Substance Use Screening and Prevention for Adolescents in Pediatric Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 722
- 试验地点
- 1
- 主要终点
- Contextual Risk and Resources - 1
研究概览
简要总结
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.
详细描述
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 .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 9 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Family Check-Up (Behavioral)
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.
干预措施: Family Check-Up (Behavioral)
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.
结局指标
主要结局
Contextual Risk and Resources - 1
时间窗: twenty-four months
Administer Centers for Epidemiological Studies Depression Scale (CESD)
Contextual Risk and Resources - 3
时间窗: twenty-four months
Administer Dyadic Adjustment Scale (DYAD)
Contextual Risk and Resources - 2
时间窗: twenty-four months
Administer Demographic Questionnaire (DEMO)
Contextual Risk and Resources - 5
时间窗: twenty-four months
Administer Me and My Neighborhood Questionnaire (MMNQ)
Youth Outcomes - 1
时间窗: twenty-four months
Administer Child Behavior Checklist (CBCL)
Contextual Risk and Resources - 4
时间窗: twenty-four months
Administer Financial Stress Questionnaire (FINCE)
Contextual Risk and Resources - 6
时间窗: twenty-four months
Administer Parent Substance Use Questionnaire (SUBST-PC)
Youth Outcomes - 2
时间窗: twenty-four months
Assess Extracurricular Activities (ECA)
Assessment of Liability and EXposure to Substance use and Antisocial behavior (ALEXSA)
时间窗: twenty-four months
Administer Assessment of Liability and EXposure to Substance use and Antisocial behavior (ALEXSA)
Parenting and Family Socialization - 4
时间窗: twenty-four months
Assess using Parental Involvement Scale (PI)
Parenting and Family Socialization - Discussion Tasks - 4
时间窗: twenty-four months
Assessment using Recognition Discussion Task
Parenting and Family Socialization - Discussion Tasks - 5
时间窗: baseline
Assessment using Family Culture Discussion Task
Youth Outcomes - 3
时间窗: twenty-four months
Administer Recent Activities Interview (RAI)
Youth Outcomes - 4
时间窗: twenty-four months
Administer Screen for Child Anxiety-Related Emotional Disorders (SCR)
Parenting and Family Socialization - 1
时间窗: twenty-four months
Evaluate using Adult Child Relationship scale (ACRS)
Parenting and Family Socialization - Discussion Tasks - 3
时间窗: twenty-four months
Assessment using Monitoring \& Listening Discussion Task
Youth Outcomes - 5
时间窗: twenty-four months
Administer Self-Report of Delinquency (SHORT) (SRD)
Youth Outcomes - 7
时间窗: twenty-four months
Administer Youth Risk Behavior Survey (YRBS)
Parenting and Family Socialization - 3
时间窗: twenty-four months
Child Daily Face-to-Face Racial Discrimination (CDIS)
Parenting and Family Socialization - 6
时间窗: twenty-four months
Assess using Parenting Children and Adolescents measure (PARCA)
Parenting and Family Socialization - 7
时间窗: twenty-four months
Assessment using Parental Rating of Peers and Social Skills (PPRSK)
Parenting and Family Socialization - Discussion Tasks - 1
时间窗: twenty-four months
Assessment using Parent Child Hot topics Discussion Task
Youth Outcomes - 6
时间窗: twenty-four months
Target Child Substance Use (TC Subst)
Parenting and Family Socialization - 2
时间窗: twenty-four months
Distressing Experiences Microaggression Scale (MIC)
Parenting and Family Socialization - 5
时间窗: twenty-four months
Parental Monitoring Interview - Parent Response, - Child Response (PMI-PR, PMI-CR)
Parenting and Family Socialization - Discussion Tasks - 2
时间窗: twenty-four months
Assessment using Parent Child Hot Topics Questionnaire (PCHT)
Assessment of Liability and EXposure to Substance use and Antisocial behavior (ALEXSA)
时间窗: 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)
时间窗: twelve months
Administer Assessment of Liability and EXposure to Substance use and Antisocial behavior (ALEXSA)
Contextual Risk and Resources - 1
时间窗: baseline
Administer Centers for Epidemiological Studies Depression Scale (CESD)
Contextual Risk and Resources - 1
时间窗: twelve months
Administer Centers for Epidemiological Studies Depression Scale (CESD)
Contextual Risk and Resources - 2
时间窗: baseline
Administer Demographic Questionnaire (DEMO)
Contextual Risk and Resources - 2
时间窗: twelve months
Administer Demographic Questionnaire (DEMO)
Contextual Risk and Resources - 3
时间窗: baseline
Administer Dyadic Adjustment Scale (DYAD)
Contextual Risk and Resources - 3
时间窗: twelve months
Administer Dyadic Adjustment Scale (DYAD)
Contextual Risk and Resources - 4
时间窗: baseline
Administer Financial Stress Questionnaire (FINCE)
Contextual Risk and Resources - 4
时间窗: twelve months
Administer Financial Stress Questionnaire (FINCE)
Contextual Risk and Resources - 5
时间窗: baseline
Administer Me and My Neighborhood Questionnaire (MMNQ)
Contextual Risk and Resources - 5
时间窗: twelve months
Administer Me and My Neighborhood Questionnaire (MMNQ)
Contextual Risk and Resources - 6
时间窗: baseline
Administer Parent Substance Use Questionnaire (SUBST-PC)
Contextual Risk and Resources - 6
时间窗: twelve months
Administer Parent Substance Use Questionnaire (SUBST-PC)
Youth Outcomes - 1
时间窗: baseline
Administer Child Behavior Checklist (CBCL)
Youth Outcomes - 1
时间窗: twelve months
Administer Child Behavior Checklist (CBCL)
Youth Outcomes - 2
时间窗: baseline
Assess Extracurricular Activities (ECA)
Youth Outcomes - 2
时间窗: twelve months
Assess Extracurricular Activities (ECA)
Youth Outcomes - 3
时间窗: baseline
Administer Recent Activities Interview (RAI)
Youth Outcomes - 3
时间窗: twelve months
Administer Recent Activities Interview (RAI)
Youth Outcomes - 4
时间窗: baseline
Administer Screen for Child Anxiety-Related Emotional Disorders (SCR)
Youth Outcomes - 4
时间窗: twelve months
Administer Screen for Child Anxiety-Related Emotional Disorders (SCR)
Youth Outcomes - 5
时间窗: baseline
Administer Self-Report of Delinquency (SHORT) (SRD)
Youth Outcomes - 5
时间窗: twelve months
Administer Self-Report of Delinquency (SHORT) (SRD)
Youth Outcomes - 6
时间窗: baseline
Target Child Substance Use (TC Subst)
Youth Outcomes - 6
时间窗: twelve months
Target Child Substance Use (TC Subst)
Youth Outcomes - 7
时间窗: baseline
Administer Youth Risk Behavior Survey (YRBS)
Youth Outcomes - 7
时间窗: twelve months
Administer Youth Risk Behavior Survey (YRBS)
Parenting and Family Socialization - 1
时间窗: baseline
Evaluate using Adult Child Relationship scale (ACRS)
Parenting and Family Socialization - 1
时间窗: twelve months
Evaluate using Adult Child Relationship scale (ACRS)
Parenting and Family Socialization - 2
时间窗: baseline
Distressing Experiences Microaggression Scale (MIC)
Parenting and Family Socialization - 2
时间窗: twelve months
Distressing Experiences Microaggression Scale (MIC)
Parenting and Family Socialization - 3
时间窗: baseline
Child Daily Face-to-Face Racial Discrimination (CDIS)
Parenting and Family Socialization - 3
时间窗: twelve months
Child Daily Face-to-Face Racial Discrimination (CDIS)
Parenting and Family Socialization - 4
时间窗: baseline
Assess using Parental Involvement Scale (PI)
Parenting and Family Socialization - 4
时间窗: twelve months
Assess using Parental Involvement Scale (PI)
Parenting and Family Socialization - 5
时间窗: baseline
Parental Monitoring Interview - Parent Response, - Child Response (PMI-PR, PMI-CR)
Parenting and Family Socialization - 5
时间窗: twelve months
Parental Monitoring Interview - Parent Response, - Child Response (PMI-PR, PMI-CR)
Parenting and Family Socialization - 6
时间窗: baseline
Assess using Parenting Children and Adolescents measure (PARCA)
Parenting and Family Socialization - 6
时间窗: twelve months
Assess using Parenting Children and Adolescents measure (PARCA)
Parenting and Family Socialization - 7
时间窗: baseline
Assessment using Parental Rating of Peers and Social Skills (PPRSK)
Parenting and Family Socialization - 7
时间窗: twelve months
Assessment using Parental Rating of Peers and Social Skills (PPRSK)
Parenting and Family Socialization - Discussion Tasks - 1
时间窗: baseline
Assessment using Parent Child Hot topics Discussion Task
Parenting and Family Socialization - Discussion Tasks - 1
时间窗: twelve months
Assessment using Parent Child Hot topics Discussion Task
Parenting and Family Socialization - Discussion Tasks - 2
时间窗: baseline
Assessment using Parent Child Hot Topics Questionnaire (PCHT)
Parenting and Family Socialization - Discussion Tasks - 2
时间窗: twelve months
Assessment using Parent Child Hot Topics Questionnaire (PCHT)
Parenting and Family Socialization - Discussion Tasks - 3
时间窗: baseline
Assessment using Monitoring \& Listening Discussion Task
Parenting and Family Socialization - Discussion Tasks - 3
时间窗: twelve months
Assessment using Monitoring \& Listening Discussion Task
Parenting and Family Socialization - Discussion Tasks - 4
时间窗: baseline
Assessment using Recognition Discussion Task
Parenting and Family Socialization - Discussion Tasks - 4
时间窗: twelve months
Assessment using Recognition Discussion Task
次要结局
未报告次要终点