Assuring Patient-centered Literacy Promotion for Underserved Children Study (APLUS)

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

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.

Study Overview

• Status: Completed
• Conditions: Literacy
• Intervention / Treatment: Behavioral: Intervention Group

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Eric B. Chandler Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group	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.
No Intervention: Regular care group; This group will receive regular care including standard guidance on shared reading. Participants in this arm will not view the video at the time of enrollment nor will they receive the text messages throughout the 6 months of the randomized controlled trial.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reading Recall	Parents will report reading occurrences in a 1 week period including a 24-hour recall.	Visit 2 (approx. 6 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
Parental Reading Beliefs Inventory	Measure of parent reading beliefs	Visit 2 (approx. 6 months)
Receipt of intervention	Parent report of receipt of guidance on shared reading	Visit 2 (approx. 6 months)

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: Robert Wood Johnson Foundation

Publications and helpful links

General Publications

• Jimenez ME, Crabtree BF, Hudson SV, Mendelsohn AL, Lima D, Shelton PA, Veras J, Lin Y, Pellerano M, Morrow L, Strom BL. Enhancing Reach Out and Read With a Video and Text Messages: A Randomized Trial in a Low-Income Predominantly Latino Sample. Acad Pediatr. 2021 Aug;21(6):968-976. doi: 10.1016/j.acap.2021.02.011. Epub 2021 Feb 19.

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2018
• Primary Completion (Actual): August 24, 2019
• Study Completion (Actual): August 24, 2019

Study Registration Dates

• First Submitted: August 4, 2017
• First Submitted That Met QC Criteria: August 4, 2017
• First Posted (Actual): August 8, 2017

Study Record Updates

• Last Update Posted (Actual): February 18, 2020
• Last Update Submitted That Met QC Criteria: February 14, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Child Development; Infants; Video; Reading; Text Messages; Cognitive Development
• Other Study ID Numbers: Pro20170000878; 73308 (Other Grant/Funding Number: Robert Wood Johnson Foundation)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No