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Circadian DysregulationNCT05098782

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

An observational study of Circadian Dysregulation, run by University of California, Berkeley at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Circadian Dysregulation
How many people
108 participants
Where
1 siteUnited States
Study dates
1 Dec 2021to 5 Oct 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • N/A

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of California, Berkeley

    Berkeley, California, 94720-1650

Other trials in United States

About this study

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.

Read the 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.

Keywords
Risk: Emotional, Cognitive, Behavioral, Social, Physical
Medical subject headings
Chronobiology Disorders, Behavior

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 6 years

  2. 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)

    Measured: 6 years

  3. 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)

    Measured: 6 years

  4. 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).

    Measured: 6 years

  5. 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

    Measured: 6 years

  6. 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

    Measured: 6 years

  7. 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.

    Measured: 6 years

  8. 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.

    Measured: 6 years

  9. Utilization Scale

    14-item; 0-4 scale. Scores can range from 0 to 56 (Higher score means more utilization).

    Measured: 6 years

  10. 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).

    Measured: 6 years

Secondary outcomes (9)

  1. 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).

    Measured: 6 years

  2. Sleep Diary

    (Not a scale) Night-to-night variability in the mid-point of sleep

    Measured: 6 years

  3. Actigraphy

    (Not a scale) Night-to-night variability in the mid-point of sleep

    Measured: 6 years

  4. Youth Ecological Momentary Assessment Composite Risk Score of Functioning - Emotional Domain

    (Not a scale) Measured via Ecological Momentary Assessment

    Measured: 6 years

  5. Youth Ecological Momentary Assessment Composite Risk Score of Functioning - Cognitive Domain

    (Not a scale) Measured via Ecological Momentary Assessment

    Measured: 6 years

  6. Youth Ecological Momentary Assessment Composite Risk Score of Functioning - Behavioral Domain

    (Not a scale) Measured via Ecological Momentary Assessment

    Measured: 6 years

  7. Youth Ecological Momentary Assessment Composite Risk Score of Functioning - Social Domain

    (Not a scale) Measured via Ecological Momentary Assessment

    Measured: 6 years

  8. Youth Ecological Momentary Assessment Composite Risk Score of Functioning - Physical Domain

    (Not a scale) Measured via Ecological Momentary Assessment

    Measured: 6 years

  9. 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.

    Measured: 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2021
  2. Study start1 Dec 2021
  3. Primary completion1 Oct 2022
  4. Study completion5 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05098782
Sponsor's protocol ID
2020-06-13428
Status last verified
Oct 2022
First submitted
12 Oct 2021
Last updated
7 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 30274649

  • Susman ES, Patino EO, Tiab SS, Dong L, Gumport NB, Sarfan LD, Hinshaw SP, Harvey AG. Transdiagnostic Sleep and Circadian Intervention in Youth: Long-Term Follow-Up of a Randomized Controlled Trial. J Am Acad Child Adolesc Psychiatry. 2025 Mar;64(3):362-374. doi: 10.1016/j.jaac.2024.05.001. Epub 2024 May 8.

    PubMed 38729603

Questions about this trial

What is this clinical trial studying?

An observational study of Circadian Dysregulation, run by University of California, Berkeley at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite Scale of Morningness (time frame: 6 years). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05098782, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2022.

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