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Completed

NCT Number: NCT03074877

Substance Use Screening and Prevention for Adolescents in Pediatric Primary Care

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.

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Key information

Conditions

Substance Use Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

9 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

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 (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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Family Check-Up

Behavioral

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

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. Contextual Risk and Resources - 1

    Time frame: baseline

    Administer Centers for Epidemiological Studies Depression Scale (CESD)

  5. Contextual Risk and Resources - 1

    Time frame: twelve months

    Administer Centers for Epidemiological Studies Depression Scale (CESD)

  6. Contextual Risk and Resources - 1

    Time frame: twenty-four months

    Administer Centers for Epidemiological Studies Depression Scale (CESD)

  7. Contextual Risk and Resources - 2

    Time frame: baseline

    Administer Demographic Questionnaire (DEMO)

  8. Contextual Risk and Resources - 2

    Time frame: twelve months

    Administer Demographic Questionnaire (DEMO)

  9. Contextual Risk and Resources - 2

    Time frame: twenty-four months

    Administer Demographic Questionnaire (DEMO)

  10. Contextual Risk and Resources - 3

    Time frame: baseline

    Administer Dyadic Adjustment Scale (DYAD)

  11. Contextual Risk and Resources - 3

    Time frame: twelve months

    Administer Dyadic Adjustment Scale (DYAD)

  12. Contextual Risk and Resources - 3

    Time frame: twenty-four months

    Administer Dyadic Adjustment Scale (DYAD)

  13. Contextual Risk and Resources - 4

    Time frame: baseline

    Administer Financial Stress Questionnaire (FINCE)

  14. Contextual Risk and Resources - 4

    Time frame: twelve months

    Administer Financial Stress Questionnaire (FINCE)

  15. Contextual Risk and Resources - 4

    Time frame: twenty-four months

    Administer Financial Stress Questionnaire (FINCE)

  16. Contextual Risk and Resources - 5

    Time frame: baseline

    Administer Me and My Neighborhood Questionnaire (MMNQ)

  17. Contextual Risk and Resources - 5

    Time frame: twelve months

    Administer Me and My Neighborhood Questionnaire (MMNQ)

  18. Contextual Risk and Resources - 5

    Time frame: twenty-four months

    Administer Me and My Neighborhood Questionnaire (MMNQ)

  19. Contextual Risk and Resources - 6

    Time frame: baseline

    Administer Parent Substance Use Questionnaire (SUBST-PC)

  20. Contextual Risk and Resources - 6

    Time frame: twelve months

    Administer Parent Substance Use Questionnaire (SUBST-PC)

  21. Contextual Risk and Resources - 6

    Time frame: twenty-four months

    Administer Parent Substance Use Questionnaire (SUBST-PC)

  22. Youth Outcomes - 1

    Time frame: baseline

    Administer Child Behavior Checklist (CBCL)

  23. Youth Outcomes - 1

    Time frame: twelve months

    Administer Child Behavior Checklist (CBCL)

  24. Youth Outcomes - 1

    Time frame: twenty-four months

    Administer Child Behavior Checklist (CBCL)

  25. Youth Outcomes - 2

    Time frame: baseline

    Assess Extracurricular Activities (ECA)

  26. Youth Outcomes - 2

    Time frame: twelve months

    Assess Extracurricular Activities (ECA)

  27. Youth Outcomes - 2

    Time frame: twenty-four months

    Assess Extracurricular Activities (ECA)

  28. Youth Outcomes - 3

    Time frame: baseline

    Administer Recent Activities Interview (RAI)

  29. Youth Outcomes - 3

    Time frame: twelve months

    Administer Recent Activities Interview (RAI)

  30. Youth Outcomes - 3

    Time frame: twenty-four months

    Administer Recent Activities Interview (RAI)

  31. Youth Outcomes - 4

    Time frame: baseline

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

  32. Youth Outcomes - 4

    Time frame: twelve months

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

  33. Youth Outcomes - 4

    Time frame: twenty-four months

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

  34. Youth Outcomes - 5

    Time frame: baseline

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

  35. Youth Outcomes - 5

    Time frame: twelve months

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

  36. Youth Outcomes - 5

    Time frame: twenty-four months

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

  37. Youth Outcomes - 6

    Time frame: baseline

    Target Child Substance Use (TC Subst)

  38. Youth Outcomes - 6

    Time frame: twelve months

    Target Child Substance Use (TC Subst)

  39. Youth Outcomes - 6

    Time frame: twenty-four months

    Target Child Substance Use (TC Subst)

  40. Youth Outcomes - 7

    Time frame: baseline

    Administer Youth Risk Behavior Survey (YRBS)

  41. Youth Outcomes - 7

    Time frame: twelve months

    Administer Youth Risk Behavior Survey (YRBS)

  42. Youth Outcomes - 7

    Time frame: twenty-four months

    Administer Youth Risk Behavior Survey (YRBS)

  43. Parenting and Family Socialization - 1

    Time frame: baseline

    Evaluate using Adult Child Relationship scale (ACRS)

  44. Parenting and Family Socialization - 1

    Time frame: twelve months

    Evaluate using Adult Child Relationship scale (ACRS)

  45. Parenting and Family Socialization - 1

    Time frame: twenty-four months

    Evaluate using Adult Child Relationship scale (ACRS)

  46. Parenting and Family Socialization - 2

    Time frame: baseline

    Distressing Experiences Microaggression Scale (MIC)

  47. Parenting and Family Socialization - 2

    Time frame: twelve months

    Distressing Experiences Microaggression Scale (MIC)

  48. Parenting and Family Socialization - 2

    Time frame: twenty-four months

    Distressing Experiences Microaggression Scale (MIC)

  49. Parenting and Family Socialization - 3

    Time frame: baseline

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

  50. Parenting and Family Socialization - 3

    Time frame: twelve months

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

  51. Parenting and Family Socialization - 3

    Time frame: twenty-four months

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

  52. Parenting and Family Socialization - 4

    Time frame: baseline

    Assess using Parental Involvement Scale (PI)

  53. Parenting and Family Socialization - 4

    Time frame: twelve months

    Assess using Parental Involvement Scale (PI)

  54. Parenting and Family Socialization - 4

    Time frame: twenty-four months

    Assess using Parental Involvement Scale (PI)

  55. Parenting and Family Socialization - 5

    Time frame: baseline

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

  56. Parenting and Family Socialization - 5

    Time frame: twelve months

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

  57. Parenting and Family Socialization - 5

    Time frame: twenty-four months

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

  58. Parenting and Family Socialization - 6

    Time frame: baseline

    Assess using Parenting Children and Adolescents measure (PARCA)

  59. Parenting and Family Socialization - 6

    Time frame: twelve months

    Assess using Parenting Children and Adolescents measure (PARCA)

  60. Parenting and Family Socialization - 6

    Time frame: twenty-four months

    Assess using Parenting Children and Adolescents measure (PARCA)

  61. Parenting and Family Socialization - 7

    Time frame: baseline

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

  62. Parenting and Family Socialization - 7

    Time frame: twelve months

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

  63. Parenting and Family Socialization - 7

    Time frame: twenty-four months

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

  64. Parenting and Family Socialization - Discussion Tasks - 1

    Time frame: baseline

    Assessment using Parent Child Hot topics Discussion Task

  65. Parenting and Family Socialization - Discussion Tasks - 1

    Time frame: twelve months

    Assessment using Parent Child Hot topics Discussion Task

  66. Parenting and Family Socialization - Discussion Tasks - 1

    Time frame: twenty-four months

    Assessment using Parent Child Hot topics Discussion Task

  67. Parenting and Family Socialization - Discussion Tasks - 2

    Time frame: baseline

    Assessment using Parent Child Hot Topics Questionnaire (PCHT)

  68. Parenting and Family Socialization - Discussion Tasks - 2

    Time frame: twelve months

    Assessment using Parent Child Hot Topics Questionnaire (PCHT)

  69. Parenting and Family Socialization - Discussion Tasks - 2

    Time frame: twenty-four months

    Assessment using Parent Child Hot Topics Questionnaire (PCHT)

  70. Parenting and Family Socialization - Discussion Tasks - 3

    Time frame: baseline

    Assessment using Monitoring & Listening Discussion Task

  71. Parenting and Family Socialization - Discussion Tasks - 3

    Time frame: twelve months

    Assessment using Monitoring & Listening Discussion Task

  72. Parenting and Family Socialization - Discussion Tasks - 3

    Time frame: twenty-four months

    Assessment using Monitoring & Listening Discussion Task

  73. Parenting and Family Socialization - Discussion Tasks - 4

    Time frame: baseline

    Assessment using Recognition Discussion Task

  74. Parenting and Family Socialization - Discussion Tasks - 4

    Time frame: twelve months

    Assessment using Recognition Discussion Task

  75. Parenting and Family Socialization - Discussion Tasks - 4

    Time frame: twenty-four months

    Assessment using Recognition Discussion Task

  76. Parenting and Family Socialization - Discussion Tasks - 5

    Time frame: baseline

    Assessment using Family Culture Discussion Task

Sponsors and collaborators

Lead sponsor

RTI International

Other

Collaborators

  • University of Pittsburgh

Registry information

Acronym: SKY

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Mar 9, 2017
Registry last updated
Nov 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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