Eveningness/SleepNCT01828320
Triple Vulnerability? Circadian Tendency, Sleep Deprivation and Adolescence
A study testing Cognitive Behavior Therapy for Insomnia, Interpersonal and Social Rhythms Therapy, Chronotherapy and Psychoeducation in people with Eveningness/Sleep, run by University of California, Berkeley at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Eveningness/Sleep
- What is being tested?
- Cognitive Behavior Therapy for Insomnia, Interpersonal and Social Rhythms Therapy, Chronotherapy and Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
- '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.
- 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;
- English language fluency;
- Able and willing to give informed assent.
Who cannot join
- 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;
- 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;
- 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);
- 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.
- 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).
- History of substance dependence in the past six months;
- Current suicide risk sufficient to preclude treatment on an outpatient basis.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Berkeley
Berkeley, California, 94720
About this study
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.
Read the 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.
- Conditions
- Eveningness/Sleep
- Being tested
- Cognitive Behavior Therapy for Insomnia, Interpersonal and Social Rhythms Therapy, Chronotherapy, Psychoeducation
- Keywords
- Risk: Emotional, Cognitive, Behavioral, Social, Physical
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavior Therapy for Insomnia, Interpersonal and Social Rhythms Therapy, ChronotherapyBehavioural
PsychoeducationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Treatment 1 | Experimental | Integrates evidence-based treatments derived from basic research on the circadian system Receives: Behavioral: Cognitive Behavior Therapy for Insomnia, Interpersonal and Social Rhythms Therapy, Chronotherapy |
| Treatment 2 | Active comparator | Psychoeducation on the inter-associations between sleep, diet, exercise and stress. Receives: Behavioral: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.
Composite Score for Behavioral Domain
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.
Measured: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.
Composite Score for Emotional Domain
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.
Measured: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.
Composite Score for Social Domain
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.
Measured: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.
Composite Score for Physical Domain
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.
Measured: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.
Secondary outcomes (17)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2017
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Eveningness/SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Allison Harvey, University of California, Berkeley
- Investigators
- Allison G Harvey, PhD, Principal investigator, University of California, Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01828320
- Sponsor's protocol ID
- R01HD071065-01A1
- Status last verified
- Aug 2025
- First submitted
- 2 Apr 2013
- Last updated
- 2 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 31773734Gumport 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.
PubMed 31678861Dong 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.
PubMed 31246052Harvey 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.
PubMed 30274649
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triple Vulnerability? Circadian Tendency, Sleep Deprivation and Adolescence
- ClinicalTrials.gov ID
- NCT01828320
- Acronym / sponsor ID
- R01HD071065-01A1
- Conditions
- Eveningness/Sleep
- Keywords
- Risk: Emotional, Cognitive, Behavioral, Social, Physical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 10 Apr 2013 (estimated)
- Results
- Posted 2 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment 1 | Experimental | Behavioral: Cognitive Behavior Therapy for Insomnia, Interpersonal and Social Rhythms Therapy, ChronotherapyIntegrates evidence-based treatments derived from basic research on the circadian system |
| Treatment 2 | Active comparator | Behavioral: PsychoeducationPsychoeducation on the inter-associations between sleep, diet, exercise and stress. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
- '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.
- 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;
- English language fluency;
- Able and willing to give informed assent.
Key exclusion criteria (7 listed)
- 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;
- 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;
- 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);
- 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.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavior Therapy for Insomnia, Interpersonal and Social Rhythms Therapy, Chronotherapy | Behavioural | Treatment 1 |
| Psychoeducation | Behavioural | Treatment 2 |
Primary outcome
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.
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
Time frame: 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
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(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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
17 secondary outcomes
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
Dim Light Melatonin Onset
Time frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
Pittsburgh Sleep Quality Index
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
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)
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
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
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
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
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
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
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
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
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
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
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
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
Time frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31773734Dong 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.
- Derived from this study: PubMed 31678861Gumport 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.
- Derived from this study: PubMed 31246052Dong 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.
- Derived from this study: PubMed 30274649Harvey 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allison G Harvey, PhD principal investigator
University of California, Berkeley
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavior Therapy for Insomnia, Interpersonal and Social Rhythms Therapy, Chronotherapy and Psychoeducation in people with Eveningness/Sleep, run by University of California, Berkeley at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01828320, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.