The Ready and Healthy for Kindergarten Study

Ready and Healthy for Kindergarten: A Primary Care Innovation to Promote a 360-degree View of Child Health

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Parenting; Health Behavior; Language Development; Literacy
• Intervention / Treatment: Behavioral: Family Wellness Program (FWP)

Detailed Description

Education is a critical social determinant of health (SDOH). Latino dual language learners face large gaps in school readiness, which perpetuate inequities in academic achievement and subsequent health. Investigators developed an online family wellness program that uses anticipatory guidance on health topics intrinsically important to school readiness (e.g., nutrition, physical activity) to introduce basic language and literacy skills to Latino dual language learners, a fast- growing and particularly high-risk group, and their families. The online family wellness program was developed through a cross-sector partnership between educators and pediatric professionals and consists of parent-child workshops and reminder text messages. The program occurs during the transition into Kindergarten, a critical developmental stage, and uses promising approaches such as group structure, strategic use of technology, and partnerships. The program tightly integrates Bright Futures anticipatory guidance with the Kindergarten curriculum. During pilot testing, the investigators found that the family wellness program was feasible, well attended, and highly acceptable. The investigators now propose testing the effect of the family wellness program on child and parenting outcomes using a rigorous mixed methods and community-engaged approach. The investigators will conduct a randomized controlled trial testing the effects of the family wellness program on child language, literacy, and social-emotional outcomes as well home health and learning routines. The investigators will also conduct a mixed methods process evaluation, which will provide insight into reach and implementation as well as user experience.

• Study Type: Interventional
• Enrollment (Actual): 396
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Child Health Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 6 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• primary caregiver of a child entering Kindergarten (4-6 years old),
• primary caregiver identifies as Hispanic/Latino/Latinx,
• family speaks Spanish at home,
• cell phone ownership,
• willing to receive text messages,
• ability to pick up program materials locally, and
• willing to accept randomization

Exclusion Criteria:

-Individuals unable to provide informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care plus school supplies and resources; 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.
Experimental: Famliy Wellness Program; 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.	Behavioral: Family Wellness Program (FWP); The FWP will consist of the following general format: (1) 8 weekly 60-minute summer workshops; (2) 4 booster workshops throughout the year; and (3) 2-3 outreach text messages per week for 10 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Home Literacy Environment Questionnaire	The home literacy environment will be assessed with the StimQ, a caregiver-reported measure of cognitive stimulation for children that includes a domain on the home literacy environment (READ scale). The READ scale includes 3 subdimensions (Book Reading Quantity, Diversity of Content, Book Reading Quality). Scores on the READ scale range from 0 to 18. Higher scores indicate more cognitive stimulation	2 months
Home Literacy Environment Questionnaire	The home literacy environment will be assessed with the StimQ, a caregiver-reported measure of cognitive stimulation for children that includes a domain on the home literacy environment (READ scale). The READ scale includes 3 subdimensions (Book Reading Quantity, Diversity of Content, Book Reading Quality). Scores on the READ scale range from 0 to 18. Higher scores indicate more cognitive stimulation	10 months
Parent Responsiveness Questionnaire	Parent responsiveness will be assessed with the StimQ, a caregiver-reported measure of cognitive stimulation for children that includes a domain on responsiveness (Parental Verbal Responsiveness scale). The Parental Verbal Responsiveness scale includes a subdimension on responsiveness during routines (Everyday Routines). Scores range from 0 to 8. Higher scores indicate more cognitive stimulation.	2 months
Parent Responsiveness Questionnaire	Parent responsiveness will be assessed with the StimQ, a caregiver-reported measure of cognitive stimulation for children that includes a domain on responsiveness (Parental Verbal Responsiveness scale). The Parental Verbal Responsiveness scale includes a subdimension on responsiveness during routines (Everyday Routines). Scores range from 0 to 8. Higher scores indicate more cognitive stimulation.	10 months
Family Health Routines Questionnaire	This is a self-report measure for family nutrition and physical activity routines, which has been validated in English and Spanish. Higher scores are consistent with healthier routines.	2 months
Family Health Routines Questionnaire	This is a self-report measure for family nutrition and physical activity routines, which has been validated in English and Spanish. Higher scores are consistent with healthier routines.	10 months
Caregiver Attitudes About Reading Questionnaire	The Parent Reading Belief Inventory is a caregiver reported measure of attitudes and knowledge about reading with children that includes subdimensions of teaching efficacy (scores range from 0 to 27), positive affect (scores range from 0 to 33), and knowledge (scores range from 0 to 15) available in English and Spanish. Higher scores indicate more favorable attitudes and greater knowledge.	2 months
Caregiver Attitudes About Reading Questionnaire	The Parent Reading Belief Inventory is a caregiver reported measure of attitudes and knowledge about reading with children that includes subdimensions of teaching efficacy (scores range from 0 to 27), positive affect (scores range from 0 to 33), and knowledge (scores range from 0 to 15) available in English and Spanish. Higher scores indicate more favorable attitudes and greater knowledge.	10 months
Child Vocabulary Assessment	Child vocabulary will be assessed using an investigator developed measure. Higher scores indicate higher skills	2 months
Child Vocabulary Assessment	Child vocabulary will be assessed using an investigator developed measure. Higher scores indicate higher skills	10 months
Child Language Skills Assessment	Child receptive language and listening skills will be assessed with the Receptive One Word Picture Vocabulary Test - Fourth Edition (ROWPVT-4) Spanish-Bilingual. Higher scores indicate higher skills.	10 months
Child Literacy Skills Assessment	Literacy skills including concepts about books, story retelling, narrative thematic knowledge, letter and sound identification will be assessed using an investigator developed measure. Higher scores indicate higher skills	2 months
Child Literacy Skills Assessment	Literacy skills including concepts about books, story retelling, narrative thematic knowledge, letter and sound identification will be assessed using an investigator developed measure. Higher scores indicate higher skills	10 months
Child Social-emotional Development Questionnaire	Social emotional development will be measured using the Strengths and Difficulties Questionnaire (SDQ), which is a brief validated behavioral screening questionnaire for 4-17 year olds. The SDQ has been widely used in research studies. The SDQ has a total of 5 scales including the hyperactivity (scores range from 0-10) and prosocial (scores range from 0-10) scales used here. Higher scores on the hyperactivity scale indicate greater hyperactivity; higher scores on the Prosocial scale indicate greater prosocial behaviors.	2 months
Child Social-emotional Development Questionnaire	Social emotional development will be measured using the Strengths and Difficulties Questionnaire (SDQ), which is a brief validated behavioral screening questionnaire for 4-17 year olds. The SDQ has been widely used in research studies. The SDQ has a total of 5 scales including the hyperactivity (scores range from 0-10) and prosocial (scores range from 0-10) scales used here. Higher scores on the hyperactivity scale indicate greater hyperactivity; higher scores on the Prosocial scale indicate greater prosocial behaviors.	10 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child Media Use Questionnaire	The ScreenQ is a caregiver report measure of media use in children. Scores range from 0 to 26 with higher score indicating more media use.	2 months
Child Media Use Questionnaire	The ScreenQ is a caregiver report measure of media use in children. Scores range from 0 to 26 with higher score indicating more media use.	10 months.
Child Sleep Routines Questionnaire	Investigator developed question on sleep habits.	2 months
Child Sleep Routines Questionnaire	Investigator developed question on sleep habits.	10 months
Child Self-regulation Questionnaire	Using observational method by using a popular children's song to measure child's self regulation.	2 months
Child Self-regulation Questionnaire	Using observational method by using a popular children's song to measure child's self regulation.	10 months

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Principal Investigator: Manuel E Jimenez, MD, MS, Rutgers University

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2023
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: February 4, 2023
• First Submitted That Met QC Criteria: February 27, 2023
• First Posted (Actual): March 8, 2023

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 18, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: community engagement; language development; early literacy; famliy literacy; bilingualism
• Additional Relevant MeSH Terms: Behavior; Communication; Health Behavior; Literacy
• Other Study ID Numbers: Pro2021001575-2; R18HS028574 (U.S. AHRQ Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified quantitative data and associated documentation may be made available to users conducting non-profit research under a written data-sharing agreement
• IPD Sharing Time Frame: Data will become available after the study is completed and primary study findings are published in peer-reviewed journals for up to 10 years after study completion.
• IPD Sharing Access Criteria: Researchers from accredited institutions may submit written requests to access de-identified quantitative data for non-profit research. Permission and access will be granted on an ad hoc basis and under a written data-sharing agreement. The dataset will be stripped of all identifiers prior to sharing and will be shared via a secure application.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No