Substance Use Screening and Prevention for Adolescents in Pediatric Primary Care

Substance Use Clinical Trial

— SKY  

Official title:

Substance Use Screening and Prevention for Adolescents in Pediatric Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03074877
• Other study ID #: 5R01DA036628-02
• Status: Completed
• Phase: N/A
• Start date: June 1, 2014
• Est. completion date: July 31, 2019

Study information

• Verified date: November 2019
• Source: RTI International
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 722
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Substance Use

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

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
RTI International	University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

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