Ignite Creation Date:
2025-12-24 @ 12:10 PM
Ignite Modification Date:
2025-12-31 @ 8:54 PM
Study NCT ID:
NCT01549561
Status:
COMPLETED
Last Update Posted:
2014-04-08
First Post:
2012-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preventing Behavior and Health Problems in Foster Teens
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 259}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-07', 'studyFirstSubmitDate': '2012-03-06', 'studyFirstSubmitQcDate': '2012-03-08', 'lastUpdatePostDateStruct': {'date': '2014-04-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in child behavior problems as assessed by the Parent Daily Report (PDR)', 'timeFrame': 'Baseline, 6 Months, 12 Months, 18 Months'}], 'secondaryOutcomes': [{'measure': 'Placement Disruptions from Foster Placement', 'timeFrame': '6 Months, 12 Months, 18 Months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['behavior problems', 'foster care', 'parent training', 'youth skills training'], 'conditions': ['Parent Management Training']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Price, J., Chamberlain, P., Landsverk, J., & Reid, J. B. (2010). KEEP foster parent training intervention: Model description and effectiveness. Child and Family Social Work, 14, 233-242.'}]}, 'descriptionModule': {'briefSummary': 'The primary goal of this study is to test the efficacy of two levels of the KEEP intervention with adolescents and their foster and kin parents in the San Diego Child Welfare System.', 'detailedDescription': 'The cost of child welfare services in the U.S. has been estimated at $20 billion per year. During the past decade, the number of teenagers in foster care has nearly doubled. Numerous studies have documented that these adolescents are at high-risk for developing serious problems, including substance use, participation in health-risking sexual behaviors, involvement in the juvenile justice system, serious educational problems and school drop-out, failed placements/foster care "drift" and homelessness. Yet, there is little research on the characteristics of interventions that can be used to guide the improvement of services for this vulnerable population of youngsters. The proposed study extends our previous research with adolescents referred for serious behavioral and emotional problems and research with elementary-aged children in foster care to a test of the efficacy of a preventive intervention for adolescents placed with foster and kin care providers in the San Diego County Child Welfare System. Two hundred and forty adolescents and their foster/kin care providers will participate (i.e., 60 in a foster/kin parent training only condition, 60 in a parent training plus youth skill training condition, and 120 in a casework "as usual" control condition). In addition to testing the efficacy of the two levels of intervention, the investigators propose to examine the effects of the intervention on a set of youth behavioral and health-related outcomes. Parenting mediators to be tested include positive parenting, parental supervision, and non-harsh discipline. Youth mediators are social competence, commitment to school, and knowledge about norms related to health-risking behaviors including substance use and high-risk sexual behavior. In addition, theoretical hypotheses about the effects of early risk/adversity factors to youth outcomes will be examined, and an economic analysis will be conducted to examine the relative benefits and costs associated with the two levels of intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any child between ages 12 and 16 years in relative or non-relative foster care\n\nExclusion Criteria:\n\n* Only medically fragile children'}, 'identificationModule': {'nctId': 'NCT01549561', 'acronym': 'KEEP2', 'briefTitle': 'Preventing Behavior and Health Problems in Foster Teens', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Social Learning Center'}, 'officialTitle': 'Preventing Behavior and Health Problems in Foster Teens', 'orgStudyIdInfo': {'id': 'KEEP2020172'}, 'secondaryIdInfos': [{'id': 'R01DA020172', 'link': 'https://reporter.nih.gov/quickSearch/R01DA020172', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Services As Usual', 'description': 'Foster care services as usual'}, {'type': 'EXPERIMENTAL', 'label': 'Parent and Youth Training', 'description': '16 Weeks of Parent Training in group context with 5 to 10 relative and non-relative foster caregivers; Youth training with skills coaches', 'interventionNames': ['Behavioral: Parent Training', 'Behavioral: Youth Skills Training']}, {'type': 'EXPERIMENTAL', 'label': 'Parent Training', 'description': '16 weeks of parent training with 5 to 10 relative and non-relative foster caregivers', 'interventionNames': ['Behavioral: Parent Training']}], 'interventions': [{'name': 'Parent Training', 'type': 'BEHAVIORAL', 'otherNames': ['Parent Management Training', 'KEEP'], 'description': '16 weeks of parent training led by a trained group facilitator', 'armGroupLabels': ['Parent Training', 'Parent and Youth Training']}, {'name': 'Youth Skills Training', 'type': 'BEHAVIORAL', 'otherNames': ['Skills Coaching'], 'description': '16 weeks of one-on-one sessions with a trained youth skills coach', 'armGroupLabels': ['Parent and Youth Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Child and Adolescent Services Research Center', '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': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}