NCT03941197

Brief 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

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

April 18, 2019

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 7, 2019

Completed
21 days until next milestone

Study Start

First participant enrolled

May 28, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2019

Completed
Last Updated

February 18, 2020

Status Verified

February 1, 2020

Enrollment Period

4 months

First QC Date

April 18, 2019

Last Update Submit

February 14, 2020

Conditions

Keywords

child developmentfamily literacy programprimary care

Outcome Measures

Primary Outcomes (1)

  • 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.

    After 8 week period.

Secondary Outcomes (3)

  • StimQ-Preschool survey

    At enrollment and after 8 week period.

  • Alphabet knowledge assessment survey

    At enrollment and after 8 week period.

  • Sight word knowledge assessment survey

    At enrollment and after 8 week period.

Study Arms (1)

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

Behavioral: Ready and Healthy for Kindergarten Family Literacy program

Interventions

Participants will participate in 8 parent-child health-themed literacy workshops. Participants will receive 2-3 text messages per week for 8 weeks.

Ready and Healthy for Kindergarten 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 is either Spanish or English.
  • Parent or legal guardian of child
  • Parent age 18 or older
  • Willing to accept text messages

You may not qualify if:

  • Children not entering Kindergarten in Fall 2019 and their parents will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manuel E Jimenez

New Brunswick, New Jersey, 08901, United States

Location

MeSH Terms

Conditions

Literacy

Condition Hierarchy (Ancestors)

CommunicationBehavior

Study Officials

  • Manuel E Jimenez, MD, MS

    Rutgers Robert Wood Johnson Medical School

    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

April 18, 2019

First Posted

May 7, 2019

Study Start

May 28, 2019

Primary Completion

September 28, 2019

Study Completion

September 28, 2019

Last Updated

February 18, 2020

Record last verified: 2020-02

Locations