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Family Wellness Program for Child Literacy and Language Development
N/A
Waitlist Available
Led By Manuel E Jimenez, MD, MS
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 months
Awards & highlights
Study Summary
This trial will test if a family wellness program can improve child literacy, language, and social-emotional outcomes for Latino dual language learners entering Kindergarten and their families.
Who is the study for?
This trial is for Hispanic/Latino/Latinx primary caregivers with a cell phone, who have a child aged 4-6 entering Kindergarten. They must speak Spanish at home, be willing to receive text messages and pick up materials locally. Caregivers unable to give informed consent cannot participate.Check my eligibility
What is being tested?
The study tests if a Family Wellness Program (FWP) can improve health routines and child literacy/language/social outcomes compared to usual care. The FWP includes summer sessions, texts, and booster sessions; the comparison group gets school supplies and resources.See study design
What are the potential side effects?
Since this trial involves educational interventions rather than medical treatments, there are no direct physical side effects expected from participating in the Family Wellness Program or receiving usual care.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Caregiver Attitudes About Reading Questionnaire
Child Language Skills Assessment
Child Literacy Skills Assessment
+5 moreSecondary outcome measures
Child Media Use Questionnaire
Child Self-regulation Questionnaire
Child Sleep Routines Questionnaire
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Famliy Wellness ProgramExperimental Treatment1 Intervention
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.
Group II: Usual care plus school supplies and resourcesActive Control1 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.
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Who is running the clinical trial?
Rutgers, The State University of New JerseyLead Sponsor
429 Previous Clinical Trials
63,812 Total Patients Enrolled
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931 Patients Enrolled for Parenting
Agency for Healthcare Research and Quality (AHRQ)FED
399 Previous Clinical Trials
6,821,928 Total Patients Enrolled
1 Trials studying Parenting
32 Patients Enrolled for Parenting
Manuel E Jimenez, MD, MSPrincipal InvestigatorRutgers University
3 Previous Clinical Trials
679 Total Patients Enrolled
1 Trials studying Parenting
630 Patients Enrolled for Parenting
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am able to understand and agree to the study's procedures and risks.I am willing to receive text messages.My family speaks Spanish at home.I am the main caregiver for a child aged 4-6.
Research Study Groups:
This trial has the following groups:- Group 1: Famliy Wellness Program
- Group 2: Usual care plus school supplies and resources
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this clinical trial restrict participation to a certain age demographic?
"This trial has precise requirements for enrollment; applicants must be aged between 4 and 6. Additionally, there are 101 trials open to minors and 109 aiming at recruitment of geriatric patients."
Answered by AI
What criteria must individuals meet to qualify for enrollment in this research project?
"This trial is enrolling 420 participants aged 4 and 6, who are primarily Hispanic/Latinx with the requirement that their primary caretaker speaks Spanish at home. Additionally, they must own a cell phone and be willing to receive text messages."
Answered by AI
Is this experiment still recruiting participants?
"Per clinicaltrials.gov, this investigation is not looking to recruit any additional patients at the present time; its initial post date was March 1st 2023 and it last updated on February 27th of that same year. Nevertheless, there are 177 other medical trials seeking participants right now."
Answered by AI
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