 6 years | |
Other | Change in Patient-Reported Outcomes Measurement Information System -Alcohol Use | Sum of 7-item; 5-point response scale. Scores can range from 7 to 35 (Higher score means higher alcohol use). | Baseline and at 6 years | |
Other | Change in Patient-Reported Outcomes Measurement Information System -Severity of Substance Use | Sum of 7-item; 5-point response scale. Scores can range from 7 to 35 (Higher score means higher severity of substance use). | Baseline and at 6 years | |
Other | Change in Patient-Reported Outcomes Measurement Information System - Companionship | Sum of 4-item; 5-point response scale. Scores can range from 4 to 20 (Higher score means higher reported companionship). | Baseline and at 6 years | |
Other | Change in Patient-Reported Outcomes Measurement Information System - Emotional Support | Sum of 4-item; 5-point response scale. Scores can range from 4 to 20 (Higher score means higher reported emotional support). | Baseline and at 6 years | |
Other | Change in Patient-Reported Outcomes Measurement Information System - Social Isolation | Sum of 4-item; 5-point response scale. Scores can range from 4 to 20 (Higher score means higher levels of social isolation). | Baseline and at 6 years | |
Other | Change in Patient-Reported Outcomes Measurement Information System - Ability to Participate in Social Roles & Activities | Sum of 4-item; 5-point response scale. Scores can range from 4 to 20 (Higher score means higher ability to participate in Social Roles & Activities). | Baseline and at 6 years | |
Other | Change in Modifiable Activity Questionnaire | 20-item. Scored by hours per week values and by Metabolic values. | Baseline and at 6 years | |
Other | Change in Physical Health Questionnaire | Sum of 15-item, 0-2 response scale. Scores can range from 0 to 30 (Higher score means worse physical symptoms) | Baseline and at 6 years | |
Other | Height | Centimeters (cm) | Baseline and at 6 years | |
Other | Weight | Pounds (lbs) | Baseline and at 6 years | |
Other | Hip circumference | Centimeters (cm) | Baseline and at 6 years | |
Other | Waist Circumference | Centimeters (cm) | Baseline and at 6 years | |
Other | Change in Utilization Scale | 14-item; 1-5 scale. Scores can range from 14 to 70 (Higher score means more automaticity in utilization) | Baseline and at 6 years | |
Other | Sleep Diary | (Not a scale) Consensus sleep diary variables calculated separately for weekdays and weekends | Baseline and at 6 years | |
Other | Actigraphy | (Not a scale) Sleep parameters will be calculated separately for weekdays and weekends | Baseline and at 6 years | |
Other | Youth Ecological Momentary Assessment Composite Risk Score of Functioning - Emotional Domain | (Not a scale) Measured via Ecological Momentary Assessment | Baseline and at 6 years | |
Other | Youth Ecological Momentary Assessment Composite Risk Score of Functioning - Cognitive Domain | (Not a scale) Measured via Ecological Momentary Assessment | Baseline and at 6 years | |
Other | Youth Ecological Momentary Assessment Composite Risk Score of Functioning - Behavioral Domain | (Not a scale) Measured via Ecological Momentary Assessment | Baseline and at 6 years | |
Other | Youth Ecological Momentary Assessment Composite Risk Score of Functioning - Social Domain | (Not a scale) Measured via Ecological Momentary Assessment | Baseline and at 6 years | |
Other | Youth Ecological Momentary Assessment Composite Risk Score of Functioning - Physical Domain | (Not a scale) Measured via Ecological Momentary Assessment | Baseline and at 6 years | |
Other | Alexian Brothers Urge to Self Injure Scale | 5-item. 0-6 point scale. Total scores can range from 0-30 (Higher Score means higher Suicidal ideation) | 6 years | |
Other | 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. | Baseline and at 6 years | |
Other | Sussex-Oxford Compassion Scale (SOCS) | Sum of 20-item, 5-point response scale. Scores can range from 20 to 100 (Higher score means higher compassion for self).
Sub-scale items included. |
Baseline and at 6 years | |
Other | Suicidal Behavior Questionnaire - Revised | 4-item. Total scores can range from 3-18 (Higher Score means higher Suicidal ideation) | 6 years | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | Utilization Scale | 14-item; 0-4 scale. Scores can range from 0 to 56 (Higher score means more utilization). | 6 years | |
Primary | 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 | 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 | |
Secondary | Sleep Diary | (Not a scale) Night-to-night variability in the mid-point of sleep | 6 years | |
Secondary | Actigraphy | (Not a scale) Night-to-night variability in the mid-point of sleep | 6 years | |
Secondary | Youth Ecological Momentary Assessment Composite Risk Score of Functioning - Emotional Domain | (Not a scale) Measured via Ecological Momentary Assessment | 6 years | |
Secondary | Youth Ecological Momentary Assessment Composite Risk Score of Functioning - Cognitive Domain | (Not a scale) Measured via Ecological Momentary Assessment | 6 years | |
Secondary | Youth Ecological Momentary Assessment Composite Risk Score of Functioning - Behavioral Domain | (Not a scale) Measured via Ecological Momentary Assessment | 6 years | |
Secondary | Youth Ecological Momentary Assessment Composite Risk Score of Functioning - Social Domain | (Not a scale) Measured via Ecological Momentary Assessment | 6 years | |
Secondary | Youth Ecological Momentary Assessment Composite Risk Score of Functioning - Physical Domain | (Not a scale) Measured via Ecological Momentary Assessment | 6 years | |
Secondary | 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 |
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