Ignite Creation Date:
2025-12-24 @ 10:00 PM
Ignite Modification Date:
2026-02-18 @ 1:50 PM
Study NCT ID:
NCT05846932
Status:
COMPLETED
Last Update Posted:
2025-12-17
First Post:
2023-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preliminary Efficacy of Occupational Therapy Integrating Horses on Self-regulation in Youth With Autism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D000068356', 'term': 'Self-Control'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-03-08', 'size': 534306, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-08-06T12:36', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': "The research assistant that rates goal attainment at the conclusion of therapy will be asked to participants' intervention assignment (OTEE HORS v OT Clinic)."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Youth with be randomized to either receive occupational therapy integrating horses (OTEE HORS) or occupational therapy in a clinic (OT Clinic)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2023-04-07', 'studyFirstSubmitQcDate': '2023-04-26', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Aberrant Behavior Checklist, Community', 'timeFrame': 'Week 1 & Week 10', 'description': 'Parent-report checklist of problematic behaviors related to hyperactivity and irritability'}], 'secondaryOutcomes': [{'measure': 'Change in Emotional Dysregulation Inventory', 'timeFrame': 'Week 1 & Week 10', 'description': 'Parent-report measure of emotional reactivity and dysphoria'}, {'measure': 'Change in Concentration of Salivary Cortisol', 'timeFrame': 'Week 1, Week 6, Week 10'}, {'measure': 'Change in Concentration of Salivary Alpha-amylase', 'timeFrame': 'Week 1, Week 6, Week 10'}, {'measure': 'Goal Attainment using Goal Attainment Scale', 'timeFrame': 'Week 10', 'description': 'Attainment of individualized self-regulation goals. Goal attainment scales range from -2 to +2 where higher values indicate greater progress towards individual goal.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['occupational therapy', 'hippotherapy', 'equine-assisted services', 'self-regulation'], 'conditions': ['Autism Spectrum Disorder']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://csuspur.org/tgec/', 'label': 'Temple Grandin Equine Center Denver'}]}, 'descriptionModule': {'briefSummary': '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:\n\n* Does occupational therapy integrating horses improve self-regulation in autistic youth\n* Does occupational therapy integrating horses affect salivary cortisol and alpha-amylase\n\nParticipants will receive 10 weeks of occupational therapy, and will be asked to provide saliva samples each week.\n\nResearchers will compare occupational therapy integrating horses to occupational therapy in a clinic to see if integrating horses affects self-regulation.', 'detailedDescription': '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.\n\nTo address both aims we will randomize 64 youth with ASD ages 6-11 years old to OTEE HORS or OT clinic.\n\nSpecific 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).\n\nSpecific 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* meet clinical cut-offs for ASD on the Autism Diagnostic Observation Schedule, Second Edition(ADOS-2) and Social Communication Questionnaire (≥ 11)\n* nonverbal IQ≥65 on Leiter International Performance Scale Third Edition (Leiter-3)\n* verbally fluent defined by meeting standard administration criteria for ADOS-2 module 3\n* score \\>10 on the irritability subscale of the aberrant behavior checklist\n* able to tolerate a helmet and ride a horse for 10 minutes while following safety rules\n* and able to provide a saliva sample\n\nExclusion Criteria:\n\n* weigh more than 200 pounds\n* smoke or regularly use steroids\n* receive outpatient occupational therapy\n* have 10+ hours horseback riding experience in the previous 6 months\n* history of animal abuse or phobia of horses\n* have a sibling previously enrolled in the study'}, 'identificationModule': {'nctId': 'NCT05846932', 'briefTitle': 'Preliminary Efficacy of Occupational Therapy Integrating Horses on Self-regulation in Youth With Autism', 'organization': {'class': 'OTHER', 'fullName': 'Colorado State University'}, 'officialTitle': 'Preliminary Efficacy of Occupational Therapy Integrating Horses on Self-regulation in Youth With Autism Spectrum Disorder', 'orgStudyIdInfo': {'id': '4049'}, 'secondaryIdInfos': [{'id': '1R21HD109957-01', 'link': 'https://reporter.nih.gov/quickSearch/1R21HD109957-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Occupational Therapy Integrating Horses', 'description': '10 weeks of occupational therapy focused on self-regulation skills, provided while participants are riding horses', 'interventionNames': ['Behavioral: OTEE HORS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Occupational Therapy in a Clinic', 'description': '10 weeks of occupational therapy focused on self-regulation skills, provided in a traditional clinic environment', 'interventionNames': ['Behavioral: OT Clinic']}], 'interventions': [{'name': 'OTEE HORS', 'type': 'BEHAVIORAL', 'description': '10 weeks of occupational therapy focused on teaching and practicing self-regulation skills, provided while participants are riding horses', 'armGroupLabels': ['Occupational Therapy Integrating Horses']}, {'name': 'OT Clinic', 'type': 'BEHAVIORAL', 'description': '10 weeks of occupational therapy focused on teaching and practicing self-regulation skills, provided in a traditional clinic', 'armGroupLabels': ['Occupational Therapy in a Clinic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80216', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Temple Grandin Equine Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}], 'overallOfficials': [{'name': 'Brittany C Peters, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Colorado State University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['ICF'], 'timeFrame': 'We will share in an appropriate data repository indefinitely, no later than the acceptance for publication of the main findings from the final dataset', 'ipdSharing': 'YES', 'description': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Colorado State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Colorado, Denver', 'class': 'OTHER'}, {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}