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Clinical Trials/NCT03074877
NCT03074877
Completed
Not Applicable

Substance Use Screening and Prevention for Adolescents in Pediatric Primary Care

RTI International1 site in 1 country722 target enrollmentJune 1, 2014
ConditionsSubstance Use

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Substance Use
Sponsor
RTI International
Enrollment
722
Locations
1
Primary Endpoint
Contextual Risk and Resources - 1
Status
Completed
Last Updated
6 years ago

Overview

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 .

Registry
clinicaltrials.gov
Start Date
June 1, 2014
End Date
July 31, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Contextual Risk and Resources - 1

Time Frame: twenty-four months

Administer Centers for Epidemiological Studies Depression Scale (CESD)

Contextual Risk and Resources - 3

Time Frame: twenty-four months

Administer Dyadic Adjustment Scale (DYAD)

Contextual Risk and Resources - 2

Time Frame: twenty-four months

Administer Demographic Questionnaire (DEMO)

Contextual Risk and Resources - 5

Time Frame: twenty-four months

Administer Me and My Neighborhood Questionnaire (MMNQ)

Youth Outcomes - 1

Time Frame: twenty-four months

Administer Child Behavior Checklist (CBCL)

Contextual Risk and Resources - 4

Time Frame: twenty-four months

Administer Financial Stress Questionnaire (FINCE)

Contextual Risk and Resources - 6

Time Frame: twenty-four months

Administer Parent Substance Use Questionnaire (SUBST-PC)

Youth Outcomes - 2

Time Frame: twenty-four months

Assess Extracurricular Activities (ECA)

Assessment of Liability and EXposure to Substance use and Antisocial behavior (ALEXSA)

Time Frame: twenty-four months

Administer Assessment of Liability and EXposure to Substance use and Antisocial behavior (ALEXSA)

Parenting and Family Socialization - 4

Time Frame: twenty-four months

Assess using Parental Involvement Scale (PI)

Parenting and Family Socialization - Discussion Tasks - 4

Time Frame: twenty-four months

Assessment using Recognition Discussion Task

Parenting and Family Socialization - Discussion Tasks - 5

Time Frame: baseline

Assessment using Family Culture Discussion Task

Youth Outcomes - 3

Time Frame: twenty-four months

Administer Recent Activities Interview (RAI)

Youth Outcomes - 4

Time Frame: twenty-four months

Administer Screen for Child Anxiety-Related Emotional Disorders (SCR)

Parenting and Family Socialization - 1

Time Frame: twenty-four months

Evaluate using Adult Child Relationship scale (ACRS)

Parenting and Family Socialization - Discussion Tasks - 3

Time Frame: twenty-four months

Assessment using Monitoring \& Listening Discussion Task

Youth Outcomes - 5

Time Frame: twenty-four months

Administer Self-Report of Delinquency (SHORT) (SRD)

Youth Outcomes - 7

Time Frame: twenty-four months

Administer Youth Risk Behavior Survey (YRBS)

Parenting and Family Socialization - 3

Time Frame: twenty-four months

Child Daily Face-to-Face Racial Discrimination (CDIS)

Parenting and Family Socialization - 6

Time Frame: twenty-four months

Assess using Parenting Children and Adolescents measure (PARCA)

Parenting and Family Socialization - 7

Time Frame: twenty-four months

Assessment using Parental Rating of Peers and Social Skills (PPRSK)

Parenting and Family Socialization - Discussion Tasks - 1

Time Frame: twenty-four months

Assessment using Parent Child Hot topics Discussion Task

Youth Outcomes - 6

Time Frame: twenty-four months

Target Child Substance Use (TC Subst)

Parenting and Family Socialization - 2

Time Frame: twenty-four months

Distressing Experiences Microaggression Scale (MIC)

Parenting and Family Socialization - 5

Time Frame: twenty-four months

Parental Monitoring Interview - Parent Response, - Child Response (PMI-PR, PMI-CR)

Parenting and Family Socialization - Discussion Tasks - 2

Time Frame: twenty-four months

Assessment using Parent Child Hot Topics Questionnaire (PCHT)

Study Sites (1)

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