The Ready and Healthy for Kindergarten Study

NCT05760573 | Active Not Recruiting

• 2 other identifiers: Pro2021001575-2R18HS028574
• Study Type: interventional
• Target: 396
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parenting; Literacy; Language Development; Health Behavior

Keywords

early literacy; language development; famliy literacy; bilingualism; community engagement

Outcome Measures

Primary Outcomes (15)

• 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 Outcomes (6)

• Child Media Use Questionnaire

  2 months

• Child Media Use Questionnaire

  10 months.

• Child Sleep Routines Questionnaire

  2 months

• Child Sleep Routines Questionnaire

  10 months

• Child Self-regulation Questionnaire

  2 months

Study Arms (2)

Usual care plus school supplies and resources

NO 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.

Famliy Wellness Program

EXPERIMENTAL

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)

Interventions

Family Wellness Program (FWP) BEHAVIORAL

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.

Famliy Wellness Program

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Individuals unable to provide informed consent

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

Child Health Institute

New Brunswick, New Jersey, 08901, United States

Location

MeSH Terms

Conditions

Literacy; Health Behavior

Condition Hierarchy (Ancestors)

Communication; Behavior

Study Officials

• Manuel E Jimenez, MD, MS

  Rutgers University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics & Family Medicine and Community Health

Study Record Dates

• First Submitted: February 4, 2023
• First Posted: March 8, 2023
• Study Start: April 15, 2023
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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.
• 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.

Locations

US (1)