Language DevelopmentNCT04423133
Bilingual Family Literacy Program Pilot
A study testing Online Family Literacy Program in people with Language Development and Literacy, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
This study will examine the feasibility of implementing a virtual bilingual health-focused family literacy program. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Language Development, Literacy, Health Behavior
- What is being tested?
- Online Family Literacy Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2020to 4 Sep 2020
- 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 either Spanish or bilingual (English and Spanish)
- Parent or legal guardian of the child
- Parent Age ≥ 18
Who cannot join
- Children not entering Kindergarten.
Trial locations and contacts
1 site in 1 country.
United States1 site
Child Health Institute of NJ
New Brunswick, New Jersey, 08901
About this study
Official title: Bilingual Family Literacy Program Pilot: Ready and Healthy for Kindergarten
This study will examine the feasibility of implementing a virtual bilingual health-focused family literacy program.
Read the detailed description
"Ready and Healthy for Kindergarten" is a bilingual family literacy program that uses anticipatory guidance on important health routines to introduce critical language and literacy skills to young Latino children entering Kindergarten and their families.
The objectives of this study are 1) To assess the feasibility of implementing the bilingual family literacy program online via video conference by collecting information on family attendance and participation, 2) To examine the acceptability of the program, and 3) To explore preliminary effects of the program on the family health and language routines as well as child language and literacy skill acquisition.
- Conditions
- Language Development, Literacy, Health Behavior
- Being tested
- Online Family Literacy Program
- Keywords
- Language development, Health routines, Literacy
- Medical subject headings
- Literacy, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Family Literacy ProgramBehavioural
Parent-child dyads will participate in 8 weekly online health-themed workshops that introduce language and literacy skills. Participants will also receive 2-3 text messages per week for the duration of the program and children's books.
| Study group | Role | What they receive |
|---|---|---|
| Online Family Literacy Program | Experimental | The Ready and Healthy for Kindergarten program is a bilingual family literacy program that uses anticipatory guidance on health routines (e.g., physical activity) to introduce language and literacy skills to children and their families delivered via an online video conference format. Receives: Behavioral: Online Family Literacy Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of sessions attended by participants
Data on the number of sessions attended by participants will be used to assess the feasibility of the online family literacy program.
Measured: 8 weeks
Acceptability of the program
Data on acceptability of the program will be collected via parent surveys
Measured: 8 weeks
Secondary outcomes (4)
StimQ Reading Scale
Reading activity will be measured using the StimQ Reading Scale. The StimQ is a structured interview. Individual items are summed and scores range from 0 to 19. Higher scores reflect higher reading activities.
Measured: Baseline, 8 weeks
StimQ Parental Verbal Responsivity Scale
Parent verbal responsiveness will be measured using the StimQ Parental Verbal Responsivity Scale. The StimQ is a structured interview. Individual items are summed and scores range from 0 to 7. Higher scores reflect higher parent verbal responsiveness.
Measured: Baseline, 8 weeks
Child Literacy Skills
Investigator developed assessments of child alphabet knowledge and sight word recognition. Higher scores reflect higher literacy skills.
Measured: Baseline, 8 weeks
Family Health Routines Assessment
Descriptive survey measuring family health routines and behaviors.
Measured: Baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start10 Jun 2020
- Primary completion4 Sep 2020
- Study completion4 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Language DevelopmentStudies of the same condition, open and under way.
- 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
- 35 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 Biomedical Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04423133
- Sponsor's protocol ID
- Pro2020000656
- Status last verified
- Sep 2020
- First submitted
- 3 Jun 2020
- Last updated
- 29 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilingual Family Literacy Program Pilot: Ready and Healthy for Kindergarten
- ClinicalTrials.gov ID
- NCT04423133
- Acronym / sponsor ID
- Pro2020000656
- Conditions
- Language Development, Literacy, Health Behavior
- Keywords
- Language development, Health routines, Literacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 10 Jun 2020 (actual)
- Primary completion
- 4 Sep 2020 (actual)
- Study completion
- 4 Sep 2020 (actual)
- First posted
- 9 Jun 2020 (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.
This study will examine the feasibility of implementing a virtual bilingual health-focused family literacy program.
Detailed description
"Ready and Healthy for Kindergarten" is a bilingual family literacy program that uses anticipatory guidance on important health routines to introduce critical language and literacy skills to young Latino children entering Kindergarten and their families.
The objectives of this study are 1) To assess the feasibility of implementing the bilingual family literacy program online via video conference by collecting information on family attendance and participation, 2) To examine the acceptability of the program, and 3) To explore preliminary effects of the program on the family health and language routines as well as child language and literacy skill acquisition.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Online Family Literacy Program | Experimental | Behavioral: Online Family Literacy ProgramThe Ready and Healthy for Kindergarten program is a bilingual family literacy program that uses anticipatory guidance on health routines (e.g., physical activity) to introduce language and literacy skills to children and their families delivered via an online video conference format. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Preferred language either Spanish or bilingual (English and Spanish)
- Parent or legal guardian of the child
- Parent Age ≥ 18
Key exclusion criteria (1 listed)
- Children not entering Kindergarten.
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 |
|---|---|---|
| Online Family Literacy ProgramParent-child dyads will participate in 8 weekly online health-themed workshops that introduce language and literacy skills. Participants will also receive 2-3 text messages per week for the duration of the program and children's books. | Behavioural | Online Family Literacy Program |
Primary outcome
Number of sessions attended by participants
Time frame: 8 weeks
Data on the number of sessions attended by participants will be used to assess the feasibility of the online family literacy program.
Acceptability of the program
Time frame: 8 weeks
Data on acceptability of the program will be collected via parent surveys
4 secondary outcomes
StimQ Reading Scale
Time frame: Baseline, 8 weeks
StimQ Parental Verbal Responsivity Scale
Time frame: Baseline, 8 weeks
Child Literacy Skills
Time frame: Baseline, 8 weeks
Family Health Routines Assessment
Time frame: Baseline, 8 weeks
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 29 Sep 2020.
- Individual participant dataSharing planned: No
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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 Biomedical Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Family Literacy Program in people with Language Development and 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 3 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 29 Sep 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?
Number of sessions attended by participants (time frame: 8 weeks). The study lists 2 primary outcomes in all. 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 29 Sep 2020.