APLUS: Assuring Patient-centered Literacy Promotion for Underserved Children Study

Sponsor

Rutgers, The State University of New Jersey (Other)

Overall Status

Completed

CT.gov ID

NCT03242850

Collaborator

Robert Wood Johnson Foundation (Other)

160

Enrollment

Location

Arms

Actual Duration (Months)

8.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Literacy	Behavioral: Intervention Group	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jan 24, 2018

Actual Primary Completion Date :

Aug 24, 2019

Actual Study Completion Date :

Aug 24, 2019

Arms and Interventions

Arm	Intervention/Treatment
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.
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.

Arm

Intervention/Treatment

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.

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.

Outcome Measures

Primary Outcome Measures

Reading Recall [Visit 2 (approx. 6 months)]
Parents will report reading occurrences in a 1 week period including a 24-hour recall.

Secondary Outcome Measures

Survey of Wellbeing of Young Children Milestones [Visit 2 (approx. 6 months)]
Parents will complete the SWYC milestones, a validated, 10 item parent report, developmental screening tool.
StimQ2 Read Scale / Parental Verbal Responsivity Scale [Visit 2 (approx. 6 months)]
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.
Parental Reading Beliefs Inventory [Visit 2 (approx. 6 months)]
Measure of parent reading beliefs
Receipt of intervention [Visit 2 (approx. 6 months)]
Parent report of receipt of guidance on shared reading

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

primary caregiver of a child age 6-15 months,
primary language English or Spanish,
cell phone ownership,
age ≥18 years,
willing to receive text messages, and
willing to accept randomization

Exclusion Criteria:

Individuals unable to provide consent
Individuals who do not meet inclusion criteria

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eric B. Chandler Health Center	New Brunswick	New Jersey	United States	08901

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Manuel E. Jimenez, MD, MS, Assistant professor, Rutgers, The State University of New Jersey

ClinicalTrials.gov Identifier:

NCT03242850

Other Study ID Numbers:

Pro20170000878
73308

First Posted:

Aug 8, 2017

Last Update Posted:

Feb 18, 2020

Last Verified:

Feb 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Manuel E. Jimenez, MD, MS, Assistant professor, Rutgers, The State University of New Jersey

Reading

Text Messages

Video

Cognitive Development

Child Development

Infants

Study Results

No Results Posted as of Feb 18, 2020