Triple Vulnerability? Circadian Tendency, Sleep Deprivation and Adolescence

University of California, Berkeley176 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

176

Conditions

Eveningness/Sleep

Interventions

Cognitive Behavior Therapy for Insomnia, Interpersonal and Social Rhythms Therapy, ChronotherapyBEHAVIORAL

PsychoeducationBEHAVIORAL

Eligibility

Sex: ALLMin age: 10 YearsMax age: 18 Years

Medical Language ↔ Plain English

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 (MASC), 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 Attention-deficit/hyperactivity disorder (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.

Locations (1)

University of California, Berkeley

Berkeley, California, United States

Outcomes

Primary Outcomes

Total Sleep Time (TST) Average on Weeknights Via Daily Sleep Diary

Total sleep time (TST) average on weeknights via Daily Sleep Diary. Change from baseline to post-treatment. The model provides estimates of the mean pre-post change in the Psychoeducation (PE) condition and the TranS-C condition.

Time frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.

Average Bedtime on Weeknights Measured Via Daily Sleep Diary

Change in average bedtime on weeknights from pre-treatment to post-treatment measured via Daily Sleep Diary. 24-hour decimal format, where times after midnight are expressed as numbers above 24 (ex. 1:30 am is 25.50). The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition.

Time frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.

Morning Eveningness Preference Measured Via Childrens Morningness Eveningness Preference Scale

Morning Eveningness preference measured via Childrens Morningness Eveningness Preference Scale(CMEP). Scores range from 10 (Extreme evening preference) to 43 (Extreme morning preference). The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition.

Time frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.

Composite Score for Cognitive Domain

Cognitive composite score reflects cognitive functioning and was calculated by averaging the standardized summary scores from two measures: Attentional Control Scale (ACS) and Youth Social Adjustment Scale-Self Report (YSAS). Summary scores were calculated as 1.)ACS = sum of 20 items rated 1- 4; range: 20-80. Higher scores indicate less attentional control; and 2.) YSAS = sum of 6 school/cognitive-related items rated 1-5; range: 6-30. Higher scores indicate worse school-related impairment. Per participant, summary scores from the ACS and YSAS were computed and then standardized. The final composite (range -2.12 to 2.39) was calculated as the mean of the two standardized scores. Higher scores indicate greater attentional difficulty and school impairment. Change in this composite score from baseline to post treatment is reported below. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition.

Data from ClinicalTrials.gov

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Secondary Outcomes

Sleepiness Scale

Sleepiness subscale from School Sleep Habits Survey (SSHB). This subscale includes 10 items rated on a 4-point scale (0 - 3), assessing sleepiness. Total scores were calculated by summing all item responses. Possible scores range from 0 to 30, with higher scores indicating greater daytime sleepiness. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition.

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

Dim Light Melatonin Onset

Melatonin levels were measured using 13 saliva samples collected at 30-minute intervals, beginning 5.5 hours before and ending 30 minutes after each participant's average bedtime (computed from 7 nights of sleep diary). For each timepoint (baseline and post-treatment), the dim light melatonin onset (DLMO) was estimated by identifying when melatonin levels crossed the 3.0 pg/ml threshold (i.e., the interpolated time). Change in the interpolated DLMO times from baseline to post treatment (which is an average of 9 weeks after the beginning of treatment) reported. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition.

Time frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment

Pittsburgh Sleep Quality Index

Pittsburgh Sleep Quality Index (PSQI). Summary score is calculated by taking the sum of item-level scores. Summary score range 0-21. A higher score means increased severity of difficulty in all sleep area components. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition.

Time frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.

Discrepancy Between Weeknights and Weekends for Total Sleep Time

The discrepancy between weeknights and weekends for Total Sleep Time(TST). The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition.

Time frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment.

Composite Risk Score of Functioning in Five Health-relevant Domains: Emotional Health (Positivity Ratio)

Composite Risk Score of Functioning in Emotional Health, measured via Ecological Momentary Assessment (EMA), assesses subjective emotional well-being across 7-days, per timepoint using a 9-item short form of the Positive and Negative Affect Scale for Children (PANAS-C), which included 4 positive affect items (min = 4, max = 20; higher scores indicate more positive affect) and 5 negative affect items (min = 5, max = 25; higher scores indicate more negative affect), each rated on a 5-point Likert scale. A positivity ratio was calculated by dividing the sum of each affect item scores by the sum of negative affect score per survey day. Higher positivity ratios (range: 0.16-4) indicate higher subjective well-being and less risk. Change in average Positivity Ratio from baseline to post treatment (which is an average of 9 weeks after the beginning of treatment) reported. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition.

Time frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment.

Child Behavior Checklist: Parent-report Emotional Health Composite Risk Score

Parent Measure. The Emotional Health Composite Risk Score was assessed with a composite score of the Anxious/Depressed and Withdrawn/Depressed subscales of Child Behavior Checklist (CBCL), calculated by taking the mean of standardized summary scores for the items within this domain. This is a parent-reported measure of a teen's emotional health, including items related to anxiety/depression. Range for composite total: 0-42, with higher scores indicating more problems. The CBCL Anxious/Depressed subscale is composed of 13-items CBCL items on a scale of 0-2, the range of scores is 0-26, with higher scores indicating more emotional problems. The CBCL Withdrawn/Depressed subscale is composed of 8-items CBCL items on a scale of 0-2, the range of scores is 0-16, with higher scores indicating more emotional problems. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition

Time frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment.

Discrepancy Between Weeknights and Weekends for Bedtime Via Daily Sleep Diary

The discrepancy between weeknights and weekends for Bedtime(BT) via Daily Sleep Diary. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition.

Time frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment.

Discrepancy Between Weeknights and Weekends for Wake Time Via Daily Sleep Diary

The discrepancy between weeknights and weekends for Wake time (WUP) via Daily Sleep Diary. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition.

Time frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment.

Composite Risk Score of Functioning in Five Health-relevant Domains: Cognitive Health

Composite Risk Score of Functioning in Cognitive Health measured via Ecological Momentary Assessment. Participants responded to 11 items that measured their concentration, distractedness, and focus related to their current activity. All items were rated on 5-point Likert scale, where higher scores respectively indicated higher levels of concentration, distractedness, and focus (min = 11, max = 55). The composite risk score was calculated by averaging participant responses over the assessment week. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition.

Time frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment

Composite Risk Score of Functioning in Five Health-relevant Domains: Behavioral Health

Composite Risk Score of Functioning in Behavioral Health measured via Ecological Momentary Assessment was assessed by directly asking participants about eating, drinking, chewing gum, and smoking behavior at the time the phone rang through 6 open-ended EMA questions. Responses were coded. The average weekly frequency of intake of junk food, caffeine, alcohol, nicotine, and other substances was tabulated. The minimum score was 0, and there was no maximum score. Higher scores indicate more risky behaviors and thus more risk. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition.

Time frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment

Composite Risk Score of Functioning in Five Health-relevant Domains: Physical Health

Composite Risk Score of Functioning in Physical Health derived from Ecological Momentary Assessment (EMA). For the physical health domain, responses to a single daily item (e.g., "Were you physically active today?") were used to create a binary score: 1 = active, 2 = inactive. Daily responses were collected over 7 days and both summed (range: 7-14) and averaged for each participant. The final composite score reflects the average of these daily values (range: 1 - 2) , where lower scores indicate greater physical activity and lower physical health risk. Change in this composite score from baseline to post treatment (which is an average of 9 weeks after the beginning of treatment) is reported below. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition.

Time frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment

Composite Risk Score of Functioning in Five Health-relevant Domains: Social Health

Composite Risk Score of Functioning in Social health measured via Ecological Momentary Assessment was assessed by directly asking participants who the participant was with at the time the phone rang. Participants' responses were then manually coded for companion type on a scale of 0-4. Participants' positivity ratios, as calculated in the Emotional Health (Positivity Ratio) Composite Risk Score of Functioning, were then grouped based on occasions when participants were alone vs. with a family member vs. with a friend vs. other. Positivity ratios within groups were averaged (min = 0.16, max = 4), where higher averages indicated higher subjective well-being and lower risk. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition.

Time frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment

Child Behavior Checklist: Parent-report Cognitive Health Composite Risk Score

Parent Measure. Cognitive Health Composite Risk Score was assessed with the Thought Problems and Attention Problems subscale of Child Behavior Checklist (CBCL), calculated by taking the mean of standardized summary scores for the items within this domain. This is a parent-reported measure of a teen's cognitive health, including items related to thought problems. Range for composite total: 0-50, with higher scores indicating more cognitive problems. The CBCL Thought Problems subscale is composed of 15-items CBCL items on a scale of 0-2, the range of scores is 0-30, with higher scores indicating more problems. The CBCL Attention Problems subscale is composed of 10-items CBCL items on a scale of 0-2, the range of scores is 0-20, with higher scores indicating more problems. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition

Time frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.

Child Behavior Checklist: Parent-report Behavioral Health Composite Risk Score

Parent Measure. The Behavioral Health Composite Risk Score was assessed with a composite score of the Rule-Breaking Behavior and Aggressive Behavior subscales of Child Behavior Checklist (CBCL), calculated by taking the mean of standardized summary scores for the items within this domain. This is a parent-reported measure of a teen's behavioral health, including items related to rule-breaking. Range for composite total: 0-70, with higher scores indicating more behavioral problems. The CBCL Rule-Breaking Behavior subscale is composed of 17-items CBCL items on a scale of 0-2, the range of scores is 0-34, with higher scores indicating more rule-breaking behavior. The CBCL Aggressive Behavior subscale is composed of 18-items CBCL items on a scale of 0-2, the range of scores is 0-36, with higher scores indicating more aggressive behavior. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition.

Time frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.

Child Behavior Checklist: Parent-report Social Health Composite Risk Score

Parent Measure. The Social Health Composite Risk Score was assessed with a composite score of the Social Problems subscale of Child Behavior Checklist (CBCL), calculated by taking the mean of standardized summary scores for the items within this domain. This is a parent-reported measure of a teen's social health. The CBCL Social Problems subscale is composed of 11-items CBCL items on a scale of 0-2, the range of scores is 0-22, with higher scores indicating more Social problems. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition.

Time frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.

Child Behavior Checklist: Parent-report Physical Health Composite Risk Score

Parent Measure. The Physical Health Composite Risk Score was assessed with a composite score of the Somatic Complaints subscale of Child Behavior Checklist (CBCL), calculated by taking the mean of standardized summary scores for the items within this domain. This is a parent-reported measure of a teen's Physical health (e.g., "vomiting"). The CBCL Somatic Complaints subscale is composed of 11-items CBCL items on a scale of 0-2, the range of scores is 0-22, with higher scores indicating more physical problems. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition.

Time frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.

Child Behavior Checklist: CBCL Sleep Composite

Parent Measure. The Sleep Health Composite Risk Score was assessed with a composite score of sleep from Child Behavior Checklist (CBCL), calculated by taking the mean of standardized summary scores for the items within this domain. This is a parent-reported measure of a teen's sleep health. The CBCL sleep subscale is composed of 7-items CBCL items on a scale of 0-2, the range of scores is 0-14, with higher scores indicating more sleep problems. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition.

Time frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.