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

Primary Purpose

Substance Use

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family Check-Up
Sponsored by
RTI International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Substance Use focused on measuring Substance Use

Eligibility Criteria

9 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Family Check-Up (FCU)

Waitlist Group

Control Group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 13, 2017
Last Updated
November 18, 2019
Sponsor
RTI International
Collaborators
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT03074877
Brief Title
Substance Use Screening and Prevention for Adolescents in Pediatric Primary Care
Acronym
SKY
Official Title
Substance Use Screening and Prevention for Adolescents in Pediatric Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2014 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RTI International
Collaborators
University of Pittsburgh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use
Keywords
Substance Use

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
722 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Family Check-Up (FCU)
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Family Check-Up
Intervention Description
The Family Check-Up (FCU) is a brief, family-based program to prevent Substance Use/Substance Use Disorder (SU/SUD) with replicated efficacy
Primary Outcome Measure Information:
Title
Assessment of Liability and EXposure to Substance use and Antisocial behavior (ALEXSA)
Description
Administer Assessment of Liability and EXposure to Substance use and Antisocial behavior (ALEXSA)
Time Frame
baseline
Title
Assessment of Liability and EXposure to Substance use and Antisocial behavior (ALEXSA)
Description
Administer Assessment of Liability and EXposure to Substance use and Antisocial behavior (ALEXSA)
Time Frame
twelve months
Title
Assessment of Liability and EXposure to Substance use and Antisocial behavior (ALEXSA)
Description
Administer Assessment of Liability and EXposure to Substance use and Antisocial behavior (ALEXSA)
Time Frame
twenty-four months
Title
Contextual Risk and Resources - 1
Description
Administer Centers for Epidemiological Studies Depression Scale (CESD)
Time Frame
baseline
Title
Contextual Risk and Resources - 1
Description
Administer Centers for Epidemiological Studies Depression Scale (CESD)
Time Frame
twelve months
Title
Contextual Risk and Resources - 1
Description
Administer Centers for Epidemiological Studies Depression Scale (CESD)
Time Frame
twenty-four months
Title
Contextual Risk and Resources - 2
Description
Administer Demographic Questionnaire (DEMO)
Time Frame
baseline
Title
Contextual Risk and Resources - 2
Description
Administer Demographic Questionnaire (DEMO)
Time Frame
twelve months
Title
Contextual Risk and Resources - 2
Description
Administer Demographic Questionnaire (DEMO)
Time Frame
twenty-four months
Title
Contextual Risk and Resources - 3
Description
Administer Dyadic Adjustment Scale (DYAD)
Time Frame
baseline
Title
Contextual Risk and Resources - 3
Description
Administer Dyadic Adjustment Scale (DYAD)
Time Frame
twelve months
Title
Contextual Risk and Resources - 3
Description
Administer Dyadic Adjustment Scale (DYAD)
Time Frame
twenty-four months
Title
Contextual Risk and Resources - 4
Description
Administer Financial Stress Questionnaire (FINCE)
Time Frame
baseline
Title
Contextual Risk and Resources - 4
Description
Administer Financial Stress Questionnaire (FINCE)
Time Frame
twelve months
Title
Contextual Risk and Resources - 4
Description
Administer Financial Stress Questionnaire (FINCE)
Time Frame
twenty-four months
Title
Contextual Risk and Resources - 5
Description
Administer Me and My Neighborhood Questionnaire (MMNQ)
Time Frame
baseline
Title
Contextual Risk and Resources - 5
Description
Administer Me and My Neighborhood Questionnaire (MMNQ)
Time Frame
twelve months
Title
Contextual Risk and Resources - 5
Description
Administer Me and My Neighborhood Questionnaire (MMNQ)
Time Frame
twenty-four months
Title
Contextual Risk and Resources - 6
Description
Administer Parent Substance Use Questionnaire (SUBST-PC)
Time Frame
baseline
Title
Contextual Risk and Resources - 6
Description
Administer Parent Substance Use Questionnaire (SUBST-PC)
Time Frame
twelve months
Title
Contextual Risk and Resources - 6
Description
Administer Parent Substance Use Questionnaire (SUBST-PC)
Time Frame
twenty-four months
Title
Youth Outcomes - 1
Description
Administer Child Behavior Checklist (CBCL)
Time Frame
baseline
Title
Youth Outcomes - 1
Description
Administer Child Behavior Checklist (CBCL)
Time Frame
twelve months
Title
Youth Outcomes - 1
Description
Administer Child Behavior Checklist (CBCL)
Time Frame
twenty-four months
Title
Youth Outcomes - 2
Description
Assess Extracurricular Activities (ECA)
Time Frame
baseline
Title
Youth Outcomes - 2
Description
Assess Extracurricular Activities (ECA)
Time Frame
twelve months
Title
Youth Outcomes - 2
Description
Assess Extracurricular Activities (ECA)
Time Frame
twenty-four months
Title
Youth Outcomes - 3
Description
Administer Recent Activities Interview (RAI)
Time Frame
baseline
Title
Youth Outcomes - 3
Description
Administer Recent Activities Interview (RAI)
Time Frame
twelve months
Title
Youth Outcomes - 3
Description
Administer Recent Activities Interview (RAI)
Time Frame
twenty-four months
Title
Youth Outcomes - 4
Description
Administer Screen for Child Anxiety-Related Emotional Disorders (SCR)
Time Frame
baseline
Title
Youth Outcomes - 4
Description
Administer Screen for Child Anxiety-Related Emotional Disorders (SCR)
Time Frame
twelve months
Title
Youth Outcomes - 4
Description
Administer Screen for Child Anxiety-Related Emotional Disorders (SCR)
Time Frame
twenty-four months
Title
Youth Outcomes - 5
Description
Administer Self-Report of Delinquency (SHORT) (SRD)
Time Frame
baseline
Title
Youth Outcomes - 5
Description
Administer Self-Report of Delinquency (SHORT) (SRD)
Time Frame
twelve months
Title
Youth Outcomes - 5
Description
Administer Self-Report of Delinquency (SHORT) (SRD)
Time Frame
twenty-four months
Title
Youth Outcomes - 6
Description
Target Child Substance Use (TC Subst)
Time Frame
baseline
Title
Youth Outcomes - 6
Description
Target Child Substance Use (TC Subst)
Time Frame
twelve months
Title
Youth Outcomes - 6
Description
Target Child Substance Use (TC Subst)
Time Frame
twenty-four months
Title
Youth Outcomes - 7
Description
Administer Youth Risk Behavior Survey (YRBS)
Time Frame
baseline
Title
Youth Outcomes - 7
Description
Administer Youth Risk Behavior Survey (YRBS)
Time Frame
twelve months
Title
Youth Outcomes - 7
Description
Administer Youth Risk Behavior Survey (YRBS)
Time Frame
twenty-four months
Title
Parenting and Family Socialization - 1
Description
Evaluate using Adult Child Relationship scale (ACRS)
Time Frame
baseline
Title
Parenting and Family Socialization - 1
Description
Evaluate using Adult Child Relationship scale (ACRS)
Time Frame
twelve months
Title
Parenting and Family Socialization - 1
Description
Evaluate using Adult Child Relationship scale (ACRS)
Time Frame
twenty-four months
Title
Parenting and Family Socialization - 2
Description
Distressing Experiences Microaggression Scale (MIC)
Time Frame
baseline
Title
Parenting and Family Socialization - 2
Description
Distressing Experiences Microaggression Scale (MIC)
Time Frame
twelve months
Title
Parenting and Family Socialization - 2
Description
Distressing Experiences Microaggression Scale (MIC)
Time Frame
twenty-four months
Title
Parenting and Family Socialization - 3
Description
Child Daily Face-to-Face Racial Discrimination (CDIS)
Time Frame
baseline
Title
Parenting and Family Socialization - 3
Description
Child Daily Face-to-Face Racial Discrimination (CDIS)
Time Frame
twelve months
Title
Parenting and Family Socialization - 3
Description
Child Daily Face-to-Face Racial Discrimination (CDIS)
Time Frame
twenty-four months
Title
Parenting and Family Socialization - 4
Description
Assess using Parental Involvement Scale (PI)
Time Frame
baseline
Title
Parenting and Family Socialization - 4
Description
Assess using Parental Involvement Scale (PI)
Time Frame
twelve months
Title
Parenting and Family Socialization - 4
Description
Assess using Parental Involvement Scale (PI)
Time Frame
twenty-four months
Title
Parenting and Family Socialization - 5
Description
Parental Monitoring Interview - Parent Response, - Child Response (PMI-PR, PMI-CR)
Time Frame
baseline
Title
Parenting and Family Socialization - 5
Description
Parental Monitoring Interview - Parent Response, - Child Response (PMI-PR, PMI-CR)
Time Frame
twelve months
Title
Parenting and Family Socialization - 5
Description
Parental Monitoring Interview - Parent Response, - Child Response (PMI-PR, PMI-CR)
Time Frame
twenty-four months
Title
Parenting and Family Socialization - 6
Description
Assess using Parenting Children and Adolescents measure (PARCA)
Time Frame
baseline
Title
Parenting and Family Socialization - 6
Description
Assess using Parenting Children and Adolescents measure (PARCA)
Time Frame
twelve months
Title
Parenting and Family Socialization - 6
Description
Assess using Parenting Children and Adolescents measure (PARCA)
Time Frame
twenty-four months
Title
Parenting and Family Socialization - 7
Description
Assessment using Parental Rating of Peers and Social Skills (PPRSK)
Time Frame
baseline
Title
Parenting and Family Socialization - 7
Description
Assessment using Parental Rating of Peers and Social Skills (PPRSK)
Time Frame
twelve months
Title
Parenting and Family Socialization - 7
Description
Assessment using Parental Rating of Peers and Social Skills (PPRSK)
Time Frame
twenty-four months
Title
Parenting and Family Socialization - Discussion Tasks - 1
Description
Assessment using Parent Child Hot topics Discussion Task
Time Frame
baseline
Title
Parenting and Family Socialization - Discussion Tasks - 1
Description
Assessment using Parent Child Hot topics Discussion Task
Time Frame
twelve months
Title
Parenting and Family Socialization - Discussion Tasks - 1
Description
Assessment using Parent Child Hot topics Discussion Task
Time Frame
twenty-four months
Title
Parenting and Family Socialization - Discussion Tasks - 2
Description
Assessment using Parent Child Hot Topics Questionnaire (PCHT)
Time Frame
baseline
Title
Parenting and Family Socialization - Discussion Tasks - 2
Description
Assessment using Parent Child Hot Topics Questionnaire (PCHT)
Time Frame
twelve months
Title
Parenting and Family Socialization - Discussion Tasks - 2
Description
Assessment using Parent Child Hot Topics Questionnaire (PCHT)
Time Frame
twenty-four months
Title
Parenting and Family Socialization - Discussion Tasks - 3
Description
Assessment using Monitoring & Listening Discussion Task
Time Frame
baseline
Title
Parenting and Family Socialization - Discussion Tasks - 3
Description
Assessment using Monitoring & Listening Discussion Task
Time Frame
twelve months
Title
Parenting and Family Socialization - Discussion Tasks - 3
Description
Assessment using Monitoring & Listening Discussion Task
Time Frame
twenty-four months
Title
Parenting and Family Socialization - Discussion Tasks - 4
Description
Assessment using Recognition Discussion Task
Time Frame
baseline
Title
Parenting and Family Socialization - Discussion Tasks - 4
Description
Assessment using Recognition Discussion Task
Time Frame
twelve months
Title
Parenting and Family Socialization - Discussion Tasks - 4
Description
Assessment using Recognition Discussion Task
Time Frame
twenty-four months
Title
Parenting and Family Socialization - Discussion Tasks - 5
Description
Assessment using Family Culture Discussion Task
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ty Ridenour, PhD
Organizational Affiliation
RTI International
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15260
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35513191
Citation
Galan CA, Meza JI, Ridenour TA, Shaw DS. Racial Discrimination Experienced by Black Parents: Enduring Mental Health Consequences for Adolescent Youth. J Am Acad Child Adolesc Psychiatry. 2022 Oct;61(10):1251-1261. doi: 10.1016/j.jaac.2022.04.015. Epub 2022 May 2.
Results Reference
derived

Learn more about this trial

Substance Use Screening and Prevention for Adolescents in Pediatric Primary Care

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