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Substance Use Screening and Prevention for Adolescents in Pediatric Primary Care

Substance Use Screening and Prevention for Adolescents in Pediatric Primary Care

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03074877
Acronym
SKY
Enrollment
722
Registered
2017-03-09
Start date
2014-06-01
Completion date
2019-07-31
Last updated
2019-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Substance Use

Keywords

Substance Use

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 .

Interventions

BEHAVIORALFamily 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

Sponsors

University of Pittsburgh
CollaboratorOTHER
RTI International
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
9 Years to 13 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Assessment of Liability and EXposure to Substance use and Antisocial behavior (ALEXSA)baselineAdminister Assessment of Liability and EXposure to Substance use and Antisocial behavior (ALEXSA)
Contextual Risk and Resources - 1baselineAdminister Centers for Epidemiological Studies Depression Scale (CESD)
Contextual Risk and Resources - 2baselineAdminister Demographic Questionnaire (DEMO)
Contextual Risk and Resources - 3baselineAdminister Dyadic Adjustment Scale (DYAD)
Contextual Risk and Resources - 4baselineAdminister Financial Stress Questionnaire (FINCE)
Contextual Risk and Resources - 5baselineAdminister Me and My Neighborhood Questionnaire (MMNQ)
Contextual Risk and Resources - 6baselineAdminister Parent Substance Use Questionnaire (SUBST-PC)
Youth Outcomes - 1baselineAdminister Child Behavior Checklist (CBCL)
Youth Outcomes - 2baselineAssess Extracurricular Activities (ECA)
Youth Outcomes - 3baselineAdminister Recent Activities Interview (RAI)
Youth Outcomes - 4baselineAdminister Screen for Child Anxiety-Related Emotional Disorders (SCR)
Youth Outcomes - 5baselineAdminister Self-Report of Delinquency (SHORT) (SRD)
Youth Outcomes - 6baselineTarget Child Substance Use (TC Subst)
Youth Outcomes - 7baselineAdminister Youth Risk Behavior Survey (YRBS)
Parenting and Family Socialization - 1baselineEvaluate using Adult Child Relationship scale (ACRS)
Parenting and Family Socialization - 2baselineDistressing Experiences Microaggression Scale (MIC)
Parenting and Family Socialization - 3baselineChild Daily Face-to-Face Racial Discrimination (CDIS)
Parenting and Family Socialization - 4baselineAssess using Parental Involvement Scale (PI)
Parenting and Family Socialization - 5baselineParental Monitoring Interview - Parent Response, - Child Response (PMI-PR, PMI-CR)
Parenting and Family Socialization - 6baselineAssess using Parenting Children and Adolescents measure (PARCA)
Parenting and Family Socialization - 7baselineAssessment using Parental Rating of Peers and Social Skills (PPRSK)
Parenting and Family Socialization - Discussion Tasks - 1baselineAssessment using Parent Child Hot topics Discussion Task
Parenting and Family Socialization - Discussion Tasks - 2baselineAssessment using Parent Child Hot Topics Questionnaire (PCHT)
Parenting and Family Socialization - Discussion Tasks - 3baselineAssessment using Monitoring & Listening Discussion Task
Parenting and Family Socialization - Discussion Tasks - 4baselineAssessment using Recognition Discussion Task
Parenting and Family Socialization - Discussion Tasks - 5baselineAssessment using Family Culture Discussion Task

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026