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

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.

Study Overview

• Status: Completed
• Conditions: Circadian Dysregulation

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.

• Study Type: Observational
• Enrollment (Actual): 108

Contacts and Locations

Study Locations

• United States
  • California
    • Berkeley, California, United States, 94720-1650
      • University of California, Berkeley

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants will be individuals who participated in a prior treatment study. They will be aged 18 and over.

Description

Inclusion Criteria:

• The inclusion criteria is individuals who participated in a previously-funded behavioral intervention (R01HD071065).

Exclusion Criteria:

• N/A

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
Change in Modifiable Activity Questionnaire	20-item. Scored by hours per week values and by Metabolic values.	Baseline and at 6 years
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
Height	Centimeters (cm)	Baseline and at 6 years
Weight	Pounds (lbs)	Baseline and at 6 years
Hip circumference	Centimeters (cm)	Baseline and at 6 years
Waist Circumference	Centimeters (cm)	Baseline and at 6 years
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
Sleep Diary	(Not a scale) Consensus sleep diary variables calculated separately for weekdays and weekends	Baseline and at 6 years
Actigraphy	(Not a scale) Sleep parameters will be calculated separately for weekdays and weekends	Baseline and at 6 years
Youth Ecological Momentary Assessment Composite Risk Score of Functioning - Emotional Domain	(Not a scale) Measured via Ecological Momentary Assessment	Baseline and at 6 years
Youth Ecological Momentary Assessment Composite Risk Score of Functioning - Cognitive Domain	(Not a scale) Measured via Ecological Momentary Assessment	Baseline and at 6 years
Youth Ecological Momentary Assessment Composite Risk Score of Functioning - Behavioral Domain	(Not a scale) Measured via Ecological Momentary Assessment	Baseline and at 6 years
Youth Ecological Momentary Assessment Composite Risk Score of Functioning - Social Domain	(Not a scale) Measured via Ecological Momentary Assessment	Baseline and at 6 years
Youth Ecological Momentary Assessment Composite Risk Score of Functioning - Physical Domain	(Not a scale) Measured via Ecological Momentary Assessment	Baseline and at 6 years
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
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
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
Suicidal Behavior Questionnaire - Revised	4-item. Total scores can range from 3-18 (Higher Score means higher Suicidal ideation)	6 years

Collaborators and Investigators

• Sponsor: University of California, Berkeley

Publications and helpful links

General Publications

• Harvey AG, Hein K, Dolsen EA, 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): October 1, 2022
• Study Completion (Actual): October 5, 2022

Study Registration Dates

• First Submitted: October 12, 2021
• First Submitted That Met QC Criteria: October 25, 2021
• First Posted (Actual): October 28, 2021

Study Record Updates

• Last Update Posted (Actual): October 7, 2022
• Last Update Submitted That Met QC Criteria: October 5, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Risk: Emotional, Cognitive, Behavioral, Social, Physical
• Additional Relevant MeSH Terms: Nervous System Diseases; Chronobiology Disorders
• Other Study ID Numbers: 2020-06-13428

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No