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Autism Spectrum DisorderNCT02465086

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

A study testing Training of linguistic recursion in people with Autism Spectrum Disorder, run by Roskilde University at 1 site in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 7 to 15 years
Conditions the study is for
Autism Spectrum Disorder
What is being tested?
Training of linguistic recursion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteDenmark
Study dates
Sep 2015to May 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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).

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Denmark1 site
  • School Ellebaekskolen

    Koege

Other trials in Denmark

About this study

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.

Read the detailed description

The following research questions are to be investigated:

  1. 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?
  2. 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.

  1. 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.
  2. 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.
  3. 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.
  4. 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.

Being tested
Training of linguistic recursion
Medical subject headings
Autism Spectrum Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Training of linguistic recursionOther

    Also called Intervention group

    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.

Study groups in NCT02465086
Study groupRoleWhat they receive
TrainingExperimentalThis arm, which is a half of the sample size, will be receiving training of linguistic recursion
Receives: Other: Training of linguistic recursion
No trainingNo interventionThe no intervention group, which is a half of the sample size, will not be recieving training in linguistic recursion.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Performance on second-order false-belief tasks

    Performance will be measured in points, given for the correct answers to the test questions.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2015 (estimated)
  2. Study startSep 2015
  3. Primary completionMay 2017 (estimated)
  4. Study completionMay 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02465086
Sponsor's protocol ID
Protocol-01/2015
Status last verified
Apr 2016
First submitted
1 Jun 2015
Last updated
6 Apr 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Training of linguistic recursion in people with Autism Spectrum Disorder, run by Roskilde University at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Performance on second-order false-belief tasks (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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2016.

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