Baby Dvd Effects on Cortisol

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dimitri Christakis, Seattle Children's Hospital
ClinicalTrials.gov Identifier:
NCT01459848
First received: October 20, 2011
Last updated: March 24, 2014
Last verified: March 2014
  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 Blind (Investigator, Outcomes Assessor)
Official Title: A Randomized Controlled Trial of Block Play vs Dvd Viewing

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

Primary Outcome Measures:
  • 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


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

Ages Eligible for Study:   9 Months to 12 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 9-12 months of age
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Seattle Children's Hospital

Additional 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
Study First Received: October 20, 2011
Last Updated: March 24, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 23, 2014