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

Karakter Kinder- en Jeugdpsychiatrie3 sites in 1 country35 target enrollmentFebruary 14, 2022

ConditionsEmotion Regulation Autism Spectrum Disorder Adolescent - Emotional Problem

Overview

Phase: N/A
Intervention: Not specified
Conditions: Emotion Regulation
Sponsor: Karakter Kinder- en Jeugdpsychiatrie
Enrollment: 35
Locations: 3
Primary Endpoint: Change from baseline on the Emotion dysregulation Index (EDI) after start of the intervention
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 14, 2022

End Date

December 2024

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Karakter Kinder- en Jeugdpsychiatrie

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

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

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.

Secondary Outcomes

Change from baseline of Goal attainment as measured on the Outcome Rating Scale (ORS) after 15 weeks(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(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(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(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(The therapist will assess the SRS each session (week 3-23).)
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).)
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))