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Developmental Monitoring and Language Promotion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE November 5, 2018
First Posted Date  ICMJE November 7, 2018
Last Update Posted Date July 10, 2019
Actual Study Start Date  ICMJE November 12, 2018
Actual Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03732911 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2018)
  • 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.
  • 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?"
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Developmental Monitoring and Language Promotion
Official Title  ICMJE Developmental Monitoring and Language Promotion
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Child Development
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Intervention
Intervention arm
Intervention: Behavioral: Intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 10, 2019)
14
Original Estimated Enrollment  ICMJE
 (submitted: November 5, 2018)
50
Actual Study Completion Date  ICMJE June 30, 2019
Actual Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03732911
Other Study ID Numbers  ICMJE Pro2018001244
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Manuel E. Jimenez, MD, MS, Rutgers, The State University of New Jersey
Study Sponsor  ICMJE Rutgers, The State University of New Jersey
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Rutgers, The State University of New Jersey
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP