Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:32 PM
Study NCT ID:
NCT03957993
Status:
COMPLETED
Last Update Posted:
2020-07-16
First Post:
2019-05-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
OT Intervention Via Telehealth for Children With ASD and ADHD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The therapist who assesses the outcomes is a different therapist than the treating (intervention) therapist.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are randomized to the Telehealth arm of the study or the Standard Care arm of the study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-14', 'studyFirstSubmitDate': '2019-05-10', 'studyFirstSubmitQcDate': '2019-05-20', 'lastUpdatePostDateStruct': {'date': '2020-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Goal Attainment Scale', 'timeFrame': 'Baseline and approximately 2 weeks after treatment (approximately 14 weeks after baseline measurement)', 'description': 'The Goal Attainment Scale is a criterion-referenced, individualized outcome measure used to assess progress on goals that are important to the child and their family. The Goal Attainment Scale is reliable, valid and responsive to change. The status of goal attainment is rated on a scale of +2 to -2 (+2 is much more than expected, -2 is much less than expected)'}, {'measure': 'Change in Canadian Occupational Performance Measure', 'timeFrame': 'Baseline and approximately 2 weeks after treatment (approximately 14 weeks after baseline measurement)', 'description': "The Canadian Occupational Performance Measure is a valid, reliable, and sensitive assessment tool that measures the caregiver/patient's perception of the participant's performance and satisfaction on goals that are important to the child and his/her caregiver. The performance and satisfaction are rated on a scale from 1-10 (1 is low performance/satisfaction, 10 is high performance/satisfaction)."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Autism Spectrum Disorder', 'Attention Deficit Hyperactivity Disorder']}, 'descriptionModule': {'briefSummary': 'This study aims to measure the impact of a telehealth-based model of occupational therapy (OT) treatment on clinical outcomes for children with autism spectrum disorder (ASD) and/or attention deficit hyperactivity disorder (ADHD). Half of the participants will receive clinic-based, in-person services and half of the participants will receive video-based, Telehealth services.', 'detailedDescription': 'Children with autism spectrum disorder (ASD) and/or attention deficit hyperactivity disorder (ADHD) often receive occupational therapy (OT), which traditionally takes place in a clinical setting. This setting may present barriers and distractors that make it hard for children to achieve their OT goals. Telehealth-based sessions provide an alternative, allowing the therapist to be virtually present within the home.Once enrolled, children will randomly be assigned to be in one of two groups: (1) Standard, in which children will receive clinic-based services as per standard of care OR (2) Telehealth, in which children will receive in-home services on a video-based platform on a timeline identical to what they would receive if they were in the Standard group. Children in both groups will participate for the duration of the episode of care, estimated to last 10-12 weeks. Assessments will be completed at initial evaluation, discharge, and three months following discharge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has a Autism Spectrum Disorder and/or Attention Deficit Hyperactivity Disorder\n* Has an active occupational therapy referral\n* Has occupational therapy goals that are directly related to performance of activities of daily living that might reasonably be affected by the environment (as determined by an evaluating therapist)\n\nExclusion Criteria:\n\n* Does not have Autism Spectrum Disorder or Attention Deficit Hyperactivity Disorder\n* Does not have an active occupational therapy referral\n* Does not have occupational therapy goals that are directly related to performance of activities of daily living that might reasonably be affected by the environment (as determined by an evaluating therapist)'}, 'identificationModule': {'nctId': 'NCT03957993', 'briefTitle': 'OT Intervention Via Telehealth for Children With ASD and ADHD', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital Medical Center, Cincinnati"}, 'officialTitle': 'Pilot Study: Addressing Home-Based Functional Challenges Via Telehealth-Based Occupational Therapy', 'orgStudyIdInfo': {'id': '2017-5623'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Occupational Therapy via Telehealth', 'description': 'Participants in the telehealth-based model will undergo occupational therapy treatment via a telehealth-based video chat platform for the entire episode of care (generally 10-12 weeks in duration). The patient will use the video chat client to connect to his/her occupational therapist, and the therapist will conduct the session over this virtual connection.', 'interventionNames': ['Other: Occupational Therapy via Telehealth']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care Occupational Therapy', 'description': 'Participants in the standard of care model will undergo occupational therapy treatment via traditional in- person encounters in an outpatient clinic setting for the entire episode of care (generally 10-12 weeks). These children will receive routine occupational treatment via in-person sessions with an occupational therapist conducted in an outpatient clinic setting.', 'interventionNames': ['Other: Standard of Care Occupational Therapy']}], 'interventions': [{'name': 'Occupational Therapy via Telehealth', 'type': 'OTHER', 'description': 'The caregiver will be with the participant in their home environment receiving occupational therapy via Telehealth (video-calling) with the occupational therapist.', 'armGroupLabels': ['Occupational Therapy via Telehealth']}, {'name': 'Standard of Care Occupational Therapy', 'type': 'OTHER', 'description': 'The caregiver and participant will be in the clinic receiving occupational therapy in-person with the occupational therapist.', 'armGroupLabels': ['Standard of Care Occupational Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital Medical Center", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Karen Harpster, PhD, OTR/L', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital Medical Center, Cincinnati"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is not a plan to make individual participant data available to other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital Medical Center, Cincinnati", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}