Clinical trial NCT05200351: Equine-assisted Therapy for Therapy-resistant Adolescents With Autism Spectrum Disorders, a Replicated AB-design
Official title: Equine-assisted Therapy for Therapy-resistant Adolescents With Autism Spectrum Disorders, a Replicated AB-design
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Emotion Regulation
Autism Spectrum Disorder
Adolescent - Emotional Problem
Lead sponsor: Karakter Kinder- en Jeugdpsychiatrie
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2022-01-20
Enrollment: 35
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 with a 1:1 allocation using permuted blocks of random sizes.
Primary purpose: TREATMENT

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 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.

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.

Primary outcomes:
measure: Change from baseline on the Emotion dysregulation Index (EDI) after start of the intervention
timeFrame: 3 times a week during 23 weeks from baseline
Secondary outcomes:
measure: Change from baseline of Quality of life as scored on the KIDSCREEN after 15 weeks and 1 year
timeFrame: 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)
measure: Change from baseline of severity of autism spectrum symptoms as measured on the Social Responsiveness Scale (SRS-2) after 15 weeks and 1 year
timeFrame: 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).
measure: Change from baseline on the Goal Attainment Scale (GAS) after the intervention after 15 weeks
timeFrame: The GAS will be assessed in the fifth (week 7-11), tenth (week12-16) en fifteenth (week 17-23) sessions.
measure: Change from baseline of self-esteem as measured on the The Rosenberg Self-Esteem Scale (RSES) after 15 weeks and 1 year
timeFrame: 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.
measure: Change from baseline of Global functioning as measured on the Child Behavior Checklist (CBCL) after 15 weeks and 1 year
timeFrame: 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).
measure: Change from baseline of Goal attainment as measured on the Outcome Rating Scale (ORS) after 15 weeks
timeFrame: The therapist will assess the SRS/ORS each session (week 3-23).
measure: Change from baseline of family functioning as measured on the VGFO on T3
timeFrame: This questionnaire will be assessed at the baseline (T0) and at week 25 (T3).
measure: Change from baseline of Global functioning as measured on the Teachers Report Form (TRF) after 15 weeks and 1 year
timeFrame: 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).
measure: Change from baseline of Global functioning as measured on the Youth Self Report (YSR) after 15 weeks and 1 year
timeFrame: 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).
measure: Change from baseline of adherence as measured on the SRS after 15 weeks
timeFrame: The therapist will assess the SRS each session (week 3-23).
Other outcomes:
Locations:
city: Ede
country: Netherlands
facility: Karakter
state: Gelderland
city: Heerjansdam
country: Netherlands
facility: Horses & Co
city: Mill
country: Netherlands
facility: De Gagelhoeve
Study officials:
affiliation: Radboud/Karakter
name: Nanda Lambregt-Rommelse, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.