Triple Vulnerability? Circadian Tendency, Sleep Deprivation and Adolescence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Total Sleep Time (TST) Average on Weeknights Via Daily Sleep Diary
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 (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.
- •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.
排除标准
- •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.
研究组 & 干预措施
Treatment 1
Integrates evidence-based treatments derived from basic research on the circadian system
干预措施: Cognitive Behavior Therapy for Insomnia, Interpersonal and Social Rhythms Therapy, Chronotherapy (Behavioral)
Treatment 2
Psychoeducation on the inter-associations between sleep, diet, exercise and stress.
干预措施: Psychoeducation (Behavioral)
结局指标
主要结局
Total Sleep Time (TST) Average on Weeknights Via Daily Sleep Diary
时间窗: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.
Total sleep time (TST) average on weeknights via Daily Sleep Diary. Change from baseline to post-treatment. The model provides estimates of the mean pre-post change in the Psychoeducation (PE) condition and the TranS-C condition.
Average Bedtime on Weeknights Measured Via Daily Sleep Diary
时间窗: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.
Change in average bedtime on weeknights from pre-treatment to post-treatment measured via Daily Sleep Diary. 24-hour decimal format, where times after midnight are expressed as numbers above 24 (ex. 1:30 am is 25.50). The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition.
Composite Score for Cognitive Domain
时间窗: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.
Cognitive composite score reflects cognitive functioning and was calculated by averaging the standardized summary scores from two measures: Attentional Control Scale (ACS) and Youth Social Adjustment Scale-Self Report (YSAS). Summary scores were calculated as 1.)ACS = sum of 20 items rated 1- 4; range: 20-80. Higher scores indicate less attentional control; and 2.) YSAS = sum of 6 school/cognitive-related items rated 1-5; range: 6-30. Higher scores indicate worse school-related impairment. Per participant, summary scores from the ACS and YSAS were computed and then standardized. The final composite (range -2.12 to 2.39) was calculated as the mean of the two standardized scores. Higher scores indicate greater attentional difficulty and school impairment. Change in this composite score from baseline to post treatment is reported below. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition.
Composite Score for Behavioral Domain
时间窗: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.
To assess functioning in the Behavioral domain, a Youth Self-Report Composite Risk Score is calculated by taking the mean of standardized summary scores from two measures: Sensation Seeking Scale for Children (SSS) and the Alcohol and Substance Use-Past 30 days (SU; items include questions on caffeine and energy drinks). Summary scores were calculated as 1.) SSS = sum of 8 items, rated 1-5, range: 8-40. Higher scores = greater sensation seeking; and 2.) SU = Sum of 23 items rated 0-7, range 0-161. Higher scores = more frequent use. For each participant, summary scores from the SSS and SU subscales were computed and standardized. The final composite (range -1.73 to 3.34) was calculated as the mean of the two standardized scores. Higher composite scores indicate higher impairment Change in this composite score from baseline to post-treatment is reported below. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition.
Composite Score for Emotional Domain
时间窗: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.
Youth Self-Report Composite Score, Emotional functioning domain is calculated by taking the mean of standardized summary scores from two measures: Children's Depression Rating Scale-Revised (CDRS) and the Multidimensional Anxiety Scale for Children (MASC). Summary scores were calculated as 1.) CDRS = Sum of 17 items. range 17-113. Higher scores indicate greater depressive symptoms; and 2.) MASC= Sum of 39 items. range 0-117. Higher scores indicate greater anxiety. For each participant, summary scores from the CDRS and MASC subscales were first computed and then standardized. The final composite (range -2.10 to 3.60) was calculated as the mean of the two standardized scores from the CDRS and MASC. Higher composite scores indicate greater emotional risk (i.e., more depression and anxiety symptoms). Change in this composite score from baseline to post treatment is reported below. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition.
Composite Score for Social Domain
时间窗: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.
Composite Score for Social Domain to assess functioning in the Social domain. Calculated by taking the average of the three subscales (ie, friends, family, romantic relationships) from the Youth Social Adjustment Scale - Self Report. Youth Social Adjustment Scale - social items only. 9 items (questions 7-15 out of the 23 item scale), item range 1-5. Summary score is calculated by taking the sum of all 9 items. no reverse coding needed. Summary score range 9-45. Higher score = more impaired adjustment. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition.
Composite Score for Physical Domain
时间窗: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.
Composite Score for Physical Domain (physical functioning) is calculated by taking the mean of standardized summary scores from two measures: Modifiable Activity Questionnaire for Adolescents (MAQ) and Physical Health Questionnaire (PHQ). Summary scores were calculated as 1.) MAQ = sum of the number of hours per week not active/exercising. Higher scores indicate greater numbers of leisure hours; and 2. PHQ-15 = sum of item (13 items for males, 14 items for females), range 0-30. Higher scores indicate worse somatic complaints. For each participant, summary scores from the MAQ and PHQ-15 subscales were first computed and then standardized. The final composite (range -3.95 to 1.86) was calculated as the mean of the two standardized scores. Higher composite scores indicate greater physical health risk. Change in this composite score from baseline to post treatment is reported below. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition.
Total Sleep Time (TST) Average on Weeknights Via Daily Sleep Diary
时间窗: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.
Total sleep time (TST) average on weeknights via Daily Sleep Diary. Change from baseline to post-treatment. The model provides estimates of the mean pre-post change in the Psychoeducation (PE) condition and the TranS-C condition.
Average Bedtime on Weeknights Measured Via Daily Sleep Diary
时间窗: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.
Change in average bedtime on weeknights from pre-treatment to post-treatment measured via Daily Sleep Diary. 24-hour decimal format, where times after midnight are expressed as numbers above 24 (ex. 1:30 am is 25.50). The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition.
Morning Eveningness Preference Measured Via Childrens Morningness Eveningness Preference Scale
时间窗: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.
Morning Eveningness preference measured via Childrens Morningness Eveningness Preference Scale(CMEP). Scores range from 10 (Extreme evening preference) to 43 (Extreme morning preference). The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition.
Composite Score for Cognitive Domain
时间窗: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.
Cognitive composite score reflects cognitive functioning and was calculated by averaging the standardized summary scores from two measures: Attentional Control Scale (ACS) and Youth Social Adjustment Scale-Self Report (YSAS). Summary scores were calculated as 1.)ACS = sum of 20 items rated 1- 4; range: 20-80. Higher scores indicate less attentional control; and 2.) YSAS = sum of 6 school/cognitive-related items rated 1-5; range: 6-30. Higher scores indicate worse school-related impairment. Per participant, summary scores from the ACS and YSAS were computed and then standardized. The final composite (range -2.12 to 2.39) was calculated as the mean of the two standardized scores. Higher scores indicate greater attentional difficulty and school impairment. Change in this composite score from baseline to post treatment is reported below. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition.
Composite Score for Behavioral Domain
时间窗: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.
To assess functioning in the Behavioral domain, a Youth Self-Report Composite Risk Score is calculated by taking the mean of standardized summary scores from two measures: Sensation Seeking Scale for Children (SSS) and the Alcohol and Substance Use-Past 30 days (SU; items include questions on caffeine and energy drinks). Summary scores were calculated as 1.) SSS = sum of 8 items, rated 1-5, range: 8-40. Higher scores = greater sensation seeking; and 2.) SU = Sum of 23 items rated 0-7, range 0-161. Higher scores = more frequent use. For each participant, summary scores from the SSS and SU subscales were computed and standardized. The final composite (range -1.73 to 3.34) was calculated as the mean of the two standardized scores. Higher composite scores indicate higher impairment Change in this composite score from baseline to post-treatment is reported below. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition.
Composite Score for Emotional Domain
时间窗: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.
Youth Self-Report Composite Score, Emotional functioning domain is calculated by taking the mean of standardized summary scores from two measures: Children's Depression Rating Scale-Revised (CDRS) and the Multidimensional Anxiety Scale for Children (MASC). Summary scores were calculated as 1.) CDRS = Sum of 17 items. range 17-113. Higher scores indicate greater depressive symptoms; and 2.) MASC= Sum of 39 items. range 0-117. Higher scores indicate greater anxiety. For each participant, summary scores from the CDRS and MASC subscales were first computed and then standardized. The final composite (range -2.10 to 3.60) was calculated as the mean of the two standardized scores from the CDRS and MASC. Higher composite scores indicate greater emotional risk (i.e., more depression and anxiety symptoms). Change in this composite score from baseline to post treatment is reported below. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition.
Composite Score for Social Domain
时间窗: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.
Composite Score for Social Domain to assess functioning in the Social domain. Calculated by taking the average of the three subscales (ie, friends, family, romantic relationships) from the Youth Social Adjustment Scale - Self Report. Youth Social Adjustment Scale - social items only. 9 items (questions 7-15 out of the 23 item scale), item range 1-5. Summary score is calculated by taking the sum of all 9 items. no reverse coding needed. Summary score range 9-45. Higher score = more impaired adjustment. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition.
Composite Score for Physical Domain
时间窗: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.
Composite Score for Physical Domain (physical functioning) is calculated by taking the mean of standardized summary scores from two measures: Modifiable Activity Questionnaire for Adolescents (MAQ) and Physical Health Questionnaire (PHQ). Summary scores were calculated as 1.) MAQ = sum of the number of hours per week not active/exercising. Higher scores indicate greater numbers of leisure hours; and 2. PHQ-15 = sum of item (13 items for males, 14 items for females), range 0-30. Higher scores indicate worse somatic complaints. For each participant, summary scores from the MAQ and PHQ-15 subscales were first computed and then standardized. The final composite (range -3.95 to 1.86) was calculated as the mean of the two standardized scores. Higher composite scores indicate greater physical health risk. Change in this composite score from baseline to post treatment is reported below. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition.
次要结局
- Sleepiness 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)
- Dim Light Melatonin Onset(Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment)
- Pittsburgh Sleep Quality Index(Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.)
- Discrepancy Between Weeknights and Weekends for Total Sleep Time(Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment.)
- Composite Risk Score of Functioning in Five Health-relevant Domains: Emotional Health (Positivity Ratio)(Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment.)
- Child Behavior Checklist: Parent-report Emotional Health Composite Risk Score(Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment.)
- Discrepancy Between Weeknights and Weekends for Bedtime Via Daily Sleep Diary(Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment.)
- Discrepancy Between Weeknights and Weekends for Wake Time Via Daily Sleep Diary(Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment.)
- Composite Risk Score of Functioning in Five Health-relevant Domains: Cognitive Health(Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment)
- Composite Risk Score of Functioning in Five Health-relevant Domains: Behavioral Health(Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment)
- Composite Risk Score of Functioning in Five Health-relevant Domains: Physical Health(Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment)
- Composite Risk Score of Functioning in Five Health-relevant Domains: Social Health(Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment)
- Child Behavior Checklist: Parent-report Cognitive Health Composite Risk Score(Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.)
- Child Behavior Checklist: Parent-report Behavioral Health Composite Risk Score(Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.)
- Child Behavior Checklist: Parent-report Social Health Composite Risk Score(Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.)
- Child Behavior Checklist: Parent-report Physical Health Composite Risk Score(Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.)
- Child Behavior Checklist: CBCL Sleep Composite(Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.)
- Pittsburgh Sleep Quality Index(Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.)
- Discrepancy Between Weeknights and Weekends for Total Sleep Time(Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment.)
- Dim Light Melatonin Onset(Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment)
- Sleepiness 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)
- Composite Risk Score of Functioning in Five Health-relevant Domains: Emotional Health (Positivity Ratio)(Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment.)
- Child Behavior Checklist: Parent-report Emotional Health Composite Risk Score(Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment.)
- Discrepancy Between Weeknights and Weekends for Bedtime Via Daily Sleep Diary(Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment.)
- Discrepancy Between Weeknights and Weekends for Wake Time Via Daily Sleep Diary(Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment.)
- Composite Risk Score of Functioning in Five Health-relevant Domains: Cognitive Health(Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment)
- Composite Risk Score of Functioning in Five Health-relevant Domains: Behavioral Health(Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment)
- Composite Risk Score of Functioning in Five Health-relevant Domains: Physical Health(Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment)
- Composite Risk Score of Functioning in Five Health-relevant Domains: Social Health(Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment)
- Child Behavior Checklist: Parent-report Cognitive Health Composite Risk Score(Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.)
- Child Behavior Checklist: Parent-report Behavioral Health Composite Risk Score(Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.)
- Child Behavior Checklist: Parent-report Social Health Composite Risk Score(Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.)
- Child Behavior Checklist: Parent-report Physical Health Composite Risk Score(Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.)
- Child Behavior Checklist: CBCL Sleep Composite(Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.)
研究者
Allison Harvey
Professor of Clinical Psychology
University of California, Berkeley