Clinical trial NCT05098782: Maintaining Behavior Change: A 6-year Follow-up of Adolescent 'Night-owls'
Official title: Maintaining Behavior Change: A 6-year Follow-up of Adolescent 'Night-owls'
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Circadian Dysregulation
Keywords: Risk: Emotional, Cognitive, Behavioral, Social, Physical
Lead sponsor: University of California, Berkeley
Sponsor class: OTHER
First posted: 2021-10-28
Enrollment: 108
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Composite Scale of Morningness
timeFrame: 6 years
measure: Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment
timeFrame: 6 years
measure: Patient-Reported Outcomes Measurement Information System - Sleep Disturbance
timeFrame: 6 years
measure: Youth Self-Report Composite Score for Emotional domain
timeFrame: 6 years
measure: Youth Self-Report Score for Cognitive Domain
timeFrame: 6 years
measure: Youth Self-Report Score for Behavioral Domain
timeFrame: 6 years
measure: Youth Self-Report Score for Social Domain
timeFrame: 6 years
measure: Youth Self-Report Score for Physical Domain
timeFrame: 6 years
measure: Utilization Scale
timeFrame: 6 years
measure: Self-Report Behavioral Automaticity Index integrated with the Utilization Scale
timeFrame: 6 years
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index
timeFrame: 6 years
measure: Sleep Diary
timeFrame: 6 years
measure: Actigraphy
timeFrame: 6 years
measure: Youth Ecological Momentary Assessment Composite Risk Score of Functioning - Emotional Domain
timeFrame: 6 years
measure: Youth Ecological Momentary Assessment Composite Risk Score of Functioning - Cognitive Domain
timeFrame: 6 years
measure: Youth Ecological Momentary Assessment Composite Risk Score of Functioning - Behavioral Domain
timeFrame: 6 years
measure: Youth Ecological Momentary Assessment Composite Risk Score of Functioning - Social Domain
timeFrame: 6 years
measure: Youth Ecological Momentary Assessment Composite Risk Score of Functioning - Physical Domain
timeFrame: 6 years
measure: Composite Sleep Health Score
timeFrame: 6 years
Other outcomes:
measure: Change in Composite Scale of Morningness (CSM)
timeFrame: Baseline and at 6 years
measure: Change in Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment
timeFrame: Baseline and at 6 years
measure: Change in Patient-Reported Outcomes Measurement Information System - Sleep Disturbance
timeFrame: Baseline and at 6 years
measure: Change in Depression, Anxiety, and Stress Scale (DASS)
timeFrame: Baseline and at 6 years
measure: Change in Patient-Reported Outcomes Measurement Information System -Cognitive Function
timeFrame: Baseline and at 6 years
measure: Change in Patient-Reported Outcomes Measurement Information System-Cognitive Function - Abilities
timeFrame: Baseline and at 6 years
measure: Change in Brief Sensation Seeking Scale
timeFrame: Baseline and at 6 years
measure: Change in Patient-Reported Outcomes Measurement Information System -Alcohol Use
timeFrame: Baseline and at 6 years
measure: Change in Patient-Reported Outcomes Measurement Information System -Severity of Substance Use
timeFrame: Baseline and at 6 years
measure: Change in Patient-Reported Outcomes Measurement Information System - Companionship
timeFrame: Baseline and at 6 years
measure: Change in Patient-Reported Outcomes Measurement Information System - Emotional Support
timeFrame: Baseline and at 6 years
measure: Change in Patient-Reported Outcomes Measurement Information System - Social Isolation
timeFrame: Baseline and at 6 years
measure: Change in Patient-Reported Outcomes Measurement Information System - Ability to Participate in Social Roles & Activities
timeFrame: Baseline and at 6 years
measure: Change in Modifiable Activity Questionnaire
timeFrame: Baseline and at 6 years
measure: Change in Physical Health Questionnaire
timeFrame: Baseline and at 6 years
measure: Height
timeFrame: Baseline and at 6 years
measure: Weight
timeFrame: Baseline and at 6 years
measure: Hip circumference
timeFrame: Baseline and at 6 years
measure: Waist Circumference
timeFrame: Baseline and at 6 years
measure: Change in Utilization Scale
timeFrame: Baseline and at 6 years
measure: Sleep Diary
timeFrame: Baseline and at 6 years
measure: Actigraphy
timeFrame: Baseline and at 6 years
measure: Youth Ecological Momentary Assessment Composite Risk Score of Functioning - Emotional Domain
timeFrame: Baseline and at 6 years
measure: Youth Ecological Momentary Assessment Composite Risk Score of Functioning - Cognitive Domain
timeFrame: Baseline and at 6 years
measure: Youth Ecological Momentary Assessment Composite Risk Score of Functioning - Behavioral Domain
timeFrame: Baseline and at 6 years
measure: Youth Ecological Momentary Assessment Composite Risk Score of Functioning - Social Domain
timeFrame: Baseline and at 6 years
measure: Youth Ecological Momentary Assessment Composite Risk Score of Functioning - Physical Domain
timeFrame: Baseline and at 6 years
measure: Alexian Brothers Urge to Self Injure Scale
timeFrame: 6 years
measure: Composite Sleep Health Score
timeFrame: Baseline and at 6 years
measure: Sussex-Oxford Compassion Scale (SOCS)
timeFrame: Baseline and at 6 years
measure: Suicidal Behavior Questionnaire - Revised
timeFrame: 6 years
Locations:
city: Berkeley
country: United States
facility: University of California, Berkeley
state: California
Study officials:
References:
citation: 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.