NCT04926311

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

June 8, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 15, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

January 18, 2023

Status Verified

January 1, 2023

Enrollment Period

12 months

First QC Date

June 8, 2021

Last Update Submit

January 17, 2023

Conditions

Keywords

Language Development DisordersSpeech and Language DisorderAcademic outcomes

Outcome Measures

Primary Outcomes (1)

  • Number of repeated school year according length of language therapy (number of days)

    Number of repeated school year according length of language therapy

    one day

Study Arms (1)

Developmental Language Disorder patients

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80480, France

Location

MeSH Terms

Conditions

Language Development DisordersSpeechLanguage Disorders

Condition Hierarchy (Ancestors)

Communication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsVerbal BehaviorCommunicationBehavior

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2021

First Posted

June 15, 2021

Study Start

June 8, 2021

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

January 18, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations