- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03941197
A Family Literacy Program for Latino Families
February 14, 2020 updated by: Manuel E. Jimenez, MD, MS, Rutgers, The State University of New Jersey
Ready and Healthy for Kindergarten- A Family Literacy Program for Latino Families
A pilot study of a health-focused family literacy program.
The program will consist of a series of 8 weekly workshops centered around different health topics (e.g.
physical activity) that introduce basic literacy skills.
The workshops are designed for children entering kindergarten and their parents
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a pilot study of a health-focused family literacy program.
The program consists of 8 weekly health-themed workshops designed to introduce basic literacy skills to children entering Kindergarten and their parents.
There will be a pre and post test assessment for participating parents and children.
During the 8 weeks, parents will receive 2-3 weekly text messages to reinforce material presented at the weekly workshop.
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Jersey
-
New Brunswick, New Jersey, United States, 08901
- Manuel E Jimenez
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Preferred language is either Spanish or English.
- Parent or legal guardian of child
- Parent age 18 or older
- Willing to accept text messages
Exclusion Criteria:
- Children not entering Kindergarten in Fall 2019 and their parents will be excluded
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ready and Healthy for Kindergarten Family Literacy Program
Ready and Healthy for Kindergarten Family Literacy Program- 8 weekly parent child workshops with text message reminders
|
Participants will participate in 8 parent-child health-themed literacy workshops.
Participants will receive 2-3 text messages per week for 8 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptability of Intervention Measure (AIM) Questionnaire
Time Frame: After 8 week period.
|
Acceptability will be measured using the Acceptability of Intervention Measure (AIM).
The AIM consists of 4 questions that assess acceptability.
Responses range from 1 (completely disagree) to 5 (completely agree).
Scales are created by averaging responses.
|
After 8 week period.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
StimQ-Preschool survey
Time Frame: At enrollment and after 8 week period.
|
Parent reported measure of the cognitive home environment for children 5 months to 6 years to assess aspects of the home environment that affect child development.
|
At enrollment and after 8 week period.
|
Alphabet knowledge assessment survey
Time Frame: At enrollment and after 8 week period.
|
Alphabet knowledge will be assessed.
|
At enrollment and after 8 week period.
|
Sight word knowledge assessment survey
Time Frame: At enrollment and after 8 week period.
|
Sight word knowledge will be assessed
|
At enrollment and after 8 week period.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Manuel E Jimenez, MD, MS, Rutgers Robert Wood Johnson Medical School
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 28, 2019
Primary Completion (Actual)
September 28, 2019
Study Completion (Actual)
September 28, 2019
Study Registration Dates
First Submitted
April 18, 2019
First Submitted That Met QC Criteria
May 3, 2019
First Posted (Actual)
May 7, 2019
Study Record Updates
Last Update Posted (Actual)
February 18, 2020
Last Update Submitted That Met QC Criteria
February 14, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- Pro2019000570
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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