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

NCT05098782 | Completed DMC

• 1 other identifier: 2020-06-13428
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Circadian Dysregulation

Keywords

Risk: Emotional, Cognitive, Behavioral, Social, Physical

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (9)

• Pittsburgh Sleep Quality Index

  6 years

• Sleep Diary

  6 years

• Actigraphy

  6 years

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

  6 years

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

  6 years

Other Outcomes (31)

• Change in Composite Scale of Morningness (CSM)

  Baseline and at 6 years

• Change in Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment

  Baseline and at 6 years

• Change in Patient-Reported Outcomes Measurement Information System - Sleep Disturbance

  Baseline and at 6 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may not qualify if:

• N/A

Sponsors & Collaborators

• University of California, Berkeley: lead

Study Sites (1)

University of California, Berkeley

Berkeley, California, 94720-1650, United States

Location

Related Publications (2)

• 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.

  PMID: 30274649 BACKGROUND

• 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.

  PMID: 38729603 DERIVED

MeSH Terms

Conditions

Chronobiology Disorders; Behavior

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of clinical psychology

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: October 28, 2021
• Study Start: December 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: October 5, 2022
• Last Updated: October 7, 2022

Record last verified: 2022-10

Locations

US (1)