Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2026-01-01 @ 1:35 PM
Study NCT ID:
NCT01073657
Status:
COMPLETED
Last Update Posted:
2015-04-28
First Post:
2010-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Supported Education Pilot
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000067250', 'term': 'Psychiatric Rehabilitation'}], 'ancestors': [{'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Marsha.Ellison@va.gov', 'phone': '781 687 3401', 'title': 'Marsha Langer Ellison, Ph.D.', 'organization': 'Veterans Health Adminstration'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Arm 1', 'description': 'Supported Education: Rehabilitation counseling using peers to achieve educational goals', 'otherNumAtRisk': 17, 'otherNumAffected': 7, 'seriousNumAtRisk': 17, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Active Control', 'description': 'Veterans received matched peer attention that did not address educational goals', 'otherNumAtRisk': 16, 'otherNumAffected': 3, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'discharged from domiciliary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'incarceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'higher level of care', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'back injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': '"Supported Education Process Measure"', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Supported Education', 'description': 'Supported Education: Rehabilitation counseling using peers to achieve educational goals Intervention group'}, {'id': 'OG001', 'title': 'General Peer Support', 'description': 'Matched peer attention no supported education service'}], 'classes': [{'categories': [{'measurements': [{'value': '26.2', 'spread': '50.2', 'groupId': 'OG000'}, {'value': '8.2', 'spread': '21.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0059', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.0', 'ciLowerLimit': '14', 'ciUpperLimit': '38', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '33.9', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Number of quarter hours spent in activities related to acquiring an education goal e.g., preparing applications, attending classes. Hours will be logged on a tally sheet adapted from the "Supported Education Process Measure" (Corrigan, 2009).', 'unitOfMeasure': 'number of quarter hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Comparison of means'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Supported Education', 'description': 'Supported Education: Rehabilitation counseling using peers to achieve educational goals'}, {'id': 'FG001', 'title': 'General Peer Support', 'description': 'Veterans received peer services that did not address educational goals'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Veterans were referred to the study by clinicians and other sources such as Veterans Upward Program and were consented and baselined over a 9 month period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm 1', 'description': 'Supported Education: Rehabilitation counseling using peers to achieve educational goals'}, {'id': 'BG001', 'title': 'Active Control', 'description': 'Veterans recived peer services that did not address educational goals'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000', 'lowerLimit': '23', 'upperLimit': '37'}, {'value': '29', 'groupId': 'BG001', 'lowerLimit': '21', 'upperLimit': '36'}, {'value': '29', 'groupId': 'BG002', 'lowerLimit': '21', 'upperLimit': '37'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-06', 'studyFirstSubmitDate': '2010-02-18', 'resultsFirstSubmitDate': '2014-12-10', 'studyFirstSubmitQcDate': '2010-02-22', 'lastUpdatePostDateStruct': {'date': '2015-04-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-02-13', 'studyFirstPostDateStruct': {'date': '2010-02-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-02-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '"Supported Education Process Measure"', 'timeFrame': '6 months', 'description': 'Number of quarter hours spent in activities related to acquiring an education goal e.g., preparing applications, attending classes. Hours will be logged on a tally sheet adapted from the "Supported Education Process Measure" (Corrigan, 2009).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Rehabilitation'], 'conditions': ['PTSD']}, 'referencesModule': {'references': [{'pmid': '22246119', 'type': 'RESULT', 'citation': 'Ellison ML, Mueller L, Smelson D, Corrigan PW, Torres Stone RA, Bokhour BG, Najavits LM, Vessella JM, Drebing C. Supporting the education goals of post-9/11 veterans with self-reported PTSD symptoms: a needs assessment. Psychiatr Rehabil J. 2012 Winter;35(3):209-17. doi: 10.2975/35.3.2012.209.217.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this project is to gather data necessary for a full scale trial of a supported education service for OIF/OEF veterans with PTSD. Forty Veterans with PTSD will be randomly assigned to an intervention group (N=20) that receives a weekly supported education intervention and a control group that receives services as usual plus an hour of attentive intervention not focused on education. We will assess and compare the number of hours of participation in community education settings and on acquiring an educational goal for the Veterans in each group.', 'detailedDescription': 'Goal: The goal of this project is to gather data on feasibility and effect size necessary for a full scale trial of a supported education service for Operation Iraq and Enduring Freedom (OIF/OEF) veterans with PTSD that will contribute to its evidence-base. Supported education is a rehabilitation and recovery based intervention that is new to VHA services and that responds to an expressed but unmet need among these warriors with war-related trauma. We propose to conduct a pilot of a supported education service and employ a process and outcome evaluation.\n\nAnticipated Impacts on Veterans Healthcare: Veterans with post traumatic stress disorder (PTSD) possess educational aspirations. Due to limited education and disability adjustment, many such veterans unsuccessfully locate employment or obtain entry level jobs with limited advancement opportunities. Even with current GI Bill funding increases, veterans experience non-financial barriers to their pursuit of educational goals. Supported education is a strategy developed within the civilian population that facilitates skill, career, and educational goals within post-secondary educational settings. It has been shown to increase educational engagement, participation, and completion, as well as improve empowerment and school efficacy. We hypothesize that supported education tailored to returning Veterans will result in similar outcomes.\n\nAims and Objectives: The goal of this project is to gather data necessary for a full scale trial of a supported education service for OIF/OEF veterans with PTSD. The following are the aims and objectives:\n\nAim 1: Using a randomized controlled design, assess the magnitude of the effect of a supported education service on hours of participation in community educational settings and on acquiring an educational goal. Objective: Assess the number of hours of participation in community education settings and on acquiring an educational goal for 40 Veterans with PTSD who are randomly assigned to an intervention group (N=20) that receives a weekly supported education intervention and a control group that receives services as usual plus an hour of attentive intervention not focused on education.\n\nAim 2. To examine whether the supported education intervention has secondary effects for improving PTSD symptoms and attitudes on recovery. Objective: Conduct pre- and post assessments of recovery attitudes and of PTSD symptoms, and then compare the control and intervention group for changes in these scores.\n\nAim 3. To acquire additional process information on the design and implementation of a supported education service necessary for a successful larger trial. Objective: Conduct a process evaluation of the implementation strategies for: participant recruitment, participant drop-out, technician training procedures, technician recovery promoting competence, and curriculum content and pacing using a standardized assessment, exit interviews, peer notes and study records.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PTSD\n* OIF/OEF Service\n\nExclusion Criteria:\n\nNone'}, 'identificationModule': {'nctId': 'NCT01073657', 'acronym': 'SEd', 'briefTitle': 'Supported Education Pilot', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Supporting Education Goals of OIF/OEF Veterans With PTSD: Pilot Process & Outcome', 'orgStudyIdInfo': {'id': 'PPO 09-254'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supported Education', 'description': 'Veterans received supported education services. A Veteran peer met weekly as needed with a subject for up to six months in a psycho-social rehabilitation service for meeting education goals. Goals included choosing a college, getting admitted or enrolled, and maintaining enrollment and completing classes.', 'interventionNames': ['Other: Supported Education']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'General Peer Support', 'description': 'Matched attention was provided by a Veteran peer who met weekly with Veterans but who focused on help with any personal goal (eg, employment, housing) but not on education.', 'interventionNames': ['Other: General Peer Support']}], 'interventions': [{'name': 'Supported Education', 'type': 'OTHER', 'otherNames': ['Psychosocial Rehabilitation'], 'description': 'Rehabilitation counseling using peers to achieve educational goals', 'armGroupLabels': ['Supported Education']}, {'name': 'General Peer Support', 'type': 'OTHER', 'description': 'Matched peer support for any personal goal other than education', 'armGroupLabels': ['General Peer Support']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01730', 'city': 'Bedford', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA', 'geoPoint': {'lat': 42.49065, 'lon': -71.27617}}], 'overallOfficials': [{'name': 'Marsha Langer Ellison, PhD MSW', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'US Department of Veterans Affairs', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}