Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:53 PM
Study NCT ID:
NCT05890456
Status:
RECRUITING
Last Update Posted:
2023-06-06
First Post:
2023-02-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Students With Involved Families and Teachers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000080103', 'term': 'Emotional Regulation'}, {'id': 'D000294', 'term': 'Adolescent Behavior'}], 'ancestors': [{'id': 'D000068356', 'term': 'Self-Control'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Students and their families will be randomly assigned to the SWIFT Program or SAU conditions. A blocked design will be used where randomization will occur at the individual level within each school once a family has agreed to study participation. This way variation between schools (blocks) will not affect the standard errors of treatment effect estimates. Key outcomes will be tested at Time 1 (T1, baseline), Time 2 (T2, 6 months post-baseline), Time 3 (T3, 12 months post-baseline), and Time 4 (T4, 18 months post-baseline).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 320}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-26', 'studyFirstSubmitDate': '2023-02-22', 'studyFirstSubmitQcDate': '2023-05-26', 'lastUpdatePostDateStruct': {'date': '2023-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Changes in Youth Emotional and Behavioral Outcomes from Baseline to 6 Months Post-Baseline', 'timeFrame': 'Baseline to 6 Months Post-Baseline', 'description': 'Emotion regulation skills measured by the Emotion Regulation Checklist. Measured at Baseline and 6 months post-Baseline.'}, {'measure': 'Mean Changes in Youth Emotional and Behavioral Outcomes from Baseline to 6 Months Post-Baseline', 'timeFrame': 'Baseline to 6 Months Post-Baseline', 'description': 'Psychopathological behaviors measured by the Child Behavior Checklist. Measured at Baseline and 6 months post-Baseline.'}, {'measure': 'Mean Changes in Youth Academic Outcomes from Baseline to 6 Months Post-Baseline', 'timeFrame': 'Baseline to 6 Months Post-Baseline', 'description': 'Academic outcomes measured by youth grades. Measured at Baseline and 6 months post-Baseline.'}, {'measure': 'Mean Changes in Youth Academic Outcomes from Baseline to 6 Months Post-Baseline', 'timeFrame': 'Baseline to 6 Months Post-Baseline', 'description': 'Academic outcomes measured by EasyCBM score. Measured at Baseline and 6 months post-Baseline.'}, {'measure': 'Mean Changes in Parenting Outcomes from Baseline to 6 Months Post-Baseline', 'timeFrame': 'Baseline to 6 Months Post-Baseline', 'description': 'Parenting outcomes measured by the Parenting Practices Questionnaire. Measured at Baseline and 6 months post-Baseline.'}], 'secondaryOutcomes': [{'measure': 'Stability in School Placement from Baseline to 6 Months', 'timeFrame': 'Baseline to 6 Months Post-Baseline', 'description': 'Measured by number of school placement moves. Measured at Baseline and 6 months post-Baseline.'}, {'measure': 'Mean Changes in Youth Emotional and Behavioral Outcomes from Baseline to 12 Months', 'timeFrame': 'Baseline to 12 Months Post-Baseline', 'description': 'Emotion regulation skills measured by the Emotion Regulation Checklist. Measured at Baseline and 12 months post-Baseline.'}, {'measure': 'Mean Changes in Youth Emotional and Behavioral Outcomes from Baseline to 12 Months', 'timeFrame': 'Baseline to 12 Months Post-Baseline', 'description': 'Psychopathological behaviors measured by the Child Behavior Checklist. Measured at Baseline and 12 months post-Baseline.'}, {'measure': 'Mean Changes in Youth Academic Outcomes from Baseline to 12 Months Post-Baseline', 'timeFrame': 'Baseline to 12 Months Post-Baseline', 'description': 'Academic outcomes measured by youth grades. Measured at Baseline and 12 months post-Baseline.'}, {'measure': 'Mean Changes in Youth Academic Outcomes from Baseline to 12 Months Post-Baseline', 'timeFrame': 'Baseline to 12 Months Post-Baseline', 'description': 'Academic outcomes measured by EasyCBM score. Measured at Baseline and 12 months post-Baseline.'}, {'measure': 'Mean Changes in Parenting Outcomes from Baseline to 12 Months Post-Baseline', 'timeFrame': 'Baseline to 12 Months Post-Baseline', 'description': 'Parenting outcomes measured by the Parenting Practices Questionnaire. Measured at Baseline and 12 months post-Baseline.'}, {'measure': 'Stability in School Placement from Baseline to 12 Months', 'timeFrame': 'Baseline to 12 Months Post-Baseline', 'description': 'Measured by number of school placement moves. Measured at Baseline and 12 months post-Baseline.'}, {'measure': 'Mean Changes in Youth Emotional and Behavioral Outcomes from Baseline to 18 Months', 'timeFrame': 'Baseline to 18 Months Post-Baseline', 'description': 'Psychopathological behaviors measured by the Child Behavior Checklist. Measured at Baseline and 18 months post-Baseline.'}, {'measure': 'Mean Changes in Youth Emotional and Behavioral Outcomes from Baseline to 18 Months', 'timeFrame': 'Baseline to 18 Months Post-Baseline', 'description': 'Emotion regulation skills measured by the Emotion Regulation Checklist. Measured at Baseline and 18 months post-Baseline.'}, {'measure': 'Mean Changes in Youth Academic Outcomes from Baseline to 18 Months Post-Baseline', 'timeFrame': 'Baseline to 18 Months Post-Baseline', 'description': 'Academic outcomes measured by youth grades. Measured at Baseline and 18 months post-Baseline.'}, {'measure': 'Mean Changes in Youth Academic Outcomes from Baseline to 18 Months Post-Baseline', 'timeFrame': 'Baseline to 18 Months Post-Baseline', 'description': 'Academic outcomes measured by EasyCBM score. Measured at Baseline and 18 months post-Baseline.'}, {'measure': 'Mean Changes in Parenting Outcomes from Baseline to 18 Months Post-Baseline', 'timeFrame': 'Baseline to 18 Months Post-Baseline', 'description': 'Parenting outcomes measured by the Parenting Practices Questionnaire. Measured at Baseline and 18 months post-Baseline.'}, {'measure': 'Stability in School Placement from Baseline to 18 Months', 'timeFrame': 'Baseline to 18 Months Post-Baseline', 'description': 'Measured by number of school placement moves. Measured at Baseline and 18 months post-Baseline.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Positive Parenting', 'Behavior Regulation', 'Academic Success'], 'conditions': ['Emotional Regulation', 'Adolescent Behavior', 'Parenting']}, 'descriptionModule': {'briefSummary': "PURPOSE: In the proposed project, the investigators seek to examine whether the SWIFT Program might be efficacious to improve students' prosocial skills and emotion and behavior regulation and improve home-school communication and the use of positive parenting practices for families. The investigators will also test whether the SWIFT program might be efficacious to improve students' longer-term school adjustment and parents' involvement in school.\n\nSETTING: Study activities will take place in ten school districts in Lane County, OR. The districts have approximately 10,000 middle school students (Grades 6-8), and approximately 60% of students are eligible for free and reduced price lunch. Some participating districts participated in the IES-funded Goal 2 study to develop the SWIFT Program.\n\nPOPULATION: 320 students in Grades 6-8 who are receiving special education services for emotional or behavioral disorders, and transitioning or at risk of transitioning between school settings and placements will be recruited. Parents and content area teachers of all participating students will be recruited to complete assessment measures. It is expected that up to 15% of the children in the study will be of Latino ethnicity and approximately 60% will be European-American and 10-20% will be of other or multiple ethnicities.\n\nINTERVENTION: The SWIFT Program is a 9-12 month intervention that includes four components: (a) behavioral progress monitoring, (b) case management of the intervention elements and coordination with the school, (c) parent support to promote parent engagement/collaboration with the school and study routines in the home, and (d) behavioral skills coaching for students.\n\nSERVICES AS USUAL (SAU) CONTROL CONDITION: The SAU students and families will continue to receive any services that they were receiving prior to their entry into the study (as will the SWIFT students and families). These may include school-based interventions and supports and related services as required in the student's IEP."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Students in grades 5 through 8\n* In school districts in the the Lane Education Service District\n* Eligible for or at risk of eligibility for special education services for emotional or behavior disorders\n* Transitioning or at risk of transitioning between school settings or placements\n* English or Spanish speaking\n\nExclusion Criteria:\n\n* Students receiving intensive family and school support services from local community mental health agencies\n* Students with a hearing or vision impairment that would limit participation in the program components or the assessment protocol.'}, 'identificationModule': {'nctId': 'NCT05890456', 'acronym': 'SWIFT-RCT', 'briefTitle': 'Students With Involved Families and Teachers', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Social Learning Center'}, 'officialTitle': 'Efficacy of the Students With Involved Families and Teachers (SWIFT) Program for Students With Emotional and Behavioral Disorders', 'orgStudyIdInfo': {'id': 'R324A190122'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Arm', 'description': 'The SWIFT Program is a 9-12 month intervention that includes four components: (a) behavioral progress monitoring, (b) clinical supervision of the intervention elements and coordination with the school, (c) parent support to promote parent engagement/collaboration with the school and study routines in the home, and (d) behavioral skills coaching for students. SWIFT students will continue to receive any school-based services that were receiving prior to entering the study.', 'interventionNames': ['Behavioral: Students with Involved Families and Teacher Program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Services As Usual Control', 'description': "The SAU students and families will continue to receive any services that they were receiving prior to their entry into the study. These may include school-based interventions and supports and related services as required in the student's Individualized Education Program.", 'interventionNames': ['Behavioral: Services As Usual']}], 'interventions': [{'name': 'Students with Involved Families and Teacher Program', 'type': 'BEHAVIORAL', 'otherNames': ['SWIFT'], 'description': 'The SWIFT Program is a 9-12 month intervention that includes four components: (a) behavioral progress monitoring, (b) clinical supervision of the intervention elements and coordination with the school, (c) parent support to promote parent engagement/collaboration with the school and study routines in the home, and (d) behavioral skills coaching for students.', 'armGroupLabels': ['Treatment Arm']}, {'name': 'Services As Usual', 'type': 'BEHAVIORAL', 'otherNames': ['SAU'], 'description': "The SAU students and families will continue to receive any services that they were receiving prior to their entry into the study. These may include school-based interventions and supports and related services as required in the student's Individualized Education Program.", 'armGroupLabels': ['Services As Usual Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97401', 'city': 'Eugene', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ted Donahue', 'role': 'CONTACT', 'email': 'tedd@oslc.org', 'phone': '541-485-2711', 'phoneExt': '1178'}, {'name': 'Julie Stubbs', 'role': 'CONTACT', 'email': 'julies@oslc.org', 'phone': '541-485-2711', 'phoneExt': '1322'}, {'name': 'Rohanna Buchanan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Oregon Social Learning Center', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}], 'centralContacts': [{'name': 'Abby Murphy', 'role': 'CONTACT', 'email': 'abbym@oslc.org', 'phone': '541-485-2711', 'phoneExt': '1115'}, {'name': 'Courtenay Padgett', 'role': 'CONTACT', 'email': 'courtp@oslc.org', 'phone': '541-485-2711', 'phoneExt': '1332'}], 'overallOfficials': [{'name': 'Rohanna Buchanan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Social Learning Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Per IES requirements...'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Social Learning Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Scientist', 'investigatorFullName': 'Rohanna Buchanan', 'investigatorAffiliation': 'Oregon Social Learning Center'}}}}