Clinical trial NCT03074877: Substance Use Screening and Prevention for Adolescents in Pediatric Primary Care
Official title: Substance Use Screening and Prevention for Adolescents in Pediatric Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use
Keywords: Substance Use
Lead sponsor: RTI International
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh
First posted: 2017-03-09
Enrollment: 722
Sex: ALL
Minimum age (years): 9
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is to test the effectiveness of integrating and adapting two National Institute on Drug Abuse (NIDA)-funded procedures for use in primary care pediatric clinics serving low-income youth: 1)the Youth Risk Index (YRI) and Transmissible Liability Index-Parent (TLI-P) nurse and/or research assistant-administered screening tools for high risk of substance use (SU) prior to high school and thus also for SUD and 2) the Family Check-Up (FCU) - a brief, family-based program to prevent SU/SUD with replicated efficacy.

Detailed description: This study is to test the effectiveness of integrating and adapting two National Institute on Drug Abuse (NIDA)-funded procedures for use in primary care pediatric clinics serving low-income youth: 1) the Youth Risk Index (YRI) and Transmissible Liability Index (TLI-P) nurse and/or research assistant-administered screening tools for high risk of substance use (SU) prior to high school and thus also for SUD and 2) the Family Check-Up (FCU) - a brief, family-based program to prevent SU/SUD with replicated efficacy.

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 .

Eligibility criteria: Inclusion Criteria:

* Child Aged 9 years, 9 months to 13 years, 11 months.
* 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:

* Inability to read English,
* 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

Primary outcomes:
measure: Assessment of Liability and EXposure to Substance use and Antisocial behavior (ALEXSA)
timeFrame: baseline
measure: Assessment of Liability and EXposure to Substance use and Antisocial behavior (ALEXSA)
timeFrame: twelve months
measure: Assessment of Liability and EXposure to Substance use and Antisocial behavior (ALEXSA)
timeFrame: twenty-four months
measure: Contextual Risk and Resources - 1
timeFrame: baseline
measure: Contextual Risk and Resources - 1
timeFrame: twelve months
measure: Contextual Risk and Resources - 1
timeFrame: twenty-four months
measure: Contextual Risk and Resources - 2
timeFrame: baseline
measure: Contextual Risk and Resources - 2
timeFrame: twelve months
measure: Contextual Risk and Resources - 2
timeFrame: twenty-four months
measure: Contextual Risk and Resources - 3
timeFrame: baseline
measure: Contextual Risk and Resources - 3
timeFrame: twelve months
measure: Contextual Risk and Resources - 3
timeFrame: twenty-four months
measure: Contextual Risk and Resources - 4
timeFrame: baseline
measure: Contextual Risk and Resources - 4
timeFrame: twelve months
measure: Contextual Risk and Resources - 4
timeFrame: twenty-four months
measure: Contextual Risk and Resources - 5
timeFrame: baseline
measure: Contextual Risk and Resources - 5
timeFrame: twelve months
measure: Contextual Risk and Resources - 5
timeFrame: twenty-four months
measure: Contextual Risk and Resources - 6
timeFrame: baseline
measure: Contextual Risk and Resources - 6
timeFrame: twelve months
measure: Contextual Risk and Resources - 6
timeFrame: twenty-four months
measure: Youth Outcomes - 1
timeFrame: baseline
measure: Youth Outcomes - 1
timeFrame: twelve months
measure: Youth Outcomes - 1
timeFrame: twenty-four months
measure: Youth Outcomes - 2
timeFrame: baseline
measure: Youth Outcomes - 2
timeFrame: twelve months
measure: Youth Outcomes - 2
timeFrame: twenty-four months
measure: Youth Outcomes - 3
timeFrame: baseline
measure: Youth Outcomes - 3
timeFrame: twelve months
measure: Youth Outcomes - 3
timeFrame: twenty-four months
measure: Youth Outcomes - 4
timeFrame: baseline
measure: Youth Outcomes - 4
timeFrame: twelve months
measure: Youth Outcomes - 4
timeFrame: twenty-four months
measure: Youth Outcomes - 5
timeFrame: baseline
measure: Youth Outcomes - 5
timeFrame: twelve months
measure: Youth Outcomes - 5
timeFrame: twenty-four months
measure: Youth Outcomes - 6
timeFrame: baseline
measure: Youth Outcomes - 6
timeFrame: twelve months
measure: Youth Outcomes - 6
timeFrame: twenty-four months
measure: Youth Outcomes - 7
timeFrame: baseline
measure: Youth Outcomes - 7
timeFrame: twelve months
measure: Youth Outcomes - 7
timeFrame: twenty-four months
measure: Parenting and Family Socialization - 1
timeFrame: baseline
measure: Parenting and Family Socialization - 1
timeFrame: twelve months
measure: Parenting and Family Socialization - 1
timeFrame: twenty-four months
measure: Parenting and Family Socialization - 2
timeFrame: baseline
measure: Parenting and Family Socialization - 2
timeFrame: twelve months
measure: Parenting and Family Socialization - 2
timeFrame: twenty-four months
measure: Parenting and Family Socialization - 3
timeFrame: baseline
measure: Parenting and Family Socialization - 3
timeFrame: twelve months
measure: Parenting and Family Socialization - 3
timeFrame: twenty-four months
measure: Parenting and Family Socialization - 4
timeFrame: baseline
measure: Parenting and Family Socialization - 4
timeFrame: twelve months
measure: Parenting and Family Socialization - 4
timeFrame: twenty-four months
measure: Parenting and Family Socialization - 5
timeFrame: baseline
measure: Parenting and Family Socialization - 5
timeFrame: twelve months
measure: Parenting and Family Socialization - 5
timeFrame: twenty-four months
measure: Parenting and Family Socialization - 6
timeFrame: baseline
measure: Parenting and Family Socialization - 6
timeFrame: twelve months
measure: Parenting and Family Socialization - 6
timeFrame: twenty-four months
measure: Parenting and Family Socialization - 7
timeFrame: baseline
measure: Parenting and Family Socialization - 7
timeFrame: twelve months
measure: Parenting and Family Socialization - 7
timeFrame: twenty-four months
measure: Parenting and Family Socialization - Discussion Tasks - 1
timeFrame: baseline
measure: Parenting and Family Socialization - Discussion Tasks - 1
timeFrame: twelve months
measure: Parenting and Family Socialization - Discussion Tasks - 1
timeFrame: twenty-four months
measure: Parenting and Family Socialization - Discussion Tasks - 2
timeFrame: baseline
measure: Parenting and Family Socialization - Discussion Tasks - 2
timeFrame: twelve months
measure: Parenting and Family Socialization - Discussion Tasks - 2
timeFrame: twenty-four months
measure: Parenting and Family Socialization - Discussion Tasks - 3
timeFrame: baseline
measure: Parenting and Family Socialization - Discussion Tasks - 3
timeFrame: twelve months
measure: Parenting and Family Socialization - Discussion Tasks - 3
timeFrame: twenty-four months
measure: Parenting and Family Socialization - Discussion Tasks - 4
timeFrame: baseline
measure: Parenting and Family Socialization - Discussion Tasks - 4
timeFrame: twelve months
measure: Parenting and Family Socialization - Discussion Tasks - 4
timeFrame: twenty-four months
measure: Parenting and Family Socialization - Discussion Tasks - 5
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: RTI International
name: Ty Ridenour, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.