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

420 Participants Needed

Trial Summary

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 data supports the effectiveness of the Family Wellness Program (FWP) treatment for child literacy and language development?

The Strengthening Families Program, a similar family intervention, has shown significant improvements in family and child outcomes, suggesting that family-based programs can be effective. Additionally, community-wide interventions promoting early literacy behaviors have led to increased reading activities between parents and children, which supports language development. ^{1 2 3 4 5}

Is the Family Wellness Program safe for participants?

The research articles reviewed do not provide specific safety data for the Family Wellness Program or similar programs under different names. ^{6 7 8 9 10}

How is the Family Wellness Program treatment different from other treatments for child literacy and language development?

The Family Wellness Program is unique because it focuses on empowering families through culturally appropriate community-led training, enhancing personal development and life skills, which is not typically emphasized in other child literacy and language development treatments. ^{11 12 13 14 15}

What is the purpose of this trial?

The goal of this clinical trial is to test whether a family wellness program enhances child and parenting outcomes among Latino dual language learners entering Kindergarten and their families. The main questions are: (1) To what extent does the family wellness program enhance home health and learning routines, and (2) To what extent does the family wellness program enhance child literacy, language, and social-emotional outcomes. All participants will be asked to complete surveys and assessments. Researchers will compare two groups: (1) Family wellness program that includes (a) 8-weekly summer sessions, (b) text messages, (c) booster sessions, and (2) usual care plus school supplies and list of resources to see if the family wellness program enhances child and parenting outcomes.

Research Team

Manuel E Jimenez, MD, MS

Principal Investigator

Rutgers University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

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

Health literacy and child health outcomes: a systematic review of the literature. [2022]

2. Spain pubmed.ncbi.nlm.nih.gov

[Strengthening family interventions for the prevention of substance abuse in children of addicted parents]. [2007]

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

Preventive interventions with low birth weight premature infants: an evaluation of their success. [2019]

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

Cultural adaptation process for international dissemination of the strengthening families program. [2022]

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

Effectiveness of a coordinated community effort to promote early literacy behaviors. [2021]

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

Local Wellness Policy 5 years later: is it making a difference for students in low-income, rural Colorado elementary schools? [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Prevalence and characteristics of campus-based employee wellness programs among United States accredited colleges and universities. [2021]

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

Nutrition component in a comprehensive child development program. I. The home visitor's role in the prenatal intervention phase. [2009]

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

Eligibility and enrollment in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC)--27 states and New York City, 2007-2008. [2022]

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

Delivering health care to children on their turf: an elementary school-based wellness center. [2019]

11. India pubmed.ncbi.nlm.nih.gov

Family support and well-being programme (FSWP): A specialized family strengthening psychosocial services for parents of children in conflict with law. [2023]

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

Playgroups offering health and well-being support for families: a systematic review. [2018]

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

Nurse practitioners and parent education: a partnership for health. [2019]

14. England pubmed.ncbi.nlm.nih.gov

Delivering an empowerment intervention to a remote Indigenous child safety workforce: Its economic cost from an agency perspective. [2021]

15. Canada pubmed.ncbi.nlm.nih.gov

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