NCT04423133

Brief Summary

This study will examine the feasibility of implementing a virtual bilingual health-focused family literacy program.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

June 10, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2020

Completed
Last Updated

September 29, 2020

Status Verified

September 1, 2020

Enrollment Period

3 months

First QC Date

June 3, 2020

Last Update Submit

September 25, 2020

Conditions

Language DevelopmentLiteracyHealth Behavior

Keywords

Language developmentHealth routinesLiteracy

Outcome Measures

Primary Outcomes (2)

  • 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.

    8 weeks

  • Acceptability of the program

    Data on acceptability of the program will be collected via parent surveys

    8 weeks

Secondary Outcomes (4)

  • StimQ Reading Scale

    Baseline, 8 weeks

  • StimQ Parental Verbal Responsivity Scale

    Baseline, 8 weeks

  • Child Literacy Skills

    Baseline, 8 weeks

  • Family Health Routines Assessment

    Baseline, 8 weeks

Study Arms (1)

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.

Behavioral: Online Family Literacy Program

Interventions

Online Family Literacy ProgramBEHAVIORAL

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.

Online Family Literacy Program

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Preferred language either Spanish or bilingual (English and Spanish)
  • Parent or legal guardian of the child
  • Parent Age ≥ 18

You may not qualify if:

  • Children not entering Kindergarten.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Child Health Institute of NJ

New Brunswick, New Jersey, 08901, United States

Location

MeSH Terms

Conditions

LiteracyHealth Behavior

Condition Hierarchy (Ancestors)

CommunicationBehavior

Study Officials

  • Manuel E Jimenez, MD, MS

    Rutgers Biomedical Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 3, 2020

First Posted

June 9, 2020

Study Start

June 10, 2020

Primary Completion

September 4, 2020

Study Completion

September 4, 2020

Last Updated

September 29, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)