search
Back to results

Reasoning Skills in Theory of Mind and Linguistic Tests in the Autistic Population

Primary Purpose

Autism Spectrum Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Training of linguistic recursion
Sponsored by
Roskilde University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Autism Spectrum Disorder

Eligibility Criteria

7 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Autism Spectrum Disorder is already established and confirmed. Participants will be recruited by contacting special schools directly, where the established diagnosis is the admission criteria.
  2. Monolinguals, Danish native speakers.
  3. Absence of significant impairments in language development.
  4. Intelligence quotient (IQ): more than 85 (i.e. within the normal range).

Exclusion Criteria:

  1. Medical treatment affecting performance (antidepressants, antipsychotic and stimulants).
  2. Subjects that have been tested with Wechsler Intelligence Scale test during the last 1.5 year.
  3. Comorbidity (difficult with Attention Deficit Hyperactivity Disorder, but other psychiatric conditions and brain damage condition of any sort should be excluded).

Sites / Locations

  • School Ellebaekskolen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Training

No training

Arm Description

This arm, which is a half of the sample size, will be receiving training of linguistic recursion

The no intervention group, which is a half of the sample size, will not be recieving training in linguistic recursion.

Outcomes

Primary Outcome Measures

Performance on second-order false-belief tasks
Performance will be measured in points, given for the correct answers to the test questions.

Secondary Outcome Measures

Full Information

First Posted
June 1, 2015
Last Updated
April 4, 2016
Sponsor
Roskilde University
search

1. Study Identification

Unique Protocol Identification Number
NCT02465086
Brief Title
Reasoning Skills in Theory of Mind and Linguistic Tests in the Autistic Population
Official Title
Reasoning Skills in Theory of Mind and Linguistic Tests in the Autistic Population
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
May 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Roskilde University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to investigate the correlation and the causality direction between mastering linguistic tests and second-order reasoning tasks in the autistic population. Linguistic tests include two types of tasks: 1. Mastery of multiple embeddings or recursion and 2. Mastery of dialogue particles. Second-order tests include standard false-belief tasks.
Detailed Description
The following research questions are to be investigated: Do particular developments in syntax such as recursion comprehension affect particular kinds of thinking such as second-order Theory of Mind reasoning in autistic children? More concretely: Does children's ability to comprehend the linguistic structure involving or consisting of recursive structures predict performance on second-order false-belief tests, beyond development in general language abilities? Does knowledge of dialogue particles predict performance on second-order false-belief tests, beyond development in language abilities and working memory? In order to investigate these questions, a between-subjects empirical design includes data collection and data analysis in two steps: one measuring the strength of correlations between variables, the other establishing causality effect via training. The study is divided into four stages: pilot, pre-testing, intervention, post-testing. The central goal of the pilot testing is to ensure reliability of tasks in Danish: vocabulary familiarity and how children understand what they are asked about. Second-order false-belief tasks and recursion tasks will be given to children in the pilot stage. Pre-testing stage is the stage where all the variables are measured (dependent, independent and confounding). Selection of pretests reflects considerations about confounding variables and inclusion criteria. Confounding variables include: verbal comprehension (from Wechsler Intelligence Scale for Children IV), working memory (from Wechsler Intelligence Scale for Children IV), comprehension of grammar and syntactic structures (from Clinical Evaluation of Language Fundamentals-4), pragmatic profile (from Clinical Evaluation of Language Fundamentals-4). Independent variables include above-mentioned linguistic tests. Dependent variable is second-order false-belief tests. At the intervention stage training of recursion comprehension for a randomized half of sample size will be provided as four individual sessions,15 minutes each. Training of recursion comprehension will include cooperative dialogue and feedback on the sentences and small dialogues analogous to the tasks in the pretests. After the training is completed, all the sample subjects will be given second-order false-belief and recursion tasks again at the post-testing stage. The goal is to recruit 60 subjects in total. For the training part 30 subjects will be assigned by randomization to the intervention group and 30 subjects- to the control group. The recruiting process and participation will not require disclosure of any personal data. Parental informed, written consent for their children to take part in the study is a prerequisite for every child's participation. Parents will also receive debriefing information in written form upon the completion of the empirical part of the study. Participants are ensured of full anonymity. All data will be anonymized by using subject's identification, and not names. All personal record of any kind, including video and tape recordings of testing, will be kept according to the Danish Privacy Law regulations. Every child will be tested individually by a trained psychologist in a quiet comfortable room away from the classroom. In case testing procedure will be in any way unpleasant or excessively demanding for some participants, the session will be cancelled, finished earlier or the number of tasks will be revised.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Training
Arm Type
Experimental
Arm Description
This arm, which is a half of the sample size, will be receiving training of linguistic recursion
Arm Title
No training
Arm Type
No Intervention
Arm Description
The no intervention group, which is a half of the sample size, will not be recieving training in linguistic recursion.
Intervention Type
Other
Intervention Name(s)
Training of linguistic recursion
Other Intervention Name(s)
Intervention group
Intervention Description
Training of recursion comprehension will include cooperative dialogue and feedback on the sentences and small dialogues. The training conditions will be further divided into marking the change of the truth-value.
Primary Outcome Measure Information:
Title
Performance on second-order false-belief tasks
Description
Performance will be measured in points, given for the correct answers to the test questions.
Time Frame
The period between the beginning of testing and final testing should not exceed two weeks. Six children will be tested and trained at the same time. The overall period is thus assessed up to 20 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Autism Spectrum Disorder is already established and confirmed. Participants will be recruited by contacting special schools directly, where the established diagnosis is the admission criteria. Monolinguals, Danish native speakers. Absence of significant impairments in language development. Intelligence quotient (IQ): more than 85 (i.e. within the normal range). Exclusion Criteria: Medical treatment affecting performance (antidepressants, antipsychotic and stimulants). Subjects that have been tested with Wechsler Intelligence Scale test during the last 1.5 year. Comorbidity (difficult with Attention Deficit Hyperactivity Disorder, but other psychiatric conditions and brain damage condition of any sort should be excluded).
Facility Information:
Facility Name
School Ellebaekskolen
City
Koege
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Reasoning Skills in Theory of Mind and Linguistic Tests in the Autistic Population

We'll reach out to this number within 24 hrs