Community Intervention for Child Development

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Premature birth, Neurological, Psychiatric, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 92

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist young children and their families in Philadelphia who face challenges due to limited access to resources. It tests a community-led program called ParentChild+, which focuses on early learning by providing families with weekly home visits and a book or toy. A comparison group, FamilyNutrition+, offers nutrition support and grocery vouchers. The study seeks to determine if these programs improve parents' mental health and children's development. Eligible families speak English or Spanish and qualify for free or reduced-price lunch or other assistance programs. As an unphased trial, this study allows families to contribute to valuable research that could enhance community support programs.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on community support and child development rather than medical treatments, so it's unlikely that medication changes are required.

What prior data suggests that this intervention is safe for children and families?

Research has shown that the ParentChild+ program has been implemented in various locations to enhance early reading skills and school readiness. While specific safety data akin to medical treatments is not available, the program involves home visits where families receive books, toys, and learning tips. This educational support is generally considered safe, as it does not involve medical procedures or drugs.

The FamilyNutrition+ program provides families with advice on healthy eating and a grocery voucher. Since it does not involve medical treatments or medications, it is considered low-risk. Both programs aim to improve the environment for young children rather than directly impacting their physical health. Consequently, these programs are expected to be safe and pose minimal risk to participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Community Intervention for Child Development trial because it explores innovative approaches to support early childhood development. Unlike traditional methods that often focus solely on educational settings, the ParentChild+ intervention takes learning into the home environment. This approach involves two 30-minute home visits per week, where both parents and children engage in activities designed to enhance learning, using new books or toys each week. It's a more personalized and hands-on method, aiming to involve the family actively in the child's developmental journey. Additionally, the FamilyNutrition+ arm provides a holistic approach by promoting healthy nutrition and offering grocery support, which is unique compared to typical educational interventions.

What evidence suggests that this trial's treatments could be effective for child development?

Research has shown that the ParentChild+ program, an intervention in this trial, positively affects a child's growth and parental care. Studies have found that this program helps children prepare for school, improves language skills, and supports overall health. It also promotes better parenting, benefiting both mothers' health and children's development. Evaluations have ranked ParentChild+ among the most effective early intervention programs, highlighting its potential to significantly improve children's early education. However, some findings suggest that results can vary, particularly in communication and motor skills. Overall, the program enhances early learning and provides valuable resources for families. Meanwhile, the FamilyNutrition+ program, another component of this trial, focuses on promoting healthy nutrition and providing grocery support, offering a different approach to supporting family well-being. ^{1 6 7 8 9}

Who Is on the Research Team?

Allyson P Mackey, PhD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

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

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)

Family previously participated in ParentChild+ with an older sibling

I have issues with my hearing or vision.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Families participate in the ParentChild+ or FamilyNutrition+ program, receiving 92 contacts over 46 weeks.

46 weeks

92 visits (in-person or remote)

Follow-up

Participants are monitored for changes in parental mental health, parenting behaviors, and child outcomes.

1-2 years

What Are the Treatments Tested in This Trial?

Interventions

• FamilyNutrition+
• ParentChild+

Trial Overview

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.

How Is the Trial Designed?

Group I: ParentChild+ Experimental Treatment 1 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 Control 1 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+.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Published Research Related to This Trial

Behavioral parent training (BPT) significantly enhances the effectiveness of routine clinical care (RCC) for children with ADHD, particularly in reducing behavioral and internalizing problems, as shown in a study of 94 children over 5 months.

While BPT + RCC improved behavioral issues, it did not significantly affect ADHD symptoms or parenting stress compared to RCC alone, suggesting that BPT may help limit the need for multiple medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of behavioral parent training for children with ADHD in routine clinical practice: a randomized controlled study. van den Hoofdakker, BJ., van der Veen-Mulders, L., Sytema, S., et al.[2019]

A randomized controlled trial involving 222 primary caregivers showed that a four-session psychoeducational group intervention significantly improved parenting practices and reduced child behavior problems compared to a wait-list control group.

The positive effects of the intervention were maintained even one year later for some participants, suggesting that this program could be an effective early intervention for parents dealing with preschoolers' behavioral issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief psychoeducational parenting program: an evaluation and 1-year follow-up. Bradley, SJ., Jadaa, DA., Brody, J., et al.[2015]

A randomized trial involving families of junior kindergartners showed that community-based large group parent training programs are more effective in improving children's behavior problems at home compared to individual clinic-based training, especially for immigrant families and those with severe behavior issues.

The community-based approach was also found to be over six times more cost-effective than individual training programs, making it a more accessible option for families in need of mental health assistance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Large group community-based parenting programs for families of preschoolers at risk for disruptive behaviour disorders: utilization, cost effectiveness, and outcome. Cunningham, CE., Bremner, R., Boyle, M.[2022]

Citations

1.

parentchildplus.org

parentchildplus.org/wp-content/uploads/2021/04/ParentChild-Research-Overview.pdf

Research Overview

Specifically, we will assess impacts on the following criteria for efficacy: maternal health, positive parenting practices, child development and school ...

2.

parentchildplus.org

parentchildplus.org/news/report-by-british-government-early-intervention-review-team-names-parent-child-home-program-to-the-top-tier-of-most-effective-early-intervention-programs/

Report by British Government Early Intervention Review ...

The report's goals are to 1) Raise awareness of the impact Early Intervention can have on child and family outcomes; and 2) Establish a rigorous review process ...

3.

foundations.org.uk

foundations.org.uk/toolkit/guidebook/parentchildplus/

Parentchild+ - Foundations

Timing. Baseline; 12-month follow-up. ; Child outcomes. Enhancing school achievement and employment; Improved child language; Supporting children's health and ...

4.

educationendowmentfoundation.org.uk

educationendowmentfoundation.org.uk/projects-and-evaluation/projects/parentchild

ParentChild+ - trial | EEF

Other outcomes gave inconsistent results: ParentChild+ had a low to moderate negative impact on children's communication, fine motor skills and ...

5.

impact.upenn.edu

impact.upenn.edu/parentchild/

ParentChild+ - Center for High Impact Philanthropy

Lessons Learned: Early childhood interventions can improve children's long-term educational outcomes; Providing support for professional caregivers as well as ...

6.

parentchildplus.org

parentchildplus.org/about/

ParentChild+ - About

We work with families, caregivers, and communities to support not only early literacy and school readiness, but early opportunities.

7.

parentchildplus.org

parentchildplus.org/wp-content/uploads/2024/09/ParentChild-By-the-Numbers-CY-2023-3.pdf

ParentChild+ By the Numbers

ParentChild+ currently implements two program models, the family home visiting model and the home-based child care model. This year, we are delighted to include ...

8.

cebc4cw.org

cebc4cw.org/program/parentchildplus/detailed

CEBC » Parentchildplus › Program › Detailed

The purpose of the study was to report five years of a school readiness intervention called “HABLA” (Home Based Activities Building Language Acquisition), a ...

9.

researchgate.net

researchgate.net/publication/340926363_Impact_Evaluation_for_the_Parent_Child_Plus_Program_Newark_Trust_for_Education

(PDF) Impact Evaluation for the Parent Child Plus Program ...

PDF | This report describes the methodology and findings from the Quality-Impact-Equity evaluation design as deployed using data from at ...