Efficacy of a Pragmatic Intervention to Improve Adaptation to Context and Interlocutor

Sponsor

Université Catholique de Louvain (Other)

Overall Status

Terminated

CT.gov ID

NCT05127863

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Autism Spectrum Disorder Developmental Language Disorder	Behavioral: social communication intervention (pragmatic)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

5 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

multiple single case studymultiple single case study

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Efficacy of a Pragmatic Intervention to Improve Adaptation to Context and Interlocutor

Actual Study Start Date :

Dec 1, 2021

Actual Primary Completion Date :

Jun 1, 2022

Actual Study Completion Date :

Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 2 to 5 ASD or TDL patients 2 to 5 ASD or TDL patients, 8 to 14 years old, with no intellectual disability.	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.

Arm

Intervention/Treatment

Experimental: 2 to 5 ASD or TDL patients

2 to 5 ASD or TDL patients, 8 to 14 years old, with no intellectual disability.

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.

Outcome Measures

Primary Outcome Measures

social communication abilities (according parents) [through study completion, an average of 6 months]
questionnaire (Children Communication Checklist) - pragmatic scale Maximum 162 (good performance), minimum 86 (bad performance)
social communication abilities (evaluated by clinician) [through study completion, an average of 6 months]
social communication task, conversations

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 14 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

diagnostic of ASD or DLD
pragmatic difficulties

Exclusion Criteria:

intellectual deficiency

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCLouvain - faculty of psychology	Louvain-la-Neuve		Belgium	1348

Sponsors and Collaborators

Université Catholique de Louvain

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Université Catholique de Louvain

ClinicalTrials.gov Identifier:

NCT05127863

Other Study ID Numbers:

PRAGMA-INTERV

First Posted:

Nov 19, 2021

Last Update Posted:

Jun 21, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Language Disorders

Language Development Disorders

Disease

Autism Spectrum Disorder

Study Results

No Results Posted as of Jun 21, 2022