Back to resultsEquine-assisted Therapy for Therapy-resistant Adolescents With Autism Spectrum Disorders, a Replicated AB-design
Primary Purpose
Emotion Regulation, Autism Spectrum Disorder, Adolescent - Emotional Problem
Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Equine assisted Therapy (EAT)
Sponsored by
About this trial
This is an interventional treatment trial for Emotion Regulation
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.
Sites / Locations
- KarakterRecruiting
- Horses & CoRecruiting
- De GagelhoeveRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EAT Intervention
Arm Description
15 sessions of EAT
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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).
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.
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
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05200351
First Posted
December 17, 2021
Last Updated
March 9, 2023
Sponsor
Karakter Kinder- en Jeugdpsychiatrie
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT05200351
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 14, 2022 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Karakter Kinder- en Jeugdpsychiatrie
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emotion Regulation, Autism Spectrum Disorder, Adolescent - Emotional Problem
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EAT Intervention
Arm Type
Experimental
Arm Description
15 sessions of EAT
Intervention Type
Behavioral
Intervention Name(s)
Equine assisted Therapy (EAT)
Intervention Description
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 Measure Information:
Title
Change from baseline on the Emotion dysregulation Index (EDI) after start of the intervention
Description
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.
Time Frame
3 times a week during 23 weeks from baseline
Secondary Outcome Measure Information:
Title
Change from baseline of Quality of life as scored on the KIDSCREEN after 15 weeks and 1 year
Description
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.
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)
Title
Change from baseline of severity of autism spectrum symptoms as measured on the Social Responsiveness Scale (SRS-2) after 15 weeks and 1 year
Description
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).
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).
Title
Change from baseline on the Goal Attainment Scale (GAS) after the intervention after 15 weeks
Description
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.
Time Frame
The GAS will be assessed in the fifth (week 7-11), tenth (week12-16) en fifteenth (week 17-23) sessions.
Title
Change from baseline of self-esteem as measured on the The Rosenberg Self-Esteem Scale (RSES) after 15 weeks and 1 year
Description
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
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.
Title
Change from baseline of Global functioning as measured on the Child Behavior Checklist (CBCL) after 15 weeks and 1 year
Description
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.
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).
Title
Change from baseline of Goal attainment as measured on the Outcome Rating Scale (ORS) after 15 weeks
Description
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.
Time Frame
The therapist will assess the SRS/ORS each session (week 3-23).
Title
Change from baseline of family functioning as measured on the VGFO on T3
Description
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.
Time Frame
This questionnaire will be assessed at the baseline (T0) and at week 25 (T3).
Title
Change from baseline of Global functioning as measured on the Teachers Report Form (TRF) after 15 weeks and 1 year
Description
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.
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).
Title
Change from baseline of Global functioning as measured on the Youth Self Report (YSR) after 15 weeks and 1 year
Description
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.
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).
Title
Change from baseline of adherence as measured on the SRS after 15 weeks
Description
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.
Time Frame
The therapist will assess the SRS each session (week 3-23).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jenny den Boer, Drs
Phone
0031-318676611
Email
j.denboer@karakter.com
First Name & Middle Initial & Last Name or Official Title & Degree
Helen Klip, Dr.
Phone
0031-243512222
Email
H.klip@karakter.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nanda Lambregt-Rommelse, Prof. Dr.
Organizational Affiliation
Radboud/Karakter
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karakter
City
Ede
State/Province
Gelderland
ZIP/Postal Code
6717 LX
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jenny den Boer, Drs
Email
Pegasus@karakter.com
Facility Name
Horses & Co
City
Heerjansdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Esther van Noort
Email
Esther@horsesenco.nl
Facility Name
De Gagelhoeve
City
Mill
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anita Blonk, Dr.
Email
Ablonk@gagelhoeve.nl
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30670226
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.
Results Reference
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Equine-assisted Therapy for Therapy-resistant Adolescents With Autism Spectrum Disorders, a Replicated AB-design
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