Developmental Monitoring and Language Promotion

July 8, 2019 updated by: Manuel E. Jimenez, MD, MS, Rutgers, The State University of New Jersey
The goal of this study is to pilot test an intervention developed to enhance parent knowledge regarding child development and encourage parents to engage in activities that promote language acquisition.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Our specific aim for this proposal is to pilot test an intervention developed to enhance parent knowledge regarding child development and the home cognitive environment comprised of distribution of (1) publicly available developmental monitoring materials, (2) age and language appropriate children's books, and (3) text message reminders. Participants in this intervention will receive: (1) educational materials about child development and developmental monitoring checklists; (2) age and language appropriate picture books; and (3) two text messages per week for a 6-month period. Differences in pre- and post-intervention knowledge regarding child development and the home cognitive environment will be assessed.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers Robert Wood Johnson Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Preferred language either English or Spanish,
  2. Parent or legal guardian,
  3. Age ≥ 18 years,
  4. Willing to accept text messages
  5. Child ≤ 20 months old

Exclusion Criteria:

  1. Individuals unable to provide consent
  2. Individuals who do not meet inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Intervention arm
Behavioral: Intervention
Participants will receive the following intervention bundle (1) educational materials about child development and developmental monitoring checklists; (2) age and language appropriate picture books; and (3) two tailored text messages per week for a 6-month period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knowledge of child development
Time Frame: Visit 2 (6 months)
We will ask parents to respond to questions regarding child development upon enrollment and at 6-month follow-up.Knowledge questions are based on CDC materials and evidence based screening tools.
Visit 2 (6 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Home cognitive environment:
Time Frame: Visit 2 (6 months)
The StimQ2 is a validated, parent-report measure of the cognitive home environment for children that assesses 4 domains: (1) availability of learning materials, (2) reading, (3) parent involvement in developmental advancement, and (4) parental verbal responsiveness. We will administer the Reading and Parental Verbal Response Scale. Participants will be asked to complete the StimQ2 pre- and post-intervention.
Visit 2 (6 months)
Frequency Shared Reading:
Time Frame: Visit 2 (6 months)
To measure how often parents read to their children, they will be asked to respond to the following question at enrollment and at 6-month follow-up, "How often did you read to your child in the last week?"
Visit 2 (6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rutgers, The State University of New Jersey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 12, 2018

Primary Completion (Actual)

June 30, 2019

Study Completion (Actual)

June 30, 2019

Study Registration Dates

First Submitted

November 5, 2018

First Submitted That Met QC Criteria

November 5, 2018

First Posted (Actual)

November 7, 2018

Study Record Updates

Last Update Posted (Actual)

July 10, 2019

Last Update Submitted That Met QC Criteria

July 8, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Pro2018001244

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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