NCT01594840

Brief Summary

This randomized trial has two sets of diapers-- a normal one and one that has tips for how to talk to and engage your toddler. The investigators are hoping that the intervention improves language development.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2012

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

Study Start

First participant enrolled

January 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 9, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

March 26, 2014

Status Verified

March 1, 2014

Enrollment Period

6 months

First QC Date

May 7, 2012

Last Update Submit

March 24, 2014

Conditions

Healthy Infants

Keywords

language developmentparental interaction

Outcome Measures

Primary Outcomes (1)

  • Language development as measured by the Mcarthur Bates CDI

    6 months after

Study Arms (2)

Changing chat

EXPERIMENTAL

Diapers will have tips on them

Device: Changing chat

Control

ACTIVE COMPARATOR

Normal diapers

Device: Changing chat

Interventions

Changing chatDEVICE

Diapers with tips

Changing chatControl

Eligibility Criteria

Age16 Months - 18 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • months of age developmentally normal English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odessa Brown

Seattle, Washington, 98101, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Center for Child Health, Behavior, and Development

Study Record Dates

First Submitted

May 7, 2012

First Posted

May 9, 2012

Study Start

January 1, 2012

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

March 26, 2014

Record last verified: 2014-03

Locations

US(1)