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

Sponsor
University of California, Berkeley (Other)
Overall Status
Recruiting
CT.gov ID
NCT05098782
Collaborator
(none)
176
1
12.9
13.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    176 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Maintaining Behavior Change: A 6-year Follow-up of Adolescent 'Night-owls'
    Actual Study Start Date :
    Dec 1, 2021
    Anticipated Primary Completion Date :
    Aug 30, 2022
    Anticipated Study Completion Date :
    Dec 30, 2022

    Outcome Measures

    Primary Outcome Measures

    1. 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).

    2. 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)

    3. 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)

    4. 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).

    5. 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

    6. 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

    7. 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.

    8. 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.

    9. Utilization Scale [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 [6 years]

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

    Secondary Outcome Measures

    1. Pittsburgh Sleep Quality Index [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 [6 years]

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

    3. Actigraphy [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 [6 years]

      (Not a scale) Measured via Ecological Momentary Assessment

    5. Youth Ecological Momentary Assessment Composite Risk Score of Functioning - Cognitive Domain [6 years]

      (Not a scale) Measured via Ecological Momentary Assessment

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

      (Not a scale) Measured via Ecological Momentary Assessment

    7. Youth Ecological Momentary Assessment Composite Risk Score of Functioning - Social Domain [6 years]

      (Not a scale) Measured via Ecological Momentary Assessment

    8. Youth Ecological Momentary Assessment Composite Risk Score of Functioning - Physical Domain [6 years]

      (Not a scale) Measured via Ecological Momentary Assessment

    9. Composite Sleep Health Score [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 Outcome Measures

    1. Change in Composite Scale of Morningness (CSM) [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 [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 [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) [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [Baseline and at 6 years]

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

    15. Change in Physical Health Questionnaire [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 [Baseline and at 6 years]

      Centimeters (cm)

    17. Weight [Baseline and at 6 years]

      Pounds (lbs)

    18. Hip circumference [Baseline and at 6 years]

      Centimeters (cm)

    19. Waist Circumference [Baseline and at 6 years]

      Centimeters (cm)

    20. Change in Utilization Scale [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 [Baseline and at 6 years]

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

    22. Actigraphy [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 [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 [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 [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 [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 [Baseline and at 6 years]

      (Not a scale) Measured via Ecological Momentary Assessment

    28. Alexian Brothers Urge to Self Injure Scale [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 [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) [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 [6 years]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • The inclusion criteria is individuals who participated in a previously-funded behavioral intervention (R01HD071065).
    Exclusion Criteria:
    • N/A

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of California, Berkeley Berkeley California United States 94720-1650

    Sponsors and Collaborators

    • University of California, Berkeley

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Allison Harvey, Professor of clinical psychology, University of California, Berkeley
    ClinicalTrials.gov Identifier:
    NCT05098782
    Other Study ID Numbers:
    • 2020-06-13428
    First Posted:
    Oct 28, 2021
    Last Update Posted:
    May 17, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Allison Harvey, Professor of clinical psychology, University of California, Berkeley
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 17, 2022