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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21HD109957-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Colorado, Denver | OTHER |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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The goal of this clinical trial is to learn about occupational therapy integrating horses for autistic youth. The main questions it aims to answer are:
Participants will receive 10 weeks of occupational therapy, and will be asked to provide saliva samples each week.
Researchers will compare occupational therapy integrating horses to occupational therapy in a clinic to see if integrating horses affects self-regulation.
The goal of this project is to quantify the unique benefits of integrating horses in occupational therapy compared to occupational therapy in a clinic (i.e., OTEE HORS vs. OT Clinic) for improving self-regulation in youth with ASD.
To address both aims we will randomize 64 youth with ASD ages 6-11 years old to OTEE HORS or OT clinic.
Specific Aim 1: Examine the preliminary efficacy of OTEE HORS compared to OT Clinic on self-regulation. Hypotheses: The OTEE HORS group will demonstrate significantly larger improvements than the OT Clinic group in five domains of self-regulation (hyperactivity [primary], irritability, emotional reactivity, dysphoria, and individual goal attainment).
Specific Aim 2: Identify potential physiological mechanisms that explain how integration of horses in occupational therapy impacts self-regulation in youth with ASD. Hypotheses 2A & B: The OTEE HORS group will demonstrate significantly larger decreases in salivary cortisol after each 60-minute therapy session and after the 10-week treatment course in comparison to the OT Clinic group. Hypotheses 2C & 2D: The OTEE HORS group will demonstrate significantly greater increases in salivary alpha-amylase after each 60-minute therapy session, and significantly greater decreases in salivary alpha-amylase over time as measured after the 10-week treatment course in comparison to the OT Clinic group. Exploratory Hypothesis 2E: Changes in physiological measures will significantly correlate with changes in Aim 1 behavioral measures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Occupational Therapy Integrating Horses | Experimental | 10 weeks of occupational therapy focused on self-regulation skills, provided while participants are riding horses |
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| Occupational Therapy in a Clinic | Active Comparator | 10 weeks of occupational therapy focused on self-regulation skills, provided in a traditional clinic environment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OTEE HORS | Behavioral | 10 weeks of occupational therapy focused on teaching and practicing self-regulation skills, provided while participants are riding horses |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Aberrant Behavior Checklist, Community | Parent-report checklist of problematic behaviors related to hyperactivity and irritability | Week 1 & Week 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Emotional Dysregulation Inventory | Parent-report measure of emotional reactivity and dysphoria | Week 1 & Week 10 |
| Change in Concentration of Salivary Cortisol | Week 1, Week 6, Week 10 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brittany C Peters, PhD | Colorado State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Temple Grandin Equine Center | Denver | Colorado | 80216 | United States |
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| Label | URL |
|---|---|
| Temple Grandin Equine Center Denver | View source |
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De-identified data will be shared in an appropriate data repository, such as the "Data and Specimen Hub" (DASH) or the "National Database for Autism Research" (NDAR). Data will be shared no later than the acceptance for publication of the main findings from the final dataset. Salimetrics will discard saliva samples after testing, and therefore saliva samples will not be available for sharing.
We will share in an appropriate data repository indefinitely, no later than the acceptance for publication of the main findings from the final dataset
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 8, 2024 | Aug 6, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D000068356 | Self-Control |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D012919 | Social Behavior |
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Youth with be randomized to either receive occupational therapy integrating horses (OTEE HORS) or occupational therapy in a clinic (OT Clinic)
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The research assistant that rates goal attainment at the conclusion of therapy will be asked to participants' intervention assignment (OTEE HORS v OT Clinic).
| OT Clinic | Behavioral | 10 weeks of occupational therapy focused on teaching and practicing self-regulation skills, provided in a traditional clinic |
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| Change in Concentration of Salivary Alpha-amylase | Week 1, Week 6, Week 10 |
| Goal Attainment using Goal Attainment Scale | Attainment of individualized self-regulation goals. Goal attainment scales range from -2 to +2 where higher values indicate greater progress towards individual goal. | Week 10 |
| D001519 | Behavior |