Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2025-12-28 @ 8:18 AM
Study NCT ID:
NCT01488292
Status:
COMPLETED
Last Update Posted:
2015-06-08
First Post:
2011-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RECAP Multi-Component Intervention Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000066553', 'term': 'Problem Behavior'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}, {'id': 'D066107', 'term': 'Social Skills'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D002652', 'term': 'Child Behavior'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D012919', 'term': 'Social Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-04', 'studyFirstSubmitDate': '2011-11-23', 'studyFirstSubmitQcDate': '2011-12-06', 'lastUpdatePostDateStruct': {'date': '2015-06-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in child emotional and behavioral problems', 'timeFrame': 'Baseline & 18 months', 'description': 'Teacher TRF, Parent CBCL, Student SBQ ratings'}, {'measure': 'Change in Woodcock Reading Mastery Test', 'timeFrame': 'Baseline & 18 months'}]}, 'conditionsModule': {'keywords': ['mental health', 'social skills'], 'conditions': ['Behavioral Problems', 'Emotional Problems']}, 'descriptionModule': {'briefSummary': "This study evaluates the efficacy of the RECAP Mental Health + Academic Program for special education students in behavioral classrooms. The program includes multiple service components: the RECAP classroom mental health curriculum, which develops students' behavioral and social skills; reading intervention; individualized skills training; and parent group. Schools are randomly assigned to the treatment or control group. This two-year multi-component mental health and academic intervention is hypothesized to improve students' mental health, social skills, and academic functioning.", 'detailedDescription': "Background Information\n\nThis research project evaluates the efficacy of the RECAP Mental Health + Academic Program, a two-year multi-component intervention for special education students in behavioral classrooms. The program has been shown to reduce students' emotional and behavioral problems and remediate academic deficits, particularly with regard to reading skills, in order to enhance academic and behavioral functioning and to facilitate special education students' appropriate transition and reintegration into the mainstream educational setting.\n\nUsing an educational and instructional approach that is familiar to school staff and students, RECAP helps teachers and parents to assist children in the development of behavioral and emotional skills that facilitate children's ability to learn and to solve problems adaptively. Many of the techniques and strategies used in RECAP are familiar to teachers, as RECAP represents an integration of basic behavioral principles. Its unique strength lies in its consistent and integrated framework, which provides a common language for students, teachers, and parents to talk about behavioral expectations and positive skills for children to learn and apply in everyday situations. Moreover, the RECAP program focuses on helping students resolve the behavioral and emotional problems that interfere with their own learning as well as the learning of other students in the classroom (e.g., due to lost instructional time via classroom disruption). In addition to this mental health curriculum, the intervention includes a reading intervention component that has been shown to significantly improve the academic progress of students with emotional and behavioral problems. In addition to the obvious fundamental need for direct remediation of this academic skills deficit that is common among these students, the reading intervention is designed to prepare special education students to participate in the academic instruction of the general education classroom at a functionally adaptive level.\n\nParticipating schools are randomly assigned to either receive the RECAP program or serve as a comparison school (services as usual). Student outcomes will be evaluated in the fall and spring of two school years, using behavioral observation, academic testing, and teacher-, parent-, and child-reports of psychopathology and social skills."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Enrollment in behavioral classroom\n\nExclusion Criteria:\n\n* Lack of legal guardian to provide consent'}, 'identificationModule': {'nctId': 'NCT01488292', 'briefTitle': 'RECAP Multi-Component Intervention Program', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University'}, 'officialTitle': 'Multi-Component Mental Health & Academic Intervention for Student Reintegration', 'orgStudyIdInfo': {'id': '090633'}, 'secondaryIdInfos': [{'id': 'R01MH077596', 'link': 'https://reporter.nih.gov/quickSearch/R01MH077596', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RECAP social skills and reading program', 'interventionNames': ['Behavioral: RECAP social skills and reading program']}, {'type': 'NO_INTERVENTION', 'label': 'Control group (services as usual)', 'description': 'Control Group (services as usual)'}], 'interventions': [{'name': 'RECAP social skills and reading program', 'type': 'BEHAVIORAL', 'description': 'weekly individual and group sessions', 'armGroupLabels': ['RECAP social skills and reading program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37212', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Susan S Han, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Susan Han', 'investigatorAffiliation': 'Vanderbilt University'}}}}