Infant DevelopmentNCT01459848
Baby Dvd Effects on Cortisol
A study testing block play and baby dvd in people with Infant Development, run by Seattle Children's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 9 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Infant Development
- What is being tested?
- block play and baby dvd
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 9-12 months of age
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle CHildrens Research Institute
Seattle, Washington, 98104
About this study
Official title: A Randomized Controlled Trial of Block Play vs Dvd Viewing
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.
- Conditions
- Infant Development
- Being tested
- block play, baby dvd
- Keywords
- Salivary cortisol measured after DVD watching or block play
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
block playBehavioural
30 minutes of block play
baby dvdBehavioural
30 minutes of dvd viewing
| Study group | Role | What they receive |
|---|---|---|
| block play | Active comparator | 30 minutes of block play with parent Receives: Behavioral: block play |
| baby dvd | Experimental | watch baby dvd with parent Receives: Behavioral: baby dvd |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 40 minutes post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infant DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dimitri Christakis, Seattle Children's Hospital
- Investigators
- Dimitri Christakis, MD, MPH, Principal investigator, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01459848
- Sponsor's protocol ID
- Baby DVD study
- Other IDs
- Endowment
- Status last verified
- Mar 2014
- First submitted
- 20 Oct 2011
- Last updated
- 26 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 23164310
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Block Play vs Dvd Viewing
- ClinicalTrials.gov ID
- NCT01459848
- Acronym / sponsor ID
- Baby DVD study
- Conditions
- Infant Development
- Keywords
- Salivary cortisol measured after DVD watching or block play
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 26 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| block play | Active comparator | Behavioral: block play30 minutes of block play with parent |
| baby dvd | Experimental | Behavioral: baby dvdwatch baby dvd with parent |
Who may qualify
- Ages
- 9 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 9-12 months of age
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| block play30 minutes of block play | Behavioural | block play |
| baby dvd30 minutes of dvd viewing | Behavioural | baby dvd |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2014.
- Derived from this study: PubMed 23164310Christakis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dimitri Christakis, MD, MPH principal investigator
Seattle Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing block play and baby dvd in people with Infant Development, run by Seattle Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
salivary cortisol (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01459848, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2014.