- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03534375
Gender Differences of Neuroanatomical and Neurophysiological Correlates of Risk-proneness in Early Adolescents
21 ottobre 2021 aggiornato da: Texas Tech University
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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Osservativo
Iscrizione (Effettivo)
8
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Texas
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Lubbock, Texas, Stati Uniti, 79409
- Texas Tech University - Department of Human Development and Family Studies
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 10 anni a 12 anni (Bambino)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
The study population will consist of healthy early adolescent (age 10-12 years) male and female subjects
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
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Female Early Adolescents
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An intervention will not be performed
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Male Early Adolescents
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An intervention will not be performed
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Female vs. Male differences of fMRI BOLD responses for SSRT Stop Signals
Lasso di tempo: 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
|
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
Lasso di tempo: 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
|
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
Lasso di tempo: 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
|
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
Lasso di tempo: 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
|
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.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Female vs. male differences in delay discounting
Lasso di tempo: 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 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.
|
Female vs. male differences in stop signal delay
Lasso di tempo: 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 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.
|
Female vs. male differences in reaction times of correct Go responses
Lasso di tempo: 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 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.
|
Female vs. male differences in commission errors in a Go-NoGo CPT
Lasso di tempo: 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 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.
|
Female vs. male differences in Flanker Inhibitory Control and Attention Test
Lasso di tempo: 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 of the NIH Toolbox Cognition Battery
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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
Lasso di tempo: 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 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.
|
Female vs. male differences in Pattern Comparison Processing Speed Test
Lasso di tempo: 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 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.
|
Female vs. male differences in risk-proneness
Lasso di tempo: 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 as measured by Impulsive Sensation Seeking Scale adapted by Raffaelli and Crocket (2003)
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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
Lasso di tempo: 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 Brief Sensation Seeking Scale (BSSS) developed by Hoyle et al (2002)
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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
Lasso di tempo: 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 abbreviated 10 item Delayed Gratification Inventory (DGI-10) by Romer, Duckworth, Sznitman, & Park (2010)
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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
Lasso di tempo: 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 Perrone, Sullivan, Pratt, & Margaryan (2004) measure of self -control adapted from the Longitudinal Study of Adolescent and Adult Health (ADD Health)
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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
Lasso di tempo: 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 General Self-Efficacy Scale (GSE) developed by Schwarzer & Jerusalem (1995)
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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.
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Female vs. male differences in commission errors in an SSRT
Lasso di tempo: 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 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.
|
Female vs. male differences in omission errors in an SSRT
Lasso di tempo: 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 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.
|
Female vs. male differences in omission errors in a Go-NoGo CPT
Lasso di tempo: 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 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.
|
Female vs. male differences in Picture Sequence Memory Test
Lasso di tempo: 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 Picture Sequence Memory Test of the NIH Toolbox Cognition Battery
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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 List Sorting Working Memory Test
Lasso di tempo: 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 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.
|
Female vs. male differences in simple visual reaction time
Lasso di tempo: 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 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.
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Elizabeth Trejos-Castillo, PhD, Texas Tech University
- Direttore dello studio: Chanaka Kahathuduwa, Texas Tech University
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
14 maggio 2018
Completamento primario (Effettivo)
30 aprile 2019
Completamento dello studio (Effettivo)
31 agosto 2019
Date di iscrizione allo studio
Primo inviato
9 maggio 2018
Primo inviato che soddisfa i criteri di controllo qualità
21 maggio 2018
Primo Inserito (Effettivo)
23 maggio 2018
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
25 ottobre 2021
Ultimo aggiornamento inviato che soddisfa i criteri QC
21 ottobre 2021
Ultimo verificato
1 ottobre 2021
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- IRB2017-914
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
INDECISO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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