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Recruiting NCT05200351

Equine-assisted Therapy for Therapy-resistant Adolescents With Autism Spectrum Disorders, a Replicated AB-design

No phase Interventional Emotion Regulation Autism Spectrum Disorder Adolescent - Emotional Problem

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Equine assisted Therapy (EAT).
Who it may be relevant to
Registry conditions: Emotion Regulation, Autism Spectrum Disorder, Adolescent - Emotional Problem. Basic parameters: 11 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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 obtaining written informed consent, participants will be randomly assigned to one of the five pre-defined baseline lengths (2-6 weeks) to increase the internal validity of the design.

Interventions

  • Behavioral Equine assisted Therapy (EAT)
    15 sessions of EAT will be given. Activities will be with or in the presence of the horse. There will be no horseriding.

Primary outcome measures

  • Change from baseline on the Emotion dysregulation Index (EDI) after start of the intervention [Time frame: 3 times a week during 23 weeks from baseline]
Secondary outcome measures (10)
  • Change from baseline of Quality of life as scored on the KIDSCREEN after 15 weeks and 1 year [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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).]
  • Change from baseline of Goal attainment as measured on the Outcome Rating Scale (ORS) after 15 weeks [Time frame: The therapist will assess the SRS/ORS each session (week 3-23).]
  • Change from baseline of family functioning as measured on the VGFO on T3 [Time frame: This questionnaire will be assessed at the baseline (T0) and at week 25 (T3).]
  • Change from baseline of Global functioning as measured on the Teachers Report Form (TRF) after 15 weeks and 1 year [Time frame: 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).]
  • Change from baseline of Global functioning as measured on the Youth Self Report (YSR) after 15 weeks and 1 year [Time frame: 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).]
  • Change from baseline of adherence as measured on the SRS after 15 weeks [Time frame: The therapist will assess the SRS each session (week 3-23).]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Netherlands · 3 centers
  • Karakter — Ede
  • Horses & Co — Heerjansdam
  • De Gagelhoeve — Mill

Publications

  • 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 30670226
  • den 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 38987737

Identifiers

NCT: NCT05200351 · 185-20 Pegasus · 636310020

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗