Healthy InfantsNCT01594840
Changing Chat: Diaper Tips to Improve Language Development
A study testing Changing chat in people with Healthy Infants, run by Seattle Children's Hospital at 1 site in United States.
Trial summary
This randomized trial has two sets of diapers-- a normal one and one that has tips for how to talk to and engage your toddler. The investigators are hoping that the intervention improves language development. Read more about this study
- Who is it for?
- Ages 16 to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Healthy Infants
- What is being tested?
- Changing chat
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Jul 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 16 to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 16-18 months of age developmentally normal English speaking
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
This randomized trial has two sets of diapers-- a normal one and one that has tips for how to talk to and engage your toddler. The investigators are hoping that the intervention improves language development.
- Conditions
- Healthy Infants
- Being tested
- Changing chat
- Keywords
- language development, parental interaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Changing chatDevice
Diapers with tips
| Study group | Role | What they receive |
|---|---|---|
| Changing chat | Experimental | Diapers will have tips on them Receives: Device: Changing chat |
| Control | Active comparator | Normal diapers Receives: Device: Changing chat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Language development as measured by the Mcarthur Bates CDI
Measured: 6 months after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2012 (estimated)
- Study startJan 2012
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy InfantsStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 70 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01594840
- Sponsor's protocol ID
- Changing chat
- Status last verified
- Mar 2014
- First submitted
- 7 May 2012
- Last updated
- 26 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
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
- Changing Chat: Diaper Tips to Improve Language Development
- ClinicalTrials.gov ID
- NCT01594840
- Acronym / sponsor ID
- Changing chat
- Conditions
- Healthy Infants
- Keywords
- language development, parental interaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 9 May 2012 (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 randomized trial has two sets of diapers-- a normal one and one that has tips for how to talk to and engage your toddler. The investigators are hoping that the intervention improves language development.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Changing chat | Experimental | Device: Changing chatDiapers will have tips on them |
| Control | Active comparator | Device: Changing chatNormal diapers |
Who may qualify
- Ages
- 16 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 16-18 months of age developmentally normal English speaking
Key exclusion criteria (1 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 |
|---|---|---|
| Changing chatDiapers with tips | Device | Changing chat, Control |
Primary outcome
Language development as measured by the Mcarthur Bates CDI
Time frame: 6 months after
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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Changing chat in people with Healthy Infants, 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 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 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?
Language development as measured by the Mcarthur Bates CDI (time frame: 6 months after). 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 26 Mar 2014.