- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT03534375
Gender Differences of Neuroanatomical and Neurophysiological Correlates of Risk-proneness in Early Adolescents
21. října 2021 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Typ studie
Pozorovací
Zápis (Aktuální)
8
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Texas
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Lubbock, Texas, Spojené státy, 79409
- Texas Tech University - Department of Human Development and Family Studies
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
10 let až 12 let (Dítě)
Přijímá zdravé dobrovolníky
Ano
Pohlaví způsobilá ke studiu
Všechno
Metoda odběru vzorků
Vzorek nepravděpodobnosti
Studijní populace
The study population will consist of healthy early adolescent (age 10-12 years) male and female subjects
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
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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
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Female vs. Male differences of fMRI BOLD responses for SSRT Stop Signals
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Female vs. male differences in delay discounting
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
|
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
Časové okno: 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)
|
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
Časové okno: 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)
|
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
Časové okno: 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)
|
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
Časové okno: 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)
|
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.
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Female vs. male differences in commission errors in an SSRT
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
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
Časové okno: 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
Časové okno: 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.
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Elizabeth Trejos-Castillo, PhD, Texas Tech University
- Ředitel studie: Chanaka Kahathuduwa, Texas Tech University
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
14. května 2018
Primární dokončení (Aktuální)
30. dubna 2019
Dokončení studie (Aktuální)
31. srpna 2019
Termíny zápisu do studia
První předloženo
9. května 2018
První předloženo, které splnilo kritéria kontroly kvality
21. května 2018
První zveřejněno (Aktuální)
23. května 2018
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
25. října 2021
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
21. října 2021
Naposledy ověřeno
1. října 2021
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- IRB2017-914
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