~0 spots leftby May 2025

Community Intervention for Child Development

Recruiting in Palo Alto (17 mi)
Overseen byAllyson P Mackey, PhD
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: University of Pennsylvania
No Placebo Group

Trial Summary

What is the purpose of this trial?

Structural inequities and historical underinvestment in marginalized communities create developmental contexts that constrain access to high-quality education, healthcare, stable housing, and other critical resources. This study evaluates effects of a strengths-based, community-led intervention on young children and their families, which aims to buffer structural inequities while recognizing families' strengths. Between ages 18-36 months, English- and Spanish-speaking families consented and were randomly assigned to the intervention group (ParentChild+) or the active control group (FamilyNutrition+). Each group received 92 contacts from a specialist matched with their demographics. For the intervention group, contact focused on supporting parents and children's early learning, and families received a book or toy each week; for the control group, contact focused on supporting child nutrition, and families received a small food voucher each week. The current study evaluates whether the intervention altered parents' mental health, children's early environments, and/or children's test performance and brain development.

Eligibility Criteria

This trial is for English- and Spanish-speaking families with children aged 18-36 months, aiming to support child development in communities facing structural inequities. It's not specified who can't join, so it seems open to those meeting the age and language criteria.

Inclusion Criteria

Live in Philadelphia
My child's guardian can communicate in English or Spanish.
Family qualifies for free or reduced-price lunch (185% or below the federal poverty line, based on income and number of people in the household, e.g. $57,000/year for a family of 2 adults and 2 children, or is currently receiving support from other government assistance programs (e.g., the Supplemental Nutrition Assistance Program, SNAP)

Exclusion Criteria

Premature birth (<34 weeks gestation)
My child was reported to have a language delay.
Family previously participated in ParentChild+ with an older sibling
See 2 more

Treatment Details

Interventions

  • FamilyNutrition+ (Behavioral Intervention)
  • ParentChild+ (Behavioral Intervention)
Trial OverviewThe study compares two programs: ParentChild+ focuses on early learning with weekly books or toys, while FamilyNutrition+ emphasizes child nutrition with weekly food vouchers. Families are randomly assigned to either group and receive 92 visits from a specialist.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: ParentChild+Experimental Treatment1 Intervention
The ParentChild+ intervention consists of two 30-minute home visits per week for 46 weeks (92 visits), in which both parent and child are present. These visits may sometimes take place remotely, if best for the family. Each week, the family receives a new book or toy, and tips for promoting child learning.
Group II: FamilyNutrition+Active Control1 Intervention
The FamilyNutrition+ active control consists of a 92-contact, 46-week program, mirroring the intervention. However, instead of meeting with an early learning specialist, families in FamilyNutrition+ receive texts, emails, and zoom calls related to healthy nutrition and recipe ideas. In addition, families receive $25/month for groceries-a similar magnitude to the cost of the books and toys they would receive in ParentChild+.

Find a Clinic Near You

Research Locations NearbySelect from list below to view details:
University of PennsylvaniaPhiladelphia, PA
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Who Is Running the Clinical Trial?

University of PennsylvaniaLead Sponsor

References