CClinicalTrials.gg
TerminatedNCT05127863Updated Jun 21, 2022

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

An interventional study of social communication intervention (pragmatic) in Autism Spectrum Disorder and Developmental Language Disorder, sponsored by Université Catholique de Louvain. Terminated at 1 site in Belgium. Open to participants aged 8 Years to 14 Years. Per ClinicalTrials.gov, last updated 2022-06-21.

Sponsored by Université Catholique de Louvain · Not applicable, Interventional, and Treatment

Why this study was terminated
The study is completed
Phase
Not applicable
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
8 Years to 14 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Autism Spectrum Disorder
  • Developmental Language Disorder
03

In context

Language Disorders

89 studies on the registry are indexed under Language Disorders; 24 are open to participants now.

This study's enrollment of 5 is below the median of 56 across 73 interventional studies indexed under Language Disorders.

Browse Language Disorders studies →

Lead sponsor

Université Catholique de Louvain is the lead sponsor of 144 studies on the registry; 57 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • diagnostic of ASD or DLD
  • pragmatic difficulties

Exclusion criteria

Exclusion Criteria:

  • intellectual deficiency
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (actual)

Study arms

  • 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)

Interventions

  • Behavioralsocial 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.

06

What researchers measure

Primary outcomes

  1. social communication abilities (according parents)

    questionnaire (Children Communication Checklist) - pragmatic scale Maximum 162 (good performance), minimum 86 (bad performance)

    Time frame: through study completion, an average of 6 months

  2. social communication abilities (evaluated by clinician)

    social communication task, conversations

    Time frame: through study completion, an average of 6 months

07

Study locations

1 site
  • UCLouvain - faculty of psychology
    Louvain-la-Neuve, 1348, Belgium
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05127863
Lead sponsor
Université Catholique de Louvain
Responsible party
Sponsor
First posted
Nov 19, 2021
Start date
Dec 1, 2021
Primary completion
Jun 1, 2022
Completion
Jun 1, 2022
Last update
Jun 21, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion