Clinical trial NCT03549377: Neural Correlates of Self-regulation on Academic Functioning
Official title: Neural Correlates of the Associations Between Sleep Functioning, Self-regulation, Academic Functioning, and Problem Behaviors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Self-Control
Keywords: Sleep
Academic functioning
Problem behaviors
College age youth
Self-regulation
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2018-06-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study sample will consist of 24 healthy college students (12 males and 12 females) between ages 18 - 24 years.

Brief summary: 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?

Detailed description: Based on the Self-Control Theory, individual differences in characteristics such as impulsivity, risk-seeking, and self-regulation consistently predict health-compromising and problem behaviors as well as academic functioning and success in adolescents and young adults.\[1\] Although suboptimal self-regulation is normative in adolescence and young adulthood, \[2\] it might result in negative consequences for adolescents' and young adults' health and well-being, including substance use, school/college dropout, or troubles with law. A recent line of research suggested that self-regulation problems are associated with insufficient and poor sleep.\[3\] As adolescents and young adults frequently report poor sleep functioning,\[4\] their self-regulation abilities might be further compromised by unfavorable sleep functioning with consequences for youths' problem behaviors and academic success. To mitigate this problem, some efforts have followed to ensure that adolescents get enough quality sleep (e.g., delayed school start times). However, the associations between sleep functioning, self-regulation, academic functioning, and problem behaviors were established predominantly using questionnaire data. Neurophysiological correlates of these associations have not been extensively studied. In the proposed study, this gap in scholarship will be addressed by linking sleep functioning to self-regulation indicated by neuropsychological and neuroanatomical data, and predicting academic achievement and problem behaviors with sleep and self-regulation. This explorative, pilot study is a first step in efforts to understand the issue; it will be carried out with a college student sample (N = 48, 50% female) which will also have implications for future research focused on adolescents (middle and high school students). Pilot data will inform the development of a larger study that will include adolescents (middle and high school students) and will support grant applications. Results will have a potential for prevention /intervention programs and policy targeting youth, such as school start times setting. This study will be carried out as a collaboration between the Department of Family Sciences at the University of Kentucky and the Department of Human Development and Family Studies at the Texas Tech University. Data will be collected following the same procedures described in this application both at the University of Kentucky and Texas Tech campuses. Research team at the Texas Tech University has submitted their own Institutional Review Board (IRB) application that is now being reviewed.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
measure: Rested versus sleep deprived group differences of fMRI BOLD responses for a Go-NoGo Continuous Performance Task (CPT)
timeFrame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
measure: Rested versus sleep deprived group differences of brain structural connectivity
timeFrame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
measure: Rested versus sleep deprived group differences of brain structure
timeFrame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
Secondary outcomes:
Other outcomes:
measure: Rested versus sleep deprived group differences in sleep time preferences
timeFrame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
measure: Rested versus sleep deprived group differences in hours of sleep
timeFrame: 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
measure: Rested versus sleep deprived group differences in low self-control
timeFrame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
measure: Rested versus sleep deprived group differences in sensation seeking and impulsivity
timeFrame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
measure: Rested versus sleep deprived group differences in internalizing behaviors
timeFrame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
measure: Rested versus sleep deprived group differences in deviance/externalizing subscales
timeFrame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
measure: Rested versus sleep deprived group differences in GPA/SAT/ACT Scores
timeFrame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
measure: Academic Dishonesty Scale
timeFrame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
measure: Rested versus sleep deprived group differences in academic concentration
timeFrame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
measure: Rested versus sleep deprived group differences in academic aspirations and expectations
timeFrame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
measure: Rested versus sleep deprived group differences in school attitudes
timeFrame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
measure: Rested versus sleep deprived group differences in Flanker Inhibitory Control and Attention Test, Dimensional Change Card Sort Test, List Sorting Working Memory Test
timeFrame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study
measure: Rested versus sleep deprived group differences in Flanker Inhibitory Control and Attention Test, Dimensional Change Card Sort Test, Picture Sequence Memory Test,
timeFrame: Up to 30 days following selection for inclusion based on prescreen, cross-sectional study
measure: Rested versus sleep deprived group differences in commission errors in Balloon Analogue Risk Task (BART), , omission errors
timeFrame: Up to 30 days following selection for inclusion based on prescreen, cross-sectional study
measure: Rested versus sleep deprived group differences in commission errors in a Go-NoGo CPT, omission errors
timeFrame: Up to 30 days following selection for inclusion based on prescreen, cross-sectional study
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Alexander T Vazsonyi, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gottfredson MR, Hirschi T. A general theory of crime. Stanford: Stanford University Press; 1990.
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.
citation: 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):e20161406. doi: 10.1542/peds.2016-1406. Epub 2016 Nov 3.
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.