Baby Dvd Effects on Cortisol

Infant Development Clinical Trial

Official title:

A Randomized Controlled Trial of Block Play vs Dvd Viewing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01459848
• Other study ID #: Baby DVD study
• Secondary ID: Endowment
• Status: Completed
• Phase: N/A
• First received: October 20, 2011
• Last updated: March 24, 2014
• Start date: January 2011
• Est. completion date: January 2012

Study information

• Verified date: March 2014
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 9 Months to 12 Months

Eligibility

Inclusion Criteria:

• 9-12 months of age

Study Design

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

Related Conditions & MeSH terms

• Infant Development

Intervention

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

Locations

Country	Name	City	State
United States	Seattle CHildrens Research Institute	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Seattle Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	salivary cortisol	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	No
Primary	salivary cortisol	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	No
Primary	salivary cortisol	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	No
Primary	salivary cortisol	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	No
Primary	salivary cortisol	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	No