Triple Vulnerability? Circadian Tendency, Sleep Deprivation and Adolescence

Not Applicable

Completed

Conditions: Eveningness/Sleep

Registration Number: NCT01828320

Lead Sponsor: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 176

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Total Sleep Time (TST) Average on Weeknights Via Daily Sleep Diary	Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.	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.
Average Bedtime on Weeknights Measured Via Daily Sleep Diary	Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.	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.
Morning Eveningness Preference Measured Via Childrens Morningness Eveningness Preference Scale	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(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.
Composite Score for Cognitive Domain	Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.	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.
Composite Score for Behavioral Domain	Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.	To assess functioning in the Behavioral domain, a Youth Self-Report Composite Risk Score is calculated by taking the mean of standardized summary scores from two measures: Sensation Seeking Scale for Children (SSS) and the Alcohol and Substance Use-Past 30 days (SU; items include questions on caffeine and energy drinks). Summary scores were calculated as 1.) SSS = sum of 8 items, rated 1-5, range: 8-40. Higher scores = greater sensation seeking; and 2.) SU = Sum of 23 items rated 0-7, range 0-161. Higher scores = more frequent use. For each participant, summary scores from the SSS and SU subscales were computed and standardized. The final composite (range -1.73 to 3.34) was calculated as the mean of the two standardized scores. Higher composite scores indicate higher 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.
Composite Score for Emotional Domain	Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.	Youth Self-Report Composite Score, Emotional functioning domain is calculated by taking the mean of standardized summary scores from two measures: Children's Depression Rating Scale-Revised (CDRS) and the Multidimensional Anxiety Scale for Children (MASC). Summary scores were calculated as 1.) CDRS = Sum of 17 items. range 17-113. Higher scores indicate greater depressive symptoms; and 2.) MASC= Sum of 39 items. range 0-117. Higher scores indicate greater anxiety. For each participant, summary scores from the CDRS and MASC subscales were first computed and then standardized. The final composite (range -2.10 to 3.60) was calculated as the mean of the two standardized scores from the CDRS and MASC. Higher composite scores indicate greater emotional risk (i.e., more depression and anxiety symptoms). 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.
Composite Score for Social Domain	Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.	Composite Score for Social Domain to assess functioning in the Social domain. Calculated by taking the average of the three subscales (ie, friends, family, romantic relationships) from the Youth Social Adjustment Scale - Self Report. Youth Social Adjustment Scale - social items only. 9 items (questions 7-15 out of the 23 item scale), item range 1-5. Summary score is calculated by taking the sum of all 9 items. no reverse coding needed. Summary score range 9-45. Higher score = more impaired adjustment. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition.
Composite Score for Physical Domain	Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.	Composite Score for Physical Domain (physical functioning) is calculated by taking the mean of standardized summary scores from two measures: Modifiable Activity Questionnaire for Adolescents (MAQ) and Physical Health Questionnaire (PHQ). Summary scores were calculated as 1.) MAQ = sum of the number of hours per week not active/exercising. Higher scores indicate greater numbers of leisure hours; and 2. PHQ-15 = sum of item (13 items for males, 14 items for females), range 0-30. Higher scores indicate worse somatic complaints. For each participant, summary scores from the MAQ and PHQ-15 subscales were first computed and then standardized. The final composite (range -3.95 to 1.86) was calculated as the mean of the two standardized scores. Higher composite scores indicate greater physical health risk. 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.

Secondary Outcome Measures

Name	Time	Method
Sleepiness Scale	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	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.
Dim Light Melatonin Onset	Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment	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.
Pittsburgh Sleep Quality Index	Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.	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.
Discrepancy Between Weeknights and Weekends for Total Sleep Time	Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment.	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.
Composite Risk Score of Functioning in Five Health-relevant Domains: Emotional Health (Positivity Ratio)	Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment.	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.
Child Behavior Checklist: Parent-report Emotional Health Composite Risk Score	Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment.	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
Discrepancy Between Weeknights and Weekends for Bedtime Via Daily Sleep Diary	Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment.	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.
Discrepancy Between Weeknights and Weekends for Wake Time Via Daily Sleep Diary	Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment.	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.
Composite Risk Score of Functioning in Five Health-relevant Domains: Cognitive Health	Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment	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.
Composite Risk Score of Functioning in Five Health-relevant Domains: Behavioral Health	Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment	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.
Composite Risk Score of Functioning in Five Health-relevant Domains: Physical Health	Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment	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.
Composite Risk Score of Functioning in Five Health-relevant Domains: Social Health	Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment	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.
Child Behavior Checklist: Parent-report Cognitive Health Composite Risk Score	Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.	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
Child Behavior Checklist: Parent-report Behavioral Health Composite Risk Score	Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.	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.
Child Behavior Checklist: Parent-report Social Health Composite Risk Score	Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.	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.
Child Behavior Checklist: Parent-report Physical Health Composite Risk Score	Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.	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.
Child Behavior Checklist: CBCL Sleep Composite	Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.	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.

Trial Locations

Locations (1): University of California, Berkeley
🇺🇸
Berkeley, California, United States
University of California, Berkeley
🇺🇸Berkeley, California, United States