Autism Spectrum Disorder Clinical Trial
Official title:
A Mixed Methods Investigation of Equine-assisted Occupational Therapy for Children With Autism
Verified date | April 2019 |
Source | Colorado State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Children with autism spectrum disorders (ASD) often participate in equine-assisted interventions, where practitioners partner with horses to improve the health and well-being of the clients they serve. One of these interventions is equine-assisted occupational therapy (EAOT). The first aim of this study is to assess the effectiveness of EAOT at improving the social, behavioral, and occupational functioning of children with ASD. Second, this study aims to conceptually develop the theory of change that guides how horses are integrated into occupational therapy for children with ASD. Eight children with ASD will participate in 10 weeks of EAOT. The quantitative strand will involve caregivers filling out measures of social functioning, self-regulation, and occupational performance on a weekly basis. Investigators hypothesize children will demonstrate improved performance on these measures during the intervention in comparison to baseline. The qualitative strand will consist of interviews with the providing occupational therapists aimed at understanding the theory behind why the intervention is effective. The results of this study will have implications for children with ASD, their families, and occupational therapists providing services to individuals with ASD.
Status | Completed |
Enrollment | 8 |
Est. completion date | December 31, 2018 |
Est. primary completion date | December 18, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years to 14 Years |
Eligibility |
Inclusion Criteria: - aged 5-14 - have an ASD diagnosis by a community provider - score =15 on the Social Communication Questionnaire - score =11 on the Aberrant Behavior Checklist-Community - meets clinical cut-offs for ASD on the Autism Diagnostic Observation Schedule, Second Edition - score =55 on the Leiter International Performance Scale, Third Edition - can tolerate a helmet - can participate in 10-minutes of riding while following safety rules - meets physical, mental, and emotional standards set forth by the Professional Association of Therapeutic Horsemanship, International Exclusion Criteria: - behavioral issues that could interfere with safety - 2 hours or more of previous experience with equine-assisted interventions in the last 6 months - weight exceeding 200 pounds |
Country | Name | City | State |
---|---|---|---|
United States | Hearts and Horses Therapeutic Riding Center | Loveland | Colorado |
Lead Sponsor | Collaborator |
---|---|
Colorado State University |
United States,
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* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Parent Perceptions of Child's Response to Treatment | Semi-structured interviews with parents to obtain their perceptions of the therapy | Two time points: 1-2 months after the intervention is complete (January-February 2018) and 5 months after intervention is complete (May 2018) | |
Other | Therapist Clinical Reasoning | Semi-structured interviews with therapists to understand their clinical reasoning guiding how the intervention was designed and delivered | Weekly basis for 10 weeks throughout intervention phase. | |
Primary | Change in Visual Analog Scale (VAS) ratings of individualized occupational performance goals | Parents rate their child's performance on an individualized goal using a sliding scale. The minimum score of 0, indicated on the left of the scale, denotes poor performance, while the maximum score 100, on the right of the scale, denotes excellent performance. | daily, during baseline and intervention phases (up to 119 days) | |
Secondary | Change in Irritability | Irritability subscale of the Aberrant Behavior Checklist- Community (ABC-C). The minimum score of 0 denotes an absence of irritable behaviors, while to maximum score of 45 denotes frequent and severe irritable behaviors. | Weekly during baseline and intervention phases, up to 18 weeks. Also during 3-month follow-up. | |
Secondary | Change in Hyperactivity | Hyperactivity subscale of the Aberrant Behavior Checklist- Community (ABC-C). The minimum score of 0 denotes an absence of hyperactive behaviors, while the maximum score of 48 denotes frequent and severe hyperactive behaviors. | Weekly during baseline and intervention phases, up to 18 weeks. Also at 3-month follow up. | |
Secondary | Change in Social Functioning | Parent ratings on the Social Responsiveness Scale, Second Edition. The scale ranges from 0 - 195, where higher scores indicate more social impairment. | 4 Time Points: initial, after 5-7 weeks of no-treatment baseline, after 10 weeks of intervention, and after a 3-month follow-up period. | |
Secondary | Change in Canadian Occupational Performance Measure | Parent ratings of performance and satisfaction with their child's progress towards individualized goals. Administered in a semi-structured interview format. Ratings range from 0 - 10, where larger scores indicate better performance or higher levels of satisfaction. | 4 Time Points: initial, after 5-7 weeks of no-treatment baseline, after 10 weeks of intervention, and after a 3-month follow-up period. |
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