An interventional study of Family Wellness Program (FWP) in Parenting, Language Development and Literacy, sponsored by Rutgers, The State University of New Jersey. Active, not recruiting at 1 site in United States. Open to participants aged 4 Years to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-22.
Sponsored by Rutgers, The State University of New Jersey · Not applicable, Interventional, and Prevention
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.
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.
201 studies on the registry are indexed under Literacy; 69 are open to participants now.
This study's enrollment of 396 is above the median of 124 across 170 interventional studies indexed under Literacy.
Browse Literacy studies →Rutgers, The State University of New Jersey is the lead sponsor of 506 studies on the registry; 131 are open to participants now.
Of its 39 completed or terminated interventional studies of FDA-regulated products, 31 (79%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
-Individuals unable to provide
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 10 months
Child Vocabulary Assessment
Child vocabulary will be assessed using an investigator developed measure. Higher scores indicate higher skills
Time frame: 2 months
Child Vocabulary Assessment
Child vocabulary will be assessed using an investigator developed measure. Higher scores indicate higher skills
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 10 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.
Time frame: 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.
Time frame: 10 months.
Child Sleep Routines Questionnaire
Investigator developed question on sleep habits.
Time frame: 2 months
Child Sleep Routines Questionnaire
Investigator developed question on sleep habits.
Time frame: 10 months
Child Self-regulation Questionnaire
Using observational method by using a popular children's song to measure child's self regulation.
Time frame: 2 months
Child Self-regulation Questionnaire
Using observational method by using a popular children's song to measure child's self regulation.
Time frame: 10 months
Plan to share: Yes — Deidentified quantitative data and associated documentation may be made available to users conducting non-profit research under a written data-sharing agreement
Supporting information: 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.
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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