Status:
RECRUITING
Equine-assisted Therapy for Therapy-resistant Adolescents With Autism Spectrum Disorders, a Replicated AB-design
Lead Sponsor:
Karakter Kinder- en Jeugdpsychiatrie
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
Conditions:
Emotion Regulation
Autism Spectrum Disorder
Eligibility:
All Genders
11-18 years
Phase:
NA
Brief Summary
The purpose of this study is to assess the (cost)effectivity of Equine assisted Therapy in adolescents with Autism Spectrum disorders.
Detailed Description
The study has a mixed-methods strategy consisting of three elements: a randomized, multiple-baseline single-case design (n=35), a qualitative study (n=8-10) and a cost-effectiveness study (n=6). After...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT05200351
Start Date
February 14 2022
End Date
December 1 2024
Last Update
November 4 2024
Active Locations (3)
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1
Karakter
Ede, Gelderland, Netherlands, 6717 LX
2
Horses & Co
Heerjansdam, Netherlands
3
De Gagelhoeve
Mill, Netherlands