Eveningness/Sleep
Conditions
Keywords
Risk: Emotional, Cognitive, Behavioral, Social, Physical
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.
Interventions
BEHAVIORALCognitive Behavior Therapy for Insomnia, Interpersonal and Social Rhythms Therapy, Chronotherapy
BEHAVIORALPsychoeducation
Sponsors
University of California, Berkeley
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No
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 (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
. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 Cognitive Health measured via Ecological Momentary Assessment. Participants responded to 11 items that measured their concentration, distractedness, and focus related to their current activity. All items were rated on 5-point Likert scale, where higher scores respectively indicated higher levels of concentration, distractedness, and focus (min = 11, max = 55). The composite risk score was calculated by averaging participant responses over the assessment week. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. |
| 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 Behavioral Health measured via Ecological Momentary Assessment was assessed by directly asking participants about eating, drinking, chewing gum, and smoking behavior at the time the phone rang through 6 open-ended EMA questions. Responses were coded. The average weekly frequency of intake of junk food, caffeine, alcohol, nicotine, and other substances was tabulated. The minimum score was 0, and there was no maximum score. Higher scores indicate more risky behaviors and thus more risk. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. |
| 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 Physical Health derived from Ecological Momentary Assessment (EMA). For the physical health domain, responses to a single daily item (e.g., Were you physically active today?) were used to create a binary score: 1 = active, 2 = inactive. Daily responses were collected over 7 days and both summed (range: 7-14) and averaged for each participant. The final composite score reflects the average of these daily values (range: 1 - 2) , where lower scores indicate greater physical activity and lower physical health risk. Change in this composite score from baseline to post treatment (which is an average of 9 weeks after the beginning of treatment) is reported below. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. |
| 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 | Composite Risk Score of Functioning in Social health measured via Ecological Momentary Assessment was assessed by directly asking participants who the participant was with at the time the phone rang. Participants' responses were then manually coded for companion type on a scale of 0-4. Participants' positivity ratios, as calculated in the Emotional Health (Positivity Ratio) Composite Risk Score of Functioning, were then grouped based on occasions when participants were alone vs. with a family member vs. with a friend vs. other. Positivity ratios within groups were averaged (min = 0.16, max = 4), where higher averages indicated higher subjective well-being and lower risk. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. |
| 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 | Sleepiness subscale from School Sleep Habits Survey (SSHB). This subscale includes 10 items rated on a 4-point scale (0 - 3), assessing sleepiness. Total scores were calculated by summing all item responses. Possible scores range from 0 to 30, with higher scores indicating greater daytime sleepiness. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. |
| 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. | Parent Measure. The Behavioral Health Composite Risk Score was assessed with a composite score of the Rule-Breaking Behavior and Aggressive Behavior subscales of Child Behavior Checklist (CBCL), calculated by taking the mean of standardized summary scores for the items within this domain. This is a parent-reported measure of a teen's behavioral health, including items related to rule-breaking. Range for composite total: 0-70, with higher scores indicating more behavioral problems. The CBCL Rule-Breaking Behavior subscale is composed of 17-items CBCL items on a scale of 0-2, the range of scores is 0-34, with higher scores indicating more rule-breaking behavior. The CBCL Aggressive Behavior subscale is composed of 18-items CBCL items on a scale of 0-2, the range of scores is 0-36, with higher scores indicating more aggressive behavior. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. |
| 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. | Parent Measure. The Social Health Composite Risk Score was assessed with a composite score of the Social Problems subscale of Child Behavior Checklist (CBCL), calculated by taking the mean of standardized summary scores for the items within this domain. This is a parent-reported measure of a teen's social health. The CBCL Social Problems subscale is composed of 11-items CBCL items on a scale of 0-2, the range of scores is 0-22, with higher scores indicating more Social problems. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. |
| 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. | Parent Measure. The Physical Health Composite Risk Score was assessed with a composite score of the Somatic Complaints subscale of Child Behavior Checklist (CBCL), calculated by taking the mean of standardized summary scores for the items within this domain. This is a parent-reported measure of a teen's Physical health (e.g., vomiting). The CBCL Somatic Complaints subscale is composed of 11-items CBCL items on a scale of 0-2, the range of scores is 0-22, with higher scores indicating more physical problems. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. |
| Child Behavior Checklist: CBCL Sleep Composite | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment. | Parent Measure. The Sleep Health Composite Risk Score was assessed with a composite score of sleep from Child Behavior Checklist (CBCL), calculated by taking the mean of standardized summary scores for the items within this domain. This is a parent-reported measure of a teen's sleep health. The CBCL sleep subscale is composed of 7-items CBCL items on a scale of 0-2, the range of scores is 0-14, with higher scores indicating more sleep problems. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. |
| 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. | Parent Measure. Cognitive Health Composite Risk Score was assessed with the Thought Problems and Attention Problems subscale of Child Behavior Checklist (CBCL), calculated by taking the mean of standardized summary scores for the items within this domain. This is a parent-reported measure of a teen's cognitive health, including items related to thought problems. Range for composite total: 0-50, with higher scores indicating more cognitive problems. The CBCL Thought Problems subscale is composed of 15-items CBCL items on a scale of 0-2, the range of scores is 0-30, with higher scores indicating more problems. The CBCL Attention Problems subscale is composed of 10-items CBCL items on a scale of 0-2, the range of scores is 0-20, with higher scores indicating more problems. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition |
| Dim Light Melatonin Onset | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment | Melatonin levels were measured using 13 saliva samples collected at 30-minute intervals, beginning 5.5 hours before and ending 30 minutes after each participant's average bedtime (computed from 7 nights of sleep diary). For each timepoint (baseline and post-treatment), the dim light melatonin onset (DLMO) was estimated by identifying when melatonin levels crossed the 3.0 pg/ml threshold (i.e., the interpolated time). Change in the interpolated DLMO times from baseline to post treatment (which is an average of 9 weeks after the beginning of treatment) reported. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. |
| Pittsburgh Sleep Quality Index | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment. | Pittsburgh Sleep Quality Index (PSQI). Summary score is calculated by taking the sum of item-level scores. Summary score range 0-21. A higher score means increased severity of difficulty in all sleep area components. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. |
| 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. | The discrepancy between weeknights and weekends for Total Sleep Time(TST). The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. |
| 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. | Composite Risk Score of Functioning in Emotional Health, measured via Ecological Momentary Assessment (EMA), assesses subjective emotional well-being across 7-days, per timepoint using a 9-item short form of the Positive and Negative Affect Scale for Children (PANAS-C), which included 4 positive affect items (min = 4, max = 20; higher scores indicate more positive affect) and 5 negative affect items (min = 5, max = 25; higher scores indicate more negative affect), each rated on a 5-point Likert scale. A positivity ratio was calculated by dividing the sum of each affect item scores by the sum of negative affect score per survey day. Higher positivity ratios (range: 0.16-4) indicate higher subjective well-being and less risk. Change in average Positivity Ratio from baseline to post treatment (which is an average of 9 weeks after the beginning of treatment) reported. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. |
| 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. | Parent Measure. The Emotional Health Composite Risk Score was assessed with a composite score of the Anxious/Depressed and Withdrawn/Depressed subscales of Child Behavior Checklist (CBCL), calculated by taking the mean of standardized summary scores for the items within this domain. This is a parent-reported measure of a teen's emotional health, including items related to anxiety/depression. Range for composite total: 0-42, with higher scores indicating more problems. The CBCL Anxious/Depressed subscale is composed of 13-items CBCL items on a scale of 0-2, the range of scores is 0-26, with higher scores indicating more emotional problems. The CBCL Withdrawn/Depressed subscale is composed of 8-items CBCL items on a scale of 0-2, the range of scores is 0-16, with higher scores indicating more emotional problems. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition |
| 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. | The discrepancy between weeknights and weekends for Bedtime(BT) via Daily Sleep Diary. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. |
| 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. | The discrepancy between weeknights and weekends for Wake time (WUP) via Daily Sleep Diary. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Dimensional Card Sorting Task | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment | — |
| 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 | — |
| 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 | — |
| 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 | — |
| Diagnosis of Psychiatric Disorders | Baseline only | Measured via Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children (KSADS) Interview |
| Children's Affective Lability 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 | Parent measure |
| Problems in School Questionnaire | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment | Parent measure |
| Parental Monitoring Questionnaire | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment | Parent measure |
| 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 | — |
| Diagnosis of 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 | Measured via Duke Structured Interview for Sleep Disorders |
| Actigraphy Measured Total Sleep Time | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment | calculated separately for weeknights and weekend nights to also compute the discrepancy between weeknights and weekend nights |
| Total Wake Time (TWT) | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment | 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 |
| Actigraphy Measured Daytime Activity Count | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment | calculated separately for weekdays and weekends |
| 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 | total sleep time (weekend nights), weekend night bedtime, weekend rise time, total wake time (SOL+WASO) weeknights, total wake time (SOL+WASO) weekend nights, naps. |
| 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 | — |
| Internet Behavior Checklist Questionnaire | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment | — |
| Rosenberg Self Esteem Scale Questionnaire | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment | — |
| Rosenberg Self Efficacy Scale Questionnaire | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment | — |
| Sleep Inertia Questionnaire | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment | — |
| 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 | — |
| Social Skills Rating Scale Questionnaire | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment | — |
| Estradiol Hormone Levels | Baseline only | from females only |
| Dehydroepiandrosterone (DHEA) Hormone Levels | Baseline only | collected via saliva sample DNA by saliva sample to examine selected circadian and emotion single nucleotide polymorphism (SNP) |
| Testosterone Hormone Levels | Baseline only | collected via saliva sample |
| Cytokines: Interleukin-6, Tumor Necrosis Factor-α, and C-reactive Protein. | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment | — |
| 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 | — |
| 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 | — |
| 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 | — |
| 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 | — |
| Therapy Process Measure | Session 2 only | Credibility Expectancy Questionnaire |
| Emotion GoNoGo Task | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment | — |
| Emotional International Affective Pictures System (IAPS) Task | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment | — |
| Forward and Backward Digit Span | Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment | — |
Countries
United States
Participant flow
Recruitment details
Based in a university clinic, from March 2013 to March 2016, youth were randomly assigned, stratified by sex and age (10-14 years, 15-18 years), in a 1:1 parallel group design, to receive either Transdiagnostic Sleep and Circadian Intervention (TranS-C) or Psychoeducation (PE). Sibling pairs (n = 3) were randomized to the same condition.
Participants by arm
| Arm | Count |
|---|---|
| Trans-C Integrates evidence-based treatments derived from basic research on the circadian system
Cognitive Behavior Therapy for Insomnia, Interpersonal and Social Rhythms Therapy, Chronotherapy | 89 |
| Psychoeducation Psychoeducation on the inter-associations between sleep, diet, exercise and stress.
Psychoeducation | 87 |
| Total | 176 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 3 |
| Overall Study | Withdrawal by Subject | 7 | 2 |
Baseline characteristics
| Characteristic | Psychoeducation | Trans-C | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 87 Participants | 89 Participants | 176 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 14.78 years STANDARD_DEVIATION 1.74 | 14.76 years STANDARD_DEVIATION 1.94 | 14.77 years STANDARD_DEVIATION 1.84 |
| Any current K-SADS Diagnosis (parent report) | 28 Participants | 21 Participants | 49 Participants |
| Any current K-SADS Diagnosis (teen report) | 29 Participants | 34 Participants | 63 Participants |
| Any past K-SADS Diagnosis (parent report) | 31 Participants | 24 Participants | 55 Participants |
| Any past K-SADS Diagnosis (teen report) | 37 Participants | 40 Participants | 77 Participants |
| Education Level (at baseline) College | 0 Participants | 1 Participants | 1 Participants |
| Education Level (at baseline) Grade 10 | 24 Participants | 22 Participants | 46 Participants |
| Education Level (at baseline) Grade 11 | 12 Participants | 13 Participants | 25 Participants |
| Education Level (at baseline) Grade 12 | 13 Participants | 12 Participants | 25 Participants |
| Education Level (at baseline) Grade 5 | 1 Participants | 4 Participants | 5 Participants |
| Education Level (at baseline) Grade 6 | 3 Participants | 4 Participants | 7 Participants |
| Education Level (at baseline) Grade 7 | 8 Participants | 6 Participants | 14 Participants |
| Education Level (at baseline) Grade 8 | 14 Participants | 11 Participants | 25 Participants |
| Education Level (at baseline) Grade 9 | 12 Participants | 16 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants | 14 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 74 Participants | 75 Participants | 149 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Family annual income ($) 100,000+ | 55 Participants | 47 Participants | 102 Participants |
| Family annual income ($) <20,000 | 4 Participants | 2 Participants | 6 Participants |
| Family annual income ($) 20,001 - 50,000 | 10 Participants | 11 Participants | 21 Participants |
| Family annual income ($) 50,001 - 100,000 | 16 Participants | 26 Participants | 42 Participants |
| Family annual income ($) Refused to answer/missing | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 11 Participants | 18 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 4 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 16 Participants | 14 Participants | 30 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 56 Participants | 58 Participants | 114 Participants |
| Region of Enrollment United States | 87 participants | 89 participants | 176 participants |
| Sex: Female, Male Female | 53 Participants | 49 Participants | 102 Participants |
| Sex: Female, Male Male | 34 Participants | 40 Participants | 74 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 89 | 0 / 87 |
| other Total, other adverse events | 0 / 89 | 0 / 87 |
| serious Total, serious adverse events | 0 / 89 | 0 / 87 |
Outcome results
Primary
Average Bedtime on Weeknights Measured Via Daily Sleep Diary
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.
Time frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Trans-C | Average Bedtime on Weeknights Measured Via Daily Sleep Diary | -0.03 hours |
| Psychoeducation | Average Bedtime on Weeknights Measured Via Daily Sleep Diary | -0.05 hours |
p-value: 0.93intent-to-treat, multilevel modeling
Primary
Composite Score for Behavioral Domain
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.
Time frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Trans-C | Composite Score for Behavioral Domain | 0.02 units on a scale |
| Psychoeducation | Composite Score for Behavioral Domain | 0.08 units on a scale |
p-value: 0.31Intent-to-treat, multilevel modeling
Primary
Composite Score for Cognitive Domain
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.
Time frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Trans-C | Composite Score for Cognitive Domain | -0.04 units on a scale |
| Psychoeducation | Composite Score for Cognitive Domain | 0.11 units on a scale |
p-value: 0.17Intent-to-treat, multilevel modeling
Primary
Composite Score for Emotional Domain
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.
Time frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Trans-C | Composite Score for Emotional Domain | -0.38 units on a scale |
| Psychoeducation | Composite Score for Emotional Domain | -0.36 units on a scale |
p-value: 0.8Intent-to-treat, multilevel modeling
Primary
Composite Score for Physical Domain
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.
Time frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Trans-C | Composite Score for Physical Domain | 0.02 units on a scale |
| Psychoeducation | Composite Score for Physical Domain | 0.00 units on a scale |
p-value: 0.83intent-to-treat, multilevel modeling
Primary
Composite Score for Social Domain
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.
Time frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Trans-C | Composite Score for Social Domain | -0.04 Composite score |
| Psychoeducation | Composite Score for Social Domain | -0.03 Composite score |
p-value: 0.96Intent-to-treat, multilevel modeling
Primary
Morning Eveningness Preference Measured Via Childrens Morningness Eveningness Preference Scale
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.
Time frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Trans-C | Morning Eveningness Preference Measured Via Childrens Morningness Eveningness Preference Scale | 3.89 score on a scale |
| Psychoeducation | Morning Eveningness Preference Measured Via Childrens Morningness Eveningness Preference Scale | 2.01 score on a scale |
p-value: 0.01Intent-to-treat, multilevel modeling
Primary
Total Sleep Time (TST) Average on Weeknights Via Daily Sleep Diary
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.
Time frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Trans-C | Total Sleep Time (TST) Average on Weeknights Via Daily Sleep Diary | 24.72 Minutes |
| Psychoeducation | Total Sleep Time (TST) Average on Weeknights Via Daily Sleep Diary | 13.02 Minutes |
p-value: 0.34Intent-to-treat, multilevel modeling
Secondary
Child Behavior Checklist: CBCL Sleep Composite
Parent Measure. The Sleep Health Composite Risk Score was assessed with a composite score of sleep from Child Behavior Checklist (CBCL), calculated by taking the mean of standardized summary scores for the items within this domain. This is a parent-reported measure of a teen's sleep health. The CBCL sleep subscale is composed of 7-items CBCL items on a scale of 0-2, the range of scores is 0-14, with higher scores indicating more sleep problems. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition.
Time frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Trans-C | Child Behavior Checklist: CBCL Sleep Composite | -1.43 Composite score |
| Psychoeducation | Child Behavior Checklist: CBCL Sleep Composite | -0.67 Composite score |
p-value: 0.01Intent-to-treat, multilevel modeling
Secondary
Child Behavior Checklist: Parent-report Behavioral Health Composite Risk Score
Parent Measure. The Behavioral Health Composite Risk Score was assessed with a composite score of the Rule-Breaking Behavior and Aggressive Behavior subscales of Child Behavior Checklist (CBCL), calculated by taking the mean of standardized summary scores for the items within this domain. This is a parent-reported measure of a teen's behavioral health, including items related to rule-breaking. Range for composite total: 0-70, with higher scores indicating more behavioral problems. The CBCL Rule-Breaking Behavior subscale is composed of 17-items CBCL items on a scale of 0-2, the range of scores is 0-34, with higher scores indicating more rule-breaking behavior. The CBCL Aggressive Behavior subscale is composed of 18-items CBCL items on a scale of 0-2, the range of scores is 0-36, with higher scores indicating more aggressive behavior. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition.
Time frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Trans-C | Child Behavior Checklist: Parent-report Behavioral Health Composite Risk Score | -0.07 Composite score |
| Psychoeducation | Child Behavior Checklist: Parent-report Behavioral Health Composite Risk Score | 0.01 Composite score |
p-value: 0.49intent-to-treat, multilevel modeling
Secondary
Child Behavior Checklist: Parent-report Cognitive Health Composite Risk Score
Parent Measure. Cognitive Health Composite Risk Score was assessed with the Thought Problems and Attention Problems subscale of Child Behavior Checklist (CBCL), calculated by taking the mean of standardized summary scores for the items within this domain. This is a parent-reported measure of a teen's cognitive health, including items related to thought problems. Range for composite total: 0-50, with higher scores indicating more cognitive problems. The CBCL Thought Problems subscale is composed of 15-items CBCL items on a scale of 0-2, the range of scores is 0-30, with higher scores indicating more problems. The CBCL Attention Problems subscale is composed of 10-items CBCL items on a scale of 0-2, the range of scores is 0-20, with higher scores indicating more problems. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition
Time frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Trans-C | Child Behavior Checklist: Parent-report Cognitive Health Composite Risk Score | -0.22 Composite score |
| Psychoeducation | Child Behavior Checklist: Parent-report Cognitive Health Composite Risk Score | 0.01 Composite score |
p-value: 0.02Intent-to-treat, multilevel modeling
Secondary
Child Behavior Checklist: Parent-report Emotional Health Composite Risk Score
Parent Measure. The Emotional Health Composite Risk Score was assessed with a composite score of the Anxious/Depressed and Withdrawn/Depressed subscales of Child Behavior Checklist (CBCL), calculated by taking the mean of standardized summary scores for the items within this domain. This is a parent-reported measure of a teen's emotional health, including items related to anxiety/depression. Range for composite total: 0-42, with higher scores indicating more problems. The CBCL Anxious/Depressed subscale is composed of 13-items CBCL items on a scale of 0-2, the range of scores is 0-26, with higher scores indicating more emotional problems. The CBCL Withdrawn/Depressed subscale is composed of 8-items CBCL items on a scale of 0-2, the range of scores is 0-16, with higher scores indicating more emotional problems. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition
Time frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Trans-C | Child Behavior Checklist: Parent-report Emotional Health Composite Risk Score | -0.07 Composite score |
| Psychoeducation | Child Behavior Checklist: Parent-report Emotional Health Composite Risk Score | -0.05 Composite score |
p-value: 0.83intent-to-treat, multilevel modeling
Secondary
Child Behavior Checklist: Parent-report Physical Health Composite Risk Score
Parent Measure. The Physical Health Composite Risk Score was assessed with a composite score of the Somatic Complaints subscale of Child Behavior Checklist (CBCL), calculated by taking the mean of standardized summary scores for the items within this domain. This is a parent-reported measure of a teen's Physical health (e.g., vomiting). The CBCL Somatic Complaints subscale is composed of 11-items CBCL items on a scale of 0-2, the range of scores is 0-22, with higher scores indicating more physical problems. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition.
Time frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Trans-C | Child Behavior Checklist: Parent-report Physical Health Composite Risk Score | -0.24 Composite score |
| Psychoeducation | Child Behavior Checklist: Parent-report Physical Health Composite Risk Score | -0.14 Composite score |
p-value: 0.42Intent-to-treat, multilevel modeling
Secondary
Child Behavior Checklist: Parent-report Social Health Composite Risk Score
Parent Measure. The Social Health Composite Risk Score was assessed with a composite score of the Social Problems subscale of Child Behavior Checklist (CBCL), calculated by taking the mean of standardized summary scores for the items within this domain. This is a parent-reported measure of a teen's social health. The CBCL Social Problems subscale is composed of 11-items CBCL items on a scale of 0-2, the range of scores is 0-22, with higher scores indicating more Social problems. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition.
Time frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Trans-C | Child Behavior Checklist: Parent-report Social Health Composite Risk Score | -0.04 Composite score |
| Psychoeducation | Child Behavior Checklist: Parent-report Social Health Composite Risk Score | .03 Composite score |
p-value: 0.6intent-to-treat, multilevel modeling
Secondary
Composite Risk Score of Functioning in Five Health-relevant Domains: Behavioral Health
Composite Risk Score of Functioning in Behavioral Health measured via Ecological Momentary Assessment was assessed by directly asking participants about eating, drinking, chewing gum, and smoking behavior at the time the phone rang through 6 open-ended EMA questions. Responses were coded. The average weekly frequency of intake of junk food, caffeine, alcohol, nicotine, and other substances was tabulated. The minimum score was 0, and there was no maximum score. Higher scores indicate more risky behaviors and thus more risk. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition.
Time frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Trans-C | Composite Risk Score of Functioning in Five Health-relevant Domains: Behavioral Health | -0.28 Composite score |
| Psychoeducation | Composite Risk Score of Functioning in Five Health-relevant Domains: Behavioral Health | -0.30 Composite score |
p-value: 0.88intent-to-treat, multilevel modeling
Secondary
Composite Risk Score of Functioning in Five Health-relevant Domains: Cognitive Health
Composite Risk Score of Functioning in Cognitive Health measured via Ecological Momentary Assessment. Participants responded to 11 items that measured their concentration, distractedness, and focus related to their current activity. All items were rated on 5-point Likert scale, where higher scores respectively indicated higher levels of concentration, distractedness, and focus (min = 11, max = 55). The composite risk score was calculated by averaging participant responses over the assessment week. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition.
Time frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Trans-C | Composite Risk Score of Functioning in Five Health-relevant Domains: Cognitive Health | 0.12 Composite score |
| Psychoeducation | Composite Risk Score of Functioning in Five Health-relevant Domains: Cognitive Health | -0.20 Composite score |
p-value: 0.05intent-to-treat, multilevel modeling
Secondary
Composite Risk Score of Functioning in Five Health-relevant Domains: Emotional Health (Positivity Ratio)
Composite Risk Score of Functioning in Emotional Health, measured via Ecological Momentary Assessment (EMA), assesses subjective emotional well-being across 7-days, per timepoint using a 9-item short form of the Positive and Negative Affect Scale for Children (PANAS-C), which included 4 positive affect items (min = 4, max = 20; higher scores indicate more positive affect) and 5 negative affect items (min = 5, max = 25; higher scores indicate more negative affect), each rated on a 5-point Likert scale. A positivity ratio was calculated by dividing the sum of each affect item scores by the sum of negative affect score per survey day. Higher positivity ratios (range: 0.16-4) indicate higher subjective well-being and less risk. Change in average Positivity Ratio from baseline to post treatment (which is an average of 9 weeks after the beginning of treatment) reported. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition.
Time frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Trans-C | Composite Risk Score of Functioning in Five Health-relevant Domains: Emotional Health (Positivity Ratio) | -0.03 ratio |
| Psychoeducation | Composite Risk Score of Functioning in Five Health-relevant Domains: Emotional Health (Positivity Ratio) | -0.01 ratio |
p-value: 0.71intent-to-treat, multilevel modeling
Secondary
Composite Risk Score of Functioning in Five Health-relevant Domains: Physical Health
Composite Risk Score of Functioning in Physical Health derived from Ecological Momentary Assessment (EMA). For the physical health domain, responses to a single daily item (e.g., Were you physically active today?) were used to create a binary score: 1 = active, 2 = inactive. Daily responses were collected over 7 days and both summed (range: 7-14) and averaged for each participant. The final composite score reflects the average of these daily values (range: 1 - 2) , where lower scores indicate greater physical activity and lower physical health risk. Change in this composite score from baseline to post treatment (which is an average of 9 weeks after the beginning of treatment) is reported below. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition.
Time frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Trans-C | Composite Risk Score of Functioning in Five Health-relevant Domains: Physical Health | 0.11 units on a scale |
| Psychoeducation | Composite Risk Score of Functioning in Five Health-relevant Domains: Physical Health | 0.11 units on a scale |
p-value: 0.97intent-to-treat, multilevel modeling
Secondary
Composite Risk Score of Functioning in Five Health-relevant Domains: Social Health
Composite Risk Score of Functioning in Social health measured via Ecological Momentary Assessment was assessed by directly asking participants who the participant was with at the time the phone rang. Participants' responses were then manually coded for companion type on a scale of 0-4. Participants' positivity ratios, as calculated in the Emotional Health (Positivity Ratio) Composite Risk Score of Functioning, were then grouped based on occasions when participants were alone vs. with a family member vs. with a friend vs. other. Positivity ratios within groups were averaged (min = 0.16, max = 4), where higher averages indicated higher subjective well-being and lower risk. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition.
Time frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Trans-C | Composite Risk Score of Functioning in Five Health-relevant Domains: Social Health | Social health: Alone | 0.04 Composite score |
| Trans-C | Composite Risk Score of Functioning in Five Health-relevant Domains: Social Health | Social health: With a family member | -0.13 Composite score |
| Trans-C | Composite Risk Score of Functioning in Five Health-relevant Domains: Social Health | Social health: With a peer | 0.12 Composite score |
| Psychoeducation | Composite Risk Score of Functioning in Five Health-relevant Domains: Social Health | Social health: Alone | 0.03 Composite score |
| Psychoeducation | Composite Risk Score of Functioning in Five Health-relevant Domains: Social Health | Social health: With a family member | -0.04 Composite score |
| Psychoeducation | Composite Risk Score of Functioning in Five Health-relevant Domains: Social Health | Social health: With a peer | 0.06 Composite score |
Comparison: Composite Risk Score of Functioning in Social Domain measured via Ecological Momentary Assessment: Alonep-value: 0.88intent-to-treat, multilevel modeling
Comparison: Composite Risk Score of Functioning in Social Domain measured via Ecological Momentary Assessment: With a family memberp-value: 0.43intent-to-treat, multilevel modeling
Comparison: Composite Risk Score of Functioning in Social Domain measured via Ecological Momentary Assessment: With a peerp-value: 0.37intent-to-treat, multilevel modeling
Secondary
Dim Light Melatonin Onset
Melatonin levels were measured using 13 saliva samples collected at 30-minute intervals, beginning 5.5 hours before and ending 30 minutes after each participant's average bedtime (computed from 7 nights of sleep diary). For each timepoint (baseline and post-treatment), the dim light melatonin onset (DLMO) was estimated by identifying when melatonin levels crossed the 3.0 pg/ml threshold (i.e., the interpolated time). Change in the interpolated DLMO times from baseline to post treatment (which is an average of 9 weeks after the beginning of treatment) reported. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition.
Time frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Trans-C | Dim Light Melatonin Onset | -0.01 hours |
| Psychoeducation | Dim Light Melatonin Onset | 0.01 hours |
p-value: 0.04Intent-to-treat, multilevel modeling
Secondary
Discrepancy Between Weeknights and Weekends for Bedtime Via Daily Sleep Diary
The discrepancy between weeknights and weekends for Bedtime(BT) via Daily Sleep Diary. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition.
Time frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Trans-C | Discrepancy Between Weeknights and Weekends for Bedtime Via Daily Sleep Diary | 0.12 Minutes |
| Psychoeducation | Discrepancy Between Weeknights and Weekends for Bedtime Via Daily Sleep Diary | 0.07 Minutes |
p-value: 0.85Intent-to-treat, multilevel modeling
Secondary
Discrepancy Between Weeknights and Weekends for Total Sleep Time
The discrepancy between weeknights and weekends for Total Sleep Time(TST). The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition.
Time frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Trans-C | Discrepancy Between Weeknights and Weekends for Total Sleep Time | 39.43 Minutes |
| Psychoeducation | Discrepancy Between Weeknights and Weekends for Total Sleep Time | -8.67 Minutes |
p-value: 0.03Intent-to-treat, multilevel modeling
Secondary
Discrepancy Between Weeknights and Weekends for Wake Time Via Daily Sleep Diary
The discrepancy between weeknights and weekends for Wake time (WUP) via Daily Sleep Diary. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition.
Time frame: Change from baseline to post-treatment, which is an average of 9 weeks after the beginning of treatment.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Trans-C | Discrepancy Between Weeknights and Weekends for Wake Time Via Daily Sleep Diary | 0.78 Minutes |
| Psychoeducation | Discrepancy Between Weeknights and Weekends for Wake Time Via Daily Sleep Diary | 0.08 Minutes |
p-value: 0.02Intent-to-treat, multilevel modeling
Secondary
Pittsburgh Sleep Quality Index
Pittsburgh Sleep Quality Index (PSQI). Summary score is calculated by taking the sum of item-level scores. Summary score range 0-21. A higher score means increased severity of difficulty in all sleep area components. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition.
Time frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Trans-C | Pittsburgh Sleep Quality Index | -1.51 score on a scale |
| Psychoeducation | Pittsburgh Sleep Quality Index | -0.62 score on a scale |
p-value: 0.04Intent-to-treat, multilevel modeling
Secondary
Sleepiness Scale
Sleepiness subscale from School Sleep Habits Survey (SSHB). This subscale includes 10 items rated on a 4-point scale (0 - 3), assessing sleepiness. Total scores were calculated by summing all item responses. Possible scores range from 0 to 30, with higher scores indicating greater daytime sleepiness. The model provides estimates of the mean pre-post change in the PE condition and the TranS-C condition.
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Trans-C | Sleepiness Scale | -1.33 units on a scale |
| Psychoeducation | Sleepiness Scale | 0.26 units on a scale |
p-value: 0.02Intent-to-treat, multilevel modeling
Other Pre-specified
Actigraphy Measured Daytime Activity Count
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
Other Pre-specified
Actigraphy Measured Total Sleep Time
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
Other Pre-specified
Children's Affective Lability Scale
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
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
Other Pre-specified
Daily Sleep Diary
total sleep time (weekend nights), weekend night bedtime, weekend rise time, 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
Other Pre-specified
Dehydroepiandrosterone (DHEA) Hormone Levels
collected via saliva sample DNA by saliva sample to examine selected circadian and emotion single nucleotide polymorphism (SNP)
Time frame: Baseline only
Other Pre-specified
Diagnosis of Psychiatric Disorders
Measured via Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children (KSADS) Interview
Time frame: Baseline only
Other Pre-specified
Diagnosis of Sleep Disorders
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
Other Pre-specified
Dimensional Card Sorting Task
Time frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
Other Pre-specified
Emotional International Affective Pictures System (IAPS) Task
Time frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
Other Pre-specified
Emotion GoNoGo Task
Time frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
Other Pre-specified
Estradiol Hormone Levels
from females only
Time frame: Baseline only
Other Pre-specified
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
Other Pre-specified
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
Other Pre-specified
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
Other Pre-specified
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
Other Pre-specified
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
Other Pre-specified
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
Other Pre-specified
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
Other Pre-specified
Internet Behavior Checklist Questionnaire
Time frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
Other Pre-specified
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
Other Pre-specified
Parental Monitoring Questionnaire
Parent measure
Time frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
Other Pre-specified
Problems in School Questionnaire
Parent measure
Time frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
Other Pre-specified
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
Other Pre-specified
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
Other Pre-specified
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
Other Pre-specified
Sleep Inertia Questionnaire
Time frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
Other Pre-specified
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
Other Pre-specified
Testosterone Hormone Levels
collected via saliva sample
Time frame: Baseline only
Other Pre-specified
Therapy Process Measure
Credibility Expectancy Questionnaire
Time frame: Session 2 only
Other Pre-specified
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
Time frame: Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
Other Pre-specified
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
Other Pre-specified
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