Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-02-06 @ 5:34 PM
Study NCT ID:
NCT02037750
Status:
COMPLETED
Last Update Posted:
2018-11-23
First Post:
2014-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Foster Teens' Risk During Transition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 173}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-20', 'studyFirstSubmitDate': '2014-01-13', 'studyFirstSubmitQcDate': '2014-01-14', 'lastUpdatePostDateStruct': {'date': '2018-11-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Placement Failures', 'timeFrame': 'between Baseline and 18-Months later'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['foster care', 'school adjustment'], 'conditions': ['School Adjustment', 'Foster Care Disruptions']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to conduct a randomized effectiveness trial to determine whether adding a preventive intervention at the transition from elementary to middle school is effective and cost effective in terms of ameliorating outcomes such as drug and tobacco use, participation in HIV- risking sexual behavior, delinquency, mental health problems, and school failure for young adolescents in foster care. The proposed LINKS intervention marries the goals of child welfare and educational systems. The aims are: a) to determine the effectiveness of the LINKS intervention on key behavioral health and school adjustment outcomes, b) to examine mechanisms of action; specifically the mediating effects of placement failure on outcomes, c) to examine the moderating role of fidelity on outcomes, and d) to examine cost effectiveness and cost avoidance of LINKS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '9 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* the focal youth will be transitioning into middle school\n* the focal youth is in either a foster or kinship care home\n* the focal youth has been in the home for a minimum of 30 days (including those who are newly placed in care and those moving from another type of placement).\n\nExclusion Criteria:\n\n* youth who are are considered medically fragile (i.e., severely physically or mentally handicapped)'}, 'identificationModule': {'nctId': 'NCT02037750', 'acronym': 'LINKS', 'briefTitle': "Foster Teens' Risk During Transition", 'organization': {'class': 'OTHER', 'fullName': 'Oregon Social Learning Center'}, 'officialTitle': "Foster Teens' Risk During Transition: Preventing Drug Use, HIV, & School Problems", 'orgStudyIdInfo': {'id': 'R01DA032634', 'link': 'https://reporter.nih.gov/quickSearch/R01DA032634', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LINKS', 'description': 'Foster parent and child participate in 16-week intervention', 'interventionNames': ['Behavioral: LINKS']}, {'type': 'NO_INTERVENTION', 'label': 'Services as Usual', 'description': 'Foster parent and child receive standard services through child welfare system'}], 'interventions': [{'name': 'LINKS', 'type': 'BEHAVIORAL', 'description': 'In the LINKS, foster/kin parents will participate in weekly group meetings led by well-trained and supervised paraprofessional facilitators (school behavioral aids and foster parents) where the curriculum is based on parent management training (PMT). In previous studies, attendance at such groups has been high, averaging about 75-80%. Missed sessions will be "made up" with an in-person visit to the foster/kin home during the week of the original session. In addition, youth in the intervention condition will receive individual skill building sessions from a Life Skills Coach to increase their competency at goal setting, refusal skills, and peer relations.', 'armGroupLabels': ['LINKS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92182-1948', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'San Diego State University Foundation', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '97401', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Social Learning Center', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}], 'overallOfficials': [{'name': 'Patricia Chamberlain, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Social Learning Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Social Learning Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'San Diego State University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}