Triple Vulnerability? Circadian Tendency, Sleep Deprivation and Adolescence

Eveningness/Sleep Clinical Trial

Official title:

Triple Vulnerability? Circadian Tendency, Sleep Deprivation and Adolescence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01828320
• Other study ID #: R01HD071065-01A1
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Est. completion date: December 2018

Study information

• Verified date: April 2019
• Source: University of California, Berkeley
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Eveningness/Sleep
• Sleep Deprivation

Intervention

Behavioral:
• Cognitive Behavior Therapy for Insomnia, Interpersonal and Social Rhythms Therapy, Chronotherapy

• Psychoeducation

Locations

Country	Name	City	State
United States	University of California, Berkeley	Berkeley	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Berkeley

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Diagnosis of Psychiatric Disorders	Measured via Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children (KSADS) Interview	Baseline only
Other	Diagnosis of Sleep Disorders	Measured via Duke Structured Interview for Sleep Disorders	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	Actigraphy Measured Total Sleep Time	calculated separately for weeknights and weekend nights to also compute the discrepancy between weeknights and weekend nights	Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
Other	Total wake time (TWT)	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	Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
Other	Actigraphy Measured Daytime activity count	calculated separately for weekdays and weekends	Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
Other	Daily Sleep Diary	total sleep time (weekend nights), weekend night bedtime, weekend risetime, total wake time (SOL+WASO) weeknights, total wake time (SOL+WASO) weekend nights, naps.	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	"Problems that are related to romantic relations" subscale of the Problem Questionnaire		Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
Other	Internet Behavior Checklist Questionnaire		Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
Other	Rosenberg Self Esteem Scale Questionnaire		Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
Other	Rosenberg Self Efficacy Scale Questionnaire		Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
Other	Sleep Inertia Questionnaire		Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
Other	Inventory of Parent and Peer Attachment Questionnaire		Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
Other	Social Skills Rating Scale Questionnaire		Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
Other	Estradiol hormone levels	from females only	Baseline only
Other	DHEA hormone levels	collected via saliva sample DNA by saliva sample to examine selected circadian and emotion single nucleotide polymorphism (SNP)	Baseline only
Other	Testosterone hormone levels	collected via saliva sample	Baseline only
Other	Cytokines: Interleukin-6, Tumor necrosis factor-a, and C-reactive protein.		Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
Other	Weight (lbs)		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	Height (feet, inches)		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	Waist circumference (cm)		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	Hip Circumference (cm)		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	Therapy Process Measure	Credibility Expectancy Questionnaire	Session 2 only
Other	Emotion GoNoGo Task		Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
Other	Emotional IAPS Task		Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
Other	Forward and Backward Digit Span		Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
Other	Dimensional Card Sorting Task		Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
Other	Food Desire Task and Snack Task (only a subsample of participants)		Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
Other	Face Naming Encoding Task (only a subsample of participants)		Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
Other	Face Naming Retrieval Task (only a subsample of participants)		Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
Other	Flanker Task (only a subsample of participants)		Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
Other	Children's Affective Lability Scale	Parent measure	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	Problems in School Questionnaire	Parent measure	Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
Other	Parental Monitoring Questionnaire	Parent measure	Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
Primary	Total sleep time (TST) average on weeknights via Daily Sleep Diary		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
Primary	Average bedtime on weeknights measured via Daily Sleep Diary		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
Primary	Morning Eveningness preference measured via Childrens Morningness Eveningness Preference Scale		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
Primary	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.	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
Primary	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.	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
Primary	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.	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
Primary	Score for Social Domain	The Youth Social Adjustment Scale (social items only) will be used to assess functioning in the Social domain.	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
Primary	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.	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	Sleepiness scale	embedded within the School Sleep Habits Survey	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	Dim Light Melatonin Onset		Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
Secondary	Pittsburgh Sleep Quality Index		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	Discrepancy between weeknights and weekends for Total Sleep Time, Bedtime, and Waketime via Daily Sleep Diary		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	Composite Risk Score of Functioning in Five Health-relevant Domains (Emotional, Cognitive, Behavioral, Social and Physical)	Measured via Ecological Momentary Assessment	Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
Secondary	Child Behavior Checklist	Parent Measure	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