Substance Use Screening and Prevention for Adolescents in Pediatric Primary Care (SKY)

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.

Study Overview

• Status: Completed
• Conditions: Substance Use
• Intervention / Treatment: Behavioral: Family Check-Up

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 .

• Study Type: Interventional
• Enrollment (Actual): 722
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15260
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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
Experimental: 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.	Behavioral: 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
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: RTI International
• Collaborators: University of Pittsburgh
• Investigators: Principal Investigator: Ty Ridenour, PhD, RTI International

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Actual): July 31, 2019
• Study Completion (Actual): July 31, 2019

Study Registration Dates

• First Submitted: February 13, 2017
• First Submitted That Met QC Criteria: March 3, 2017
• First Posted (Actual): March 9, 2017

Study Record Updates

• Last Update Posted (Actual): November 20, 2019
• Last Update Submitted That Met QC Criteria: November 18, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Substance Use
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: 5R01DA036628-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No