Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2026-01-08 @ 2:45 AM
Study NCT ID:
NCT02468505
Status:
COMPLETED
Last Update Posted:
2019-07-12
First Post:
2015-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
STEPS: Stepped Transition in Education Program for Students With ASD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-09', 'studyFirstSubmitDate': '2015-06-04', 'studyFirstSubmitQcDate': '2015-06-09', 'lastUpdatePostDateStruct': {'date': '2019-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Questionnaire to measure feasibility and program acceptability', 'timeFrame': '16 weeks', 'description': 'parent- and youth self-report measure of utility of program, acceptability, and consumer satisfaction'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Structured transition support program', "Transition 'as usual'"], 'conditions': ['Autism Spectrum Disorder']}, 'descriptionModule': {'briefSummary': 'Young adults who have Autism Spectrum Disorder (ASD) without co-occurring intellectual impairment face a fairly unique set of challenges as they transition out of secondary school. These students are often quite capable of succeeding in higher education and many of them have interest in pursuing advanced degrees, but the nature of their disability and associated deficits (e.g., poor time management and poor self-regulation) may impede success. Individualized, appropriately timed, and developmentally sensitive transition and support services may promote optimal outcomes for these young people. The goal of this project is to develop a comprehensive program to promote successful transition of students with ASD from high school to post-secondary education.', 'detailedDescription': "The investigators propose to refine and then evaluate a novel transition support and intervention program for adolescents and young adults with ASD: STEPS \\[Stepped Transition in Education Program for Students with ASD\\]. By targeting improved self-regulation (SR) and self-determination (SD) in young people with ASD, the investigators assert that this program may have positive outcomes with respective to college adjustment and functional behavior. Although the program will be finalized during the first phase of the proposed project, at present STEPS is comprised of two levels (or steps), which match the student's particular needs in relation to transition planning. In Step 1, students facing transition (i.e., have identified the college they will attend (either 2-year or 4-year institution) but are still in high school) and their caregivers will receive information to assist in transition planning, undergo readiness self-assessments (to identify degree of preparedness for post-secondary school), and participate in interactive sessions online and in person to promote self-knowledge and determination. The goal of Step 1 is to assist families and students with transition planning, specifically ensuring that families and students have the tools needed to make informed choices and take necessary steps (e.g., remediating identified skill deficits) to increase the likelihood of a successful transition out of high school. In Step 2, college students with ASD will receive fairly intensive supports and interventions, including individual counseling, structured support services, social integration activities, and coaching to promote academic and social success. The following specific aims are proposed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be 16 to 25 years\n* Must have clinical diagnosis of autism spectrum disorder\n* Must be preparing for postsecondary education or enrolled in postsecondary education\n\nExclusion Criteria:\n\n* Intellectual disability\n* Psychiatric disturbance that warrants immediate treatment'}, 'identificationModule': {'nctId': 'NCT02468505', 'acronym': 'STEPS', 'briefTitle': 'STEPS: Stepped Transition in Education Program for Students With ASD', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Polytechnic Institute and State University'}, 'officialTitle': 'STEPS: Stepped Transition in Education Program for Students With ASD', 'orgStudyIdInfo': {'id': 'R34MH104337', 'link': 'https://reporter.nih.gov/quickSearch/R34MH104337', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'STEPS', 'description': 'structured psychosocial transition support that includes individual counseling, and education/training for parent and school personnel', 'interventionNames': ['Behavioral: STEPS']}, {'type': 'NO_INTERVENTION', 'label': 'TAU', 'description': 'typical transition services and supports'}], 'interventions': [{'name': 'STEPS', 'type': 'BEHAVIORAL', 'description': 'time-limited behavioral counseling, online materials, training', 'armGroupLabels': ['STEPS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24061', 'city': 'Blacksburg', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Polytechnic Institute and State University', 'geoPoint': {'lat': 37.22957, 'lon': -80.41394}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Polytechnic Institute and State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Yasuo Miyazaki', 'investigatorAffiliation': 'Virginia Polytechnic Institute and State University'}}}}