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

Circadian Dysregulation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05098782
• Other study ID #: 2020-06-13428
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Chronobiology Disorders
• Circadian Dysregulation

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