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Triple Vulnerability? Circadian Tendency, Sleep Deprivation and Adolescence

Primary Purpose

Eveningness/Sleep

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavior Therapy for Insomnia, Interpersonal and Social Rhythms Therapy, Chronotherapy
Psychoeducation
Sponsored by
University of California, Berkeley
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eveningness/Sleep focused on measuring Risk: Emotional, Cognitive, Behavioral, Social, Physical

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California, Berkeley

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment 1

Treatment 2

Arm Description

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

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

Outcomes

Primary Outcome Measures

Total sleep time (TST) average on weeknights via Daily Sleep Diary
Average bedtime on weeknights measured via Daily Sleep Diary
Morning Eveningness preference measured via Childrens Morningness Eveningness Preference Scale
Composite Score for Cognitive Domain
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.
Composite Score for Behavioral Domain
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.
Composite Score for Emotional Domain
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.
Score for Social Domain
The Youth Social Adjustment Scale (social items only) will be used to assess functioning in the Social domain.
Composite Score for Physical Domain
A composite score of the Modifiable Activity Questionnaire and Physical Health Questionnaire will be used to assess functioning in the Physical domain.

Secondary Outcome Measures

Sleepiness scale
embedded within the School Sleep Habits Survey
Dim Light Melatonin Onset
Pittsburgh Sleep Quality Index
Discrepancy between weeknights and weekends for Total Sleep Time, Bedtime, and Waketime via Daily Sleep Diary
Composite Risk Score of Functioning in Five Health-relevant Domains (Emotional, Cognitive, Behavioral, Social and Physical)
Measured via Ecological Momentary Assessment
Child Behavior Checklist
Parent Measure

Full Information

First Posted
April 2, 2013
Last Updated
April 15, 2019
Sponsor
University of California, Berkeley
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1. Study Identification

Unique Protocol Identification Number
NCT01828320
Brief Title
Triple Vulnerability? Circadian Tendency, Sleep Deprivation and Adolescence
Official Title
Triple Vulnerability? Circadian Tendency, Sleep Deprivation and Adolescence
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Berkeley

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eveningness/Sleep
Keywords
Risk: Emotional, Cognitive, Behavioral, Social, Physical

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
176 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment 1
Arm Type
Experimental
Arm Description
Integrates evidence-based treatments derived from basic research on the circadian system
Arm Title
Treatment 2
Arm Type
Active Comparator
Arm Description
Psychoeducation on the inter-associations between sleep, diet, exercise and stress.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavior Therapy for Insomnia, Interpersonal and Social Rhythms Therapy, Chronotherapy
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation
Primary Outcome Measure Information:
Title
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, and to 6-month and 12-month followups
Title
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, and to 6-month and 12-month followups
Title
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, and to 6-month and 12-month followups
Title
Composite Score for Cognitive Domain
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.
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
Title
Composite Score for Behavioral Domain
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.
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
Title
Composite Score for Emotional Domain
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.
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
Title
Score for Social Domain
Description
The Youth Social Adjustment Scale (social items only) will be used to assess functioning in the Social domain.
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
Title
Composite Score for Physical Domain
Description
A composite score of the Modifiable Activity Questionnaire and Physical Health Questionnaire will be used to assess functioning in the Physical domain.
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
Secondary Outcome Measure Information:
Title
Sleepiness scale
Description
embedded within the School Sleep Habits Survey
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
Title
Dim Light Melatonin Onset
Time Frame
Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
Title
Pittsburgh Sleep Quality Index
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
Title
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 treatment, and to 6-month and 12-month followups
Title
Composite Risk Score of Functioning in Five Health-relevant Domains (Emotional, Cognitive, Behavioral, Social and Physical)
Description
Measured via Ecological Momentary Assessment
Time Frame
Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
Title
Child Behavior Checklist
Description
Parent Measure
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
Other Pre-specified Outcome Measures:
Title
Diagnosis of Psychiatric Disorders
Description
Measured via Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children (KSADS) Interview
Time Frame
Baseline only
Title
Diagnosis of Sleep Disorders
Description
Measured via Duke Structured Interview for Sleep Disorders
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
Title
Actigraphy Measured Total Sleep Time
Description
calculated separately for weeknights and weekend nights to also compute the discrepancy between weeknights and weekend nights
Time Frame
Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
Title
Total wake time (TWT)
Description
Actigraphy Measured Sleep Onset Latency (SOL; calculated separately for weeknights and weekend nights) and Wake After Sleep Onset (WASO; calculated separately for weeknights and weekend nights) to create Total Wake Time (SOL+WASO) for weeknights, weekends and to also compute the discrepancy between weeknights and weekend nights
Time Frame
Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
Title
Actigraphy Measured Daytime activity count
Description
calculated separately for weekdays and weekends
Time Frame
Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
Title
Daily Sleep Diary
Description
total sleep time (weekend nights), weekend night bedtime, weekend risetime, total wake time (SOL+WASO) weeknights, total wake time (SOL+WASO) weekend nights, naps.
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
Title
"Problems that are related to romantic relations" subscale of the Problem Questionnaire
Time Frame
Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
Title
Internet Behavior Checklist Questionnaire
Time Frame
Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
Title
Rosenberg Self Esteem Scale Questionnaire
Time Frame
Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
Title
Rosenberg Self Efficacy Scale Questionnaire
Time Frame
Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
Title
Sleep Inertia Questionnaire
Time Frame
Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
Title
Inventory of Parent and Peer Attachment Questionnaire
Time Frame
Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
Title
Social Skills Rating Scale Questionnaire
Time Frame
Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
Title
Estradiol hormone levels
Description
from females only
Time Frame
Baseline only
Title
DHEA hormone levels
Description
collected via saliva sample DNA by saliva sample to examine selected circadian and emotion single nucleotide polymorphism (SNP)
Time Frame
Baseline only
Title
Testosterone hormone levels
Description
collected via saliva sample
Time Frame
Baseline only
Title
Cytokines: Interleukin-6, Tumor necrosis factor-α, and C-reactive protein.
Time Frame
Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
Title
Weight (lbs)
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
Title
Height (feet, inches)
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
Title
Waist circumference (cm)
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
Title
Hip Circumference (cm)
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
Title
Therapy Process Measure
Description
Credibility Expectancy Questionnaire
Time Frame
Session 2 only
Title
Emotion GoNoGo Task
Time Frame
Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
Title
Emotional IAPS Task
Time Frame
Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
Title
Forward and Backward Digit Span
Time Frame
Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
Title
Dimensional Card Sorting Task
Time Frame
Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
Title
Food Desire Task and Snack Task (only a subsample of participants)
Time Frame
Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
Title
Face Naming Encoding Task (only a subsample of participants)
Time Frame
Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
Title
Face Naming Retrieval Task (only a subsample of participants)
Time Frame
Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
Title
Flanker Task (only a subsample of participants)
Time Frame
Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
Title
Children's Affective Lability Scale
Description
Parent measure
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
Title
Problems in School Questionnaire
Description
Parent measure
Time Frame
Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
Title
Parental Monitoring Questionnaire
Description
Parent measure
Time Frame
Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 (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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allison G Harvey, PhD
Organizational Affiliation
University of California, Berkeley
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Berkeley
City
Berkeley
State/Province
California
ZIP/Postal Code
94720
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31773734
Citation
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.
Results Reference
derived
PubMed Identifier
31678861
Citation
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.
Results Reference
derived
PubMed Identifier
31246052
Citation
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.
Results Reference
derived
PubMed Identifier
30274649
Citation
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.
Results Reference
derived

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Triple Vulnerability? Circadian Tendency, Sleep Deprivation and Adolescence

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