Efficacy of a Pragmatic Intervention to Improve Adaptation to Context and Interlocutor
Primary Purpose
Autism Spectrum Disorder, Developmental Language Disorder
Status
Terminated
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
social communication intervention (pragmatic)
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder
Eligibility Criteria
Inclusion Criteria:
- diagnostic of ASD or DLD
- pragmatic difficulties
Exclusion Criteria:
- intellectual deficiency
Sites / Locations
- UCLouvain - faculty of psychology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
2 to 5 ASD or TDL patients
Arm Description
2 to 5 ASD or TDL patients, 8 to 14 years old, with no intellectual disability.
Outcomes
Primary Outcome Measures
social communication abilities (according parents)
questionnaire (Children Communication Checklist) - pragmatic scale Maximum 162 (good performance), minimum 86 (bad performance)
social communication abilities (evaluated by clinician)
social communication task, conversations
Secondary Outcome Measures
Full Information
NCT ID
NCT05127863
First Posted
November 8, 2021
Last Updated
June 14, 2022
Sponsor
Université Catholique de Louvain
1. Study Identification
Unique Protocol Identification Number
NCT05127863
Brief Title
Efficacy of a Pragmatic Intervention to Improve Adaptation to Context and Interlocutor
Official Title
Efficacy of a Pragmatic Intervention to Improve Adaptation to Context and Interlocutor
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Why Stopped
The study is completed
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
June 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Université Catholique de Louvain
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Developmental Language Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
multiple single case study
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2 to 5 ASD or TDL patients
Arm Type
Experimental
Arm Description
2 to 5 ASD or TDL patients, 8 to 14 years old, with no intellectual disability.
Intervention Type
Behavioral
Intervention Name(s)
social communication intervention (pragmatic)
Intervention Description
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.
Primary Outcome Measure Information:
Title
social communication abilities (according parents)
Description
questionnaire (Children Communication Checklist) - pragmatic scale Maximum 162 (good performance), minimum 86 (bad performance)
Time Frame
through study completion, an average of 6 months
Title
social communication abilities (evaluated by clinician)
Description
social communication task, conversations
Time Frame
through study completion, an average of 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnostic of ASD or DLD
pragmatic difficulties
Exclusion Criteria:
intellectual deficiency
Facility Information:
Facility Name
UCLouvain - faculty of psychology
City
Louvain-la-Neuve
ZIP/Postal Code
1348
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of a Pragmatic Intervention to Improve Adaptation to Context and Interlocutor
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