COMPLETEDN/A

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.

Sponsor

University of California, Berkeley

Enrollment

108 participants

Sites

1 locations

Start Date

December 2021

Completion

October 2022

Circadian Dysregulation

Enrollment & Timeline

Completed

Target N

108

participants

Sites

locations

Duration

10 months

total trial span

Rate

pts/month needed

At 1 sites, each site needs to enroll approximately 11.0 patients/month to hit the enrollment target on schedule.

View on ClinicalTrials.gov

Ask AI

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Modifying the Impact of Eveningness Chronotype ("Night-Owls") in Youth: A Randomized Controlled Trial.

Harvey Allison G, Hein Kerrie, Dolsen Emily A et al.Journal of the American Academy of Child and Adolescent Psychiatry2019

DOI PubMed

Transdiagnostic Sleep and Circadian Intervention in Youth: Long-Term Follow-Up of a Randomized Controlled Trial.

Susman Eli S, Patino Estephania Ovalle, Tiab Sondra S et al.Journal of the American Academy of Child and Adolescent Psychiatry2025

DOI PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

Ask AI

Fetching protocol from ClinicalTrials.gov…

COMPLETEDN/A

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

Sponsor

University of California, Berkeley

Enrollment

108 participants

Sites

1 locations

Start Date

December 2021

Completion

October 2022

Circadian Dysregulation

Enrollment & Timeline

Completed

Target N

108

participants

Sites

locations

Duration

10 months

total trial span

Rate

pts/month needed

At 1 sites, each site needs to enroll approximately 11.0 patients/month to hit the enrollment target on schedule.

View on ClinicalTrials.gov

Ask AI

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Modifying the Impact of Eveningness Chronotype ("Night-Owls") in Youth: A Randomized Controlled Trial.

Harvey Allison G, Hein Kerrie, Dolsen Emily A et al.Journal of the American Academy of Child and Adolescent Psychiatry2019

DOI PubMed

Transdiagnostic Sleep and Circadian Intervention in Youth: Long-Term Follow-Up of a Randomized Controlled Trial.

Susman Eli S, Patino Estephania Ovalle, Tiab Sondra S et al.Journal of the American Academy of Child and Adolescent Psychiatry2025

DOI PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

Ask AI

Primary Outcomes

Composite Scale of Morningness

6 years

Sum of 13-item; Mix of 4-point and 5-point response scale. Scores can range from 13 (extreme evening) to 55 (extreme morning).

Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment

6 years

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)

Patient-Reported Outcomes Measurement Information System - Sleep Disturbance

6 years

Sum of 8-items rated on a 5-point response scale. Scores can range from 8 to 40 (Higher score means more Sleep Disturbance)

Youth Self-Report Composite Score for Emotional domain

6 years

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).

Youth Self-Report Score for Cognitive Domain

6 years

(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

Youth Self-Report Score for Behavioral Domain

6 years

(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

Youth Self-Report Score for Social Domain

6 years

(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.

Youth Self-Report Score for Physical Domain

6 years

(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.

Utilization Scale

6 years

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

Self-Report Behavioral Automaticity Index integrated with the Utilization Scale

6 years

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

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

Enrollment & Timeline

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

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

Enrollment & Timeline

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Primary Outcomes

Eligibility

Trial Sites (1)