Baby Dvd Effects on Cortisol

This study is currently recruiting participants.

Verified October 2011 by Seattle Children's Hospital

Sponsor:

Information provided by (Responsible Party):

Dimitri Christakis, Seattle Children's Hospital

ClinicalTrials.gov Identifier:

NCT01459848

First received: October 20, 2011

Last updated: October 24, 2011

Last verified: October 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

October 20, 2011

Last Updated Date

October 24, 2011

Start Date ^ICMJE

January 2011

Estimated Primary Completion Date

January 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

salivary cortisol [ Time Frame: Baseline ] [ Designated as safety issue: No ]
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.
salivary cortisol [ Time Frame: 10 minutes post baseline ] [ Designated as safety issue: No ]
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
salivary cortisol [ Time Frame: 20 minutes post baseline ] [ Designated as safety issue: No ]
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
salivary cortisol [ Time Frame: 30 minutes post baseline ] [ Designated as safety issue: No ]
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
salivary cortisol [ Time Frame: 40 minutes post baseline ] [ Designated as safety issue: No ]
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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01459848 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Baby Dvd Effects on Cortisol

Official Title ^ICMJE

A Randomized Controlled Trial of Block Play vs Dvd Viewing

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)

Condition ^ICMJE

Infant Development

Intervention ^ICMJE

Behavioral: block play
30 minutes of block play
Behavioral: baby dvd
30 minutes of dvd viewing

Study Arm (s)

Active Comparator: block play
30 minutes of block play with parent

Intervention: Behavioral: block play
Experimental: baby dvd
watch baby dvd with parent

Intervention: Behavioral: baby dvd

Publications *

Christakis DA, Liekweg K, Garrison MM, Wright JA. Infant video viewing and salivary cortisol responses: a randomized experiment. J Pediatr. 2013 May;162(5):1035-40. doi: 10.1016/j.jpeds.2012.10.032. Epub 2012 Nov 16.

* 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

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2012

Estimated Primary Completion Date

January 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

9-12 months of age

Gender

Both

Ages

9 Months to 12 Months

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: dimitri christakis, md

206 884 8237

dachris@uw.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01459848

Other Study ID Numbers ^ICMJE

Baby DVD study, Endowment

Has Data Monitoring Committee

Responsible Party

Dimitri Christakis, Seattle Children's Hospital

Study Sponsor ^ICMJE

Seattle Children's Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Dimitri Christakis, MD, MPH

Seattle Children's

Information Provided By

Seattle Children's Hospital

Verification Date

October 2011

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

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