Developmental Language DisordersNCT00607334
Experimental Word Learning in Children With and Without Language Impairment
A study testing Word-learning in people with Developmental Language Disorders, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The purpose of this study is to compare the performances of normally developing children and children with Language Impairment (LI) in three different experimental settings designed to promote vocabulary acquisition. Read more about this study
- Who is it for?
- Ages 36 to 47 monthsHealthy volunteers can take part
- Conditions the study is for
- Developmental Language Disorders
- What is being tested?
- Word-learning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2003to Jul 2007
- 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 36 to 47 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- For GP subjects: - diagnosis of Language Impairment
- enrolled in language therapy
- age between 3:0 (years:months) and 3:11
- For GC subjects: - normal performance in a language screening procedure
- normal performance in an expressive vocabulary test
Who cannot join
- For GP subjects: - hearing impairments
- diagnosed neurological or behavioral conditions
- major cognitive impairment
- For GC subjects: - communication complaints from caregivers
- history of previous enrollment in language therapy
Trial locations and contacts
1 site in 1 country.
Brazil1 site
USP - Faculty of Medicine - Department of Physiotherapy, Communication Sciences and Disorders, Occupational Therapy
São Paulo, São Paulo
About this study
Official title: Experimental Word Learning in Children With Normal Development and Children With Language Impairment
The purpose of this study is to compare the performances of normally developing children and children with Language Impairment (LI) in three different experimental settings designed to promote vocabulary acquisition. This comparison will also provide evidence to support different intervention approaches designed to increase vocabulary abilities, which has been proved to be one of the major deficits of young children with LI.
- Conditions
- Developmental Language Disorders
- Being tested
- Word-learning
- Keywords
- Child Language, Language Therapy, Vocabulary
- Medical subject headings
- Language Development Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Word-learningBehavioural
Exposure to five nonwords for three sessions of controlled interaction with the experimenter
Word-learningBehavioural
Exposure to five nonwords for three sessions of controlled interaction with the experimenter
| Study group | Role | What they receive |
|---|---|---|
| GP | Experimental | Children with Developmental Language Impairments were enrolled in this group. Receives: Behavioral: Word-learning |
| GC | Experimental | Children with normal language development were enrolled in this group. Receives: Behavioral: Word-learning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance on a post-test administered after every word-learning session.
Measured: Three weeks
Secondary outcomes (1)
Occurence of correct spontaneous productions of the taught words during the experimental procedure
Measured: Three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2008 (estimated)
- Study startJul 2003
- Primary completionJun 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental Language DisordersStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Debora M. Befi-Lopes, PhD, Study chair, University of Sao PauloJuliana P. Gândara, PhD student, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00607334
- Sponsor's protocol ID
- 24061316
- Status last verified
- Oct 2007
- First submitted
- 22 Jan 2008
- Last updated
- 5 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experimental Word Learning in Children With Normal Development and Children With Language Impairment
- ClinicalTrials.gov ID
- NCT00607334
- Acronym / sponsor ID
- 24061316
- Conditions
- Developmental Language Disorders
- Keywords
- Child Language, Language Therapy, Vocabulary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jul 2003
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 5 Feb 2008 (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 purpose of this study is to compare the performances of normally developing children and children with Language Impairment (LI) in three different experimental settings designed to promote vocabulary acquisition. This comparison will also provide evidence to support different intervention approaches designed to increase vocabulary abilities, which has been proved to be one of the major deficits of young children with LI.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GP | Experimental | Behavioral: Word-learningChildren with Developmental Language Impairments were enrolled in this group. |
| GC | Experimental | Behavioral: Word-learningChildren with normal language development were enrolled in this group. |
Who may qualify
- Ages
- 36 to 47 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- For GP subjects: - diagnosis of Language Impairment
- enrolled in language therapy
- age between 3:0 (years:months) and 3:11
- For GC subjects: - normal performance in a language screening procedure
- normal performance in an expressive vocabulary test
Key exclusion criteria (5 listed)
- For GP subjects: - hearing impairments
- diagnosed neurological or behavioral conditions
- major cognitive impairment
- For GC subjects: - communication complaints from caregivers
- history of previous enrollment in language therapy
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 |
|---|---|---|
| Word-learningExposure to five nonwords for three sessions of controlled interaction with the experimenter | Behavioural | GP |
| Word-learningExposure to five nonwords for three sessions of controlled interaction with the experimenter | Behavioural | GC |
Primary outcome
Performance on a post-test administered after every word-learning session.
Time frame: Three weeks
1 secondary outcome
Occurence of correct spontaneous productions of the taught words during the experimental procedure
Time frame: Three weeks
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 5 Feb 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.
Debora M. Befi-Lopes, PhD study chair
University of Sao Paulo
Juliana P. Gândara, PhD student principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Word-learning in people with Developmental Language Disorders, run by University of Sao Paulo at 1 site in Brazil.
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 5 inclusion and 5 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 5 Feb 2008. 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 Brazil. 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?
Performance on a post-test administered after every word-learning session. (time frame: Three weeks). 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 5 Feb 2008.