NCT03534375

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

May 14, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 23, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

October 25, 2021

Status Verified

October 1, 2021

Enrollment Period

12 months

First QC Date

May 9, 2018

Last Update Submit

October 21, 2021

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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.

  • 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.

  • 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.

  • 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 Outcomes (12)

  • Female vs. male differences in delay discounting

    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

    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

    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

    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

    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.

  • +7 more secondary outcomes

Other Outcomes (6)

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

    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 an SSRT

    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 Go-NoGo CPT

    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.

  • +3 more other outcomes

Study Arms (2)

Female Early Adolescents

Other: The study is an observational cross sectional study

Male Early Adolescents

Other: The study is an observational cross sectional study

Interventions

An intervention will not be performed

Female Early AdolescentsMale Early Adolescents

Eligibility Criteria

Age10 Years - 12 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsYes, participant eligibility is based on self-representation of gender identity.
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of healthy early adolescent (age 10-12 years) male and female subjects

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Tech University - Department of Human Development and Family Studies

Lubbock, Texas, 79409, United States

Location

MeSH Terms

Conditions

CoitusAdolescent Behavior

Condition Hierarchy (Ancestors)

Sexual BehaviorBehavior

Study Officials

  • Elizabeth Trejos-Castillo, PhD

    Texas Tech University

    PRINCIPAL INVESTIGATOR
  • Chanaka Kahathuduwa

    Texas Tech University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2018

First Posted

May 23, 2018

Study Start

May 14, 2018

Primary Completion

April 30, 2019

Study Completion

August 31, 2019

Last Updated

October 25, 2021

Record last verified: 2021-10

Locations