NCT01459848

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 26, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

March 26, 2014

Status Verified

March 1, 2014

Enrollment Period

1 year

First QC Date

October 20, 2011

Last Update Submit

March 24, 2014

Conditions

Infant Development

Keywords

Salivary cortisol measured after DVD watching or block play

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

block play

ACTIVE COMPARATOR

30 minutes of block play with parent

Behavioral: block play

baby dvd

EXPERIMENTAL

watch baby dvd with parent

Behavioral: baby dvd

Interventions

block playBEHAVIORAL

30 minutes of block play

block play
baby dvdBEHAVIORAL

30 minutes of dvd viewing

baby dvd

Eligibility Criteria

Age9 Months - 12 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • months of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seattle CHildrens Research Institute

Seattle, Washington, 98104, United States

Location

Related Publications (1)

  • 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.

    PMID: 23164310DERIVED

Study Officials

  • Dimitri Christakis, MD, MPH

    Seattle Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 20, 2011

First Posted

October 26, 2011

Study Start

January 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

March 26, 2014

Record last verified: 2014-03

Locations

US(1)