The Ready and Healthy for Kindergarten Study

Health Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05760573
• Other study ID #: Pro2021001575-2
• Secondary ID: R18HS028574
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 15, 2023
• Est. completion date: August 30, 2026

Study information

• Verified date: February 2024
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 420
• Est. completion date: August 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Health Behavior
• Language Development
• Literacy
• Parenting

Intervention

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.

Locations

Country	Name	City	State
United States	Child Health Institute	New Brunswick	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Child Vocabulary Assessment	Child vocabulary will be assessed using an investigator developed measure. Higher scores indicate higher skills	2 months
Primary	Child Vocabulary Assessment	Child vocabulary will be assessed using an investigator developed measure. Higher scores indicate higher skills	10 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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.
Secondary	Child Sleep Routines Questionnaire	Investigator developed question on sleep habits.	2 months
Secondary	Child Sleep Routines Questionnaire	Investigator developed question on sleep habits.	10 months
Secondary	Child Self-regulation Questionnaire	Using observational method by using a popular children's song to measure child's self regulation.	2 months
Secondary	Child Self-regulation Questionnaire	Using observational method by using a popular children's song to measure child's self regulation.	10 months