Completed

Triple Vulnerability? Circadian Tendency, Sleep Deprivation and Adolescence

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What is being tested

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

+ Psychoeducation

Behavioral
Who is being recruted

Behavior

From 10 to 18 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: March 2013
See protocol details

Summary

Principal SponsorUniversity of California, Berkeley
Last updated: September 2, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

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.

Principal SponsorUniversity of California, Berkeley
Last updated: September 2, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

176 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 10 to 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Behavior

Criteria

5 inclusion criteria required to participate
Able and willing to give informed assent

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

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

English language fluency

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7 exclusion criteria prevent from participating
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)

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

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

Current suicide risk sufficient to preclude treatment on an outpatient basis

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Integrates evidence-based treatments derived from basic research on the circadian system

Group II

Active Comparator
Psychoeducation on the inter-associations between sleep, diet, exercise and stress.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of California, Berkeley

Berkeley, United StatesOpen University of California, Berkeley in Google Maps
CompletedOne Study Center