Expired Study
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Berkeley, California 94720


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion criteria. 1. 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. 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 (MASQ), 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 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. 1. 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; 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.


Study is Available At:


Original ID:

R01HD071065-01A1


NCT ID:

NCT01828320


Secondary ID:


Study Acronym:


Brief Title:

Triple Vulnerability? Circadian Tendency, Sleep Deprivation and Adolescence


Official Title:

Triple Vulnerability? Circadian Tendency, Sleep Deprivation and Adolescence


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

10 Years


Maximum Age:

18 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of California, Berkeley


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

176


Enrollment Type:

Actual


Overall Contact Information

Official Name:Allison G Harvey, PhD
Principal Investigator
University of California, Berkeley

Study Dates

Start Date:March 2013
Completion Date:December 2018
Completion Type:Actual
Primary Completion Date:December 2017
Primary Completion Type:Actual
Verification Date:April 2019
Last Changed Date:April 15, 2019
First Received Date:April 2, 2013

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Child Behavior Checklist
Time Frame:Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatm
Safety Issues:False
Description:Parent Measure
Outcome Type:Secondary Outcome
Measure:Composite Risk Score of Functioning in Five Health-relevant Domains (Emotional, Cognitive, Behavioral, Social and Physical)
Time Frame:Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatm
Safety Issues:False
Description:Measured via Ecological Momentary Assessment
Outcome Type:Secondary Outcome
Measure:Discrepancy between weeknights and weekends for Total Sleep Time, Bedtime, and Waketime via Daily Sleep Diary
Time Frame:Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatm
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Pittsburgh Sleep Quality Index
Time Frame:Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatm
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Dim Light Melatonin Onset
Time Frame:Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatm
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Sleepiness scale
Time Frame:Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatm
Safety Issues:False
Description:embedded within the School Sleep Habits Survey
Outcome Type:Primary Outcome
Measure:Composite Score for Physical Domain
Time Frame:Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatm
Safety Issues:False
Description:A composite score of the Modifiable Activity Questionnaire and Physical Health Questionnaire will be used to assess functioning in the Physical domain.
Outcome Type:Primary Outcome
Measure:Score for Social Domain
Time Frame:Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatm
Safety Issues:False
Description:The Youth Social Adjustment Scale (social items only) will be used to assess functioning in the Social domain.
Outcome Type:Primary Outcome
Measure:Composite Score for Emotional Domain
Time Frame:Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatm
Safety Issues:False
Description:A composite score of the Child Depression Rating Scale and Multidimensional Anxiety Scale for Children will be used to assess functioning in the Emotional domain.
Outcome Type:Primary Outcome
Measure:Composite Score for Behavioral Domain
Time Frame:Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatm
Safety Issues:False
Description:A composite score of the Alcohol and Substance Use (Past 30 days items only) and Sensation Seeking Scale will be used to assess functioning in the Behavioral domain.
Outcome Type:Primary Outcome
Measure:Composite Score for Cognitive Domain
Time Frame:Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatm
Safety Issues:False
Description:A composite score of the Attentional Control Scale and Youth Social Adjustment Scale (school/cognitive items only) will be used to assess functioning in the Cognitive domain.
Outcome Type:Primary Outcome
Measure: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 treatm
Safety Issues:False
Outcome Type:Primary Outcome
Measure: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 treatm
Safety Issues:False
Outcome Type: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 treatm
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Cognitive Behavior Therapy for Insomnia, Interpers
Arm Name:Treatment 1
Intervention Type:Behavioral
Name:Psychoeducation
Arm Name:Treatment 2

Study Arms

Study Arm Type:Active Comparator
Arm Name:Treatment 2
Description:Psychoeducation on the inter-associations between sleep, diet, exercise and stress.
Study Arm Type:Experimental
Arm Name:Treatment 1
Description:Integrates evidence-based treatments derived from basic research on the circadian system

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of California, Berkeley

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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