GenderNCT03534375
Gender Differences of Neuroanatomical and Neurophysiological Correlates of Risk-proneness in Early Adolescents
An observational study of Gender and Early Adolescent Behavior, run by Texas Tech University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 10 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Gender, Early Adolescent Behavior
- What is being tested?
- The study is an observational cross sectional study
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2018to 31 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study population will consist of healthy early adolescent (age 10-12 years) male and female subjects
Who may be able to join
- Early adolescents (age 10-12 years)
- Male and female
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Texas Tech University - Department of Human Development and Family Studies
Lubbock, Texas, 79409
About this study
Official title: Gender Differences in Risk-proneness, Gratification Delay, Self-control, Self-efficacy, Executive Functions and Their Neurophysiological and Neuroanatomical Correlates 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.
- Conditions
- Gender, Early Adolescent Behavior
- Being tested
- The study is an observational cross sectional study
- Medical subject headings
- Coitus, Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The study is an observational cross sectional studyOther
An intervention will not be performed
| Study group | Role | What they receive |
|---|---|---|
| Female Early Adolescents | Not described Receives: Other: The study is an observational cross sectional study | |
| Male Early Adolescents | Not described Receives: Other: The study is an observational cross sectional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 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
Measured: 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
Female vs. male differences of brain structural connectivity as measured by diffusion tensor imaging and analyzed using tract-based spatial statistics
Measured: 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
Female vs. male differences of brain structure as determined by voxel based morphometry of structural magnetic resonance imaging data
Measured: 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 (12)
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
Measured: 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
Female vs. male differences in stop signal delay of a stop signal reaction time task performed in the magnetic resonance imaging scanner
Measured: 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
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
Measured: 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 Go-NoGo CPT
Female vs. male differences commission errors in a Go-NoGo continuous performance task performed in the magnetic resonance imaging scanner
Measured: 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
Female vs. male differences in Flanker Inhibitory Control and Attention Test of the NIH Toolbox Cognition Battery
Measured: 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
Female vs. male differences in Dimensional Change Card Sort Test of the NIH Toolbox Cognition Battery
Measured: 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
Female vs. male differences in Pattern Comparison Processing Speed Test of the NIH Toolbox Cognition Battery
Measured: 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
Female vs. male differences in risk-proneness as measured by Impulsive Sensation Seeking Scale adapted by Raffaelli and Crocket (2003)
Measured: 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 sensation seeking
Female vs. male differences in Brief Sensation Seeking Scale (BSSS) developed by Hoyle et al (2002)
Measured: 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 gratification delay
Female vs. male differences in abbreviated 10 item Delayed Gratification Inventory (DGI-10) by Romer, Duckworth, Sznitman, \& Park (2010)
Measured: 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 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)
Measured: 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 self-efficacy
Female vs. male differences in General Self-Efficacy Scale (GSE) developed by Schwarzer \& Jerusalem (1995)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start14 May 2018
- Primary completion30 Apr 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GenderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth Trejos-Castillo, PhD, Principal investigator, Texas Tech UniversityChanaka Kahathuduwa, Study director, Texas Tech University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03534375
- Sponsor's protocol ID
- IRB2017-914
- Status last verified
- Oct 2021
- First submitted
- 9 May 2018
- Last updated
- 25 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gender Differences in Risk-proneness, Gratification Delay, Self-control, Self-efficacy, Executive Functions and Their Neurophysiological and Neuroanatomical Correlates in Early Adolescents
- ClinicalTrials.gov ID
- NCT03534375
- Acronym / sponsor ID
- IRB2017-914
- Conditions
- Gender, Early Adolescent Behavior
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Texas Tech UniversityUniversity, hospital or other
- Study start
- 14 May 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 23 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Female Early Adolescents | – | Other: The study is an observational cross sectional study |
| Male Early Adolescents | – | Other: The study is an observational cross sectional study |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study population will consist of healthy early adolescent (age 10-12 years) male and female subjects
Key inclusion criteria (2 listed)
- Early adolescents (age 10-12 years)
- Male and female
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The study is an observational cross sectional studyAn intervention will not be performed | Other | Female Early Adolescents, Male Early Adolescents |
Primary outcome
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
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
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
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
12 secondary outcomes
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 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 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 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 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 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 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 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 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 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 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 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Trejos-Castillo, PhD principal investigator
Texas Tech University
Chanaka Kahathuduwa study director
Texas Tech University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gender and Early Adolescent Behavior, run by Texas Tech University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2021.