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.
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.
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:
- 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.
- Conditions
- Autism Spectrum Disorder
- 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 group | Role | What they receive |
|---|---|---|
| Training | Experimental | This arm, which is a half of the sample size, will be receiving training of linguistic recursion Receives: Other: Training of linguistic recursion |
| No training | No intervention | The 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.
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.
- First posted8 Jun 2015 (estimated)
- Study startSep 2015
- Primary completionMay 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Roskilde University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irina Polyanskaya, Roskilde University
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reasoning Skills in Theory of Mind and Linguistic Tests in the Autistic Population
- ClinicalTrials.gov ID
- NCT02465086
- Acronym / sponsor ID
- Protocol-01/2015
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Roskilde UniversityUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 8 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training | Experimental | Other: Training of linguistic recursionThis arm, which is a half of the sample size, will be receiving training of linguistic recursion |
| No training | No intervention | –The no intervention group, which is a half of the sample size, will not be recieving training in linguistic recursion. |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training of linguistic recursionAlso: Intervention groupTraining 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. | Other | Training |
Primary outcome
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.
Performance will be measured in points, given for the correct answers to the test questions.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2016.
- Individual participant dataSharing planned: No
Related trials for Autism Spectrum Disorder
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.