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Triple Vulnerability? Circadian Tendency, Sleep Deprivation and Adolescence

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ClinicalTrials.gov Identifier: NCT01828320
Recruitment Status : Completed
First Posted : April 10, 2013
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Allison Harvey, University of California, Berkeley

Brief Summary:
There is an urgent need to identify modifiable mechanisms contributing to risk and vulnerability among youth. The investigators test the hypothesis that eveningness, the tendency to go to sleep late and wake late, is an important contributor to, and even cause of, vicious cycles that escalate vulnerability and risk among youth. This study seeks to determine whether two interventions to reduce eveningness can reduce risk and confer resilience in critical aspects of health, development and functioning in youth.

Condition or disease Intervention/treatment Phase
Eveningness/Sleep Behavioral: Cognitive Behavior Therapy for Insomnia, Interpersonal and Social Rhythms Therapy, Chronotherapy Behavioral: Psychoeducation Not Applicable

Detailed Description:
Teens who exhibit a circadian tendency toward eveningness ('night-owls') follow a delayed sleep schedule, increasing activity later in the day and both going to sleep and getting up later, compared to morning-types ('larks'). The circadian tendency toward eveningness during adolescence arises from a confluence of psychosocial, behavioral and biological factors and is an important contributor to, and maybe even cause of, vicious cycles that escalate vulnerability and risk for poor health and major forms of psychopathology. Indeed, an evening circadian tendency has been associated with a wide range of adverse effects including poorer health, poorer academic performance, poorer self-regulation, greater use of substances, greater tendency for impulsivity, more depression and anxiety, greater emotional instability and more aggressive and antisocial behavior. While the biological shift toward eveningness during puberty may be difficult to modify, the psychosocial and behavioral contributors are modifiable. Moreover, modifying these contributors will eliminate key factors that exacerbate the biological shift. The proposed research will advance current knowledge on the role of eveningness as a mechanism contributing to poorer outcomes during adolescence. The investigators aim to reduce eveningness among 10-18 year olds via an intervention which integrates evidence-based treatments derived from basic research on the circadian system (Treatment 1) compared to a psychoeducational intervention that highlights the interplay between sleep, diet, exercise and stress (Treatment 2). The investigators will randomly allocate adolescents with an evening circadian tendency, and who are 'at risk' in at least one of five health domains (emotional, cognitive, behavioral, social, physical), to either: (a) Treatment 1 (n = 86) or (b) Treatment 2 (n = 86). Measures will be taken pre-treatment, post-treatment, and at 6 and 12 months post-treatment. This research is a first step within a longer term plan to accelerate knowledge on the potentially powerful positive effects, for the developing neural system, of simple, disseminable psychosocial interventions specifically designed to target modifiable risk factors across adolescence.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Triple Vulnerability? Circadian Tendency, Sleep Deprivation and Adolescence
Study Start Date : March 2013
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: Treatment 1
Integrates evidence-based treatments derived from basic research on the circadian system
Behavioral: Cognitive Behavior Therapy for Insomnia, Interpersonal and Social Rhythms Therapy, Chronotherapy
Active Comparator: Treatment 2
Psychoeducation on the inter-associations between sleep, diet, exercise and stress.
Behavioral: Psychoeducation



Primary Outcome Measures :
  1. Total sleep time (TST) average on weeknights via Daily Sleep Diary [ Time Frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment, and to 6-month and 12-month followups ]
  2. Average bedtime on weeknights measured via Daily Sleep Diary [ Time Frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment, and to 6-month and 12-month followups ]
  3. Morning Eveningness preference measured via Childrens Morningness Eveningness Preference Scale [ Time Frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment, and to 6-month and 12-month followups ]
  4. Composite Score for Cognitive Domain [ Time Frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment, and to 6-month and 12-month followups ]
    A composite score of the Attentional Control Scale and Youth Social Adjustment Scale (school/cognitive items only) will be used to assess functioning in the Cognitive domain.

  5. Composite Score for Behavioral Domain [ Time Frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment, and to 6-month and 12-month followups ]
    A composite score of the Alcohol and Substance Use (Past 30 days items only) and Sensation Seeking Scale will be used to assess functioning in the Behavioral domain.

  6. Composite Score for Emotional Domain [ Time Frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment, and to 6-month and 12-month followups ]
    A composite score of the Child Depression Rating Scale and Multidimensional Anxiety Scale for Children will be used to assess functioning in the Emotional domain.

  7. Score for Social Domain [ Time Frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment, and to 6-month and 12-month followups ]
    The Youth Social Adjustment Scale (social items only) will be used to assess functioning in the Social domain.

  8. Composite Score for Physical Domain [ Time Frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment, and to 6-month and 12-month followups ]
    A composite score of the Modifiable Activity Questionnaire and Physical Health Questionnaire will be used to assess functioning in the Physical domain.


Secondary Outcome Measures :
  1. Sleepiness scale [ Time Frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment, and to 6-month and 12-month followups ]
    embedded within the School Sleep Habits Survey

  2. Dim Light Melatonin Onset [ Time Frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment ]
  3. Pittsburgh Sleep Quality Index [ Time Frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment, and to 6-month and 12-month followups ]
  4. Discrepancy between weeknights and weekends for Total Sleep Time, Bedtime, and Waketime via Daily Sleep Diary [ Time Frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment, and to 6-month and 12-month followups ]
  5. Composite Risk Score of Functioning in Five Health-relevant Domains (Emotional, Cognitive, Behavioral, Social and Physical) [ Time Frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment ]
    Measured via Ecological Momentary Assessment

  6. Child Behavior Checklist [ Time Frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment, and to 6-month and 12-month followups ]
    Parent Measure


Other Outcome Measures:
  1. Diagnosis of Psychiatric Disorders [ Time Frame: Baseline only ]
    Measured via Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children (KSADS) Interview

  2. Diagnosis of Sleep Disorders [ Time Frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment, and to 6-month and 12-month followups ]
    Measured via Duke Structured Interview for Sleep Disorders

  3. Actigraphy Measured Total Sleep Time [ Time Frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment ]
    calculated separately for weeknights and weekend nights to also compute the discrepancy between weeknights and weekend nights

  4. Total wake time (TWT) [ Time Frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment ]
    Actigraphy Measured Sleep Onset Latency (SOL; calculated separately for weeknights and weekend nights) and Wake After Sleep Onset (WASO; calculated separately for weeknights and weekend nights) to create Total Wake Time (SOL+WASO) for weeknights, weekends and to also compute the discrepancy between weeknights and weekend nights

  5. Actigraphy Measured Daytime activity count [ Time Frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment ]
    calculated separately for weekdays and weekends

  6. Daily Sleep Diary [ Time Frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment, and to 6-month and 12-month followups ]
    total sleep time (weekend nights), weekend night bedtime, weekend risetime, total wake time (SOL+WASO) weeknights, total wake time (SOL+WASO) weekend nights, naps.

  7. "Problems that are related to romantic relations" subscale of the Problem Questionnaire [ Time Frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment ]
  8. Internet Behavior Checklist Questionnaire [ Time Frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment ]
  9. Rosenberg Self Esteem Scale Questionnaire [ Time Frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment ]
  10. Rosenberg Self Efficacy Scale Questionnaire [ Time Frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment ]
  11. Sleep Inertia Questionnaire [ Time Frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment ]
  12. Inventory of Parent and Peer Attachment Questionnaire [ Time Frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment ]
  13. Social Skills Rating Scale Questionnaire [ Time Frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment ]
  14. Estradiol hormone levels [ Time Frame: Baseline only ]
    from females only

  15. DHEA hormone levels [ Time Frame: Baseline only ]
    collected via saliva sample DNA by saliva sample to examine selected circadian and emotion single nucleotide polymorphism (SNP)

  16. Testosterone hormone levels [ Time Frame: Baseline only ]
    collected via saliva sample

  17. Cytokines: Interleukin-6, Tumor necrosis factor-α, and C-reactive protein. [ Time Frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment ]
  18. Weight (lbs) [ Time Frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment, and to 6-month and 12-month followups ]
  19. Height (feet, inches) [ Time Frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment, and to 6-month and 12-month followups ]
  20. Waist circumference (cm) [ Time Frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment, and to 6-month and 12-month followups ]
  21. Hip Circumference (cm) [ Time Frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment, and to 6-month and 12-month followups ]
  22. Therapy Process Measure [ Time Frame: Session 2 only ]
    Credibility Expectancy Questionnaire

  23. Emotion GoNoGo Task [ Time Frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment ]
  24. Emotional IAPS Task [ Time Frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment ]
  25. Forward and Backward Digit Span [ Time Frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment ]
  26. Dimensional Card Sorting Task [ Time Frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment ]
  27. Food Desire Task and Snack Task (only a subsample of participants) [ Time Frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment ]
  28. Face Naming Encoding Task (only a subsample of participants) [ Time Frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment ]
  29. Face Naming Retrieval Task (only a subsample of participants) [ Time Frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment ]
  30. Flanker Task (only a subsample of participants) [ Time Frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment ]
  31. Children's Affective Lability Scale [ Time Frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment, and to 6-month and 12-month followups ]
    Parent measure

  32. Problems in School Questionnaire [ Time Frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment ]
    Parent measure

  33. Parental Monitoring Questionnaire [ Time Frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment ]
    Parent measure



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria.

  1. Scoring within the lowest quartile of the Children's Morningness-Eveningness Preferences Scale (CMEP; 27 or lower) and a 7-day sleep diary showing a sleep onset time of of 10:40 pm or later for 10-13 year olds, 11 pm or later for 14-16 year olds, and 11:20 pm or later for 17-18 year olds at least 3 nights per week. Must have had the current pattern of late bedtimes for the last 3 months.
  2. 'At risk' in one of the five health domains: emotional, behavioral, social, physical, and cognitive. Emotional risk will be operationalized as a score of 4 or above on any of the following items on the Child Depression Rating Scale: Difficulty Having Fun, Social Withdrawal, Irritability, Depressed Feelings, Excessive Weeping, or a T-score of 61 or above on the Multidimensional Anxiety Scale for Children (MASQ), based on age group (10-11 years, 12-15 year, 16-19 years) using the MASC-10 Profile. Behavioral risk will be operationalized as a Sensation Seeking Scale score greater than 3.93 for males ages 10-13, greater than 3.19 for females 10-13, greater than 4.07 for males 14-18, or greater than 3.19 for females 14-18; taking ADHD medication or Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children (KSADs) diagnosis of ADHD; current alcohol or substance abuse; or past alcohol or substance dependence. Social and cognitive risk will be defined as "worse" than others the teen's age in one or more social behavior from Child Behavior Checklist (CBCL) Section VI or failing one or more academic class from CBCL Section VII, respectively. Physical risk will be operationalized as a Physical Health Questionnaire-15 score of 4 or above, six or more days of school absences, or a BMI above the 85th percentile for the participant's sex and age.
  3. Age between 10 and 18 and living with a parent or guardian and and attending a class/job by 9am at least 3 days per week;
  4. English language fluency;
  5. Able and willing to give informed assent.

Exclusion criteria.

  1. An active, progressive physical illness (e.g., cancer, respiratory disorder) or neurological degenerative disease directly related to the onset and course of the sleep disturbance;
  2. Evidence from clinical diagnosis or report by youth or parent of sleep apnea, restless legs or periodic limb movements during sleep. Youth presenting with provisional diagnoses of any of these disorders (e.g., sleep apnea) will be referred for a non-study polysomnography (PSG) evaluation at the parent's discretion and will be enrolled only if the diagnosis is disconfirmed;
  3. Mental retardation, autism spectrum disorder, or other significantly impairing pervasive developmental disorder. Based on previous recruitment experiences in our youth depression study, we expect this exclusion to be invoked very infrequently (once every few years);
  4. Bipolar disorder or schizophrenia or another current Axis I disorder if there is a significant risk of harm and/or decompensation if treatment of that comorbid condition is delayed as a function of participating in any stage of this study. Otherwise, we will allow all other comorbid psychiatric conditions to (i) to maximize representativeness and (ii) because a byproduct may be that the treatment constitutes a helpful 'transdiagnostic' treatment for youth across psychiatric disorders.
  5. A medication-free group may be difficult to recruit and would likely be unrepresentative. Hence, participants will not be excluded on the basis of stable use of medications (> 4 weeks). The exception was use of hypnotics and other medications known to alter sleep (e.g., melatonin).
  6. History of substance dependence in the past six months;
  7. Current suicide risk sufficient to preclude treatment on an outpatient basis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01828320


Locations
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United States, California
University of California, Berkeley
Berkeley, California, United States, 94720
Sponsors and Collaborators
University of California, Berkeley
Investigators
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Principal Investigator: Allison G Harvey, PhD University of California, Berkeley
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Allison Harvey, Professor of Clinical Psychology, University of California, Berkeley
ClinicalTrials.gov Identifier: NCT01828320    
Other Study ID Numbers: R01HD071065-01A1 ( U.S. NIH Grant/Contract )
First Posted: April 10, 2013    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Keywords provided by Allison Harvey, University of California, Berkeley:
Risk: Emotional, Cognitive, Behavioral, Social, Physical
Additional relevant MeSH terms:
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Sleep Deprivation
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Neurologic Manifestations
Mental Disorders