NCT03242850

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 8, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

January 24, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2019

Completed
Last Updated

February 18, 2020

Status Verified

February 1, 2020

Enrollment Period

1.6 years

First QC Date

August 4, 2017

Last Update Submit

February 14, 2020

Conditions

Keywords

ReadingText MessagesVideoCognitive DevelopmentChild DevelopmentInfants

Outcome Measures

Primary Outcomes (1)

  • Reading Recall

    Parents will report reading occurrences in a 1 week period including a 24-hour recall.

    Visit 2 (approx. 6 months)

Secondary Outcomes (4)

  • Survey of Wellbeing of Young Children Milestones

    Visit 2 (approx. 6 months)

  • StimQ2 Read Scale / Parental Verbal Responsivity Scale

    Visit 2 (approx. 6 months)

  • Parental Reading Beliefs Inventory

    Visit 2 (approx. 6 months)

  • Receipt of intervention

    Visit 2 (approx. 6 months)

Study Arms (2)

Regular care group

NO INTERVENTION

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.

Intervention group

EXPERIMENTAL
Behavioral: Intervention Group

Interventions

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 group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Individuals unable to provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eric B. Chandler Health Center

New Brunswick, New Jersey, 08901, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Literacy

Condition Hierarchy (Ancestors)

CommunicationBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

August 4, 2017

First Posted

August 8, 2017

Study Start

January 24, 2018

Primary Completion

August 24, 2019

Study Completion

August 24, 2019

Last Updated

February 18, 2020

Record last verified: 2020-02

Locations