Self-Control Clinical Trial
Official title:
Neural Correlates of the Associations Between Sleep Functioning, Self-regulation, Academic Functioning, and Problem Behaviors
NCT number | NCT03549377 |
Other study ID # | 44065 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 11, 2018 |
Est. completion date | August 31, 2019 |
Verified date | September 2019 |
Source | University of Kentucky |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The main objectives of the study include: 1. What are the differences in self-regulation and its neurophysiological and neuroanatomical correlates between college students with poor and excellent sleep functioning? 2. Does sleep functioning (assessed both by questionnaires and actigraphy), and self-control/self-regulation (questionnaire and imaging data) predict academic achievement and problem behaviors in college students?
Status | Completed |
Enrollment | 30 |
Est. completion date | August 31, 2019 |
Est. primary completion date | August 31, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 24 Years |
Eligibility |
Inclusion Criteria: Healthy college-age youth between the ages of 18 and 24 years Exclusion Criteria: - Gross impairment of vision or hearing - Inability to read and follow written instructions - Physical, neurological, or concurrent psychiatric impairments - Regular intake of psychotropic medication (such as methylphenidate used to treat Attention Deficit Hyperactivity Disorder (ADHD), antidepressants, or anti-anxiety medication) - A history of head injury that resulted in loss of consciousness/a history of brain surgery/or seizures - A current/past history of smoking and/or alcohol or drug abuse (i.e., five or more drinks in one sitting or 15 drinks or more during a week for men, and four drinks on one occasion or eight drinks over the course of a week for women; additionally, regular drug use, including marijuana) - Current pregnancy - Any metallic objects in your body (such as braces, pacemakers, surgical devices, piercings that cannot be removed etc.) Enrollment of the subjects will start in May 2018 and will be finished by the end of December 2018. |
Country | Name | City | State |
---|---|---|---|
United States | University of Kentucky | Lexington | Kentucky |
Lead Sponsor | Collaborator |
---|---|
Alexander Vazsonyi |
United States,
Gottfredson MR, Hirschi T. A general theory of crime. Stanford: Stanford University Press; 1990.
Owens JA, Dearth-Wesley T, Lewin D, Gioia G, Whitaker RC. Self-Regulation and Sleep Duration, Sleepiness, and Chronotype in Adolescents. Pediatrics. 2016 Dec;138(6). pii: e20161406. Epub 2016 Nov 3. — View Citation
Steinberg L, Albert D, Cauffman E, Banich M, Graham S, Woolard J. Age differences in sensation seeking and impulsivity as indexed by behavior and self-report: evidence for a dual systems model. Dev Psychol. 2008 Nov;44(6):1764-78. doi: 10.1037/a0012955. — View Citation
Wheaton AG, Jones SE, Cooper AC, Croft JB. Short Sleep Duration Among Middle School and High School Students - United States, 2015. MMWR Morb Mortal Wkly Rep. 2018 Jan 26;67(3):85-90. doi: 10.15585/mmwr.mm6703a1. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Rested versus sleep deprived group differences in sleep time preferences | Morningness-eveningness Questionnaire | Up to 45 days following selection for inclusion based on prescreen, cross-sectional study | |
Other | Rested versus sleep deprived group differences in hours of sleep | Sleep quantity | Up to 45 days following selection for inclusion based on prescreen, cross-sectional studyUp to 45 days following selection for inclusion based on prescreen, cross-sectional study | |
Other | Rested versus sleep deprived group differences in low self-control | Low Self-Control Scale (LSC) Low self-control scale (24 items) measures low self-control. The total score ranges from 1 to 5. Five subscales called impulsivity, simple tasks, risk seeking, physical activities, self-centered, and temper, each provide subscale score ranging from 1 to 5. Higher values indicate higher lower self-control, in other words, worse outcomes. A total score is developed by averaging all 24 items across all subscales. Subscale scores also represent the averaged responses to their corresponding items. |
Up to 45 days following selection for inclusion based on prescreen, cross-sectional study | |
Other | Rested versus sleep deprived group differences in sensation seeking and impulsivity | Zuckerman Impulsivity and Sensation Seeking Scale Impulsivity and Sensation Seeking Scale (19 items) measures impulsivity and sensation seeking. Total score ranges from 0 to 19. Impulsivity (i.e., one of the two subscales) score ranges from 0 to 8 (8 items), whereas Sensation Seeking score ranges from 0 to 11 (11 items). For total as well as for each subscale scores, higher values indicate more impulsivity and sensation seeking, respectively. Total and subscale scores are computed by summing the responses (19, 11, and 8 items respectively). |
Up to 45 days following selection for inclusion based on prescreen, cross-sectional study | |
Other | Rested versus sleep deprived group differences in internalizing behaviors | Weinberger Adjustment Inventory | Up to 45 days following selection for inclusion based on prescreen, cross-sectional study | |
Other | Rested versus sleep deprived group differences in deviance/externalizing subscales | Normative Deviance Scale, Short Form Normative Deviance Scale-Short Form (21 items); the scale measures involvement in deviant and norm-violating behaviors. Total scores range from 1 to 5. Seven subscale scores (i.e., vandalism, alcohol use, drug use, school misconduct, general deviance, theft, assault) each range from 1 to 5, 3 items each. Higher scores indicate greater deviance (more frequent involvement), in other word, worse outcome. A total score, as well as subscale scores, are computed by averaging responses of the corresponding items. |
Up to 45 days following selection for inclusion based on prescreen, cross-sectional study | |
Other | Rested versus sleep deprived group differences in GPA/SAT/ACT Scores | Grade point average (GPA)/Scholastic Aptitude Test (SAT)/American College Test (ACT) Score | Up to 45 days following selection for inclusion based on prescreen, cross-sectional study | |
Other | Academic Dishonesty Scale | Rested versus sleep deprived group differences in school attitudes | Up to 45 days following selection for inclusion based on prescreen, cross-sectional study | |
Other | Rested versus sleep deprived group differences in academic concentration | Academic Concentration Measure | Up to 45 days following selection for inclusion based on prescreen, cross-sectional study | |
Other | Rested versus sleep deprived group differences in academic aspirations and expectations | Academic Expectations and Aspirations | Up to 45 days following selection for inclusion based on prescreen, cross-sectional study | |
Other | Rested versus sleep deprived group differences in school attitudes | School Attitudes Assessment Survey | Up to 45 days following selection for inclusion based on prescreen, cross-sectional study | |
Other | Rested versus sleep deprived group differences in Flanker Inhibitory Control and Attention Test, Dimensional Change Card Sort Test, List Sorting Working Memory Test | NIH toolbox Cognition Battery | Up to 45 days following selection for inclusion based on prescreen, cross-sectional study | |
Other | Rested versus sleep deprived group differences in Flanker Inhibitory Control and Attention Test, Dimensional Change Card Sort Test, Picture Sequence Memory Test, | NIH toolbox Cognition Battery | Up to 30 days following selection for inclusion based on prescreen, cross-sectional study | |
Other | Rested versus sleep deprived group differences in commission errors in Balloon Analogue Risk Task (BART), , omission errors | Balloon Analogue Risk Task (BART) | Up to 30 days following selection for inclusion based on prescreen, cross-sectional study | |
Other | Rested versus sleep deprived group differences in commission errors in a Go-NoGo CPT, omission errors | Go/NoGo continuous performance task (CPT) | Up to 30 days following selection for inclusion based on prescreen, cross-sectional study | |
Primary | Rested versus sleep deprived group differences of Functional magnetic resonance imaging (fMRI) Blood oxygenation level dependent (BOLD) responses for Stop Signal Reaction Time Task (SSRT) Stop Signals | Rested versus sleep deprived group differences of functional magnetic resonance imaging reactivity of the whole brain while performing a Stop Signal Reaction Time Task | Up to 45 days following selection for inclusion based on prescreen, cross-sectional study | |
Primary | Rested versus sleep deprived group differences of fMRI BOLD responses for a Go-NoGo Continuous Performance Task (CPT) | Rested versus sleep deprived group differences of functional magnetic resonance imaging reactivity of the whole brain while performing a Go-NoGo Continuous Performance Task | Up to 45 days following selection for inclusion based on prescreen, cross-sectional study | |
Primary | Rested versus sleep deprived group differences of brain structural connectivity | Rested versus sleep deprived group differences of brain structural connectivity as measured by diffusion tensor imaging and analyzed using tract-based spatial statistics | Up to 45 days following selection for inclusion based on prescreen, cross-sectional study | |
Primary | Rested versus sleep deprived group differences of brain structure | Rested versus sleep deprived group differences of brain structure as determined by voxel based morphometry of structural magnetic resonance imaging data | Up to 45 days following selection for inclusion based on prescreen, cross-sectional study |
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