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Evaluating a Strengths-based Community-grounded Intervention

NCT06701240 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 199

Last updated 2025-07-16

No results posted yet for this study

Summary

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.

Conditions

  • Parenting
  • Child Development
  • Brain Development
  • Household and Family

Interventions

BEHAVIORAL

ParentChild+

92-session early literacy focused intervention

BEHAVIORAL

FamilyNutrition+

92-session active control focused on child nutrition

Sponsors & Collaborators

Principal Investigators

  • Allyson P Mackey, PhD · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Months
Max Age
36 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-08
Primary Completion
2025-06-01
Completion
2027-08-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06701240 on ClinicalTrials.gov