Baby Dvd Effects on Cortisol

March 24, 2014 updated by: Dimitri Christakis, Seattle Children's Hospital

A Randomized Controlled Trial of Block Play vs Dvd Viewing

The investigators will do an experiment where 9-12 month old infants are randomized to 30 minutes of block play or 30 minutes of watching a baby DVD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98104
        • Seattle Childrens Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 months to 1 year (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 9-12 months of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: block play
30 minutes of block play with parent
Behavioral: block play
30 minutes of block play
Experimental: baby dvd
watch baby dvd with parent
Behavioral: baby dvd
30 minutes of dvd viewing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
salivary cortisol
Time Frame: Baseline
Study will be assessing babies' neuroendocrine responses to play vs TV viewing. Salivary cortisol, as an indicator of neuroendocrine response, will be measured over time with the intervals as specified under time frame. For each time point, investigator will adjust for prior ones in a repeated measures analysis.
Baseline
salivary cortisol
Time Frame: 10 minutes post baseline
Study will be assessing babies' neuroendocrine responses to play vs TV viewing. Salivary cortisol, as an indicator of neuroendocrine response, will be measured over time with the intervals as specified under time frame. For each time point, investigator will adjust for prior ones in a repeated measures analysis
10 minutes post baseline
salivary cortisol
Time Frame: 20 minutes post baseline
Study will be assessing babies' neuroendocrine responses to play vs TV viewing. Salivary cortisol, as an indicator of neuroendocrine response, will be measured over time with the intervals as specified under time frame. For each time point, investigator will adjust for prior ones in a repeated measures analysis
20 minutes post baseline
salivary cortisol
Time Frame: 30 minutes post baseline
Study will be assessing babies' neuroendocrine responses to play vs TV viewing. Salivary cortisol, as an indicator of neuroendocrine response, will be measured over time with the intervals as specified under time frame. For each time point, investigator will adjust for prior ones in a repeated measures analysis
30 minutes post baseline
salivary cortisol
Time Frame: 40 minutes post baseline
Study will be assessing babies' neuroendocrine responses to play vs TV viewing. Salivary cortisol, as an indicator of neuroendocrine response, will be measured over time with the intervals as specified under time frame. For each time point, investigator will adjust for prior ones in a repeated measures analysis
40 minutes post baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seattle Children's Hospital

Investigators

  • Principal Investigator: Dimitri Christakis, MD, MPH, Seattle Children's

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

October 20, 2011

First Submitted That Met QC Criteria

October 24, 2011

First Posted (Estimate)

October 26, 2011

Study Record Updates

Last Update Posted (Estimate)

March 26, 2014

Last Update Submitted That Met QC Criteria

March 24, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Baby DVD study
  • Endowment (Other Grant/Funding Number: Adkins endowment)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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