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

November 18, 2019 updated by: RTI International
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
722

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
RTI International

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Pittsburgh

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ty Ridenour, PhD, RTI International

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 13, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 9, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 20, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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