NCT01828320|CompletedResultsDMC
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Sponsor study identifier
interventional
176
1 country
1
Study Start
March 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2017
Actual (reported)Study Completion
December 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2013
Date type not reportedThis date has not been verified as actual or estimated.
April 2, 2013
Actual (reported)April 10, 2013
Actual (reported)December 2017
Actual (reported)December 2018
Actual (reported)September 2, 2025
Actual (reported)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.
Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.
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.
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
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.
Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.
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.
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.
Diagnosis of Psychiatric Disorders
Baseline only
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
Actigraphy Measured Total Sleep Time
Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment
Integrates evidence-based treatments derived from basic research on the circadian system
Psychoeducation on the inter-associations between sleep, diet, exercise and stress.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of California, Berkeley
Berkeley, California, 94720, United States
Dong L, Dolsen MR, Martinez AJ, Notsu H, Harvey AG. A transdiagnostic sleep and circadian intervention for adolescents: six-month follow-up of a randomized controlled trial. J Child Psychol Psychiatry. 2020 Jun;61(6):653-661. doi: 10.1111/jcpp.13154. Epub 2019 Nov 26.
Gumport NB, Dolsen EA, Harvey AG. Usefulness and utilization of treatment elements from the Transdiagnostic Sleep and Circadian Intervention for adolescents with an evening circadian preference. Behav Res Ther. 2019 Dec;123:103504. doi: 10.1016/j.brat.2019.103504. Epub 2019 Nov 1.
Allison G Harvey, PhD
University of California, Berkeley
176 participants (actual enrollment reported by the registry).
First Submitted
April 2, 2013
First Posted
April 10, 2013
Study Start
March 2013
Date type not reportedThis date has not been verified as actual or estimated.
Psychoeducation to Sick-listed Individuals With Mental Health Problems
Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.
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.
Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.
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.
Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.
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.
Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.
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.
Change from baseline to post treatment, which is an average of 9 weeks after the beginning of treatment.
Contact the study team to confirm eligibility.
Dong L, Gumport NB, Martinez AJ, Harvey AG. Is improving sleep and circadian problems in adolescence a pathway to improved health? A mediation analysis. J Consult Clin Psychol. 2019 Sep;87(9):757-771. doi: 10.1037/ccp0000423. Epub 2019 Jun 27.
Harvey AG, Hein K, Dolsen EA, Dong L, Rabe-Hesketh S, Gumport NB, Kanady J, Wyatt JK, Hinshaw SP, Silk JS, Smith RL, Thompson MA, Zannone N, Blum DJ. Modifying the Impact of Eveningness Chronotype ("Night-Owls") in Youth: A Randomized Controlled Trial. J Am Acad Child Adolesc Psychiatry. 2018 Oct;57(10):742-754. doi: 10.1016/j.jaac.2018.04.020. Epub 2018 Aug 15.
Primary Completion
December 2017
Actual (reported)Study Completion
December 2018
Actual (reported)Last Updated
September 2, 2025
Results First Posted
September 2, 2025
Record last verified: 2025-08
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Source: ClinicalTrials.gov.
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