Language Development DisordersDYSPHADEVNCT04926311
Efficiency of Speech and Language Intervention on Achievement of Children With Developmental Language Disorder
An observational study of Language Development Disorders and Speech and Language Disorder, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Children with Developmental Language Disorder (DLD) have many linguistic difficulties in syntax, lexicon, morphology and phonology. Frequently, they also present co-occurrent (or comorbidities) impairments which further impaired school learning. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Language Development Disorders, Speech and Language Disorder, Therapy
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jun 2021to 1 Jun 2022
- Phase
- Observational
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients agreed to participate in the study will respond by phone to a questionnaire providing information on modalities of speech and langage intervention therapy, their course of school and academic studies, potentially associated developmental disorders and their management. Analysis will focused on the effects of speech and langage therapy modalities (intensity, age onset, duration), comorbidities and their management if concerned, special education resource teacher or specialized board-level support during the school trajectory on the school grade repetition in the patients of the study.
Who may be able to join
- patients Have been diagnosed in the University Hospital of Amiens-Picardie with a Developmental Language Disorder
- patients must be aged 12 or older,
- patients must be agreed answering the questionnaire
Who cannot join
- Children with a neurological pathology or handicap as epilepsy, cerebral palsy, sequelae of severe brain injury (traumatic or ischemic or inflammatory...)
- patients with a severe mental retardation
- patients with autism
- patients with bipolar illness
- patients with psychosis
Trial locations and contacts
1 site in 1 country.
About this study
Children with Developmental Language Disorder (DLD) have many linguistic difficulties in syntax, lexicon, morphology and phonology. Frequently, they also present co-occurrent (or comorbidities) impairments which further impaired school learning. Thus, they have poor academic outcomes and many of these children have been maintained at least one time in a classroom, sometime more.
The purpose of this project is to determine which modalities of speech and language therapy are the more efficient on academic outcomes of children with DLD. The main modalities that will be studied are the duration of speech and language intervention, the age at which begins the intervention and the intensity (number of intervention sessions per week).
- Keywords
- Language Development Disorders, Speech and Language Disorder, Academic outcomes
- Medical subject headings
- Language Development Disorders, Speech, Language Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Developmental Language Disorder patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of repeated school year according length of language therapy (number of days)
Number of repeated school year according length of language therapy
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2021
- Study start8 Jun 2021
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Language Development DisordersStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04926311
- Sponsor's protocol ID
- PI2018_843_0052
- Acronym
- DYSPHADEV
- Status last verified
- Jan 2023
- First submitted
- 8 Jun 2021
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Speech and Language Intervention on Achievement of Children With Developmental Language Disorder
- ClinicalTrials.gov ID
- NCT04926311
- Acronym / sponsor ID
- DYSPHADEV / PI2018_843_0052
- Keywords
- Language Development Disorders, Speech and Language Disorder, Academic outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 8 Jun 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 15 Jun 2021 (actual)
- 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.
Children with Developmental Language Disorder (DLD) have many linguistic difficulties in syntax, lexicon, morphology and phonology. Frequently, they also present co-occurrent (or comorbidities) impairments which further impaired school learning. Thus, they have poor academic outcomes and many of these children have been maintained at least one time in a classroom, sometime more.
The purpose of this project is to determine which modalities of speech and language therapy are the more efficient on academic outcomes of children with DLD. The main modalities that will be studied are the duration of speech and language intervention, the age at which begins the intervention and the intensity (number of intervention sessions per week).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Developmental Language Disorder patients | – | – |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients agreed to participate in the study will respond by phone to a questionnaire providing information on modalities of speech and langage intervention therapy, their course of school and academic studies, potentially associated developmental disorders and their management. Analysis will focused on the effects of speech and langage therapy modalities (intensity, age onset, duration), comorbidities and their management if concerned, special education resource teacher or specialized board-level support during the school trajectory on the school grade repetition in the patients of the study.
Key inclusion criteria (3 listed)
- patients Have been diagnosed in the University Hospital of Amiens-Picardie with a Developmental Language Disorder
- patients must be aged 12 or older,
- patients must be agreed answering the questionnaire
Key exclusion criteria (5 listed)
- Children with a neurological pathology or handicap as epilepsy, cerebral palsy, sequelae of severe brain injury (traumatic or ischemic or inflammatory...)
- patients with a severe mental retardation
- patients with autism
- patients with bipolar illness
- patients with psychosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of repeated school year according length of language therapy (number of days)
Time frame: one day
Number of repeated school year according length of language therapy
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 18 Jan 2023.
- Individual participant dataSharing planned: No
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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?
An observational study of Language Development Disorders and Speech and Language Disorder, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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 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 18 Jan 2023. 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 France. 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?
Number of repeated school year according length of language therapy (number of days) (time frame: one day). 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 18 Jan 2023.