MedDataX Logo

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

NCT ID: NCT03534375

Last Updated: 2021-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-14

Study Completion Date

2019-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gender Early Adolescent Behavior

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Female Early Adolescents

The study is an observational cross sectional study

Intervention Type OTHER

An intervention will not be performed

Male Early Adolescents

The study is an observational cross sectional study

Intervention Type OTHER

An intervention will not be performed

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

The study is an observational cross sectional study

An intervention will not be performed

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

10 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Texas Tech University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Elizabeth Trejos-Castillo, PhD

Role: PRINCIPAL_INVESTIGATOR

Texas Tech University

Chanaka Kahathuduwa

Role: STUDY_DIRECTOR

Texas Tech University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Texas Tech University - Department of Human Development and Family Studies

Lubbock, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB2017-914

Identifier Type: -

Identifier Source: org_study_id