Autism Spectrum Disorder Trial, Recruiting NCT05673096 Sponsor: University of Southern Denmark Condition: Autism Spectrum Disorder
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Autism Spectrum Disorder Trial, Recruiting

NCT05673096
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Children who are between 2 and 6 years old (inclusive of both ages)
  • Children who have been diagnosed with Autism Spectrum Disorder (ASD) under a specific international diagnostic system (ICD-10), with one of these diagnosis codes: DF84.0, DF84.1, DF84.5, or DF84.8
  • Children whose ASD diagnosis has been confirmed using a standardised autism assessment tool called the ADOS-2, with a severity score of 4 or higher
  • Children whose ASD diagnosis has also been checked against a separate standard diagnostic checklist (DSM-5 Autism Spectrum Disorder Checklist)
  • Children where ASD is the main developmental condition, even if other conditions are also present, and where the diagnosis was confirmed through a clinical conference
  • Families where at least one parent or guardian has enough Danish or English language skills to communicate with the therapist
  • Families where the parent or legal guardian has signed a consent form agreeing to participate

Who may not be able to join:

  • Children who already have a brother or sister taking part in this trial
  • Children or parents who have a hearing or vision impairment
  • Parents or guardians who are not able to attend regular sessions with the therapist (this is assessed at the initial consent meeting)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Niels Bilenberg, Professor, Department of Child and Adolescent Mental Health Odense, Mental Health Services in the Region of Southern Denmark + Clinical Institute, University of Southern Denmark

Phone: +4599448683

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
University of Southern Denmark
Registry
ClinicalTrials.gov
Start date
13 March 2023
Est. completion
1 March 2026

Where this trial is recruiting

🇩🇰 Denmark

Primary endpoints

Autism Symptoms

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov