NCT03732911

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

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

November 5, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

November 12, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

July 10, 2019

Status Verified

June 1, 2019

Enrollment Period

8 months

First QC Date

November 5, 2018

Last Update Submit

July 8, 2019

Conditions

Child Development

Keywords

Child DevelopmentCognitive Home EnvironmentLiteracy promotionText Messages

Outcome Measures

Primary Outcomes (1)

  • Knowledge of child development

    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 Outcomes (2)

  • Home cognitive environment:

    Visit 2 (6 months)

  • Frequency Shared Reading:

    Visit 2 (6 months)

Study Arms (1)

Intervention

EXPERIMENTAL

Intervention arm

Behavioral: Intervention

Interventions

InterventionBEHAVIORAL

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.

Intervention

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Preferred language either English or Spanish,
  • Parent or legal guardian,
  • Age ≥ 18 years,
  • Willing to accept text messages
  • Child ≤ 20 months old

You may not qualify if:

  • Individuals unable to provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

Location

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 5, 2018

First Posted

November 7, 2018

Study Start

November 12, 2018

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

July 10, 2019

Record last verified: 2019-06

Locations

US(1)