Substance Use Screening and Prevention for Adolescents in Pediatric Primary Care
- Conditions
- Substance Use
- Interventions
- Behavioral: Family Check-Up
- Registration Number
- NCT03074877
- Lead Sponsor
- RTI International
- 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 .
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 722
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Waitlist Group Family Check-Up 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 (FCU) Family Check-Up 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.
- Primary Outcome Measures
Name Time Method Contextual Risk and Resources - 1 twenty-four months Administer Centers for Epidemiological Studies Depression Scale (CESD)
Contextual Risk and Resources - 3 twenty-four months Administer Dyadic Adjustment Scale (DYAD)
Contextual Risk and Resources - 2 twenty-four months Administer Demographic Questionnaire (DEMO)
Contextual Risk and Resources - 5 twenty-four months Administer Me and My Neighborhood Questionnaire (MMNQ)
Youth Outcomes - 1 twenty-four months Administer Child Behavior Checklist (CBCL)
Contextual Risk and Resources - 4 twenty-four months Administer Financial Stress Questionnaire (FINCE)
Contextual Risk and Resources - 6 twenty-four months Administer Parent Substance Use Questionnaire (SUBST-PC)
Youth Outcomes - 2 twenty-four months Assess Extracurricular Activities (ECA)
Assessment of Liability and EXposure to Substance use and Antisocial behavior (ALEXSA) twenty-four months Administer Assessment of Liability and EXposure to Substance use and Antisocial behavior (ALEXSA)
Parenting and Family Socialization - 4 twenty-four months Assess using Parental Involvement Scale (PI)
Parenting and Family Socialization - Discussion Tasks - 4 twenty-four months Assessment using Recognition Discussion Task
Parenting and Family Socialization - Discussion Tasks - 5 baseline Assessment using Family Culture Discussion Task
Youth Outcomes - 3 twenty-four months Administer Recent Activities Interview (RAI)
Youth Outcomes - 4 twenty-four months Administer Screen for Child Anxiety-Related Emotional Disorders (SCR)
Parenting and Family Socialization - 1 twenty-four months Evaluate using Adult Child Relationship scale (ACRS)
Parenting and Family Socialization - Discussion Tasks - 3 twenty-four months Assessment using Monitoring \& Listening Discussion Task
Youth Outcomes - 5 twenty-four months Administer Self-Report of Delinquency (SHORT) (SRD)
Youth Outcomes - 7 twenty-four months Administer Youth Risk Behavior Survey (YRBS)
Parenting and Family Socialization - 3 twenty-four months Child Daily Face-to-Face Racial Discrimination (CDIS)
Parenting and Family Socialization - 6 twenty-four months Assess using Parenting Children and Adolescents measure (PARCA)
Parenting and Family Socialization - 7 twenty-four months Assessment using Parental Rating of Peers and Social Skills (PPRSK)
Parenting and Family Socialization - Discussion Tasks - 1 twenty-four months Assessment using Parent Child Hot topics Discussion Task
Youth Outcomes - 6 twenty-four months Target Child Substance Use (TC Subst)
Parenting and Family Socialization - 2 twenty-four months Distressing Experiences Microaggression Scale (MIC)
Parenting and Family Socialization - 5 twenty-four months Parental Monitoring Interview - Parent Response, - Child Response (PMI-PR, PMI-CR)
Parenting and Family Socialization - Discussion Tasks - 2 twenty-four months Assessment using Parent Child Hot Topics Questionnaire (PCHT)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States