NCT07641244

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
40mo left

Started Apr 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
Apr 2026Aug 2029

Study Start

First participant enrolled

April 4, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 11, 2026

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2029

Last Updated

June 11, 2026

Status Verified

June 1, 2026

Enrollment Period

3.4 years

First QC Date

June 3, 2026

Last Update Submit

June 8, 2026

Conditions

Keywords

DepressionAnxietyInternalizing DisordersExternalizing DisordersInflammationPovertyChild Mental HealthPsychopathologyStress

Outcome Measures

Primary Outcomes (1)

  • Brain response to fMRI tasks

    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

Study Arms (2)

Monetary Incentive Delay fMRI task

EXPERIMENTAL

fMRI task to engage cortical striatal neural circuity

Other: Psychological fMRI task

Emotional N-back fMRI task

EXPERIMENTAL

fMRI task to engage working memory and socioemotional processing neural circuitry

Other: Psychological fMRI task

Interventions

fMRI task to engage in cortical striatal neural circuitry during reward

Monetary Incentive Delay fMRI task

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Youth not between ages 5 and 14 at the start of the intervention
  • Parent not enrolled in the Every Dollar Counts program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Evanston, Illinois, 60208, United States

RECRUITING

MeSH Terms

Conditions

Anxiety DisordersMental DisordersDepressionInflammation

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 3, 2026

First Posted

June 11, 2026

Study Start

April 4, 2026

Primary Completion (Estimated)

August 31, 2029

Study Completion (Estimated)

August 31, 2029

Last Updated

June 11, 2026

Record last verified: 2026-06

Locations