Study Stopped
Low enrollment.
Reach Home and Read
1 other identifier
interventional
7
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 24, 2018
CompletedStudy Start
First participant enrolled
September 20, 2018
CompletedFirst Posted
Study publicly available on registry
October 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 2, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 2, 2019
CompletedOctober 21, 2019
October 1, 2019
6 months
January 24, 2018
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 INTERVENTIONReach Home and Read
EXPERIMENTALThis arm will receive the Reach Home and Read early literacy intervention
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.
Eligibility Criteria
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
- Duke Universitylead
Study Sites (1)
Duke Children's Primary Care
Durham, North Carolina, 27710, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SEQUENTIAL
- 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