Substance UseSKYNCT03074877
Substance Use Screening and Prevention for Adolescents in Pediatric Primary Care
A study testing Family Check-Up in people with Substance Use, run by RTI International at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 9 to 13 years
- Conditions the study is for
- Substance Use
- What is being tested?
- Family Check-Up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 722 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2014to 31 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
About this study
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.
Read the 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 .
- Conditions
- Substance Use
- Being tested
- Family Check-Up
- Keywords
- Substance Use
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Check-UpBehavioural
The Family Check-Up (FCU) is a brief, family-based program to prevent Substance Use/Substance Use Disorder (SU/SUD) with replicated efficacy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: twenty-four months
Contextual Risk and Resources - 1
Administer Centers for Epidemiological Studies Depression Scale (CESD)
Measured: baseline
Contextual Risk and Resources - 1
Administer Centers for Epidemiological Studies Depression Scale (CESD)
Measured: twelve months
Contextual Risk and Resources - 1
Administer Centers for Epidemiological Studies Depression Scale (CESD)
Measured: twenty-four months
Contextual Risk and Resources - 2
Administer Demographic Questionnaire (DEMO)
Measured: baseline
Contextual Risk and Resources - 2
Administer Demographic Questionnaire (DEMO)
Measured: twelve months
Contextual Risk and Resources - 2
Administer Demographic Questionnaire (DEMO)
Measured: twenty-four months
Contextual Risk and Resources - 3
Administer Dyadic Adjustment Scale (DYAD)
Measured: baseline
Contextual Risk and Resources - 3
Administer Dyadic Adjustment Scale (DYAD)
Measured: twelve months
Contextual Risk and Resources - 3
Administer Dyadic Adjustment Scale (DYAD)
Measured: twenty-four months
Contextual Risk and Resources - 4
Administer Financial Stress Questionnaire (FINCE)
Measured: baseline
Contextual Risk and Resources - 4
Administer Financial Stress Questionnaire (FINCE)
Measured: twelve months
Contextual Risk and Resources - 4
Administer Financial Stress Questionnaire (FINCE)
Measured: twenty-four months
Contextual Risk and Resources - 5
Administer Me and My Neighborhood Questionnaire (MMNQ)
Measured: baseline
Contextual Risk and Resources - 5
Administer Me and My Neighborhood Questionnaire (MMNQ)
Measured: twelve months
Contextual Risk and Resources - 5
Administer Me and My Neighborhood Questionnaire (MMNQ)
Measured: twenty-four months
Contextual Risk and Resources - 6
Administer Parent Substance Use Questionnaire (SUBST-PC)
Measured: baseline
Contextual Risk and Resources - 6
Administer Parent Substance Use Questionnaire (SUBST-PC)
Measured: twelve months
Contextual Risk and Resources - 6
Administer Parent Substance Use Questionnaire (SUBST-PC)
Measured: twenty-four months
Youth Outcomes - 1
Administer Child Behavior Checklist (CBCL)
Measured: baseline
Youth Outcomes - 1
Administer Child Behavior Checklist (CBCL)
Measured: twelve months
Youth Outcomes - 1
Administer Child Behavior Checklist (CBCL)
Measured: twenty-four months
Youth Outcomes - 2
Assess Extracurricular Activities (ECA)
Measured: baseline
Youth Outcomes - 2
Assess Extracurricular Activities (ECA)
Measured: twelve months
Youth Outcomes - 2
Assess Extracurricular Activities (ECA)
Measured: twenty-four months
Youth Outcomes - 3
Administer Recent Activities Interview (RAI)
Measured: baseline
Youth Outcomes - 3
Administer Recent Activities Interview (RAI)
Measured: twelve months
Youth Outcomes - 3
Administer Recent Activities Interview (RAI)
Measured: twenty-four months
Youth Outcomes - 4
Administer Screen for Child Anxiety-Related Emotional Disorders (SCR)
Measured: baseline
Youth Outcomes - 4
Administer Screen for Child Anxiety-Related Emotional Disorders (SCR)
Measured: twelve months
Youth Outcomes - 4
Administer Screen for Child Anxiety-Related Emotional Disorders (SCR)
Measured: twenty-four months
Youth Outcomes - 5
Administer Self-Report of Delinquency (SHORT) (SRD)
Measured: baseline
Youth Outcomes - 5
Administer Self-Report of Delinquency (SHORT) (SRD)
Measured: twelve months
Youth Outcomes - 5
Administer Self-Report of Delinquency (SHORT) (SRD)
Measured: twenty-four months
Youth Outcomes - 6
Target Child Substance Use (TC Subst)
Measured: baseline
Youth Outcomes - 6
Target Child Substance Use (TC Subst)
Measured: twelve months
Youth Outcomes - 6
Target Child Substance Use (TC Subst)
Measured: twenty-four months
Youth Outcomes - 7
Administer Youth Risk Behavior Survey (YRBS)
Measured: baseline
Youth Outcomes - 7
Administer Youth Risk Behavior Survey (YRBS)
Measured: twelve months
Youth Outcomes - 7
Administer Youth Risk Behavior Survey (YRBS)
Measured: twenty-four months
Parenting and Family Socialization - 1
Evaluate using Adult Child Relationship scale (ACRS)
Measured: baseline
Parenting and Family Socialization - 1
Evaluate using Adult Child Relationship scale (ACRS)
Measured: twelve months
Parenting and Family Socialization - 1
Evaluate using Adult Child Relationship scale (ACRS)
Measured: twenty-four months
Parenting and Family Socialization - 2
Distressing Experiences Microaggression Scale (MIC)
Measured: baseline
Parenting and Family Socialization - 2
Distressing Experiences Microaggression Scale (MIC)
Measured: twelve months
Parenting and Family Socialization - 2
Distressing Experiences Microaggression Scale (MIC)
Measured: twenty-four months
Parenting and Family Socialization - 3
Child Daily Face-to-Face Racial Discrimination (CDIS)
Measured: baseline
Parenting and Family Socialization - 3
Child Daily Face-to-Face Racial Discrimination (CDIS)
Measured: twelve months
Parenting and Family Socialization - 3
Child Daily Face-to-Face Racial Discrimination (CDIS)
Measured: twenty-four months
Parenting and Family Socialization - 4
Assess using Parental Involvement Scale (PI)
Measured: baseline
Parenting and Family Socialization - 4
Assess using Parental Involvement Scale (PI)
Measured: twelve months
Parenting and Family Socialization - 4
Assess using Parental Involvement Scale (PI)
Measured: twenty-four months
Parenting and Family Socialization - 5
Parental Monitoring Interview - Parent Response, - Child Response (PMI-PR, PMI-CR)
Measured: baseline
Parenting and Family Socialization - 5
Parental Monitoring Interview - Parent Response, - Child Response (PMI-PR, PMI-CR)
Measured: twelve months
Parenting and Family Socialization - 5
Parental Monitoring Interview - Parent Response, - Child Response (PMI-PR, PMI-CR)
Measured: twenty-four months
Parenting and Family Socialization - 6
Assess using Parenting Children and Adolescents measure (PARCA)
Measured: baseline
Parenting and Family Socialization - 6
Assess using Parenting Children and Adolescents measure (PARCA)
Measured: twelve months
Parenting and Family Socialization - 6
Assess using Parenting Children and Adolescents measure (PARCA)
Measured: twenty-four months
Parenting and Family Socialization - 7
Assessment using Parental Rating of Peers and Social Skills (PPRSK)
Measured: baseline
Parenting and Family Socialization - 7
Assessment using Parental Rating of Peers and Social Skills (PPRSK)
Measured: twelve months
Parenting and Family Socialization - 7
Assessment using Parental Rating of Peers and Social Skills (PPRSK)
Measured: twenty-four months
Parenting and Family Socialization - Discussion Tasks - 1
Assessment using Parent Child Hot topics Discussion Task
Measured: baseline
Parenting and Family Socialization - Discussion Tasks - 1
Assessment using Parent Child Hot topics Discussion Task
Measured: twelve months
Parenting and Family Socialization - Discussion Tasks - 1
Assessment using Parent Child Hot topics Discussion Task
Measured: twenty-four months
Parenting and Family Socialization - Discussion Tasks - 2
Assessment using Parent Child Hot Topics Questionnaire (PCHT)
Measured: baseline
Parenting and Family Socialization - Discussion Tasks - 2
Assessment using Parent Child Hot Topics Questionnaire (PCHT)
Measured: twelve months
Parenting and Family Socialization - Discussion Tasks - 2
Assessment using Parent Child Hot Topics Questionnaire (PCHT)
Measured: twenty-four months
Parenting and Family Socialization - Discussion Tasks - 3
Assessment using Monitoring \& Listening Discussion Task
Measured: baseline
Parenting and Family Socialization - Discussion Tasks - 3
Assessment using Monitoring \& Listening Discussion Task
Measured: twelve months
Parenting and Family Socialization - Discussion Tasks - 3
Assessment using Monitoring \& Listening Discussion Task
Measured: twenty-four months
Parenting and Family Socialization - Discussion Tasks - 4
Assessment using Recognition Discussion Task
Measured: baseline
Parenting and Family Socialization - Discussion Tasks - 4
Assessment using Recognition Discussion Task
Measured: twelve months
Parenting and Family Socialization - Discussion Tasks - 4
Assessment using Recognition Discussion Task
Measured: twenty-four months
Parenting and Family Socialization - Discussion Tasks - 5
Assessment using Family Culture Discussion Task
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study start1 Jun 2014
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 722 participants (actual)
Sponsor and investigators
- Lead sponsor
- RTI International
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh
- Responsible party
- Sponsor
- Investigators
- Ty Ridenour, PhD, Principal investigator, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03074877
- Sponsor's protocol ID
- 5R01DA036628-02
- Acronym
- SKY
- Status last verified
- Nov 2019
- First submitted
- 13 Feb 2017
- Last updated
- 20 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35513191
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Substance Use Screening and Prevention for Adolescents in Pediatric Primary Care
- ClinicalTrials.gov ID
- NCT03074877
- Acronym / sponsor ID
- SKY / 5R01DA036628-02
- Conditions
- Substance Use
- Keywords
- Substance Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 722 participants (actual)
- Lead sponsor
- RTI InternationalUniversity, hospital or other
- Collaborators
- University of Pittsburgh
- Study start
- 1 Jun 2014 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 9 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Family Check-Up (FCU) | Experimental | Behavioral: Family Check-UpFamilies 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. |
| Waitlist Group | Experimental | Behavioral: Family Check-UpFamilies 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. |
| 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. |
Who may qualify
- Ages
- 9 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family Check-UpThe Family Check-Up (FCU) is a brief, family-based program to prevent Substance Use/Substance Use Disorder (SU/SUD) with replicated efficacy | Behavioural | Family Check-Up (FCU), Waitlist Group |
Primary outcome
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)
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)
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)
Contextual Risk and Resources - 1
Time frame: baseline
Administer Centers for Epidemiological Studies Depression Scale (CESD)
Contextual Risk and Resources - 1
Time frame: twelve months
Administer Centers for Epidemiological Studies Depression Scale (CESD)
Contextual Risk and Resources - 1
Time frame: twenty-four months
Administer Centers for Epidemiological Studies Depression Scale (CESD)
Contextual Risk and Resources - 2
Time frame: baseline
Administer Demographic Questionnaire (DEMO)
Contextual Risk and Resources - 2
Time frame: twelve months
Administer Demographic Questionnaire (DEMO)
Contextual Risk and Resources - 2
Time frame: twenty-four months
Administer Demographic Questionnaire (DEMO)
Contextual Risk and Resources - 3
Time frame: baseline
Administer Dyadic Adjustment Scale (DYAD)
Contextual Risk and Resources - 3
Time frame: twelve months
Administer Dyadic Adjustment Scale (DYAD)
Contextual Risk and Resources - 3
Time frame: twenty-four months
Administer Dyadic Adjustment Scale (DYAD)
Contextual Risk and Resources - 4
Time frame: baseline
Administer Financial Stress Questionnaire (FINCE)
Contextual Risk and Resources - 4
Time frame: twelve months
Administer Financial Stress Questionnaire (FINCE)
Contextual Risk and Resources - 4
Time frame: twenty-four months
Administer Financial Stress Questionnaire (FINCE)
Contextual Risk and Resources - 5
Time frame: baseline
Administer Me and My Neighborhood Questionnaire (MMNQ)
Contextual Risk and Resources - 5
Time frame: twelve months
Administer Me and My Neighborhood Questionnaire (MMNQ)
Contextual Risk and Resources - 5
Time frame: twenty-four months
Administer Me and My Neighborhood Questionnaire (MMNQ)
Contextual Risk and Resources - 6
Time frame: baseline
Administer Parent Substance Use Questionnaire (SUBST-PC)
Contextual Risk and Resources - 6
Time frame: twelve months
Administer Parent Substance Use Questionnaire (SUBST-PC)
Contextual Risk and Resources - 6
Time frame: twenty-four months
Administer Parent Substance Use Questionnaire (SUBST-PC)
Youth Outcomes - 1
Time frame: baseline
Administer Child Behavior Checklist (CBCL)
Youth Outcomes - 1
Time frame: twelve months
Administer Child Behavior Checklist (CBCL)
Youth Outcomes - 1
Time frame: twenty-four months
Administer Child Behavior Checklist (CBCL)
Youth Outcomes - 2
Time frame: baseline
Assess Extracurricular Activities (ECA)
Youth Outcomes - 2
Time frame: twelve months
Assess Extracurricular Activities (ECA)
Youth Outcomes - 2
Time frame: twenty-four months
Assess Extracurricular Activities (ECA)
Youth Outcomes - 3
Time frame: baseline
Administer Recent Activities Interview (RAI)
Youth Outcomes - 3
Time frame: twelve months
Administer Recent Activities Interview (RAI)
Youth Outcomes - 3
Time frame: twenty-four months
Administer Recent Activities Interview (RAI)
Youth Outcomes - 4
Time frame: baseline
Administer Screen for Child Anxiety-Related Emotional Disorders (SCR)
Youth Outcomes - 4
Time frame: twelve months
Administer Screen for Child Anxiety-Related Emotional Disorders (SCR)
Youth Outcomes - 4
Time frame: twenty-four months
Administer Screen for Child Anxiety-Related Emotional Disorders (SCR)
Youth Outcomes - 5
Time frame: baseline
Administer Self-Report of Delinquency (SHORT) (SRD)
Youth Outcomes - 5
Time frame: twelve months
Administer Self-Report of Delinquency (SHORT) (SRD)
Youth Outcomes - 5
Time frame: twenty-four months
Administer Self-Report of Delinquency (SHORT) (SRD)
Youth Outcomes - 6
Time frame: baseline
Target Child Substance Use (TC Subst)
Youth Outcomes - 6
Time frame: twelve months
Target Child Substance Use (TC Subst)
Youth Outcomes - 6
Time frame: twenty-four months
Target Child Substance Use (TC Subst)
Youth Outcomes - 7
Time frame: baseline
Administer Youth Risk Behavior Survey (YRBS)
Youth Outcomes - 7
Time frame: twelve months
Administer Youth Risk Behavior Survey (YRBS)
Youth Outcomes - 7
Time frame: twenty-four months
Administer Youth Risk Behavior Survey (YRBS)
Parenting and Family Socialization - 1
Time frame: baseline
Evaluate using Adult Child Relationship scale (ACRS)
Parenting and Family Socialization - 1
Time frame: twelve months
Evaluate using Adult Child Relationship scale (ACRS)
Parenting and Family Socialization - 1
Time frame: twenty-four months
Evaluate using Adult Child Relationship scale (ACRS)
Parenting and Family Socialization - 2
Time frame: baseline
Distressing Experiences Microaggression Scale (MIC)
Parenting and Family Socialization - 2
Time frame: twelve months
Distressing Experiences Microaggression Scale (MIC)
Parenting and Family Socialization - 2
Time frame: twenty-four months
Distressing Experiences Microaggression Scale (MIC)
Parenting and Family Socialization - 3
Time frame: baseline
Child Daily Face-to-Face Racial Discrimination (CDIS)
Parenting and Family Socialization - 3
Time frame: twelve months
Child Daily Face-to-Face Racial Discrimination (CDIS)
Parenting and Family Socialization - 3
Time frame: twenty-four months
Child Daily Face-to-Face Racial Discrimination (CDIS)
Parenting and Family Socialization - 4
Time frame: baseline
Assess using Parental Involvement Scale (PI)
Parenting and Family Socialization - 4
Time frame: twelve months
Assess using Parental Involvement Scale (PI)
Parenting and Family Socialization - 4
Time frame: twenty-four months
Assess using Parental Involvement Scale (PI)
Parenting and Family Socialization - 5
Time frame: baseline
Parental Monitoring Interview - Parent Response, - Child Response (PMI-PR, PMI-CR)
Parenting and Family Socialization - 5
Time frame: twelve months
Parental Monitoring Interview - Parent Response, - Child Response (PMI-PR, PMI-CR)
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 - 6
Time frame: baseline
Assess using Parenting Children and Adolescents measure (PARCA)
Parenting and Family Socialization - 6
Time frame: twelve months
Assess using Parenting Children and Adolescents measure (PARCA)
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: baseline
Assessment using Parental Rating of Peers and Social Skills (PPRSK)
Parenting and Family Socialization - 7
Time frame: twelve months
Assessment using Parental Rating of Peers and Social Skills (PPRSK)
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: baseline
Assessment using Parent Child Hot topics Discussion Task
Parenting and Family Socialization - Discussion Tasks - 1
Time frame: twelve months
Assessment using Parent Child Hot topics Discussion Task
Parenting and Family Socialization - Discussion Tasks - 1
Time frame: twenty-four months
Assessment using Parent Child Hot topics Discussion Task
Parenting and Family Socialization - Discussion Tasks - 2
Time frame: baseline
Assessment using Parent Child Hot Topics Questionnaire (PCHT)
Parenting and Family Socialization - Discussion Tasks - 2
Time frame: twelve months
Assessment using Parent Child Hot Topics Questionnaire (PCHT)
Parenting and Family Socialization - Discussion Tasks - 2
Time frame: twenty-four months
Assessment using Parent Child Hot Topics Questionnaire (PCHT)
Parenting and Family Socialization - Discussion Tasks - 3
Time frame: baseline
Assessment using Monitoring \& Listening Discussion Task
Parenting and Family Socialization - Discussion Tasks - 3
Time frame: twelve months
Assessment using Monitoring \& Listening Discussion Task
Parenting and Family Socialization - Discussion Tasks - 3
Time frame: twenty-four months
Assessment using Monitoring \& Listening Discussion Task
Parenting and Family Socialization - Discussion Tasks - 4
Time frame: baseline
Assessment using Recognition Discussion Task
Parenting and Family Socialization - Discussion Tasks - 4
Time frame: twelve months
Assessment using Recognition Discussion Task
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2019.
- Derived from this study: PubMed 35513191Galan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ty Ridenour, PhD principal investigator
RTI International
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Check-Up in people with Substance Use, run by RTI International at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Liability and EXposure to Substance use and Antisocial behavior (ALEXSA) (time frame: baseline). The study lists 76 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03074877, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2019.