Clinical trial NCT03534375: Gender Differences of Neuroanatomical and Neurophysiological Correlates of Risk-proneness in Early Adolescents
Official title: Gender Differences in Risk-proneness, Gratification Delay, Self-control, Self-efficacy, Executive Functions and Their Neurophysiological and Neuroanatomical Correlates in Early Adolescents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gender
Early Adolescent Behavior
Lead sponsor: Texas Tech University
Sponsor class: OTHER
First posted: 2018-05-23
Enrollment: 8
Sex: ALL
Minimum age (years): 10
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of healthy early adolescent (age 10-12 years) male and female subjects

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Female vs. Male differences of fMRI BOLD responses for SSRT Stop Signals
timeFrame: 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.
measure: Female vs. Male differences of fMRI BOLD responses in a Go-NoGo CPT
timeFrame: 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.
measure: Female vs. Male differences of brain structural connectivity
timeFrame: 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.
measure: Female vs. Male differences of brain structure
timeFrame: 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 outcomes:
measure: Female vs. male differences in delay discounting
timeFrame: 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.
measure: Female vs. male differences in stop signal delay
timeFrame: 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.
measure: Female vs. male differences in reaction times of correct Go responses
timeFrame: 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.
measure: Female vs. male differences in commission errors in a Go-NoGo CPT
timeFrame: 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.
measure: Female vs. male differences in Flanker Inhibitory Control and Attention Test
timeFrame: 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.
measure: Female vs. male differences in Dimensional Change Card Sort Test
timeFrame: 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.
measure: Female vs. male differences in Pattern Comparison Processing Speed Test
timeFrame: 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.
measure: Female vs. male differences in risk-proneness
timeFrame: 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.
measure: Female vs. male differences in sensation seeking
timeFrame: 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.
measure: Female vs. male differences in gratification delay
timeFrame: 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.
measure: Female vs. male differences in self-control
timeFrame: 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.
measure: Female vs. male differences in self-efficacy
timeFrame: 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 outcomes:
measure: Female vs. male differences in commission errors in an SSRT
timeFrame: 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.
measure: Female vs. male differences in omission errors in an SSRT
timeFrame: 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.
measure: Female vs. male differences in omission errors in a Go-NoGo CPT
timeFrame: 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.
measure: Female vs. male differences in Picture Sequence Memory Test
timeFrame: 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.
measure: Female vs. male differences in List Sorting Working Memory Test
timeFrame: 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.
measure: Female vs. male differences in simple visual reaction time
timeFrame: 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.
Locations:
city: Lubbock
country: United States
facility: Texas Tech University - Department of Human Development and Family Studies
state: Texas
Study officials:
affiliation: Texas Tech University
name: Elizabeth Trejos-Castillo, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Texas Tech University
name: Chanaka Kahathuduwa
role: STUDY_DIRECTOR
References: