The Ready and Healthy for Kindergarten Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Parenting, Language Development, Literacy, Health Behavior

Intervention / Treatment
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* Behavioral: Family Wellness Program (FWP)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual care plus school supplies and resources<br>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<br>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)<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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early literacy, language development, famliy literacy, bilingualism, community engagement