Clinical trial NCT04772898: Effectiveness of a 6-week Hippotherapy Program in Children With Autism Spectrum Disorder
Official title: Effectiveness of a 6-week Hippotherapy Program in Children With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: Creighton University
Sponsor class: OTHER
First posted: 2021-02-26
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The prevalence of autism spectrum disorders (ASD) has increased dramatically in the last decade. The increasing occurrence of ASD creates an imperative need to test the effectiveness and efficacy mechanisms of appropriate interventions. Hippotherapy (HPOT) is a treatment option that has been show beneficial for children with ASD as well as other children with developmental disorders. The current projects focuses on understanding the mechanisms of HPOT efficacy and evaluating a short-term HPOT program for children with ASD.

Detailed description: The incidence of autism spectrum disorders (ASD) has increased dramatically in the last decade. The latest report from the Centers for Disease Control and Prevention state that 1 in 59 children are being diagnosed with ASD and it is four times more prevalent in boys than girls. Common treatments for children with ASD are applied behavioral therapy, occupational and speech therapy, which are used solely or in combination. Hippotherapy (HPOT) is another treatment option that has been shown to positively impact various aspects of behavior. This pilot project aims to determine the effects of a 6-week HPOT program on movement and social behavior of children with ASD and to investigate the underlying mechanisms of why HPOT is successful for ASD through the coupling of physiological and temperamental responses between horse and rider. The approach involves examining these skills pre, during, and post HPOT intervention in children diagnosed with ASD. A group of aged matched children with typical development will serve as the control group. Innovative measures of physiological coupling and temperament between horse and rider as well as objective and quantitative measures of movement and social behavior and caregiver perception will be collected. The investigators anticipate that following completion of the proposed study, they will provide the necessary foundation to understand the mechanisms of HPOT, and thus provide a new framework to test clinical trials of HPOT and human-animal interaction, and ultimately improve the lives of those diagnosed with ASD and their families.

Eligibility criteria: For the children with Autism Spectrum Disorders:

Inclusion Criteria:

1. diagnosis of ASD based upon the Autism Diagnostic Observation Schedule and parent interview,
2. medical approval for participation in the HPOT activity,
3. no other medical or psychiatric diagnoses besides ASD
4. tolerate helmet on head and attachments of the movement and heart rate sensors.

The inclusion criteria for the TD children will be:

1. no diagnosis or family history of ASD
2. no other neurodevelopmental or musculoskeletal disorder
3. tolerate helmet on head and attachments of the movement and heart rate sensors.
4. medical approval for participation in the HPOT activity,

Exclusion Criteria:

1. under 5 years of age or over 10 years of age
2. has a serious comorbid medical diagnosis
3. major vision or hearing impairments
4. severe behavioral problems
5. an orthopedic or genetic diagnosis

Primary outcomes:
measure: Social Responsiveness Scale (SRS)
timeFrame: Change from Pre (baseline) to Post (after completion of 6 weeks of intervention)
measure: Postural Control
timeFrame: Change from Pre (baseline) to Post (6 weeks after hippotherapy intervention)
measure: Cross Sample Entropy Between the Heart Rate Sensors of the Horse and Rider
timeFrame: During week 1, week 3 and week 6 of the treatment sessions
Secondary outcomes:
measure: Correlation Between Horse Temperament and Therapeutic Outcomes
timeFrame: from baseline to 6 weeks
measure: Aberrant Behavior Checklist
timeFrame: Change from baseline to 6 weeks
Other outcomes:
Locations:
city: Gretna
country: United States
facility: Hearthland Equine Therapeutic Riding Academy
state: Nebraska
Study officials:
affiliation: Creighton University
name: Anastasia Kyvelidou, PhD
role: PRINCIPAL_INVESTIGATOR
References: