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

199 Participants Needed

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.

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 data supports the effectiveness of the treatment FamilyNutrition+, ParentChild+?

Research shows that early intervention services and parent-led developmental training can significantly improve developmental outcomes in children, especially those at high risk or with developmental delays. Additionally, parenting programs have been effective in reducing parental distress and improving child behavior, suggesting that similar community-based interventions like FamilyNutrition+ and ParentChild+ could be beneficial. ^{1 2 3 4 5}

Is the Community Intervention for Child Development safe for humans?

The research articles reviewed do not provide specific safety data for the Community Intervention for Child Development or its related programs like FamilyNutrition+ and ParentChild+. However, they discuss the feasibility and effectiveness of developmental screenings and community programs, which are generally considered safe and beneficial for child development. ^{6 7 8 9 10}

How is the ParentChild+ treatment different from other treatments for child development?

ParentChild+ is unique because it focuses on early intervention by involving both children and their parents in a community setting, providing therapeutic day care and mother-child interaction groups, which is different from traditional individual or clinic-based programs. This approach emphasizes social and economic support, parental education, and developmental screening, making it more comprehensive and community-oriented compared to other treatments. ^{7 10 11 12 13}

Research Team

Allyson P Mackey, PhD

Principal Investigator

University of Pennsylvania

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

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Early Intervention Services Improve School-age Functional Outcome Among Neonatal Intensive Care Unit Graduates. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Developmental training by parents of the very young child with potential handicap. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of a mother-infant or toddler parenting program: demonstrating effectiveness in practice. [2014]

4. United States pubmed.ncbi.nlm.nih.gov

Parenting intervention for externalizing behavior problems in children born premature: an initial examination. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of behavioral parent training for children with ADHD in routine clinical practice: a randomized controlled study. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Routine developmental screening implemented in urban primary care settings: more evidence of feasibility and effectiveness. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Evaluation of Community Programs for Early Childhood Development: Parental Perspectives and Recommendations. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Cumulative Risk and Externalizing Behaviors during Infancy in a Predominantly Latine Sample. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

SAFE START: AN EARLY CHILDHOOD MENTAL HEALTH PROGRAM IN A TERTIARY HEALTHCARE SETTING-A CRITICAL REVIEW. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Early intervention for families experiencing homelessness: A pilot randomized trial comparing two parenting programs. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Intervention with high-risk infants and toddlers. [2018]

12. United States pubmed.ncbi.nlm.nih.gov

Brief psychoeducational parenting program: an evaluation and 1-year follow-up. [2015]

13. England 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. [2022]