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Developmental Monitoring and Language Promotion

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ClinicalTrials.gov Identifier: NCT03732911
Recruitment Status : Completed
First Posted : November 7, 2018
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Manuel E. Jimenez, MD, MS, Rutgers, The State University of New Jersey

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Child Development Behavioral: Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Developmental Monitoring and Language Promotion
Actual Study Start Date : November 12, 2018
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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?"



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03732911


Locations
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United States, New Jersey
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08901
Sponsors and Collaborators
Rutgers, The State University of New Jersey

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Responsible Party: Manuel E. Jimenez, MD, MS, Assistant Professor, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT03732911     History of Changes
Other Study ID Numbers: Pro2018001244
First Posted: November 7, 2018    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Manuel E. Jimenez, MD, MS, Rutgers, The State University of New Jersey:
Child Development
Cognitive Home Environment
Literacy promotion
Text Messages