Family Wellness Program for Child Literacy and Language Development

Overseen By Daniel Lima, MSW

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Rutgers, The State University of New Jersey

Disqualifiers: Unable to provide informed consent

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

Compensation: Varies

Number of Visits: 8

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a family wellness program can enhance child literacy, language skills, and social-emotional development for Latino children entering kindergarten. Researchers seek to understand if the program also improves health and learning routines at home. Participants will be divided into two groups: one will join the Family Wellness Program (FWP), while the other will receive usual care along with some school supplies and resources. Ideal participants are Hispanic or Latino parents or caregivers who speak Spanish at home and have a child starting kindergarten.

As an unphased trial, this study provides a unique opportunity to contribute to research that could improve educational and developmental outcomes for Latino children.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the Family Wellness Program is safe for child literacy and language development?

Research on the Family Wellness Program (FWP) lacks specific safety data. However, similar programs often aim to improve family routines and child development. These programs are generally considered safe because they involve learning activities rather than medical treatments. Participants typically engage in workshops, receive text messages, and attend follow-up sessions, all of which are non-invasive and unlikely to cause harm. Although specific data on side effects or negative events is absent, the program's nature suggests it is well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Family Wellness Program (FWP) because it takes a proactive approach to child literacy and language development by involving parents directly in their children's early education. Unlike standard programs that might only provide school supplies or teacher-led interventions, FWP offers a series of interactive parent-child workshops before and during kindergarten. This hands-on approach not only equips families with educational resources but also fosters a collaborative learning environment, potentially boosting children's literacy skills more effectively. The program's unique structure aims to strengthen family involvement in early education, which is seen as a vital factor in long-term academic success.

What evidence suggests that the Family Wellness Program is effective for enhancing child literacy and language development?

Research has shown that family wellness programs can significantly enhance children's early reading and language skills. One study found that children in these programs performed better in reading tasks than those not enrolled. Another study demonstrated that these programs also aid children's social and emotional development and improve parenting skills. Evidence from past trials suggests that family involvement in reading activities benefits both children and parents. Overall, the data supports that family wellness programs lead to improved learning and emotional outcomes for children. In this trial, participants in the Family Wellness Program will attend eight weekly parent-child workshops and four booster sessions, while another group will receive usual care plus school supplies and resources. ^{4 6 7 8 9}

Who Is on the Research Team?

Manuel E Jimenez, MD, MS

Principal Investigator

Rutgers University

Are You a Good Fit for This Trial?

This trial is for Hispanic/Latino/Latinx primary caregivers with a cell phone, who have a child aged 4-6 entering Kindergarten. They must speak Spanish at home, be willing to receive text messages and pick up materials locally. Caregivers unable to give informed consent cannot participate.

Inclusion Criteria

Cell phone ownership

Primary caregiver identifies as Hispanic/Latino/Latinx

I am willing to receive text messages.

Exclusion Criteria

I am able to understand and agree to the study's procedures and risks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Family Wellness Program

Participants engage in 8 weekly parent-child workshops prior to kindergarten, including text messages and booster sessions

8 weeks

8 visits (in-person)

Booster Sessions

Participants receive 4 booster sessions during the child's kindergarten year

4 sessions over 10 months

Follow-up

Participants are monitored for child and parenting outcomes, including language, literacy, and social-emotional development

10 months

What Are the Treatments Tested in This Trial?

Interventions

• Family Wellness Program (FWP)

Trial Overview The study tests if a Family Wellness Program (FWP) can improve health routines and child literacy/language/social outcomes compared to usual care. The FWP includes summer sessions, texts, and booster sessions; the comparison group gets school supplies and resources.

How Is the Trial Designed?

Group I: Famliy Wellness Program Experimental Treatment 1 Intervention

This group will be enrolled in the Family Wellness Program which consists of 8 weekly parent-child workshops prior to the children entering kindergarten as well as 4 booster sessions during the child's kindergarten year. As part of the program families will receive school supplies, books and resources.

Group II: Usual care plus school supplies and resources Active Control 1 Intervention

This group will not be enrolled in the Family Wellness Program. They will receive usual care from their regular clinician plus a backpack with schools supplies and a list of resources.

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials

415

Recruited

6,777,000+

Published Research Related to This Trial

The Strengthening Families Program (SFP) is an effective family skills training intervention for preventing substance abuse, originally developed in the 1980s and adapted for diverse cultural contexts since the 1990s.

SFP has been successfully implemented in 17 countries, with a comprehensive cultural adaptation process that includes language translation, staff training, and ongoing support to ensure quality and effectiveness in various populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cultural adaptation process for international dissemination of the strengthening families program. Kumpfer, KL., Pinyuchon, M., Teixeira de Melo, A., et al.[2022]

The home-use DVD version of the Strengthening Families Program (SFP) demonstrated a significant improvement in program outcomes, outperforming traditional group norms in 13 out of 15 comparisons, with an average effect size increase of 28%.

This study suggests that delivering family-based interventions through affordable technology like DVDs can be as effective as traditional group classes, highlighting a potential cost-effective alternative for families and agencies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Parenting Behavior Intervention (the Strengthening Families Program) for Families: Noninferiority Trial of Different Program Delivery Methods. Kumpfer, KL., Brown, JL.[2020]

Interventions for low birthweight (LBW) premature children have shown only modest success in improving neurodevelopmental outcomes, despite facilitating better parent-child interactions.

A detailed review of 19 intervention programs, including the Infant Health and Development Program, highlights the need for future research to focus on long-term developmental effects and to replicate successful strategies across different settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventive interventions with low birth weight premature infants: an evaluation of their success. McCarton, CM., Wallace, IF., Bennett, FC.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12202239/

An Online Family Literacy and Wellness Program for Latino ... We refined an 8-week family literacy and wellness program and conducted a pilot randomized controlled trial (RCT) with a waitlist control.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0190740920308082

The effect of family literacy programs on the development ... Family literacy programs have the potential to develop children's early literacy skills. · Children in the experimental group performed significantly better than ...

3. tandfonline.com tandfonline.com/doi/full/10.1080/02702711.2025.2539697?src=

The Effect of the Family Literacy Program on Parents and ... The study spanned 25 months and covered both preschool and primary school levels. The analysis results showed that family literacy was initially low in the ...

4. air.org air.org/sites/default/files/2021-06/F5LA_researchbrief_AIR_single_page_0.pdf

Children's Elementary School Outcomes After Participating ... The First 5 LA Family Literacy Initiative is a comprehensive program to promote language and literacy development, parenting knowledge.

5. researchgate.net researchgate.net/publication/344956370_The_effect_of_family_literacy_programs_on_the_development_of_children's_early_literacy_in_kindergarten_settings

The effect of family literacy programs on the development ... The results showed that the children in the experimental group of the program scored significantly higher than the control group in the early ...

6. withpower.com withpower.com/trial/phase-parenting-2-2023-372aa

Family Wellness Program for Child Literacy and Language ... The research articles reviewed do not provide specific safety data for the Family Wellness Program or similar programs under different names.

7. frontiersin.org frontiersin.org/journals/health-services/articles/10.3389/frhs.2025.1575781/full

The Family Wellness Program: a bench to bedside ... This report details a bench to bedside translation of behavioral and social science research into a clinical program as a result of a collaboration between ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05339464

NCT05339464 | Ready and Healthy for Kindergarten This study pilot tests a family wellness program that promotes academic and physical readiness for school among Latino dual language learners using a mixed ...

9. tnlcommunityfund.org.uk tnlcommunityfund.org.uk/media/insights/documents/Mindwise-updated-evaluation.pdf?mtime=20190813104358&focal=none

Family Wellness Project Evaluation report The overall aim is to enhance the mental health and well-being of children under 12, their families and / or carers. The project offers: • One- ...