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Completed

NCT Number: NCT05098782

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.

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Key information

Conditions

Circadian Dysregulation Behavior Chronobiology Disorders Nervous System Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, Berkeley

Berkeley, California, 94720-1650, 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. 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • N/A

Treatment and study plan

Primary outcomes

  1. Composite Scale of Morningness

    Time frame: 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).

  2. Patient-Reported Outcomes Measurement Information System - Sleep Related Impairment

    Time frame: 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)

  3. Patient-Reported Outcomes Measurement Information System - Sleep Disturbance

    Time frame: 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)

  4. Youth Self-Report Composite Score for Emotional domain

    Time frame: 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).

  5. Youth Self-Report Score for Cognitive Domain

    Time frame: 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

  6. Youth Self-Report Score for Behavioral Domain

    Time frame: 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

  7. Youth Self-Report Score for Social Domain

    Time frame: 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.

  8. Youth Self-Report Score for Physical Domain

    Time frame: 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.

  9. Utilization Scale

    Time frame: 6 years

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

  10. Self-Report Behavioral Automaticity Index integrated with the Utilization Scale

    Time frame: 6 years

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

Secondary outcomes

  1. Pittsburgh Sleep Quality Index

    Time frame: 6 years

    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).

  2. Sleep Diary

    Time frame: 6 years

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

  3. Actigraphy

    Time frame: 6 years

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

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

    Time frame: 6 years

    (Not a scale) Measured via Ecological Momentary Assessment

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

    Time frame: 6 years

    (Not a scale) Measured via Ecological Momentary Assessment

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

    Time frame: 6 years

    (Not a scale) Measured via Ecological Momentary Assessment

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

    Time frame: 6 years

    (Not a scale) Measured via Ecological Momentary Assessment

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

    Time frame: 6 years

    (Not a scale) Measured via Ecological Momentary Assessment

  9. Composite Sleep Health Score

    Time frame: 6 years

    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.

Other outcomes

  1. Change in Composite Scale of Morningness (CSM)

    Time frame: Baseline and at 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).

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

    Time frame: Baseline and at 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)

  3. Change in Patient-Reported Outcomes Measurement Information System - Sleep Disturbance

    Time frame: Baseline and at 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)

  4. Change in Depression, Anxiety, and Stress Scale (DASS)

    Time frame: Baseline and at 6 years

    Sum of 21 item scale, ranging 0-3. Scores can range from 0 to 63 (Higher score means worse outcome).

  5. Change in Patient-Reported Outcomes Measurement Information System -Cognitive Function

    Time frame: Baseline and at 6 years

    Sum of 6-item; 5-point response scale. Scores can range from 6 to 30 (Higher score means higher cognitive function ).

  6. Change in Patient-Reported Outcomes Measurement Information System-Cognitive Function - Abilities

    Time frame: Baseline and at 6 years

    Sum of 6-item; 5-point response scale. Scores can range from 6 to 30 (Higher score means higher cognitive function and abilities).

  7. Change in Brief Sensation Seeking Scale

    Time frame: Baseline and at 6 years

    8-item; 5-point response scale; Scores can range from 8 to 40 (Higher score means higher sensation seeking).

  8. Change in Patient-Reported Outcomes Measurement Information System -Alcohol Use

    Time frame: Baseline and at 6 years

    Sum of 7-item; 5-point response scale. Scores can range from 7 to 35 (Higher score means higher alcohol use).

  9. Change in Patient-Reported Outcomes Measurement Information System -Severity of Substance Use

    Time frame: Baseline and at 6 years

    Sum of 7-item; 5-point response scale. Scores can range from 7 to 35 (Higher score means higher severity of substance use).

  10. Change in Patient-Reported Outcomes Measurement Information System - Companionship

    Time frame: Baseline and at 6 years

    Sum of 4-item; 5-point response scale. Scores can range from 4 to 20 (Higher score means higher reported companionship).

  11. Change in Patient-Reported Outcomes Measurement Information System - Emotional Support

    Time frame: Baseline and at 6 years

    Sum of 4-item; 5-point response scale. Scores can range from 4 to 20 (Higher score means higher reported emotional support).

  12. Change in Patient-Reported Outcomes Measurement Information System - Social Isolation

    Time frame: Baseline and at 6 years

    Sum of 4-item; 5-point response scale. Scores can range from 4 to 20 (Higher score means higher levels of social isolation).

  13. Change in Patient-Reported Outcomes Measurement Information System - Ability to Participate in Social Roles & Activities

    Time frame: Baseline and at 6 years

    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).

  14. Change in Modifiable Activity Questionnaire

    Time frame: Baseline and at 6 years

    20-item. Scored by hours per week values and by Metabolic values.

  15. Change in Physical Health Questionnaire

    Time frame: Baseline and at 6 years

    Sum of 15-item, 0-2 response scale. Scores can range from 0 to 30 (Higher score means worse physical symptoms)

  16. Height

    Time frame: Baseline and at 6 years

    Centimeters (cm)

  17. Weight

    Time frame: Baseline and at 6 years

    Pounds (lbs)

  18. Hip circumference

    Time frame: Baseline and at 6 years

    Centimeters (cm)

  19. Waist Circumference

    Time frame: Baseline and at 6 years

    Centimeters (cm)

  20. Change in Utilization Scale

    Time frame: Baseline and at 6 years

    14-item; 1-5 scale. Scores can range from 14 to 70 (Higher score means more automaticity in utilization)

  21. Sleep Diary

    Time frame: Baseline and at 6 years

    (Not a scale) Consensus sleep diary variables calculated separately for weekdays and weekends

  22. Actigraphy

    Time frame: Baseline and at 6 years

    (Not a scale) Sleep parameters will be calculated separately for weekdays and weekends

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

    Time frame: Baseline and at 6 years

    (Not a scale) Measured via Ecological Momentary Assessment

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

    Time frame: Baseline and at 6 years

    (Not a scale) Measured via Ecological Momentary Assessment

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

    Time frame: Baseline and at 6 years

    (Not a scale) Measured via Ecological Momentary Assessment

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

    Time frame: Baseline and at 6 years

    (Not a scale) Measured via Ecological Momentary Assessment

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

    Time frame: Baseline and at 6 years

    (Not a scale) Measured via Ecological Momentary Assessment

  28. Alexian Brothers Urge to Self Injure Scale

    Time frame: 6 years

    5-item. 0-6 point scale. Total scores can range from 0-30 (Higher Score means higher Suicidal ideation)

  29. Composite Sleep Health Score

    Time frame: Baseline and at 6 years

    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.

  30. Sussex-Oxford Compassion Scale (SOCS)

    Time frame: Baseline and at 6 years

    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.

  31. Suicidal Behavior Questionnaire - Revised

    Time frame: 6 years

    4-item. Total scores can range from 3-18 (Higher Score means higher Suicidal ideation)

Sponsors and collaborators

Lead sponsor

University of California, Berkeley

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 28, 2021
Registry last updated
Oct 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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