Substance Use Screening and Prevention for Adolescents in Pediatric Primary Care
NCT ID: NCT03074877
Last Updated: 2019-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
722 participants
INTERVENTIONAL
2014-06-01
2019-07-31
Brief Summary
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Detailed Description
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The following three aims focus on evaluating and refining the adaptation of the YRI \& TLI-P program for primary-care use: 1) to replicate the effectiveness of the YRI \& TLI-P screening tool in terms of concurrent and predictive validity and the engagement rate in the FCU; 2) to identify and address challenges in implementing and integrating the YRI \& TLI-P/FCU prevention strategy within a primary care clinic serving urban, low-income youth; and 3) to test the effectiveness of the YRI \& TLI-P/FCU on emerging SU, sexual activity, and conduct problems, as well as the putative mediators of these outcomes including parenting and parental well-being.
Based on prior FCU efficacy studies, 500 dyads of parents and their 9 years, 9 months to 13 years, 11 months old children from low-income, ethnically diverse families will be recruited from two large primary care clinics in an urban community. The FCU will be delivered for two or three years to test impact of dosage. Participants will be followed-up one year after completing FCU to evaluate longitudinal outcomes of the Integrated YRI \& TLI-P/FCU .
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Family Check-Up (FCU)
Families recruited in Year 1 who are randomized to the FCU group will be provided with the Family Check-Up (FCU) after the initial in-home assessment and after 1 year follow-up assessment. The FCU is a brief (i.e., typically 3-5 sessions per year) family-centered intervention. The FCU intervention process consists of 3, and in some cases, 4 components: a) family assessment, b) a "Get to Know You" session, c) feedback, and d) follow-up treatment sessions.
Family Check-Up
The Family Check-Up (FCU) is a brief, family-based program to prevent Substance Use/Substance Use Disorder (SU/SUD) with replicated efficacy
Waitlist Group
Families recruited in Year 1 who are randomized to the wait-list group, and all families recruited in Year 2 will be assigned to the wait-list group. This group will receive the materials provided to all families, noted above, and the initial in-home assessment within 2 weeks of the screening to be conducted by a trained research assistant. At 1 year post-screening, the families in the wait-list group will be administered the follow-up assessment and will begin the Family Check-Up (FCU) intervention.
Family Check-Up
The Family Check-Up (FCU) is a brief, family-based program to prevent Substance Use/Substance Use Disorder (SU/SUD) with replicated efficacy
Control Group
These families will be recruited in Year 3 of the study. These families will be provided the materials noted above and will receive the in-home assessments conducted by a trained research assistant. The initial in-home assessments will be conducted within 2 weeks of the screening, and follow-up assessments conducted 1 year post-screening.
No interventions assigned to this group
Interventions
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Family Check-Up
The Family Check-Up (FCU) is a brief, family-based program to prevent Substance Use/Substance Use Disorder (SU/SUD) with replicated efficacy
Eligibility Criteria
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Inclusion Criteria
* A biological or adoptive parents or legal guardian with appropriate documentation with custody of the child.
* Either child or parent's score on screening assessment score must fall in elevated risk range.
* Child must be recipient of needs based Medicaid or family income must be at or below 150% Health and Human Services (HHS) Poverty Guidelines.
Exclusion Criteria
* Having moderate to severe mental disability (based on medical records),
* Child not accompanied by a biological or adoptive parent with legal custody or legal guardian with appropriate documentation
* Participant in the Early Steps Project
9 Years
13 Years
ALL
No
Sponsors
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University of Pittsburgh
OTHER
RTI International
OTHER
Responsible Party
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Principal Investigators
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Ty Ridenour, PhD
Role: PRINCIPAL_INVESTIGATOR
RTI International
Locations
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University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Countries
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References
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Galan CA, Meza JI, Ridenour TA, Shaw DS. Racial Discrimination Experienced by Black Parents: Enduring Mental Health Consequences for Adolescent Youth. J Am Acad Child Adolesc Psychiatry. 2022 Oct;61(10):1251-1261. doi: 10.1016/j.jaac.2022.04.015. Epub 2022 May 2.
Other Identifiers
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