HealthyNCT00428376
Does Block Play Improve Language Acquisition: A Randomized Trial
A study testing Building Blocks in people with Healthy, run by University of Washington.
Trial summary
This is a randomized controlled trial of distributing blocks to children ages 1.5 -2.5 years of age to see if language acquisition improves. Read more about this study
- Who is it for?
- Ages 18 to 30 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Building Blocks
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Sep 2005to Sep 2006
- 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 18 to 30 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- healthy children
Who cannot join
- developmental delay, non-English
About this study
Official title: Clinical Trial of Building Block Distribution in Children
This is a randomized controlled trial of distributing blocks to children ages 1.5 -2.5 years of age to see if language acquisition improves.
Read the detailed description
Children in age group are randomized to get two sets of blocks or not. Outcomes include language development assessed using the Macarthur Bates CDI 6 months after enrollment.
- Conditions
- Healthy
- Being tested
- Building Blocks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Building BlocksDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Macarthur Bates Language Inventory
Secondary outcomes (2)
TV viewing
Block play
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2007 (estimated)
- Study startSep 2005
- Primary completionSep 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Single group
- Masking
- Single blind
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Megablocks
- Investigators
- Dimitri Christakis, MD MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00428376
- Sponsor's protocol ID
- 05-0636-01
- Status last verified
- Sep 2008
- First submitted
- 26 Jan 2007
- Last updated
- 29 Sep 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Building Block Distribution in Children
- ClinicalTrials.gov ID
- NCT00428376
- Acronym / sponsor ID
- 05-0636-01
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Megablocks
- Study start
- Sep 2005
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 30 Jan 2007 (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.
This is a randomized controlled trial of distributing blocks to children ages 1.5 -2.5 years of age to see if language acquisition improves.
Detailed description
Children in age group are randomized to get two sets of blocks or not. Outcomes include language development assessed using the Macarthur Bates CDI 6 months after enrollment.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 30 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- healthy children
Key exclusion criteria (1 listed)
- developmental delay, non-English
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 |
|---|---|---|
| Building Blocks | Device | – |
Primary outcome
Macarthur Bates Language Inventory
2 secondary outcomes
TV viewing
Block play
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 29 Sep 2008.
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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
University of Washington
Questions about this trial
What is this clinical trial studying?
A study testing Building Blocks in people with Healthy, run by University of Washington.
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 1 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 29 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
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?
Macarthur Bates Language Inventory. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2008.