N/A
N=176
Triple Vulnerability? Circadian Tendency, Sleep Deprivation and Adolescence
Eveningness/Sleep
Bottom Line
View on ClinicalTrials.gov: NCT01828320 ↗Enrolled (actual)
176
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Total Sleep Time (TST) Average on Weeknights Via Daily Sleep Diary — 24.72; 13.02 Minutes — p=0.34
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cognitive Behavior Therapy for Insomnia, Interpersonal and Social Rhythms Therapy, Chronotherapy (Behavioral); Psychoeducation (Behavioral)
- Age
- Pediatric, Adult · 10+ yrs
- Sex
- All
- Sponsor
- University of California, Berkeley
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Sleep Time (TST) Average on Weeknights Via Daily Sleep Diary |
24.72; 13.02 | 0.34 |
| PRIMARY Average Bedtime on Weeknights Measured Via Daily Sleep Diary |
-0.03; -0.05 | 0.93 |
| PRIMARY Morning Eveningness Preference Measured Via Childrens Morningness Eveningness Preference Scale |
3.89; 2.01 | 0.01 sig |
| PRIMARY Composite Score for Cognitive Domain |
-0.04; 0.11 | 0.17 |
| PRIMARY Composite Score for Behavioral Domain |
0.02; 0.08 | 0.31 |
| PRIMARY Composite Score for Emotional Domain |
-0.38; -0.36 | 0.80 |
| PRIMARY Composite Score for Social Domain |
-0.04; -0.03 | 0.96 |
| PRIMARY Composite Score for Physical Domain |
0.02; 0.00 | 0.83 |
| SECONDARY Sleepiness Scale |
-1.33; 0.26 | 0.02 sig |
| SECONDARY Dim Light Melatonin Onset |
-0.01; 0.01 | 0.04 sig |
| SECONDARY Pittsburgh Sleep Quality Index |
-1.51; -0.62 | 0.04 sig |
| SECONDARY Discrepancy Between Weeknights and Weekends for Total Sleep Time |
39.43; -8.67 | 0.03 sig |
| SECONDARY Composite Risk Score of Functioning in Five Health-relevant Domains: Emotional Health (Positivity Ratio) |
-0.03; -0.01 | 0.71 |
| SECONDARY Child Behavior Checklist: Parent-report Emotional Health Composite Risk Score |
-0.07; -0.05 | 0.83 |
| SECONDARY Discrepancy Between Weeknights and Weekends for Bedtime Via Daily Sleep Diary |
0.12; 0.07 | 0.85 |
| SECONDARY Discrepancy Between Weeknights and Weekends for Wake Time Via Daily Sleep Diary |
0.78; 0.08 | 0.02 sig |
| SECONDARY Composite Risk Score of Functioning in Five Health-relevant Domains: Cognitive Health |
0.12; -0.20 | 0.05 |
| SECONDARY Composite Risk Score of Functioning in Five Health-relevant Domains: Behavioral Health |
-0.28; -0.30 | 0.88 |
| SECONDARY Composite Risk Score of Functioning in Five Health-relevant Domains: Physical Health |
0.11; 0.11 | 0.97 |
| SECONDARY Composite Risk Score of Functioning in Five Health-relevant Domains: Social Health |
0.04; 0.03; -0.13; -0.04; 0.12; 0.06 | 0.88 |
| SECONDARY Child Behavior Checklist: Parent-report Cognitive Health Composite Risk Score |
-0.22; 0.01 | 0.02 sig |
| SECONDARY Child Behavior Checklist: Parent-report Behavioral Health Composite Risk Score |
-0.07; 0.01 | 0.49 |
| SECONDARY Child Behavior Checklist: Parent-report Social Health Composite Risk Score |
-0.04; .03 | 0.60 |
| SECONDARY Child Behavior Checklist: Parent-report Physical Health Composite Risk Score |
-0.24; -0.14 | 0.42 |
| SECONDARY Child Behavior Checklist: CBCL Sleep Composite |
-1.43; -0.67 | 0.01 sig |
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.
Eligibility Criteria
Inclusion criteria.
- 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.
Exclusion criteria.
- 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.
Data sourced from ClinicalTrials.gov (NCT01828320). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.