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Behavioral Intervention
Community Intervention for Child Development
N/A
Waitlist Available
Led By Allyson P Mackey, PhD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Must not have
Neurological or psychiatric condition
Hearing or vision problem
Timeline
Screening 3 weeks
Treatment Varies
Follow Up collected at age 1-2 and 3-4
Awards & highlights
No Placebo-Only Group
Summary
"This trial evaluates the effects of a community-led program on young children and their families to address inequalities in access to education, healthcare, and stable housing. Families with children between 18-36 months were
Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Since this trial involves educational and nutritional interventions rather than medical treatments, traditional side effects aren't expected. However, there may be indirect impacts on family dynamics or stress levels.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a neurological or psychiatric condition.
Select...
I have issues with my hearing or vision.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ collected at age 1-2 and 3-4
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~collected at age 1-2 and 3-4
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Child behavioral problems
Child emotional problems
Child vocabulary
+5 moreSecondary study objectives
Child cortical surface area
Child cortical thickness
Child fluctuation amplitude
+6 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
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+.
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Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,082 Previous Clinical Trials
42,727,131 Total Patients Enrolled
Allyson P Mackey, PhDPrincipal InvestigatorUniversity of Pennsylvania