Ignite Creation Date:
2025-12-24 @ 1:57 PM
Ignite Modification Date:
2026-01-06 @ 7:19 PM
Study NCT ID:
NCT03157895
Status:
UNKNOWN
Last Update Posted:
2019-07-31
First Post:
2017-04-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Trial of Connecting to Promote Foster Teen Well-Being
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Interviewers should be blind to condition.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2020-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-29', 'studyFirstSubmitDate': '2017-04-27', 'studyFirstSubmitQcDate': '2017-05-16', 'lastUpdatePostDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Opportunities for prosocial involvement in the family', 'timeFrame': '1 and 2 year follow up', 'description': 'Alabama Parenting Questionnaire (Shelton et al., 1999)'}, {'measure': 'Problem solving skills (youth)', 'timeFrame': '1 and 2 year follow up', 'description': 'Raising Healthy Children (Catalano et al., 2005)'}, {'measure': 'Refusal skills (youth)', 'timeFrame': '1 and 2 year follow up', 'description': 'Seattle Social Development Project (1999)'}, {'measure': "Children's coping", 'timeFrame': '1 and 2 year follow up', 'description': 'University of Washington Parenting Clinic (2001)'}, {'measure': 'Rewards and recognition in the family scale', 'timeFrame': '1 and 2 year follow up', 'description': 'Raising Healthy Children (Catalano et al., 2005)'}, {'measure': 'Change in family guidelines', 'timeFrame': '1 and 2 year follow up', 'description': 'Alabama Parenting Questionnaire (1999)'}, {'measure': 'Change in caregiver monitoring', 'timeFrame': '1 and 2 year follow up', 'description': 'Parental Monitoring; Kerr and Stattin (2000). Raising Healthy Children monitoring scale (Catalano et al., 2005).'}, {'measure': 'Change in inconsistent discipline and consequences', 'timeFrame': '1 and 2 year follow up', 'description': 'Alabama Parenting Questionnaire (Shelton et al., 1999)'}], 'primaryOutcomes': [{'measure': 'Delay in drug use initiation', 'timeFrame': '2 year follow up', 'description': 'Monitoring the Future (Johnston et al., 2002). Communities that Care Youth Survey (CTC) (Hawkins \\& Catalano, 2004).'}, {'measure': 'Substance use frequency', 'timeFrame': '2 year follow up', 'description': 'Monitoring the Future (Johnston et al., 2002). Communities that Care Youth Survey (Hawkins \\& Catalano, 2004).'}, {'measure': 'Non-violent delinquent behavior frequency', 'timeFrame': '2 year follow up', 'description': 'Seattle Social Development Project (SSDP) (Hawkins et al., 1999). Raising Healthy Children (Catalano et al., 2005).'}, {'measure': 'Violent delinquent behavior frequency', 'timeFrame': '2 year follow up', 'description': 'Seattle Social Development Project (Hawkins et al., 1999).'}, {'measure': 'Delay in initiation of sexual activity', 'timeFrame': '2 year follow up', 'description': 'National Longitudinal Survey of Youth (Center for Human Research, 2003). Sexual Risk and Behavior Attitudes and Self Efficacy Scale (Basen Enquist et al., 1996). Communities that Care Youth Survey (Hawkins \\& Catalano, 2004).'}], 'secondaryOutcomes': [{'measure': 'Residential placement stability', 'timeFrame': '2 year follow up', 'description': 'Child Welfare Administrative Data'}, {'measure': 'Growth in caregiver/youth bonding', 'timeFrame': '1 and 2 year follow up', 'description': 'Communities that Care Youth Survey (Hawkins \\& Catalano, 2004). Armsden \\& Greenberg (1987).'}, {'measure': 'Youth attitudes about HIV related risks', 'timeFrame': '1 and 2 year follow up', 'description': 'Sexual Risk and Behavior Attitudes and Self Efficacy Scale (Basen Enquist et al.,1996)'}, {'measure': 'Youth attitudes favorable toward substance use', 'timeFrame': '1 and 2 year follow up', 'description': 'Communities that Care Youth Survey (Hawkins \\& Catalano, 2004)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Foster Families'], 'conditions': ['Relationship, Family (Foster)', 'Substance Use Prevention']}, 'referencesModule': {'references': [{'pmid': '27891209', 'type': 'BACKGROUND', 'citation': 'Haggerty KP, Barkan SE, Skinner M, Ben Packard W, Cole JJ. Feasibility of Connecting, a Substance-Abuse Prevention Program for Foster Teens and their Caregivers. J Soc Social Work Res. 2016 Winter;7(4):639-659. doi: 10.1086/686986. Epub 2016 Oct 18.'}, {'pmid': '26052172', 'type': 'BACKGROUND', 'citation': 'Barkan SE, Salazar AM, Estep K, Mattos LM, Eichenlaub C, Haggerty KP. Adapting an evidence based parenting program for child welfare involved teens and their caregivers. Child Youth Serv Rev. 2014 Jun;41:53-61. doi: 10.1016/j.childyouth.2014.03.006.'}, {'pmid': '26052173', 'type': 'BACKGROUND', 'citation': 'Storer HL, Barkan SE, Stenhouse LL, Eichenlaub C, Mallillin A, Haggerty KP. In search of connection: The foster youth and caregiver relationship. Child Youth Serv Rev. 2014 Jul;42:110-117. doi: 10.1016/j.childyouth.2014.04.008.'}, {'pmid': '24347754', 'type': 'BACKGROUND', 'citation': 'Storer HL, Barkan SE, Sherman EL, Haggerty KP, Mattos LM. Promoting Relationship Building and Connection: Adapting an Evidence-Based Parenting Program for Families Involved in the Child Welfare System. Child Youth Serv Rev. 2012 Sep 1;34(9):10.1016/j.childyouth.2012.05.017. doi: 10.1016/j.childyouth.2012.05.017.'}, {'pmid': '29861503', 'type': 'BACKGROUND', 'citation': 'Salazar AM, McCowan KJ, Cole JJ, Skinner ML, Noell BR, Colito JM, Haggerty KP, Barkan SE. Developing Relationship-Building Tools for Foster Families Caring for Teens who are LGBTQ2S. Child Welfare. 2018;96(2):75-97.'}, {'pmid': '35788868', 'type': 'DERIVED', 'citation': 'Haggerty KP, Barkan SE, Caouette JD, Skinner ML, Hanson KG. Two-Year Risk Behavior Outcomes from Connecting, a Prevention Program for Caregivers and Youth in Foster Care. Prev Sci. 2023 Jan;24(1):15-26. doi: 10.1007/s11121-022-01390-4. Epub 2022 Jul 4.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the efficacy of a self-directed parenting program called Connecting in reducing risk of substance use and other risky behaviors in young foster teens (ages 11-15). Half of the participants will receive services as usual from the foster system, while half will participate in the Connecting program. Connecting is a 10-week, self-directed parenting workbook with two digital video discs (DVDs). Families receive weekly telephone support as they complete the program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '11 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Foster youth ages 11-15 years\n* In current placement 60+ days\n* In relative/suitable adult care, in licensed relative/suitable adult care, in licensed foster care, in dependency guardianship\n* Caregiver and teen speak English well enough to use the program manual and respond to survey questions\n\nExclusion Criteria:\n\n* The teen has regularly used drugs or alcohol in the last 30 days\n* The teen has been involved in the criminal justice system\n* The placement is not viewed as stable\n* The caregiver is not committed to a long-term placement\n* The teen will not likely be in the placement for at least 6 months\n* Group home placements and behavioral rehabilitative services placements'}, 'identificationModule': {'nctId': 'NCT03157895', 'briefTitle': 'A Trial of Connecting to Promote Foster Teen Well-Being', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'A Trial of Connecting to Prevent Drug Abuse and Risky Behavior in Foster Teens', 'orgStudyIdInfo': {'id': 'D012912S'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Program group', 'description': "This group receives the Connecting program with telephone support. It's anticipated the program will take up to 14 weeks to complete.", 'interventionNames': ['Behavioral: Connecting']}, {'type': 'NO_INTERVENTION', 'label': 'Comparison group', 'description': "This group receives Children's Administration services as usual."}], 'interventions': [{'name': 'Connecting', 'type': 'BEHAVIORAL', 'otherNames': ['Staying Connected With Your Teen'], 'description': 'Connecting was adapted for use within the child welfare system from the Staying Connected With Your Teen program that has been demonstrated to prevent substance abuse, risky sexual behavior, and violence during adolescence.', 'armGroupLabels': ['Program group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98115', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'The Social Development Research Group, University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}, {'name': 'Alliance for Child Welfare Excellence', 'class': 'UNKNOWN'}, {'name': 'Washington State Department of Social and Health Services', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Social Development Research Group', 'investigatorFullName': 'Kevin Haggerty', 'investigatorAffiliation': 'University of Washington'}}}}