Equine assisted activities and therapies in children with autism spectrum disorder: A systematic review and a meta-analysis.
Tomasz Trzmiel, Barbara Purandare, Michał Michalak...
https://pubmed.ncbi.nlm.nih.gov/30670226Actively Recruiting
Phase Not Applicable
Age: 11Years - 18Years
All Genders
ID05200351
Equine-assisted Therapy for Therapy-resistant Adolescents With Autism Spectrum Disorders, a Replicated AB-design
Led by Karakter Kinder- en Jeugdpsychiatrie · Updated on 2024-11-04
35
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
K
Karakter Kinder- en Jeugdpsychiatrie
Lead Sponsor
Z
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the cost-effectiveness of Equine Assisted Therapy (EAT) in adolescents aged 11 to 18 years with Autism Spectrum Disorders (ASD) who have difficulty regulating emotions despite regular therapy. This study uses a mixed-methods approach including a randomized multiple-baseline single-case design, a qualitative study, and a cost-effectiveness analysis to assess therapy outcomes and impact. Participants will receive 15 sessions of EAT, involving activities with or near horses but without horseback riding. After consent, participants will be randomly assigned to one of five baseline periods lasting 2 to 6 weeks to strengthen the study design. The intervention period spans approximately 15 weeks, with various assessments scheduled throughout. During the study, researchers will measure changes in emotion regulation using the Emotion Dysregulation Index three times a week over 23 weeks. Other assessments include quality of life, autism symptom severity, self-esteem, global functioning, goal attainment, and family functioning at multiple time points up to one year after starting therapy. Therapists will also monitor adherence and progress during sessions. Participants' safety and medication stability will be monitored throughout the study.
CONDITIONS
Brief Title
Equine-assisted Therapy for Therapy-resistant Adolescents With Autism Spectrum Disorders, a Replicated AB-design
Who Can Participate
Age: 11Years - 18Years
All Genders
Eligibility Criteria
You may qualify if you...
- Between 11 and 18 years old
- Clinical diagnosis of autism spectrum disorders according to DSM 5 by a registered healthcare professional
- Insufficient emotion regulation after at least 1.5 years of regular therapy, indicated by a clinical cut-off score on the Emotion Dysregulation Index
- Comorbidities allowed if they do not interfere with safety
You will not qualify if you...
- Unable to respond to questions (parents or adolescents)
- No access to an Internet connection
- Insufficient mastery of Dutch language in parents or adolescents
- Physically unable to work safely with horses
- Unstable medication use
- IQ equal to or below 80 on Wechsler Intelligence Scale for Children
- Allergic or phobic to horses
- Insufficient regulation to safely handle horses
- Received therapy involving horses within the last two years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Baseline
Duration - 2 to 6 weeks
Participants undergo a baseline period lasting 2 to 6 weeks before starting therapy to establish initial measures.
Multiple assessments during baseline period
Outpatient Treatment
Duration - Approximately 15 weeks
Participants receive 15 sessions of equine-assisted therapy involving activities with or near horses, without horseriding.
3 sessions per week for 15 weeks
Follow-up
Duration - Up to 1 year
Participants are followed for up to 1 year after therapy to assess long-term outcomes on emotion regulation, quality of life, and other measures.
Assessments at week 25 and 1 year post-baseline
Trial Site Locations
Total: 3 locations
1
Karakter
Ede, Gelderland, Netherlands, 6717 LX
Actively Recruiting
2
Horses & Co
Heerjansdam, Netherlands
Actively Recruiting
3
De Gagelhoeve
Mill, Netherlands
Actively Recruiting
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Research Team
J
Jenny den Boer, Drs
H
Helen Klip, Dr.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Study Protocol: Pegasus: psychotherapy incorporating horses for 'therapy-resistant' adolescents with autism spectrum disorders, a study with series of randomised, baseline controlled n-of-1 trials.
Jenny C den Boer, Helen Klip, Anita Blonk...
https://pubmed.ncbi.nlm.nih.gov/38987737