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CompletedNCT03074877SKYUpdated Nov 20, 2019

Substance Use Screening and Prevention for Adolescents in Pediatric Primary Care

An interventional study of Family Check-Up in Substance Use, sponsored by RTI International. Completed at 1 site in United States. Open to participants aged 9 Years to 13 Years. Per ClinicalTrials.gov, last updated 2019-11-20.

Sponsored by RTI International · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 2 years 8 months after the study started (first participant enrolled Jun 2014, registered Feb 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
722
Allocation
Randomized
Ages
9 Years to 13 Years
Sex
All
01

Study 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.

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 .

02

Conditions studied

  • Substance Use

Keywords

  • Substance Use
03

In context

Substance-Related Disorders

2,181 studies on the registry are indexed under Substance-Related Disorders; 399 are open to participants now.

This study's enrollment of 722 is above the median of 108 across 1,770 interventional studies indexed under Substance-Related Disorders.

Browse Substance-Related Disorders studies →

Lead sponsor

RTI International is the lead sponsor of 84 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
9 Years to 13 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
722 participants (actual)

Study arms

  • 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

  • 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

  • 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.

Interventions

  • BehavioralFamily 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

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: baseline

  2. 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)

    Time frame: twelve months

  3. 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)

    Time frame: twenty-four months

  4. Contextual Risk and Resources - 1

    Administer Centers for Epidemiological Studies Depression Scale (CESD)

    Time frame: baseline

  5. Contextual Risk and Resources - 1

    Administer Centers for Epidemiological Studies Depression Scale (CESD)

    Time frame: twelve months

  6. Contextual Risk and Resources - 1

    Administer Centers for Epidemiological Studies Depression Scale (CESD)

    Time frame: twenty-four months

  7. Contextual Risk and Resources - 2

    Administer Demographic Questionnaire (DEMO)

    Time frame: baseline

  8. Contextual Risk and Resources - 2

    Administer Demographic Questionnaire (DEMO)

    Time frame: twelve months

  9. Contextual Risk and Resources - 2

    Administer Demographic Questionnaire (DEMO)

    Time frame: twenty-four months

  10. Contextual Risk and Resources - 3

    Administer Dyadic Adjustment Scale (DYAD)

    Time frame: baseline

  11. Contextual Risk and Resources - 3

    Administer Dyadic Adjustment Scale (DYAD)

    Time frame: twelve months

  12. Contextual Risk and Resources - 3

    Administer Dyadic Adjustment Scale (DYAD)

    Time frame: twenty-four months

  13. Contextual Risk and Resources - 4

    Administer Financial Stress Questionnaire (FINCE)

    Time frame: baseline

  14. Contextual Risk and Resources - 4

    Administer Financial Stress Questionnaire (FINCE)

    Time frame: twelve months

  15. Contextual Risk and Resources - 4

    Administer Financial Stress Questionnaire (FINCE)

    Time frame: twenty-four months

  16. Contextual Risk and Resources - 5

    Administer Me and My Neighborhood Questionnaire (MMNQ)

    Time frame: baseline

  17. Contextual Risk and Resources - 5

    Administer Me and My Neighborhood Questionnaire (MMNQ)

    Time frame: twelve months

  18. Contextual Risk and Resources - 5

    Administer Me and My Neighborhood Questionnaire (MMNQ)

    Time frame: twenty-four months

  19. Contextual Risk and Resources - 6

    Administer Parent Substance Use Questionnaire (SUBST-PC)

    Time frame: baseline

  20. Contextual Risk and Resources - 6

    Administer Parent Substance Use Questionnaire (SUBST-PC)

    Time frame: twelve months

  21. Contextual Risk and Resources - 6

    Administer Parent Substance Use Questionnaire (SUBST-PC)

    Time frame: twenty-four months

  22. Youth Outcomes - 1

    Administer Child Behavior Checklist (CBCL)

    Time frame: baseline

  23. Youth Outcomes - 1

    Administer Child Behavior Checklist (CBCL)

    Time frame: twelve months

  24. Youth Outcomes - 1

    Administer Child Behavior Checklist (CBCL)

    Time frame: twenty-four months

  25. Youth Outcomes - 2

    Assess Extracurricular Activities (ECA)

    Time frame: baseline

  26. Youth Outcomes - 2

    Assess Extracurricular Activities (ECA)

    Time frame: twelve months

  27. Youth Outcomes - 2

    Assess Extracurricular Activities (ECA)

    Time frame: twenty-four months

  28. Youth Outcomes - 3

    Administer Recent Activities Interview (RAI)

    Time frame: baseline

  29. Youth Outcomes - 3

    Administer Recent Activities Interview (RAI)

    Time frame: twelve months

  30. Youth Outcomes - 3

    Administer Recent Activities Interview (RAI)

    Time frame: twenty-four months

  31. Youth Outcomes - 4

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

    Time frame: baseline

  32. Youth Outcomes - 4

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

    Time frame: twelve months

  33. Youth Outcomes - 4

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

    Time frame: twenty-four months

  34. Youth Outcomes - 5

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

    Time frame: baseline

  35. Youth Outcomes - 5

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

    Time frame: twelve months

  36. Youth Outcomes - 5

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

    Time frame: twenty-four months

  37. Youth Outcomes - 6

    Target Child Substance Use (TC Subst)

    Time frame: baseline

  38. Youth Outcomes - 6

    Target Child Substance Use (TC Subst)

    Time frame: twelve months

  39. Youth Outcomes - 6

    Target Child Substance Use (TC Subst)

    Time frame: twenty-four months

  40. Youth Outcomes - 7

    Administer Youth Risk Behavior Survey (YRBS)

    Time frame: baseline

  41. Youth Outcomes - 7

    Administer Youth Risk Behavior Survey (YRBS)

    Time frame: twelve months

  42. Youth Outcomes - 7

    Administer Youth Risk Behavior Survey (YRBS)

    Time frame: twenty-four months

  43. Parenting and Family Socialization - 1

    Evaluate using Adult Child Relationship scale (ACRS)

    Time frame: baseline

  44. Parenting and Family Socialization - 1

    Evaluate using Adult Child Relationship scale (ACRS)

    Time frame: twelve months

  45. Parenting and Family Socialization - 1

    Evaluate using Adult Child Relationship scale (ACRS)

    Time frame: twenty-four months

  46. Parenting and Family Socialization - 2

    Distressing Experiences Microaggression Scale (MIC)

    Time frame: baseline

  47. Parenting and Family Socialization - 2

    Distressing Experiences Microaggression Scale (MIC)

    Time frame: twelve months

  48. Parenting and Family Socialization - 2

    Distressing Experiences Microaggression Scale (MIC)

    Time frame: twenty-four months

  49. Parenting and Family Socialization - 3

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

    Time frame: baseline

  50. Parenting and Family Socialization - 3

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

    Time frame: twelve months

  51. Parenting and Family Socialization - 3

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

    Time frame: twenty-four months

  52. Parenting and Family Socialization - 4

    Assess using Parental Involvement Scale (PI)

    Time frame: baseline

  53. Parenting and Family Socialization - 4

    Assess using Parental Involvement Scale (PI)

    Time frame: twelve months

  54. Parenting and Family Socialization - 4

    Assess using Parental Involvement Scale (PI)

    Time frame: twenty-four months

  55. Parenting and Family Socialization - 5

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

    Time frame: baseline

  56. Parenting and Family Socialization - 5

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

    Time frame: twelve months

  57. Parenting and Family Socialization - 5

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

    Time frame: twenty-four months

  58. Parenting and Family Socialization - 6

    Assess using Parenting Children and Adolescents measure (PARCA)

    Time frame: baseline

  59. Parenting and Family Socialization - 6

    Assess using Parenting Children and Adolescents measure (PARCA)

    Time frame: twelve months

  60. Parenting and Family Socialization - 6

    Assess using Parenting Children and Adolescents measure (PARCA)

    Time frame: twenty-four months

  61. Parenting and Family Socialization - 7

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

    Time frame: baseline

  62. Parenting and Family Socialization - 7

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

    Time frame: twelve months

  63. Parenting and Family Socialization - 7

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

    Time frame: twenty-four months

  64. Parenting and Family Socialization - Discussion Tasks - 1

    Assessment using Parent Child Hot topics Discussion Task

    Time frame: baseline

  65. Parenting and Family Socialization - Discussion Tasks - 1

    Assessment using Parent Child Hot topics Discussion Task

    Time frame: twelve months

  66. Parenting and Family Socialization - Discussion Tasks - 1

    Assessment using Parent Child Hot topics Discussion Task

    Time frame: twenty-four months

  67. Parenting and Family Socialization - Discussion Tasks - 2

    Assessment using Parent Child Hot Topics Questionnaire (PCHT)

    Time frame: baseline

  68. Parenting and Family Socialization - Discussion Tasks - 2

    Assessment using Parent Child Hot Topics Questionnaire (PCHT)

    Time frame: twelve months

  69. Parenting and Family Socialization - Discussion Tasks - 2

    Assessment using Parent Child Hot Topics Questionnaire (PCHT)

    Time frame: twenty-four months

  70. Parenting and Family Socialization - Discussion Tasks - 3

    Assessment using Monitoring \& Listening Discussion Task

    Time frame: baseline

  71. Parenting and Family Socialization - Discussion Tasks - 3

    Assessment using Monitoring \& Listening Discussion Task

    Time frame: twelve months

  72. Parenting and Family Socialization - Discussion Tasks - 3

    Assessment using Monitoring \& Listening Discussion Task

    Time frame: twenty-four months

  73. Parenting and Family Socialization - Discussion Tasks - 4

    Assessment using Recognition Discussion Task

    Time frame: baseline

  74. Parenting and Family Socialization - Discussion Tasks - 4

    Assessment using Recognition Discussion Task

    Time frame: twelve months

  75. Parenting and Family Socialization - Discussion Tasks - 4

    Assessment using Recognition Discussion Task

    Time frame: twenty-four months

  76. Parenting and Family Socialization - Discussion Tasks - 5

    Assessment using Family Culture Discussion Task

    Time frame: baseline

07

Study locations

1 site
  • University of Pittsburgh
    Pittsburgh, Pennsylvania 15260, United States
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2014 to primary completion in Jul 2019, 61 months.

Of 812 non-industry interventional studies with no phase under Substance-Related Disorders, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's 61 months is above that.

Counting every sponsor, half of 855 studies reached it within 32 months; a quarter within 16 and three quarters within 51.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 13, 2017
First posted
Mar 9, 2017
StartActual
Jun 1, 2014
Primary completionActual
Jul 31, 2019
CompletionActual
Jul 31, 2019
Last update
Nov 20, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 20, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03074877
Lead sponsor
RTI International
Collaborators
University of Pittsburgh
Responsible party
Sponsor
First posted
Mar 9, 2017
Start date
Jun 1, 2014
Primary completion
Jul 31, 2019
Completion
Jul 31, 2019
Last update
Nov 20, 2019

Study contacts

Ty Ridenour, PhD
principal investigator · RTI International

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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