Triple Vulnerability? Circadian Tendency, Sleep Deprivation and Adolescence
NCT ID: NCT01828320
Last Updated: 2025-09-02
Study Results
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View full resultsBasic Information
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COMPLETED
NA
176 participants
INTERVENTIONAL
2013-03-31
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Treatment 1
Integrates evidence-based treatments derived from basic research on the circadian system
Cognitive Behavior Therapy for Insomnia, Interpersonal and Social Rhythms Therapy, Chronotherapy
Treatment 2
Psychoeducation on the inter-associations between sleep, diet, exercise and stress.
Psychoeducation
Interventions
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Cognitive Behavior Therapy for Insomnia, Interpersonal and Social Rhythms Therapy, Chronotherapy
Psychoeducation
Eligibility Criteria
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Inclusion Criteria
2. 'At risk' in one of the five health domains: emotional, behavioral, social, physical, and cognitive. Emotional risk will be operationalized as a score of 4 or above on any of the following items on the Child Depression Rating Scale: Difficulty Having Fun, Social Withdrawal, Irritability, Depressed Feelings, Excessive Weeping, or a T-score of 61 or above on the Multidimensional Anxiety Scale for Children (MASC), based on age group (10-11 years, 12-15 year, 16-19 years) using the MASC-10 Profile. Behavioral risk will be operationalized as a Sensation Seeking Scale score greater than 3.93 for males ages 10-13, greater than 3.19 for females 10-13, greater than 4.07 for males 14-18, or greater than 3.19 for females 14-18; taking Attention-deficit/hyperactivity disorder (ADHD) medication or Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children (KSADs) diagnosis of ADHD; current alcohol or substance abuse; or past alcohol or substance dependence. Social and cognitive risk will be defined as "worse" than others the teen's age in one or more social behavior from Child Behavior Checklist (CBCL) Section VI or failing one or more academic class from CBCL Section VII, respectively. Physical risk will be operationalized as a Physical Health Questionnaire-15 score of 4 or above, six or more days of school absences, or a BMI above the 85th percentile for the participant's sex and age.
3. Age between 10 and 18 and living with a parent or guardian and and attending a class/job by 9am at least 3 days per week;
4. English language fluency;
5. Able and willing to give informed assent.
Exclusion Criteria
2. Evidence from clinical diagnosis or report by youth or parent of sleep apnea, restless legs or periodic limb movements during sleep. Youth presenting with provisional diagnoses of any of these disorders (e.g., sleep apnea) will be referred for a non-study polysomnography (PSG) evaluation at the parent's discretion and will be enrolled only if the diagnosis is disconfirmed;
3. Mental retardation, autism spectrum disorder, or other significantly impairing pervasive developmental disorder. Based on previous recruitment experiences in our youth depression study, we expect this exclusion to be invoked very infrequently (once every few years);
4. Bipolar disorder or schizophrenia or another current Axis I disorder if there is a significant risk of harm and/or decompensation if treatment of that comorbid condition is delayed as a function of participating in any stage of this study. Otherwise, we will allow all other comorbid psychiatric conditions to (i) to maximize representativeness and (ii) because a byproduct may be that the treatment constitutes a helpful 'transdiagnostic' treatment for youth across psychiatric disorders.
5. A medication-free group may be difficult to recruit and would likely be unrepresentative. Hence, participants will not be excluded on the basis of stable use of medications (\> 4 weeks). The exception was use of hypnotics and other medications known to alter sleep (e.g., melatonin).
6. History of substance dependence in the past six months;
7. Current suicide risk sufficient to preclude treatment on an outpatient basis.
10 Years
18 Years
ALL
No
Sponsors
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University of California, Berkeley
OTHER
Responsible Party
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Allison Harvey
Professor of Clinical Psychology
Principal Investigators
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Allison G Harvey, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, Berkeley
Locations
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University of California, Berkeley
Berkeley, California, United States
Countries
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References
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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.
Gumport 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.
Dong 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.
Harvey 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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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