Assuring Patient-centered Literacy Promotion for Underserved Children Study

Literacy Clinical Trial

— APLUS  

Official title:

Assuring Patient-centered Literacy Promotion for Underserved Children to Promote School Readiness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03242850
• Other study ID #: Pro20170000878
• Secondary ID: 73308
• Status: Completed
• Phase: N/A
• Start date: January 24, 2018
• Est. completion date: August 24, 2019

Study information

• Verified date: February 2020
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study tests whether an enhanced primary cared based literacy promotion intervention consisting of a video and text message will increase shared reading occurrences between parents and children compared to the standard version.

Description:

This is a randomized controlled trial aimed at assessing the effectiveness of an enhanced intervention consisting of a video and a series of text messages in promoting shared reading between parents and children. Participants will be randomized to one of two study arms (1) the enhanced intervention consisting of a video in the waiting room, standard guidance on shared reading, and a series of text messages (2) regular care which includes standard guidance on shared reading. The primary outcome will be shared reading occurrences. Secondary outcomes will include receipt of intervention, measure of the cognitive home environment, developmental screening results, and measure of parent reading beliefs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: August 24, 2019
• Est. primary completion date: August 24, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. primary caregiver of a child age 6-15 months,

2. primary language English or Spanish,

3. cell phone ownership,

4. age =18 years,

5. willing to receive text messages, and

6. willing to accept randomization

Exclusion Criteria:

1. Individuals unable to provide consent

2. Individuals who do not meet inclusion criteria

Related Conditions & MeSH terms

• Literacy

Intervention

Behavioral:
• Intervention Group
This group will view a video on shared reading upon enrollment, receive standard guidance on shared reading, and receive a series of text messages for a period of 6 months.

Locations

Country	Name	City	State
United States	Eric B. Chandler Health Center	New Brunswick	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	Robert Wood Johnson Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reading Recall	Parents will report reading occurrences in a 1 week period including a 24-hour recall.	Visit 2 (approx. 6 months)
Secondary	Survey of Wellbeing of Young Children Milestones	Parents will complete the SWYC milestones, a validated, 10 item parent report, developmental screening tool.	Visit 2 (approx. 6 months)
Secondary	StimQ2 Read Scale / Parental Verbal Responsivity Scale	The StimQ2 is a parent reported measure of the cognitive home environment for children age 5 months to 6 years that assesses 4 domains: (1) Availability of Learning Materials (2) Reading (3) Parent Involvement in Developmental Advancement (4) Parental Verbal Responsiveness.	Visit 2 (approx. 6 months)
Secondary	Parental Reading Beliefs Inventory	Measure of parent reading beliefs	Visit 2 (approx. 6 months)
Secondary	Receipt of intervention	Parent report of receipt of guidance on shared reading	Visit 2 (approx. 6 months)