- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07641244
Experimental Evidence of the Impact of Parental Income on Child Mental Health and Neuroimmune Function
Growing up in a lower-income family robustly predicts worse mental health in adolescence and early adulthood. How does variability in family income "get under the skin" of the developing child and via what mechanisms does it increase risk for mental illness? Moreover, could supplements to family income at critical developmental periods help to prevent later youth mental illness? To address these questions, we leverage an innovative existing double blind randomized controlled trial of 3-years of substantial income supplements to parents.
By experimentally studying the impacts of these income supplements on families and subsequent youth development, we can examine causal pathways from family income to risk for mental illness via family stress and neuroimmune mechanisms in ways never done before. Moreover, by measuring the longer-term impact of 3 years of income supplements to parents on their child's neuroimmune signaling and risk for mental illness, we can examine the policy implications for child development of unconditional cash transfers to parents and identify how and for whom these supplements help. We will test these basic and translational questions in a sample of 1,200 youth with lower-income parents randomly assigned to receive either a substantial monthly income supplement or a minimal monthly supplement for 3 years, starting when youth were between age 5 - 14 years old. We will follow up with youth and their parent 1 - 2 and 3 - 4 years after the intervention and examine whether income supplements predict better youth mental health during adolescence, as well as whether factors like child age and neighborhood quality modulate intervention effects. Additionally, we explore family stress mechanisms through which the intervention may impact child mental health. Finally, we will measure peripheral inflammation (inflammatory biomarkers and classical monocytes) and use MRI to assess threat, reward, and regulatory neural activity and connectivity among 500 of these youth. Our central hypothesis is that income supplements will decrease family and youth stress and improve parenting, which will improve neuroimmune signaling and decrease risk for psychopathology. Moreover, these effects will remain years after termination of the transfers and be strongest among families who received the intervention earlier in the child's life. This research will provide timely, relevant public health knowledge that will help policy makers understand the longer-term brain, immune, and mental health impacts of cash transfers to parents, while also advancing the science of the sociocontextual and neuroimmune pathways through which variability in family income impacts risk for psychopathology.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Trinh L Ha
- Número de teléfono: (847) 868-2409
- Correo electrónico: trinh.ha@northwestern.edu
Copia de seguridad de contactos de estudio
- Nombre: Cary R Nusslock, PhD
- Correo electrónico: nusslock@northwestern.edu
Ubicaciones de estudio
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Illinois
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Evanston, Illinois, Estados Unidos, 60208
- Reclutamiento
- Northwestern University
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Contacto:
- Cary R Nusslock
- Número de teléfono: (847) 868-2409
- Correo electrónico: edcyouth@u.northwestern.edu
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Child of a participant enrolled in the Every Dollar Counts intervention. Youth were between ages 5 and 14 at the start of the intervention (followed up when ages 10 to 18)
- Biological parent who lives with the child must be part of the original income study
- For the in-person neuroimaging subsample: family must live within a 2-hour drive of downtown Chicago
Exclusion Criteria:
- Youth not between ages 5 and 14 at the start of the intervention
- Parent not enrolled in the Every Dollar Counts program
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Monetary Incentive Delay fMRI task
fMRI task to engage cortical striatal neural circuity
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fMRI task to engage in cortical striatal neural circuitry during reward
Emotional n-back fMRI task to engage in socioemotional and working memory
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Experimental: Emotional N-back fMRI task
fMRI task to engage working memory and socioemotional processing neural circuitry
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fMRI task to engage in cortical striatal neural circuitry during reward
Emotional n-back fMRI task to engage in socioemotional and working memory
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Brain response to fMRI tasks
Periodo de tiempo: 5 years
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The monetary incentive delay and emotional n-back tasks will increase neural activity in reward and working memory and socioemotional processes within the brain.
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5 years
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- EXZVPWZBLUE8
- 1R01MH139198-01 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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