Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Neural Correlates of Self-regulation on Academic Functioning

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03549377
Recruitment Status : Completed
First Posted : June 8, 2018
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
Alexander Vazsonyi, University of Kentucky

Tracking Information
First Submitted Date May 14, 2018
First Posted Date June 8, 2018
Last Update Posted Date September 17, 2019
Actual Study Start Date May 11, 2018
Actual Primary Completion Date August 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 24, 2018)
  • 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 [ Time Frame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study ]
    Rested versus sleep deprived group differences of functional magnetic resonance imaging reactivity of the whole brain while performing a Stop Signal Reaction Time Task
  • Rested versus sleep deprived group differences of fMRI BOLD responses for a Go-NoGo Continuous Performance Task (CPT) [ Time Frame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study ]
    Rested versus sleep deprived group differences of functional magnetic resonance imaging reactivity of the whole brain while performing a Go-NoGo Continuous Performance Task
  • Rested versus sleep deprived group differences of brain structural connectivity [ Time Frame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study ]
    Rested versus sleep deprived group differences of brain structural connectivity as measured by diffusion tensor imaging and analyzed using tract-based spatial statistics
  • Rested versus sleep deprived group differences of brain structure [ Time Frame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study ]
    Rested versus sleep deprived group differences of brain structure as determined by voxel based morphometry of structural magnetic resonance imaging data
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03549377 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: June 10, 2018)
  • Rested versus sleep deprived group differences in sleep time preferences [ Time Frame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study ]
    Morningness-eveningness Questionnaire
  • Rested versus sleep deprived group differences in hours of sleep [ Time Frame: 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 ]
    Sleep quantity
  • Rested versus sleep deprived group differences in low self-control [ Time Frame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study ]
    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.
  • Rested versus sleep deprived group differences in sensation seeking and impulsivity [ Time Frame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study ]
    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).
  • Rested versus sleep deprived group differences in internalizing behaviors [ Time Frame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study ]
    Weinberger Adjustment Inventory
  • Rested versus sleep deprived group differences in deviance/externalizing subscales [ Time Frame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study ]
    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.
  • Rested versus sleep deprived group differences in GPA/SAT/ACT Scores [ Time Frame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study ]
    Grade point average (GPA)/Scholastic Aptitude Test (SAT)/American College Test (ACT) Score
  • Academic Dishonesty Scale [ Time Frame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study ]
    Rested versus sleep deprived group differences in school attitudes
  • Rested versus sleep deprived group differences in academic concentration [ Time Frame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study ]
    Academic Concentration Measure
  • Rested versus sleep deprived group differences in academic aspirations and expectations [ Time Frame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study ]
    Academic Expectations and Aspirations
  • Rested versus sleep deprived group differences in school attitudes [ Time Frame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study ]
    School Attitudes Assessment Survey
  • Rested versus sleep deprived group differences in Flanker Inhibitory Control and Attention Test, Dimensional Change Card Sort Test, List Sorting Working Memory Test [ Time Frame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study ]
    NIH toolbox Cognition Battery
  • Rested versus sleep deprived group differences in Flanker Inhibitory Control and Attention Test, Dimensional Change Card Sort Test, Picture Sequence Memory Test, [ Time Frame: Up to 30 days following selection for inclusion based on prescreen, cross-sectional study ]
    NIH toolbox Cognition Battery
  • Rested versus sleep deprived group differences in commission errors in Balloon Analogue Risk Task (BART), , omission errors [ Time Frame: Up to 30 days following selection for inclusion based on prescreen, cross-sectional study ]
    Balloon Analogue Risk Task (BART)
  • Rested versus sleep deprived group differences in commission errors in a Go-NoGo CPT, omission errors [ Time Frame: Up to 30 days following selection for inclusion based on prescreen, cross-sectional study ]
    Go/NoGo continuous performance task (CPT)
Original Other Pre-specified Outcome Measures
 (submitted: May 24, 2018)
  • Rested versus sleep deprived group differences in sleep time preferences [ Time Frame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study ]
    Morningness-eveningness Questionnaire
  • Rested versus sleep deprived group differences in hours of sleep [ Time Frame: 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 ]
    Sleep quantity
  • Rested versus sleep deprived group differences in low self-control [ Time Frame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study ]
    Low Self-Control Scale (LSC)
  • Rested versus sleep deprived group differences in sensation seeking and impulsivity [ Time Frame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study ]
    Zuckerman Impulsivity and Sensation Seeking Scale
  • Rested versus sleep deprived group differences in internalizing behaviors [ Time Frame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study ]
    Weinberger Adjustment Inventory
  • Rested versus sleep deprived group differences in deviance/externalizing subscales [ Time Frame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study ]
    Normative Deviance Scale (NDS)
  • Rested versus sleep deprived group differences in GPA/SAT/ACT Scores [ Time Frame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study ]
    Grade point average (GPA)/Scholastic Aptitude Test (SAT)/American College Test (ACT) Score
  • Academic Dishonesty Scale [ Time Frame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study ]
    Rested versus sleep deprived group differences in school attitudes
  • Rested versus sleep deprived group differences in academic concentration [ Time Frame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study ]
    Academic Concentration Measure
  • Rested versus sleep deprived group differences in academic aspirations and expectations [ Time Frame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study ]
    Academic Expectations and Aspirations
  • Rested versus sleep deprived group differences in school attitudes [ Time Frame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study ]
    School Attitudes Assessment Survey
  • Rested versus sleep deprived group differences in Flanker Inhibitory Control and Attention Test, Dimensional Change Card Sort Test, List Sorting Working Memory Test [ Time Frame: Up to 45 days following selection for inclusion based on prescreen, cross-sectional study ]
    NIH toolbox Cognition Battery
  • Rested versus sleep deprived group differences in Flanker Inhibitory Control and Attention Test, Dimensional Change Card Sort Test, Picture Sequence Memory Test, [ Time Frame: Up to 30 days following selection for inclusion based on prescreen, cross-sectional study ]
    NIH toolbox Cognition Battery
  • Rested versus sleep deprived group differences in commission errors in Balloon Analogue Risk Task (BART), , omission errors [ Time Frame: Up to 30 days following selection for inclusion based on prescreen, cross-sectional study ]
    Balloon Analogue Risk Task (BART)
  • Rested versus sleep deprived group differences in commission errors in a Go-NoGo CPT, omission errors [ Time Frame: Up to 30 days following selection for inclusion based on prescreen, cross-sectional study ]
    Go/NoGo continuous performance task (CPT)
 
Descriptive Information
Brief Title 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
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.
Study Type Observational
Study Design Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Self-Control
Intervention Behavioral: Deception
Participants will be deceived during delayed gratification task.
Study Groups/Cohorts
  • Rested
    Based on Pittsburgh Sleep Quality Index, participants scoring in the top 10-20% will be assigned to the rested group and will experience deception as part of the delayed gratification task
    Intervention: Behavioral: Deception
  • Sleep-deprived
    Based on Pittsburgh Sleep Quality Index, participants scoring in the bottom 10-20% will be assigned to the sleep-deprived group and will experience deception as part of the delayed gratification task
    Intervention: Behavioral: Deception
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 16, 2019)
30
Original Estimated Enrollment
 (submitted: May 24, 2018)
48
Actual Study Completion Date August 31, 2019
Actual Primary Completion Date August 31, 2019   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 24 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03549377
Other Study ID Numbers 44065
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: No plan at this time
Responsible Party Alexander Vazsonyi, University of Kentucky
Study Sponsor Alexander Vazsonyi
Collaborators Not Provided
Investigators
Principal Investigator: Alexander T Vazsonyi, Ph.D. University of Kentucky
PRS Account University of Kentucky
Verification Date September 2019