- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03534375
Gender Differences of Neuroanatomical and Neurophysiological Correlates of Risk-proneness in Early Adolescents
21 de octubre de 2021 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
De observación
Inscripción (Actual)
8
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Texas
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Lubbock, Texas, Estados Unidos, 79409
- Texas Tech University - Department of Human Development and Family Studies
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
10 años a 12 años (Niño)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
The study population will consist of healthy early adolescent (age 10-12 years) male and female subjects
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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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
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Female vs. Male differences of fMRI BOLD responses for SSRT Stop Signals
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Female vs. male differences in delay discounting
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
|
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Female vs. male differences in Dimensional Change Card Sort Test
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Female vs. male differences in commission errors in an SSRT
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Elizabeth Trejos-Castillo, PhD, Texas Tech University
- Director de estudio: Chanaka Kahathuduwa, Texas Tech University
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
14 de mayo de 2018
Finalización primaria (Actual)
30 de abril de 2019
Finalización del estudio (Actual)
31 de agosto de 2019
Fechas de registro del estudio
Enviado por primera vez
9 de mayo de 2018
Primero enviado que cumplió con los criterios de control de calidad
21 de mayo de 2018
Publicado por primera vez (Actual)
23 de mayo de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
25 de octubre de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
21 de octubre de 2021
Última verificación
1 de octubre de 2021
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- IRB2017-914
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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