Equine-assisted Therapy for Therapy-resistant Adolescents With Autism Spectrum Disorders, a Replicated AB-design
2 other identifiers
interventional
35
1 country
3
Brief Summary
The purpose of this study is to assess the (cost)effectivity of Equine assisted Therapy in adolescents with Autism Spectrum disorders.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2022
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 17, 2021
CompletedFirst Posted
Study publicly available on registry
January 20, 2022
CompletedStudy Start
First participant enrolled
February 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedNovember 4, 2024
November 1, 2024
2.8 years
December 17, 2021
November 1, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline on the Emotion dysregulation Index (EDI) after start of the intervention
The EDI-short form is a validated, change-sensitive, 13-item caregiver report measure of emotion regulation impairment for individuals who are at least 6 years of age. The scale used is Not at all=0, Mild=1, Moderate=2, Severe=3, or Very Severe=4. The EDI short form includes two scales: a 7-item Reactivity Index and a 6-item Dysphoria Index. Index raw scores will be converted into t-scores.
3 times a week during 23 weeks from baseline
Secondary Outcomes (10)
Change from baseline of Quality of life as scored on the KIDSCREEN after 15 weeks and 1 year
The KIDSCREEN-27 will be assessed at baseline (T0), at week 2-6 (T1), at week17-23 (T2), week 25 (T3) and after 1 year (T4)
Change from baseline of severity of autism spectrum symptoms as measured on the Social Responsiveness Scale (SRS-2) after 15 weeks and 1 year
The SRS-2 (parents) will be assessed at baseline (T0), at week 2-6 (T1), at week17-23 (T2), week 25 (T3) and after 1 year (T4).
Change from baseline on the Goal Attainment Scale (GAS) after the intervention after 15 weeks
The GAS will be assessed in the fifth (week 7-11), tenth (week12-16) en fifteenth (week 17-23) sessions.
Change from baseline of self-esteem as measured on the The Rosenberg Self-Esteem Scale (RSES) after 15 weeks and 1 year
Rosenberg Self-Esteem Scale will be assessed at the baseline (T0), at week 2-6 (T1), at week17-23 (T2), week 25 (T3) and after 1 year.
Change from baseline of Global functioning as measured on the Child Behavior Checklist (CBCL) after 15 weeks and 1 year
The whole version will be assessed at baseline, short version at week 2-6 (T1), at week17-23 (T2), week 25 (T3) and after 1 year (T4).
- +5 more secondary outcomes
Study Arms (1)
EAT Intervention
EXPERIMENTAL15 sessions of EAT
Interventions
15 sessions of EAT will be given. Activities will be with or in the presence of the horse. There will be no horseriding.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Karakter
Ede, Gelderland, 6717 LX, Netherlands
Horses & Co
Heerjansdam, Netherlands
De Gagelhoeve
Mill, Netherlands
Related Publications (2)
Trzmiel T, Purandare B, Michalak M, Zasadzka E, Pawlaczyk M. Equine assisted activities and therapies in children with autism spectrum disorder: A systematic review and a meta-analysis. Complement Ther Med. 2019 Feb;42:104-113. doi: 10.1016/j.ctim.2018.11.004. Epub 2018 Nov 5.
PMID: 30670226BACKGROUNDden Boer JC, Klip H, Blonk A, Lenselink M, Kaijdoe SPT, Tielkes M, van Zandbeek A, Bres G, Herinx M, Staal WG, Rommelse N. 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. BMC Psychiatry. 2024 Jul 10;24(1):499. doi: 10.1186/s12888-024-05879-w.
PMID: 38987737DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nanda Lambregt-Rommelse, Prof. Dr.
Radboud/Karakter
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2021
First Posted
January 20, 2022
Study Start
February 14, 2022
Primary Completion
December 1, 2024
Study Completion
December 1, 2024
Last Updated
November 4, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share