LiteracyNCT03941197
A Family Literacy Program for Latino Families
A study testing Ready and Healthy for Kindergarten Family Literacy program in people with Literacy, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Literacy
- What is being tested?
- Ready and Healthy for Kindergarten Family Literacy program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2019to 28 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Preferred language is either Spanish or English.
- Parent or legal guardian of child
- Parent age 18 or older
- Willing to accept text messages
Who cannot join
- Children not entering Kindergarten in Fall 2019 and their parents will be excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Literacy
- Being tested
- Ready and Healthy for Kindergarten Family Literacy program
- Keywords
- child development, family literacy program, primary care
- Medical subject headings
- Literacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ready and Healthy for Kindergarten Family Literacy programBehavioural
Participants will participate in 8 parent-child health-themed literacy workshops. Participants will receive 2-3 text messages per week for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Ready and Healthy for Kindergarten Family Literacy Program | Experimental | Ready and Healthy for Kindergarten Family Literacy Program- 8 weekly parent child workshops with text message reminders Receives: Behavioral: Ready and Healthy for Kindergarten Family Literacy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of Intervention Measure (AIM) Questionnaire
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.
Measured: After 8 week period.
Secondary outcomes (3)
StimQ-Preschool survey
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.
Measured: At enrollment and after 8 week period.
Alphabet knowledge assessment survey
Alphabet knowledge will be assessed.
Measured: At enrollment and after 8 week period.
Sight word knowledge assessment survey
Sight word knowledge will be assessed
Measured: At enrollment and after 8 week period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start28 May 2019
- Primary completion28 Sep 2019
- Study completion28 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LiteracyStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel E. Jimenez, MD, MS, Rutgers, The State University of New Jersey
- Investigators
- Manuel E Jimenez, MD, MS, Principal investigator, Rutgers Robert Wood Johnson Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03941197
- Sponsor's protocol ID
- Pro2019000570
- Status last verified
- Feb 2020
- First submitted
- 18 Apr 2019
- Last updated
- 18 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ready and Healthy for Kindergarten- A Family Literacy Program for Latino Families
- ClinicalTrials.gov ID
- NCT03941197
- Acronym / sponsor ID
- Pro2019000570
- Conditions
- Literacy
- Keywords
- child development, family literacy program, primary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 28 May 2019 (actual)
- Primary completion
- 28 Sep 2019 (actual)
- Study completion
- 28 Sep 2019 (actual)
- First posted
- 7 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ready and Healthy for Kindergarten Family Literacy Program | Experimental | Behavioral: Ready and Healthy for Kindergarten Family Literacy programReady and Healthy for Kindergarten Family Literacy Program- 8 weekly parent child workshops with text message reminders |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Preferred language is either Spanish or English.
- Parent or legal guardian of child
- Parent age 18 or older
- Willing to accept text messages
Key exclusion criteria (1 listed)
- Children not entering Kindergarten in Fall 2019 and their parents will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ready and Healthy for Kindergarten Family Literacy programParticipants will participate in 8 parent-child health-themed literacy workshops. Participants will receive 2-3 text messages per week for 8 weeks. | Behavioural | Ready and Healthy for Kindergarten Family Literacy Program |
Primary outcome
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.
3 secondary outcomes
StimQ-Preschool survey
Time frame: At enrollment and after 8 week period.
Alphabet knowledge assessment survey
Time frame: At enrollment and after 8 week period.
Sight word knowledge assessment survey
Time frame: At enrollment and after 8 week period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuel E Jimenez, MD, MS principal investigator
Rutgers Robert Wood Johnson Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ready and Healthy for Kindergarten Family Literacy program in people with Literacy, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of Intervention Measure (AIM) Questionnaire (time frame: After 8 week period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2020.