NCT03699592

Brief Summary

This will be a time series prospective cohort and comparison group design to evaluate the effect on home literacy environments of the Reach Home and Read intervention as compared to standard programming provided by home visiting staff. The intervention will consist of staff training for East Durham Children's Initiative (EDCI) early childhood staff and the provision of an age appropriate book at their home visits. The control group will be children receiving the current EDCI home visiting programming. The intervention group will receive standard EDCI programming and the Reach Home and Read intervention administered by the EDCI early childhood home visiting staff. The standardized StimQ home literacy assessment tool will be used to measure changes in the home literacy environment. Additionally, a qualitative portion of this study will inform future research and tool-kit design. The design is a qualitative descriptive study that utilizes the methodologies of focus groups for data collection.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

January 24, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

September 20, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 9, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2019

Completed
Last Updated

October 21, 2019

Status Verified

October 1, 2019

Enrollment Period

6 months

First QC Date

January 24, 2018

Last Update Submit

October 17, 2019

Conditions

Outcome Measures

Primary Outcomes (7)

  • Home Literacy Environment

    Stim-Q scores

    6 months

  • Number of participants that enjoyed the program measured by a survey

    Up to 6 months

  • Number of participants that liked the books provided in the program measured by a survey

    Up to 6 months

  • Number of participants that stated they liked the information provided about early literacy measured by a survey

    Up to 6 months

  • Number of staff members that stated they liked the program as measured by a survey

    Up to 6 months

  • Number of staff members that stated the program was easy to administer as measured by a survey

    Up to 6 months

  • Number of staff members that stated they liked the books provided in the program measured by a survey

    Up to 6 months

Study Arms (2)

Control

NO INTERVENTION

Reach Home and Read

EXPERIMENTAL

This arm will receive the Reach Home and Read early literacy intervention

Behavioral: Reach Home and Read Toolkit

Interventions

The toolkit currently includes one age-appropriate book along with a set of educational pamphlets explaining the importance home literacy. These educational materials focus on appropriate literacy milestones and descriptions of how parents can engage with their children around books. In addition, we will create an information sheet outlining zipcode-specific community literacy resources, including location and information on how to access the library, where to obtain low-cost books, and a schedule of literacy promotion activities in their community (e.g. community reading sessions). All materials will also be translated into Spanish by a certified interpreter, and will be reviewed to ensure that they are written at a fifth grade reading level. Additionally, EDCI families receiving this intervention will also receive an additional new book at each home visit conducted during the study period.

Reach Home and Read

Eligibility Criteria

Age6 Months - 12 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Families who live within the EDCI zone Families who can read and write in English and/or Spanish Families with children aged 6 months to 12 months at the time of enrollment Children born at \>37 weeks gestation

You may not qualify if:

  • Parent with severe medical or mental health condition limiting ability to attend appointments Child with severe medical or mental health condition limiting ability to attend appointments or participate in behavioral therapies Parent and child plan to move out of state in the next 6 months, or plan to live in another state for 2 months or longer within the next 6 months (ex., summer vacation).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke Children's Primary Care

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Literacy

Condition Hierarchy (Ancestors)

CommunicationBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SEQUENTIAL
Model Details: time series prospective cohort and comparison group design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2018

First Posted

October 9, 2018

Study Start

September 20, 2018

Primary Completion

April 2, 2019

Study Completion

April 2, 2019

Last Updated

October 21, 2019

Record last verified: 2019-10

Locations