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Completed

NCT Number: NCT03534375

Gender Differences of Neuroanatomical and Neurophysiological Correlates of Risk-proneness in Early Adolescents

Risk-taking in early adolescence have has been found to be normative and even formative as it might fulfill the youth's needs to experiment different sensations, make independent decisions and learn from their consequences. Several theoretical models have suggested that male and female adolescents differ in risk-taking as a product of individual/contextual factors and neocortical functioning; however, the neurophysiological and neuropsychological correlates of those differences continue to be underexplored. Informed by Evolutionary Neuroandrogenic Theory, the investigators examine the links between gender, risk-proneness, gratification delay, self-control, self-efficacy, executive functions and neurophysiological-neuroanatomical correlates in early adolescents (age 10-12 years). Participants (N=24; 50% females) will complete behavioral measurements on study constructs and perform neuropsychological tests using fMRI scanning (e.g., Go/NoGo continuous performance, stop-signal reaction time, NIH Cognition Battery, delay discounting). Female and male groups will be compared on all outcome measures.

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Key information

Age range

10 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Texas Tech University - Department of Human Development and Family Studies

Lubbock, Texas, 79409, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Early adolescents (age 10-12 years)
  • Male and female

Exclusion criteria

  • Gross impairment of vision or hearing that would prevent the participants from performing neuropsychological tasks
  • Inability to read and follow written instructions
  • WISC-V IQ score of < 80
  • Physical, neurological or concurrent psychiatric impairments that could affect cognitive and motor functions
  • Regular intake of medication that could alter visual, auditory, cognitive or motor functions
  • History of head injury that resulted in loss of consciousness / history of brain surgery
  • Current / past history of smoking and / or alcohol or drug abuse
  • Absolute contraindications to undergo MRI

Treatment and study plan

The study is an observational cross sectional study

Other

An intervention will not be performed

Primary outcomes

  1. Female vs. Male differences of fMRI BOLD responses for SSRT Stop Signals

    Time frame: Outcome will be measured on the first study visit (day 1) of each subject. This will also be the only time point of measurement. Outcomes of all recruited subjects within the specified study period will be considered when reporting the outcome measure.

    Female vs. male differences of functional magnetic resonance imaging reactivity of the whole brain while performing a Stop Signal Reaction Time Task

  2. Female vs. Male differences of fMRI BOLD responses in a Go-NoGo CPT

    Time frame: Outcome will be measured on the first study visit (day 1) of each subject. This will also be the only time point of measurement. Outcomes of all recruited subjects within the specified study period will be considered when reporting the outcome measure.

    Female vs. male differences of functional magnetic resonance imaging reactivity of the whole brain while performing a Go-NoGo Continuous Performance Task

  3. Female vs. Male differences of brain structural connectivity

    Time frame: Outcome will be measured on the first study visit (day 1) of each subject. This will also be the only time point of measurement. Outcomes of all recruited subjects within the specified study period will be considered when reporting the outcome measure.

    Female vs. male differences of brain structural connectivity as measured by diffusion tensor imaging and analyzed using tract-based spatial statistics

  4. Female vs. Male differences of brain structure

    Time frame: Outcome will be measured on the first study visit (day 1) of each subject. This will also be the only time point of measurement. Outcomes of all recruited subjects within the specified study period will be considered when reporting the outcome measure.

    Female vs. male differences of brain structure as determined by voxel based morphometry of structural magnetic resonance imaging data

Secondary outcomes

  1. Female vs. male differences in delay discounting

    Time frame: Outcome will be measured on the first study visit (day 1) of each subject. This will also be the only time point of measurement. Outcomes of all recruited subjects within the specified study period will be considered when reporting the outcome measure.

    Female vs. male differences in delay discounting as measures using a delay discounting task presented on a laptop computer

  2. Female vs. male differences in stop signal delay

    Time frame: Outcome will be measured on the first study visit (day 1) of each subject. This will also be the only time point of measurement. Outcomes of all recruited subjects within the specified study period will be considered when reporting the outcome measure.

    Female vs. male differences in stop signal delay of a stop signal reaction time task performed in the magnetic resonance imaging scanner

  3. Female vs. male differences in reaction times of correct Go responses

    Time frame: Outcome will be measured on the first study visit (day 1) of each subject. This will also be the only time point of measurement. Outcomes of all recruited subjects within the specified study period will be considered when reporting the outcome measure.

    Female vs. male differences in reaction times of correct Go responses performed in a Go-NoGo continuous performance task performed in the magnetic resonance imaging scanner

  4. Female vs. male differences in commission errors in a Go-NoGo CPT

    Time frame: Outcome will be measured on the first study visit (day 1) of each subject. This will also be the only time point of measurement. Outcomes of all recruited subjects within the specified study period will be considered when reporting the outcome measure.

    Female vs. male differences commission errors in a Go-NoGo continuous performance task performed in the magnetic resonance imaging scanner

  5. Female vs. male differences in Flanker Inhibitory Control and Attention Test

    Time frame: Outcome will be measured on the first study visit (day 1) of each subject. This will also be the only time point of measurement. Outcomes of all recruited subjects within the specified study period will be considered when reporting the outcome measure.

    Female vs. male differences in Flanker Inhibitory Control and Attention Test of the NIH Toolbox Cognition Battery

  6. Female vs. male differences in Dimensional Change Card Sort Test

    Time frame: Outcome will be measured on the first study visit (day 1) of each subject. This will also be the only time point of measurement. Outcomes of all recruited subjects within the specified study period will be considered when reporting the outcome measure.

    Female vs. male differences in Dimensional Change Card Sort Test of the NIH Toolbox Cognition Battery

  7. Female vs. male differences in Pattern Comparison Processing Speed Test

    Time frame: Outcome will be measured on the first study visit (day 1) of each subject. This will also be the only time point of measurement. Outcomes of all recruited subjects within the specified study period will be considered when reporting the outcome measure.

    Female vs. male differences in Pattern Comparison Processing Speed Test of the NIH Toolbox Cognition Battery

  8. Female vs. male differences in risk-proneness

    Time frame: Outcome will be measured on the first study visit (day 1) of each subject. This will also be the only time point of measurement. Outcomes of all recruited subjects within the specified study period will be considered when reporting the outcome measure.

    Female vs. male differences in risk-proneness as measured by Impulsive Sensation Seeking Scale adapted by Raffaelli and Crocket (2003)

  9. Female vs. male differences in sensation seeking

    Time frame: Outcome will be measured on the first study visit (day 1) of each subject. This will also be the only time point of measurement. Outcomes of all recruited subjects within the specified study period will be considered when reporting the outcome measure.

    Female vs. male differences in Brief Sensation Seeking Scale (BSSS) developed by Hoyle et al (2002)

  10. Female vs. male differences in gratification delay

    Time frame: Outcome will be measured on the first study visit (day 1) of each subject. This will also be the only time point of measurement. Outcomes of all recruited subjects within the specified study period will be considered when reporting the outcome measure.

    Female vs. male differences in abbreviated 10 item Delayed Gratification Inventory (DGI-10) by Romer, Duckworth, Sznitman, & Park (2010)

  11. Female vs. male differences in self-control

    Time frame: Outcome will be measured on the first study visit (day 1) of each subject. This will also be the only time point of measurement. Outcomes of all recruited subjects within the specified study period will be considered when reporting the outcome measure.

    Female vs. male differences in Perrone, Sullivan, Pratt, & Margaryan (2004) measure of self -control adapted from the Longitudinal Study of Adolescent and Adult Health (ADD Health)

  12. Female vs. male differences in self-efficacy

    Time frame: Outcome will be measured on the first study visit (day 1) of each subject. This will also be the only time point of measurement. Outcomes of all recruited subjects within the specified study period will be considered when reporting the outcome measure.

    Female vs. male differences in General Self-Efficacy Scale (GSE) developed by Schwarzer & Jerusalem (1995)

Other outcomes

  1. Female vs. male differences in commission errors in an SSRT

    Time frame: Outcome will be measured on the first study visit (day 1) of each subject. This will also be the only time point of measurement. Outcomes of all recruited subjects within the specified study period will be considered when reporting the outcome measure.

    Female vs. male differences in commission errors in a stop signal reaction time task performed in the magnetic resonance imaging scanner

  2. Female vs. male differences in omission errors in an SSRT

    Time frame: Outcome will be measured on the first study visit (day 1) of each subject. This will also be the only time point of measurement. Outcomes of all recruited subjects within the specified study period will be considered when reporting the outcome measure.

    Female vs. male differences in omission errors in a stop signal reaction time task performed in the magnetic resonance imaging scanner

  3. Female vs. male differences in omission errors in a Go-NoGo CPT

    Time frame: Outcome will be measured on the first study visit (day 1) of each subject. This will also be the only time point of measurement. Outcomes of all recruited subjects within the specified study period will be considered when reporting the outcome measure.

    Female vs. male differences omission errors in a Go-NoGo continuous performance task performed in the magnetic resonance imaging scanner

  4. Female vs. male differences in Picture Sequence Memory Test

    Time frame: Outcome will be measured on the first study visit (day 1) of each subject. This will also be the only time point of measurement. Outcomes of all recruited subjects within the specified study period will be considered when reporting the outcome measure.

    Female vs. male differences in Picture Sequence Memory Test of the NIH Toolbox Cognition Battery

  5. Female vs. male differences in List Sorting Working Memory Test

    Time frame: Outcome will be measured on the first study visit (day 1) of each subject. This will also be the only time point of measurement. Outcomes of all recruited subjects within the specified study period will be considered when reporting the outcome measure.

    Female vs. male differences in List Sorting Working Memory Test of the NIH Toolbox Cognition Battery

  6. Female vs. male differences in simple visual reaction time

    Time frame: Outcome will be measured on the first study visit (day 1) of each subject. This will also be the only time point of measurement. Outcomes of all recruited subjects within the specified study period will be considered when reporting the outcome measure.

    Female vs. male differences in a simple visual reaction time task programmed and presented in PsychoPy software environment on a laptop computer

Sponsors and collaborators

Lead sponsor

Texas Tech University

Other

Registry information

Official study title

Gender Differences in Risk-proneness, Gratification Delay, Self-control, Self-efficacy, Executive Functions and Their Neurophysiological and Neuroanatomical Correlates in Early Adolescents

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 23, 2018
Registry last updated
Oct 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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