Equine-assisted therapy for adolescents with autism who struggle with emotion regulation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness and cost-effectiveness of Equine Assisted Therapy (EAT) for adolescents aged 11-18 with Autism Spectrum Disorders (ASD) who have not responded well to traditional therapies. It employs a mixed-methods approach, including a randomized multiple-baseline single-case design with 35 participants, a qualitative study with 8-10 participants, and a cost-effectiveness analysis involving 6 participants. Participants will be randomly assigned to varying baseline lengths to enhance the study's internal validity.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* between 11-18 years old;
* a clinical diagnosis of autism spectrum disorders according the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM 5) as diagnosed by a Beroepen in de Individuele Gezondheidszorg (BIG) registered healthcare professional;
* insufficient emotion regulation after regular therapy for at least 1,5 years as indicated by a score above clinical cut-off (T-score = 65) on the EDI;
* comorbidities are allowed except for those interfering with safety.

Exclusion Criteria:

* unable to respond to questions (parents or adolescents);
* no access to an Internet connection;
* insufficient mastery of Dutch language in parents or adolescents;
* physically incapable to work with the horses;
* unstable medication use;
* total intelligence quotient (IQ) equal to or below 80 on the Wechsler Intelligence Scale for Children (WISC-III-R or WISC-V);
* allergic or phobic to horses;
* insufficient regulation to safely handle the horses;
* therapy with horses within the last two years.

Where it's running

• Karakter
  Ede, Gelderland, Netherlands Recruiting
• Horses & Co
  Heerjansdam, Netherlands Recruiting
• De Gagelhoeve
  Mill, Netherlands Recruiting

Study contacts

• Principal investigator: Nanda Lambregt-Rommelse, Prof. Dr. — Radboud/Karakter
• Study coordinator: Jenny den Boer, Drs
• Email: j.denboer@karakter.com
• Phone: 0031-318676611

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.