Assuring Patient-centered Literacy Promotion for Underserved Children Study

NCT ID: NCT03242850

Last Updated: 2020-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-24
• Study Completion Date: 2019-08-24

Brief 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.

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.

Conditions

Literacy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention group

Group Type: EXPERIMENTAL

Intervention Group

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Robert Wood Johnson Foundation

OTHER

Sponsor Role: collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Manuel E. Jimenez, MD, MS

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Eric B. Chandler Health Center

New Brunswick, New Jersey, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33618060 (View on PubMed)

Other Identifiers

73308

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Pro20170000878

Identifier Type: -

Identifier Source: org_study_id