Clinical trial NCT01828320: Triple Vulnerability? Circadian Tendency, Sleep Deprivation and Adolescence
Official title: Triple Vulnerability? Circadian Tendency, Sleep Deprivation and Adolescence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eveningness/Sleep
Keywords: Risk: Emotional, Cognitive, Behavioral, Social, Physical
Lead sponsor: University of California, Berkeley
Sponsor class: OTHER
First posted: 2013-04-10
Enrollment: 176
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Total sleep time (TST) average on weeknights via Daily Sleep Diary
timeFrame: 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
measure: Average bedtime on weeknights measured via Daily Sleep Diary
timeFrame: 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
measure: Morning Eveningness preference measured via Childrens Morningness Eveningness Preference Scale
timeFrame: 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
measure: Composite Score for Cognitive Domain
timeFrame: 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
measure: Composite Score for Behavioral Domain
timeFrame: 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
measure: Composite Score for Emotional Domain
timeFrame: 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
measure: Score for Social Domain
timeFrame: 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
measure: Composite Score for Physical Domain
timeFrame: 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
Secondary outcomes:
measure: Sleepiness scale
timeFrame: 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
measure: Dim Light Melatonin Onset
timeFrame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
measure: Pittsburgh Sleep Quality Index
timeFrame: 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
measure: Discrepancy between weeknights and weekends for Total Sleep Time, Bedtime, and Waketime via Daily Sleep Diary
timeFrame: 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
measure: Composite Risk Score of Functioning in Five Health-relevant Domains (Emotional, Cognitive, Behavioral, Social and Physical)
timeFrame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
measure: Child Behavior Checklist
timeFrame: 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
Other outcomes:
measure: Diagnosis of Psychiatric Disorders
timeFrame: Baseline only
measure: Diagnosis of Sleep Disorders
timeFrame: 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
measure: Actigraphy Measured Total Sleep Time
timeFrame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
measure: Total wake time (TWT)
timeFrame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
measure: Actigraphy Measured Daytime activity count
timeFrame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
measure: Daily Sleep Diary
timeFrame: 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
measure: "Problems that are related to romantic relations" subscale of the Problem Questionnaire
timeFrame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
measure: Internet Behavior Checklist Questionnaire
timeFrame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
measure: Rosenberg Self Esteem Scale Questionnaire
timeFrame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
measure: Rosenberg Self Efficacy Scale Questionnaire
timeFrame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
measure: Sleep Inertia Questionnaire
timeFrame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
measure: Inventory of Parent and Peer Attachment Questionnaire
timeFrame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
measure: Social Skills Rating Scale Questionnaire
timeFrame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
measure: Estradiol hormone levels
timeFrame: Baseline only
measure: DHEA hormone levels
timeFrame: Baseline only
measure: Testosterone hormone levels
timeFrame: Baseline only
measure: Cytokines: Interleukin-6, Tumor necrosis factor-α, and C-reactive protein.
timeFrame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
measure: Weight (lbs)
timeFrame: 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
measure: Height (feet, inches)
timeFrame: 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
measure: Waist circumference (cm)
timeFrame: 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
measure: Hip Circumference (cm)
timeFrame: 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
measure: Therapy Process Measure
timeFrame: Session 2 only
measure: Emotion GoNoGo Task
timeFrame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
measure: Emotional IAPS Task
timeFrame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
measure: Forward and Backward Digit Span
timeFrame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
measure: Dimensional Card Sorting Task
timeFrame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
measure: Food Desire Task and Snack Task (only a subsample of participants)
timeFrame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
measure: Face Naming Encoding Task (only a subsample of participants)
timeFrame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
measure: Face Naming Retrieval Task (only a subsample of participants)
timeFrame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
measure: Flanker Task (only a subsample of participants)
timeFrame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
measure: Children's Affective Lability Scale
timeFrame: 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
measure: Problems in School Questionnaire
timeFrame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
measure: Parental Monitoring Questionnaire
timeFrame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
Locations:
city: Berkeley
country: United States
facility: University of California, Berkeley
state: California
Study officials:
affiliation: University of California, Berkeley
name: Allison G Harvey, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dong L, Dolsen MR, Martinez AJ, Notsu H, Harvey AG. A transdiagnostic sleep and circadian intervention for adolescents: six-month follow-up of a randomized controlled trial. J Child Psychol Psychiatry. 2020 Jun;61(6):653-661. doi: 10.1111/jcpp.13154. Epub 2019 Nov 26.
citation: Gumport NB, Dolsen EA, Harvey AG. Usefulness and utilization of treatment elements from the Transdiagnostic Sleep and Circadian Intervention for adolescents with an evening circadian preference. Behav Res Ther. 2019 Dec;123:103504. doi: 10.1016/j.brat.2019.103504. Epub 2019 Nov 1.
citation: Dong L, Gumport NB, Martinez AJ, Harvey AG. Is improving sleep and circadian problems in adolescence a pathway to improved health? A mediation analysis. J Consult Clin Psychol. 2019 Sep;87(9):757-771. doi: 10.1037/ccp0000423. Epub 2019 Jun 27.
citation: 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.