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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05127863
Other study ID # PRAGMA-INTERV
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date December 1, 2021
Est. completion date June 1, 2022

Study information

Verified date June 2022
Source Université Catholique de Louvain
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Patients with Developmental Language Disorder (DLD) or Autism Spectrum Disorder (ASD) have communicational difficulties to adapt their language to context and to interlocutors. These difficulties have long term impacts on education and social life of these patients. Speech language therapists (SLT) helps child and teenagers with pragmatic and communicational disorders. Nevertheless, few research evaluated the efficacy of such interventions. In the present research, the students will do a literature review to identify efficacy intervention's strategies of pragmatic disorders. Then, 2 to 5 patients, aged from 8 to 14 years old, with ASD or DLD and pragmatic disorders, and who haven't intellectual disorder will be recruited. They will come to the faculty of psychology of UCLouvain before the beginning of the intervention. In this pretest session, parents will answer questionnaires et children will have tests in order to evaluate their pragmatic abilities (during 30 minutes), like conversations, role plays, communication referential tasks, etc. This evaluation will be video recorded to code pragmatic abilities. Then, a group intervention of ten sessions will be proposed (1 session per week, 10 weeks). Activities will include role plays, conversations, etc. At the end of the intervention period, a post test session, like the pretest session, will be proposed to evaluate intervention efficacy. The design is multiple study cases. This is the best design to control efficacy of these kind of interventions considering the inter-individual variability of DLD and ASD patients. This study is original since few research evaluated the efficiency of pragmatic intervention. Some studies demonstrated the efficacy of pragmatic intervention in DLD and ASD patients but theses researches were conducted in English-speaking countries. Furthermore, the present research will propose a group intervention, which weren't proposed in the literature to our knowledge (individual intervention). If the group intervention is efficacy, the cost-benefice ratio would be interested.


Recruitment information / eligibility

Status Terminated
Enrollment 5
Est. completion date June 1, 2022
Est. primary completion date June 1, 2022
Accepts healthy volunteers No
Gender All
Age group 8 Years to 14 Years
Eligibility Inclusion Criteria: - diagnostic of ASD or DLD - pragmatic difficulties Exclusion Criteria: - intellectual deficiency

Study Design


Intervention

Behavioral:
social communication intervention (pragmatic)
10 sessions of group intervention in order to improve pragmatic/social communication. one session of one hour per week. Activities will included role play, conversations, etc.

Locations

Country Name City State
Belgium UCLouvain - faculty of psychology Louvain-la-Neuve

Sponsors (1)

Lead Sponsor Collaborator
Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary social communication abilities (according parents) questionnaire (Children Communication Checklist) - pragmatic scale Maximum 162 (good performance), minimum 86 (bad performance) through study completion, an average of 6 months
Primary social communication abilities (evaluated by clinician) social communication task, conversations through study completion, an average of 6 months
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