Equine-assisted therapy for adolescents with autism who struggle with emotion regulation
Equine-assisted Therapy for Therapy-resistant Adolescents With Autism Spectrum Disorders, a Replicated AB-design
This study is testing if Equine Assisted Therapy can help teenagers with autism who have trouble managing their emotions feel better when traditional therapies haven't worked for them.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 11 Years to 18 Years |
| Sex | All |
| Sponsor | Karakter Kinder- en Jeugdpsychiatrie Academic / other |
| Locations | 3 sites (Ede, Gelderland and 2 other locations) |
| Trial ID | NCT05200351 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 11-18 with a clinical diagnosis of autism spectrum disorders and insufficient emotion regulation after at least 1.5 years of regular therapy.
Not a fit: Patients who are physically incapable of working with horses or have severe comorbidities that interfere with safety may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a novel and effective treatment option for adolescents with autism who have difficulty regulating their emotions.
How similar studies have performed: While equine-assisted therapies have shown promise in various contexts, this specific approach for therapy-resistant adolescents with autism is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Ede, Gelderland and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.