NCT03074877

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
722

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

February 13, 2017

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 9, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

November 20, 2019

Status Verified

November 1, 2019

Enrollment Period

5.2 years

First QC Date

February 13, 2017

Last Update Submit

November 18, 2019

Conditions

Substance Use

Keywords

Substance Use

Outcome Measures

Primary Outcomes (76)

  • 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

Study Arms (3)

Family Check-Up (FCU)

EXPERIMENTAL

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

Waitlist Group

EXPERIMENTAL

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

Control Group

NO 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.

Interventions

Family Check-UpBEHAVIORAL

The Family Check-Up (FCU) is a brief, family-based program to prevent Substance Use/Substance Use Disorder (SU/SUD) with replicated efficacy

Family Check-Up (FCU)Waitlist Group

Eligibility Criteria

Age9 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

Related Publications (1)

  • 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.

    PMID: 35513191DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Ty Ridenour, PhD

    RTI International

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2017

First Posted

March 9, 2017

Study Start

June 1, 2014

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

November 20, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)