Text Messaging Pilot Study | NCT03281356

Studies
Text Messaging Pilot Study

NCT03281356

Sponsor

Rutgers, The State University of New Jersey

Status

Completed

Last Update Posted

Sep 13, 2017Actual

Enrollment

16Actual

Phase

Not Applicable

Conditions

Literacy

Interventions

Intervention Group

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 9, 2017Actual

Primary Completion Date

Jun 13, 2017Actual

Completion Date

Jun 13, 2017Actual

First Submitted Date

Sep 11, 2017

First Submission Date that Met QC Criteria

Sep 11, 2017

First Posted Date

Sep 13, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 11, 2017

Last Update Posted Date

Sep 13, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Manuel E. Jimenez, MD, MS, Assistant Professor, Rutgers, The State University of New JerseyPrincipal Investigator

Lead Sponsor

Rutgers, The State University of New JerseyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This pilot study aims to assess the acceptability, feasibility, and preliminary effectiveness of text messages designed to encourage shared reading among urban parents. We hypothesize that parents will report reading more often to their children after receiving the text messages.

Detailed Description

This is a single arm, pilot study. The participants enrolled will receive two text messages per week for a 4 week period (a total of 8 messages). At the end of the study period we will assess change in number of reading occurrences using a validated measure. Parents will also complete a brief acceptability survey.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention Group	Experimental		Behavioral: Intervention Group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intervention Group	Behavioral	Participants will receive a total of 8 text messages during a 4 week period.	Intervention Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Acceptability Survey	Three questions on the participants feedback on the program.	Visit 2 (1 month)

Secondary Outcomes

Measure	Description	Time Frame
Stim Q Survey	The StimQ is a parent reported measure of the cognitive home environment	Visit 2 (1 month)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Preferred language either English or Spanish,
Parent or legal guardian,
Age ≥ 18,
Willing to accept text messages

Exclusion Criteria:

Individuals unable to provide consent
Individuals who do not meet inclusion criteria

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rutgers Robert Wood Johnson Medical School		New Brunswick	New Jersey	08901	United States

ID	Term
D003142	Communication
D001519	Behavior