Language AcquisitionNCT00926510
The Use of a Language Toolkit for Toddlers
A study testing Language toolkit and Safety counseling in people with Language Acquisition, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
To investigate whether young children with isolated expressive language delay benefit from early intervention with a simple language toolkit and brief instructions provided to their caregivers. Read more about this study
- Who is it for?
- Ages 14 to 19 months
- Conditions the study is for
- Language Acquisition
- What is being tested?
- Language toolkit and Safety counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Sep 2011
- 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 14 to 19 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 14.5 to 18.5 months
- Below average expressive language
- Otherwise normal development
Who cannot join
- Other developmental delay
- Non-English primary language
Trial locations and contacts
1 site in 1 country.
United States1 site
North Carolina Children's Hospital
Chapel Hill, North Carolina, 27516
About this study
Official title: Two to Talk: The Use of a Language Toolkit for Toddlers
To investigate whether young children with isolated expressive language delay benefit from early intervention with a simple language toolkit and brief instructions provided to their caregivers.
We hypothesize that children whose families are provided the language toolkit will develop more words over the subsequent 3 months.
- Conditions
- Language Acquisition
- Being tested
- Language toolkit, Safety counseling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Language toolkitBehavioural
Simple toolkit of interactive things to stimulate language.
Safety counselingBehavioural
Smoke detector and general safety counseling
| Study group | Role | What they receive |
|---|---|---|
| Language Toolkit | Experimental | Language toolkit composed of simple tools that parents can use to interact with child and help language acquisition. Receives: Behavioral: Language toolkit |
| 2 | Placebo comparator | Safety counseling and smoke detector Receives: Behavioral: Safety counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Language/Words acquisition
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2009 (estimated)
- Study startAug 2009
- Primary completionJun 2010
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Language AcquisitionStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Steiner, MD, University of North Carolina, Chapel Hill
- Investigators
- Michael J Steiner, MD, Study director, UNC HospitalsJennifer Hartz, MD, Principal investigator, UNC HospitalsMary Ann Cross, MD, Principal investigator, UNC HospitalsKaren L Wysocki, MS, M Ed, Study director, UNC Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00926510
- Sponsor's protocol ID
- 09-0549
- Status last verified
- Oct 2011
- First submitted
- 22 Jun 2009
- Last updated
- 12 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two to Talk: The Use of a Language Toolkit for Toddlers
- ClinicalTrials.gov ID
- NCT00926510
- Acronym / sponsor ID
- 09-0549
- Conditions
- Language Acquisition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 23 Jun 2009 (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.
To investigate whether young children with isolated expressive language delay benefit from early intervention with a simple language toolkit and brief instructions provided to their caregivers.
We hypothesize that children whose families are provided the language toolkit will develop more words over the subsequent 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Language Toolkit | Experimental | Behavioral: Language toolkitLanguage toolkit composed of simple tools that parents can use to interact with child and help language acquisition. |
| 2 | Placebo comparator | Behavioral: Safety counselingSafety counseling and smoke detector |
Who may qualify
- Ages
- 14 to 19 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 14.5 to 18.5 months
- Below average expressive language
- Otherwise normal development
Key exclusion criteria (2 listed)
- Other developmental delay
- Non-English primary language
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 |
|---|---|---|
| Language toolkitSimple toolkit of interactive things to stimulate language. | Behavioural | Language Toolkit |
| Safety counselingSmoke detector and general safety counseling | Behavioural | 2 |
Primary outcome
Language/Words acquisition
Time frame: 3 months
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 12 Oct 2011.
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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.
Michael J Steiner, MD study director
UNC Hospitals
Jennifer Hartz, MD principal investigator
UNC Hospitals
Mary Ann Cross, MD principal investigator
UNC Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Language toolkit and Safety counseling in people with Language Acquisition, run by University of North Carolina, Chapel Hill 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 3 inclusion and 2 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 12 Oct 2011. 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. Some participants in this study may receive a placebo. 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/Words acquisition (time frame: 3 months). 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 12 Oct 2011.