Substance Use Screening and Prevention for Adolescents in Pediatric Primary Care

Study Overview
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Brief Summary
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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
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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 .

Official Title
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Substance Use Screening and Prevention for Adolescents in Pediatric Primary Care

Conditions
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Substance Use

Intervention / Treatment
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* Behavioral: Family Check-Up


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Family Check-Up (FCU)<br>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<br>* The Family Check-Up (FCU) is a brief, family-based program to prevent Substance Use/Substance Use Disorder (SU/SUD) with replicated efficacy<br>|
| Experimental: Waitlist Group<br>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<br>* The Family Check-Up (FCU) is a brief, family-based program to prevent Substance Use/Substance Use Disorder (SU/SUD) with replicated efficacy<br>|
| No Intervention: Control Group<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Substance Use