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Baby Dvd Effects on Cortisol

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01459848
First Posted: October 26, 2011
Last Update Posted: March 26, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dimitri Christakis, Seattle Children's Hospital
  Purpose
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.

Condition Intervention
Infant Development Behavioral: block play Behavioral: baby dvd

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Official Title: A Randomized Controlled Trial of Block Play vs Dvd Viewing

Further study details as provided by Dimitri Christakis, Seattle Children's Hospital:

Primary Outcome Measures:
  • 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.

  • 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

  • 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

  • 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

  • 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


Estimated Enrollment: 50
Study Start Date: January 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   9 Months to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 9-12 months of age
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01459848


Locations
United States, Washington
Seattle CHildrens Research Institute
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Seattle Children's Hospital
Investigators
Principal Investigator: Dimitri Christakis, MD, MPH Seattle Children's
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dimitri Christakis, Professor, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT01459848     History of Changes
Other Study ID Numbers: Baby DVD study
Endowment ( Other Grant/Funding Number: Adkins endowment )
First Submitted: October 20, 2011
First Posted: October 26, 2011
Last Update Posted: March 26, 2014
Last Verified: March 2014

Keywords provided by Dimitri Christakis, Seattle Children's Hospital:
Salivary cortisol measured after DVD watching or block play