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Emotion RegulationNCT05200351

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

A study testing Equine assisted Therapy (EAT) in people with Emotion Regulation and Autism Spectrum Disorder, run by Karakter Kinder- en Jeugdpsychiatrie at 3 sites in Netherlands.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this study is to assess the (cost)effectivity of Equine assisted Therapy in adolescents with Autism Spectrum disorders. Read more about this study

Who is it for?
Ages 11 to 18 years
What is being tested?
Equine assisted Therapy (EAT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
3 sitesNetherlands
Study dates
14 Feb 2022to Dec 2024
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 11 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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);
Show all 9Show fewer
  • allergic or phobic to horses;
  • insufficient regulation to safely handle the horses;
  • therapy with horses within the last two years.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jenny den Boer, Drs contact

0031-318676611

j.denboer@karakter.com

Helen Klip, Dr. contact

0031-243512222

H.klip@karakter.com

Netherlands3 sites, 3 recruiting
  • Karakter

    Ede, Gelderland, 6717 LX

    Jenny den Boer, Drs, Pegasus@karakter.com

    Recruiting
  • Horses & Co

    Heerjansdam

    Esther van Noort, Esther@horsesenco.nl

    Recruiting
  • De Gagelhoeve

    Mill

    Anita Blonk, Dr., Ablonk@gagelhoeve.nl

    Recruiting

Other trials in Netherlands

About this study

The purpose of this study is to assess the (cost)effectivity of Equine assisted Therapy in adolescents with Autism Spectrum disorders.

Read the 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.

Being tested
Equine assisted Therapy (EAT)
Medical subject headings
Emotional Regulation, Autism Spectrum Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Equine assisted Therapy (EAT)Behavioural

    15 sessions of EAT will be given. Activities will be with or in the presence of the horse. There will be no horseriding.

Study groups in NCT05200351
Study groupRoleWhat they receive
EAT InterventionExperimental15 sessions of EAT
Receives: Behavioral: Equine assisted Therapy (EAT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 times a week during 23 weeks from baseline

Secondary outcomes (10)
  1. Change from baseline of Quality of life as scored on the KIDSCREEN after 15 weeks and 1 year

    The KIDSCREEN-27 is a generic health-related quality of life (HRQOL) questionnaire for children aged 8-18 years. There is a self-complete version (child and a proxy version (parent). It consists of 27 items measuring five dimensions: physical well-being, psychological well-being, parent relations \& autonomy, social support \& peers and school environment. Items are answered on a five-point Likert-type scale assessing frequency (never (1), seldom (2), sometimes (3), often (4), and always (5)) or intensity (not at all (1), slightly (2), moderately (3), very (4), and extremely (5)) with a one-week recall period. Negatively formulated items are recoded and the sum scores for respective dimensions are converted into T scores with a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate better HRQOL.

    Measured: 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)

  2. 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 Social Responsiveness Scale (SRS-2) measures deficits in social behavior associated with ASD and can be used to assess the severity of symptoms in ASD. The questionnaire will be completed by multiple raters (parents and teachers). The SRS-2 consists of 65 items scored in a Likert-like scale format ranging from not true=1, sometimes true=2, often true=3 to almost always true =4. It is designed to identify social impairment intrinsic to ASD and to quantify its severity across the duration of the treatment. A total score and five treatment subscale scores (Social Awareness; Social Cognition; Social Communication; Social Motivation; and Restricted Interests and Repetitive Behavior) are obtained. The accepted diagnostic criteria (cut point) for the SRS-2 for the association with a diagnosis of ASD are:<=59 (normal); 60-75 (mild to moderate ASD); and =>76 (severe ASD).

    Measured: 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).

  3. Change from baseline on the Goal Attainment Scale (GAS) after the intervention after 15 weeks

    Goal Attainment Scale is a method of scoring the extent to which the patient's individual goals are achieved in the course of the intervention. In effect, each patient has his own outcome measure, but this is scored in a standardized way as to allow statistical analysis. Each goal is rated on a six-point scale, capturing the degree of attainment for each goal area: The present situation is scored -2 (stable). When the patient improves, but achieves less than the expected level this is scored -1 and the expected level is scored 0. When he achieves a better than expected outcome this is scored +1 (somewhat better than the goal) or +2 (much better). Achieving a worse than expected outcome is scored -3 (somewhat worse) In this study, a maximum of 3-4 goals are identified, which are incorporated into a single GAS score.

    Measured: The GAS will be assessed in the fifth (week 7-11), tenth (week12-16) en fifteenth (week 17-23) sessions.

  4. Change from baseline of self-esteem as measured on the The Rosenberg Self-Esteem Scale (RSES) after 15 weeks and 1 year

    The Rosenberg Self-Esteem Scale (RSES) [31] will be used to assess self-esteem. It is a widely used 10-item Likert-scale self-esteem measure. Items are answered on a four-point scale - ranging from strongly agree to strongly disagree - measuring positive and negative feelings towards the self. The Dutch version of the RSES is found to be a one-dimensional scale with high internal consistency and congruent validity and a Cronbach's alpha of 0.89

    Measured: 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.

  5. Change from baseline of Global functioning as measured on the Child Behavior Checklist (CBCL) after 15 weeks and 1 year

    For assessing emotional and/or behavioral problems we will use the CBCL/6-18, completed by parents , the TRF/6-18, completed by teachers, and the YSR/11-18, completed by youths. They include more than 100 items assessing behavioral and emotional problems that are answered on a three-point Likert-type scale (0 = not true, 1 = somewhat or sometimes true, 2 = very true or often true) by parents. The scores will display eight problem scales. The sum of the problem scales 1, 2 and 3 form the 'internalizing behavior' scale, whereas 7 and 8 form 'externalizing behavior'. All subscales together count for the total problem scale. T-scores are computed from raw scores; higher scores on the syndrome scales indicate a greater severity of problems. A T-score of 63 (90th percentile) demarcates the clinical range, which is an indication that a child needs professional help. For the competence scales, lower scores indicate greater severity. A T-score < 37 indicates the clinical range.

    Measured: 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).

  6. Change from baseline of Goal attainment as measured on the Outcome Rating Scale (ORS) after 15 weeks

    For collecting client feedback we will use a brief questionnaires, the Outcome Rating Scale (ORS), which will be easily administered on a regular basis during treatment (https://www.scottdmiller.com/ scholarly-publications-handouts-vitae/).This allows treatment sessions to be evaluated at any time to ascertain whether or not individual treatments are 'on the right track' towards a successful outcome. The ORS is primarily focused on the well-being of the client and is administered at the beginning of the treatment session. The SRS is administered at the end of the session and deals with how the client has experienced the treatment session. The outcomes of the questionnaires are reflected in a graph on an iPad (or on paper when an iPad is not available) per interview to allow the height of the score and progress to be visualized during the sessions.

    Measured: The therapist will assess the SRS/ORS each session (week 3-23).

  7. Change from baseline of family functioning as measured on the VGFO on T3

    Family functioning is assessed using a validated questionnaire: the Family Functioning Questionnaire (VGFO, 34 items) (https://www.praktikon.nl/wat-we-doen/vragenlijsten/vgo). The Family Functioning Questionnaire can be answered on a four-point scale ranging from 1 (not applicable) to 4 (completely applicable) with lower scores indicating more problems in family functioning.

    Measured: This questionnaire will be assessed at the baseline (T0) and at week 25 (T3).

  8. Change from baseline of Global functioning as measured on the Teachers Report Form (TRF) after 15 weeks and 1 year

    For assessing emotional and/or behavioral problems we will use the TRF/6-18, completed by teachers. They include more than 100 items assessing behavioral and emotional problems that are answered on a three-point Likert-type scale (0 = not true, 1 = somewhat or sometimes true, 2 = very true or often true) by parents. The scores will display eight problem scales. The sum of the problem scales 1, 2 and 3 form the 'internalizing behavior' scale, whereas 7 and 8 form 'externalizing behavior'. All subscales together count for the total problem scale. T-scores are computed from raw scores; higher scores on the syndrome scales indicate a greater severity of problems. A T-score of 63 (90th percentile) demarcates the clinical range, which is an indication that a child needs professional help. For the competence scales, lower scores indicate greater severity. A T-score < 37 indicates the clinical range.

    Measured: 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).

  9. Change from baseline of Global functioning as measured on the Youth Self Report (YSR) after 15 weeks and 1 year

    For assessing emotional and/or behavioral problems we will use the YSR/11-18, completed by youths. They include more than 100 items assessing behavioral and emotional problems that are answered on a three-point Likert-type scale (0 = not true, 1 = somewhat or sometimes true, 2 = very true or often true) by parents. The scores will display eight problem scales. The sum of the problem scales 1, 2 and 3 form the 'internalizing behavior' scale, whereas 7 and 8 form 'externalizing behavior'. All subscales together count for the total problem scale. T-scores are computed from raw scores; higher scores on the syndrome scales indicate a greater severity of problems. A T-score of 63 (90th percentile) demarcates the clinical range, which is an indication that a child needs professional help. For the competence scales, lower scores indicate greater severity. A T-score < 37 indicates the clinical range.

    Measured: 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).

  10. Change from baseline of adherence as measured on the SRS after 15 weeks

    For collecting client feedback we will use a brief questionnaires, the Session Rating Scale (SRS), which will be easily administered on a regular basis during treatment (https://www.scottdmiller.com/ scholarly-publications-handouts-vitae/).This allows treatment sessions to be evaluated at any time to ascertain whether or not individual treatments are 'on the right track' towards a successful outcome. The ORS is primarily focused on the well-being of the client and is administered at the beginning of the treatment session. The SRS is administered at the end of the session and deals with how the client has experienced the treatment session. The outcomes of the questionnaires are reflected in a graph on an iPad (or on paper when an iPad is not available) per interview to allow the height of the score and progress to be visualized during the sessions.

    Measured: The therapist will assess the SRS each session (week 3-23).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2022
  2. Study start14 Feb 2022
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
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.
Masking
None (open label)
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05200351
Sponsor's protocol ID
185-20 Pegasus
Other IDs
636310020
Status last verified
Nov 2024
First submitted
17 Dec 2021
Last updated
4 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 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.

    PubMed 38987737

Questions about this trial

What is this clinical trial studying?

A study testing Equine assisted Therapy (EAT) in people with Emotion Regulation and Autism Spectrum Disorder, run by Karakter Kinder- en Jeugdpsychiatrie at 3 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jenny den Boer, Drs (0031-318676611, j.denboer@karakter.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05200351, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2024.

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