LiteracyNCT03699592
Reach Home and Read
A study testing Reach Home and Read Toolkit in people with Literacy, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Literacy
- What is being tested?
- Reach Home and Read Toolkit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2018to 2 Apr 2019
- 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 6 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Children's Primary Care
Durham, North Carolina, 27710
About this study
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.
Read the detailed description
The ROR-h Toolkit: 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. The investigators will conduct pre-study, preliminary testing of the toolkit among at least five families and EDCI staff participating in EDCI's Parent Café, and incorporate changes. In addition, the investigators 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 using web-based technology (Microsoft Word). Additionally, EDCI families receiving this intervention will also receive an additional new book at each home visit conducted during the study period.
The baseline cohort of 50 families will be recruited from families receiving EDCI early childhood home visits. Families will be approached by EDCI staff and will be asked whether they are interested in being contacted about participation in the study. Because our intervention includes children aged 6-12 months, EDCI staff will approach all families with children aged 5-11 months who participate in the early childhood program. If a family agrees to be contacted, a trained research assistant will contact and consent the family by phone. Once consent is obtained, baseline demographic information will be collected via REDCap. This information will include patient age, patient race, number of children in the family, parent age, parent education, insurance, and primary language spoken in the home. Baseline StimQ assessment data will also be collected and entered into REDCap. When possible, information will be entered into REDCap electronically by the family from their own electronic device. When this is not possible, the research assistant will collect this data electronically in person or by phone.
Once the family is enrolled and baseline StimQ data has been collected, EDCI staff will continue to provide their standard home visiting services. After three months, families will be sent a follow up StimQ assessment to be completed electronically via REDCap. If the family does not complete this follow up, they will be contacted by the research assistant to complete this follow up at two week intervals for 6 weeks.
Once the baseline cohort has completed their 3 month study period, EDCI staff will receive tool-kit training. The study PI (Erickson) will conduct a one-hour training session with all EDCI home visitors. The training will cover the importance of literacy in health and wellness, the impact of exposure to books and reading in children and how this affects their social and emotional development, and how to implement this model of teaching in their home visit. EDCI home visitors will also complete online modules validated by ROR.
Once training is complete, recruitment and enrollment for the intervention group will begin. Families will be approached by EDCI staff and will undergo the same recruitment and enrollment procedure as above. We plan to enroll and additional 50 families in this cohort. Demographic information and baseline StimQ data will be conducted as above. Once families are enrolled, EDCI staff will provide the literacy toolkit described above at the next scheduled home visit and engage actively with the family around the importance of early literacy using the kit as a tool to model positive interactions. EDCI staff will provide an additional book at each scheduled monthly visit over the next 3 months and an additional fact sheet outlining age appropriate literacy milestones at 3 months. At the completion of the 3 month intervention period, families will be sent a follow up StimQ assessment to be completed electronically via REDCap. If the family does not complete this follow up, they will be contacted by the research assistant to complete this follow up at two week intervals for 6 weeks. Families will also be provided with acceptability surveys at this time.
For the qualitative portion of this study, 15-20 key informants will be recruited. Interviews and/or focus groups will be held at the EDCI office and facilitated by a member of the DOCR research services team versed in qualitative data collection and analysis. The facilitator will utilize a guide during group discussions and/or interviews which will serve to structure conversations around relevant questions. Study participants will be asked to answer a few demographic questions before sharing experiences and perspectives. The groups and/or interviews will be recorded on a secure digital recorder; the audio file will be uploaded immediately to a secure Duke server. Individual participation will last approximately 1 hour and refreshments will be provided.
- Conditions
- Literacy
- Being tested
- Reach Home and Read Toolkit
- Medical subject headings
- Literacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reach Home and Read ToolkitBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Reach Home and Read | Experimental | This arm will receive the Reach Home and Read early literacy intervention Receives: Behavioral: Reach Home and Read Toolkit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Home Literacy Environment
Stim-Q scores
Measured: 6 months
Number of participants that enjoyed the program measured by a survey
Measured: Up to 6 months
Number of participants that liked the books provided in the program measured by a survey
Measured: Up to 6 months
Number of participants that stated they liked the information provided about early literacy measured by a survey
Measured: Up to 6 months
Number of staff members that stated they liked the program as measured by a survey
Measured: Up to 6 months
Number of staff members that stated the program was easy to administer as measured by a survey
Measured: Up to 6 months
Number of staff members that stated they liked the books provided in the program measured by a survey
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start20 Sep 2018
- Primary completion2 Apr 2019
- Study completion2 Apr 2019
Why it stopped: Low enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LiteracyStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- time series prospective cohort and comparison group design
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03699592
- Sponsor's protocol ID
- Pro00086166
- Status last verified
- Oct 2019
- First submitted
- 24 Jan 2018
- Last updated
- 21 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reach Home and Read
- ClinicalTrials.gov ID
- NCT03699592
- Acronym / sponsor ID
- Pro00086166
- Conditions
- Literacy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 20 Sep 2018 (actual)
- Primary completion
- 2 Apr 2019 (actual)
- Study completion
- 2 Apr 2019 (actual)
- First posted
- 9 Oct 2018 (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 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.
Detailed description
The ROR-h Toolkit: 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. The investigators will conduct pre-study, preliminary testing of the toolkit among at least five families and EDCI staff participating in EDCI's Parent Café, and incorporate changes. In addition, the investigators 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 using web-based technology (Microsoft Word). Additionally, EDCI families receiving this intervention will also receive an additional new book at each home visit conducted during the study period.
The baseline cohort of 50 families will be recruited from families receiving EDCI early childhood home visits. Families will be approached by EDCI staff and will be asked whether they are interested in being contacted about participation in the study. Because our intervention includes children aged 6-12 months, EDCI staff will approach all families with children aged 5-11 months who participate in the early childhood program. If a family agrees to be contacted, a trained research assistant will contact and consent the family by phone. Once consent is obtained, baseline demographic information will be collected via REDCap. This information will include patient age, patient race, number of children in the family, parent age, parent education, insurance, and primary language spoken in the home. Baseline StimQ assessment data will also be collected and entered into REDCap. When possible, information will be entered into REDCap electronically by the family from their own electronic device. When this is not possible, the research assistant will collect this data electronically in person or by phone.
Once the family is enrolled and baseline StimQ data has been collected, EDCI staff will continue to provide their standard home visiting services. After three months, families will be sent a follow up StimQ assessment to be completed electronically via REDCap. If the family does not complete this follow up, they will be contacted by the research assistant to complete this follow up at two week intervals for 6 weeks.
Once the baseline cohort has completed their 3 month study period, EDCI staff will receive tool-kit training. The study PI (Erickson) will conduct a one-hour training session with all EDCI home visitors. The training will cover the importance of literacy in health and wellness, the impact of exposure to books and reading in children and how this affects their social and emotional development, and how to implement this model of teaching in their home visit. EDCI home visitors will also complete online modules validated by ROR.
Once training is complete, recruitment and enrollment for the intervention group will begin. Families will be approached by EDCI staff and will undergo the same recruitment and enrollment procedure as above. We plan to enroll and additional 50 families in this cohort. Demographic information and baseline StimQ data will be conducted as above. Once families are enrolled, EDCI staff will provide the literacy toolkit described above at the next scheduled home visit and engage actively with the family around the importance of early literacy using the kit as a tool to model positive interactions. EDCI staff will provide an additional book at each scheduled monthly visit over the next 3 months and an additional fact sheet outlining age appropriate literacy milestones at 3 months. At the completion of the 3 month intervention period, families will be sent a follow up StimQ assessment to be completed electronically via REDCap. If the family does not complete this follow up, they will be contacted by the research assistant to complete this follow up at two week intervals for 6 weeks. Families will also be provided with acceptability surveys at this time.
For the qualitative portion of this study, 15-20 key informants will be recruited. Interviews and/or focus groups will be held at the EDCI office and facilitated by a member of the DOCR research services team versed in qualitative data collection and analysis. The facilitator will utilize a guide during group discussions and/or interviews which will serve to structure conversations around relevant questions. Study participants will be asked to answer a few demographic questions before sharing experiences and perspectives. The groups and/or interviews will be recorded on a secure digital recorder; the audio file will be uploaded immediately to a secure Duke server. Individual participation will last approximately 1 hour and refreshments will be provided.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- time series prospective cohort and comparison group design
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Reach Home and Read | Experimental | Behavioral: Reach Home and Read ToolkitThis arm will receive the Reach Home and Read early literacy intervention |
Who may qualify
- Ages
- 6 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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).
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 |
|---|---|---|
| Reach Home and Read ToolkitThe 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. | Behavioural | Reach Home and Read |
Primary outcome
Home Literacy Environment
Time frame: 6 months
Stim-Q scores
Number of participants that enjoyed the program measured by a survey
Time frame: Up to 6 months
Number of participants that liked the books provided in the program measured by a survey
Time frame: Up to 6 months
Number of participants that stated they liked the information provided about early literacy measured by a survey
Time frame: Up to 6 months
Number of staff members that stated they liked the program as measured by a survey
Time frame: Up to 6 months
Number of staff members that stated the program was easy to administer as measured by a survey
Time frame: Up to 6 months
Number of staff members that stated they liked the books provided in the program measured by a survey
Time frame: Up to 6 months
Results and safety
The study was stopped early (reason given: Low enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reach Home and Read Toolkit in people with Literacy, run by Duke University 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 1 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: stopped early, as of the sponsor's last update on 21 Oct 2019. 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 was stopped early (reason given: Low enrollment.). Results are not available in the source record.
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?
Home Literacy Environment (time frame: 6 months). The study lists 7 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 21 Oct 2019; AzTrials last refreshed its copy on 1 Nov 2026.