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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03534375
Other study ID # IRB2017-914
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 14, 2018
Est. completion date August 31, 2019

Study information

Verified date October 2021
Source Texas Tech University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 8
Est. completion date August 31, 2019
Est. primary completion date April 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 12 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
The study is an observational cross sectional study
An intervention will not be performed

Locations

Country Name City State
United States Texas Tech University - Department of Human Development and Family Studies Lubbock Texas

Sponsors (1)

Lead Sponsor Collaborator
Texas Tech University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Female vs. male differences in commission errors in an SSRT Female vs. male differences in commission errors in a stop signal reaction time task performed in the magnetic resonance imaging scanner 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.
Other Female vs. male differences in omission errors in an SSRT Female vs. male differences in omission errors in a stop signal reaction time task performed in the magnetic resonance imaging scanner 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.
Other Female vs. male differences in omission errors in a Go-NoGo CPT Female vs. male differences omission errors in a Go-NoGo continuous performance task performed in the magnetic resonance imaging scanner 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.
Other Female vs. male differences in Picture Sequence Memory Test Female vs. male differences in Picture Sequence Memory Test of the NIH Toolbox Cognition Battery 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.
Other Female vs. male differences in List Sorting Working Memory Test Female vs. male differences in List Sorting Working Memory Test of the NIH Toolbox Cognition Battery 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.
Other Female vs. male differences in simple visual reaction time Female vs. male differences in a simple visual reaction time task programmed and presented in PsychoPy software environment on a laptop computer 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.
Primary Female vs. Male differences of fMRI BOLD responses for SSRT Stop Signals Female vs. male differences of functional magnetic resonance imaging reactivity of the whole brain while performing a Stop Signal Reaction Time Task 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.
Primary Female vs. Male differences of fMRI BOLD responses in a Go-NoGo CPT Female vs. male differences of functional magnetic resonance imaging reactivity of the whole brain while performing a Go-NoGo Continuous Performance Task 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.
Primary Female vs. Male differences of brain structural connectivity Female vs. male differences of brain structural connectivity as measured by diffusion tensor imaging and analyzed using tract-based spatial statistics 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.
Primary Female vs. Male differences of brain structure Female vs. male differences of brain structure as determined by voxel based morphometry of structural magnetic resonance imaging data 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.
Secondary Female vs. male differences in delay discounting Female vs. male differences in delay discounting as measures using a delay discounting task presented on a laptop computer 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.
Secondary Female vs. male differences in stop signal delay Female vs. male differences in stop signal delay of a stop signal reaction time task performed in the magnetic resonance imaging scanner 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.
Secondary Female vs. male differences in reaction times of correct Go responses 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 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.
Secondary Female vs. male differences in commission errors in a Go-NoGo CPT Female vs. male differences commission errors in a Go-NoGo continuous performance task performed in the magnetic resonance imaging scanner 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.
Secondary Female vs. male differences in Flanker Inhibitory Control and Attention Test Female vs. male differences in Flanker Inhibitory Control and Attention Test of the NIH Toolbox Cognition Battery 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.
Secondary Female vs. male differences in Dimensional Change Card Sort Test Female vs. male differences in Dimensional Change Card Sort Test of the NIH Toolbox Cognition Battery 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.
Secondary Female vs. male differences in Pattern Comparison Processing Speed Test Female vs. male differences in Pattern Comparison Processing Speed Test of the NIH Toolbox Cognition Battery 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.
Secondary Female vs. male differences in risk-proneness Female vs. male differences in risk-proneness as measured by Impulsive Sensation Seeking Scale adapted by Raffaelli and Crocket (2003) 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.
Secondary Female vs. male differences in sensation seeking Female vs. male differences in Brief Sensation Seeking Scale (BSSS) developed by Hoyle et al (2002) 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.
Secondary Female vs. male differences in gratification delay Female vs. male differences in abbreviated 10 item Delayed Gratification Inventory (DGI-10) by Romer, Duckworth, Sznitman, & Park (2010) 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.
Secondary Female vs. male differences in self-control 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) 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.
Secondary Female vs. male differences in self-efficacy Female vs. male differences in General Self-Efficacy Scale (GSE) developed by Schwarzer & Jerusalem (1995) 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.
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