- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Trinh L Ha
- Numéro de téléphone: (847) 868-2409
- E-mail: trinh.ha@northwestern.edu
Sauvegarde des contacts de l'étude
- Nom: Cary R Nusslock, PhD
- E-mail: nusslock@northwestern.edu
Lieux d'étude
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Illinois
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Evanston, Illinois, États-Unis, 60208
- Recrutement
- Northwestern University
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Contact:
- Cary R Nusslock
- Numéro de téléphone: (847) 868-2409
- E-mail: edcyouth@u.northwestern.edu
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
Accepte les volontaires sains
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Non randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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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Expérimental: 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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Brain response to fMRI tasks
Délai: 5 years
|
The monetary incentive delay and emotional n-back tasks will increase neural activity in reward and working memory and socioemotional processes within the brain.
|
5 years
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- EXZVPWZBLUE8
- 1R01MH139198-01 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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