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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05098782
Other study ID # 2020-06-13428
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2021
Est. completion date October 5, 2022

Study information

Verified date October 2022
Source University of California, Berkeley
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of California, Berkeley Berkeley California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Berkeley

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

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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