NCT02465086

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 8, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

April 6, 2016

Status Verified

April 1, 2016

Enrollment Period

1.7 years

First QC Date

June 1, 2015

Last Update Submit

April 4, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Performance on second-order false-belief tasks

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

    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.

Study Arms (2)

Training

EXPERIMENTAL

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

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.

Interventions

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.

Also known as: Intervention group
Training

Eligibility Criteria

Age7 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School Ellebaekskolen

Koege, Denmark

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD fellow

Study Record Dates

First Submitted

June 1, 2015

First Posted

June 8, 2015

Study Start

September 1, 2015

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

April 6, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations