- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Trinh L Ha
- Phone Number: (847) 868-2409
- Email: trinh.ha@northwestern.edu
Study Contact Backup
- Name: Cary R Nusslock, PhD
- Email: nusslock@northwestern.edu
Study Locations
-
-
Illinois
-
Evanston, Illinois, United States, 60208
- Recruiting
- Northwestern University
-
Contact:
- Cary R Nusslock
- Phone Number: (847) 868-2409
- Email: edcyouth@u.northwestern.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Monetary Incentive Delay fMRI task
fMRI task to engage cortical striatal neural circuity
|
fMRI task to engage in cortical striatal neural circuitry during reward
Emotional n-back fMRI task to engage in socioemotional and working memory
|
|
Experimental: Emotional N-back fMRI task
fMRI task to engage working memory and socioemotional processing neural circuitry
|
fMRI task to engage in cortical striatal neural circuitry during reward
Emotional n-back fMRI task to engage in socioemotional and working memory
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Brain response to fMRI tasks
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EXZVPWZBLUE8
- 1R01MH139198-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mental Disorders
-
Kansas State UniversityAugusta University; Dartmouth College; University of CincinnatiEnrolling by invitationMental Disorders, Severe | Mental Illness PersistentUnited States
-
Rutgers, The State University of New JerseyRecruiting
-
Virginia Commonwealth UniversityCompletedMental Health DisordersUnited States
-
Johns Hopkins UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedMental Health DisordersCongo
-
Norwegian University of Science and TechnologySt. Olavs HospitalCompletedMental Health DisordersNorway
-
York UniversityCanadian Institutes of Health Research (CIHR); North York General HospitalCompletedMental Health DisordersCanada
-
Mindstate Design LabsCompleted
-
University of HaifaCompletedMental Health DisordersIsrael
-
VA Boston Healthcare SystemUS Department of Veterans AffairsCompletedMental Health DisordersUnited States
-
Radboud University Medical CenterZonMw: The Netherlands Organisation for Health Research and Development; Onze...RecruitingMental Disorders, SevereNetherlands
Clinical Trials on Psychological fMRI task
-
University Hospital, CaenUnknownSchizophrenia | Interpersonal Relations | Magnetic Resonance Imaging, FunctionalFrance
-
KU LeuvenUnknownObsessive-Compulsive DisorderBelgium
-
Virginia Commonwealth UniversityNational Center for Advancing Translational Sciences (NCATS)CompletedPsychology, Social | Social Interaction | Interpersonal Relations | Behavior, SocialUnited States
-
Andrew MayerRecruitingTraumatic Brain Injury | Aging Disorder | Magnetic Resonance Imaging (MRI)United States
-
University of MinnesotaNational Institute on Drug Abuse (NIDA)Recruiting
-
National Institute of Mental Health (NIMH)WithdrawnAttention Deficit Hyperactivity Disorder | Normal Physiology | Disruptive Mood Dysregulation DisorderUnited States
-
IRCCS Centro Neurolesi "Bonino-Pulejo"Recruiting
-
NYU Langone HealthNational Institute on Drug Abuse (NIDA)Completed
-
Washington University School of MedicineAmerican Tinnitus AssociationTerminated
-
Montana State UniversityNational Heart, Lung, and Blood Institute (NHLBI); Baylor University; Blackfeet...RecruitingMental Health | Psychological Stress | Cardiometabolic ConditionsUnited States