Preventing Health Disparities in Hispanic Youth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 主要终点
- Diagnostic Interview Schedule for Children - Predictives Change Measure
研究概览
简要总结
This study seeks to investigate the efficacy and mechanisms of a highly promising "Culturally Informed Family Therapy for Adolescents" in preventing the emergence of two important health disparities in Hispanic youth, namely drug use & HIV and other sexually transmitted infections (STI). The proposed study is submitted as part of a P60 application entitled "NCMHD Center for Culturally-Tailored Hispanic Health Disparities Research (El Centro)", in response to the NIH RFA-MD-06-002: Establishing Comprehensive NCMHD Research Centers of Excellence.
This study investigates: 1) the efficacy of the treatment in reducing existing psychiatric, behavioral and family problems in youth, and 2) the indicated prevention effects of the intervention on the emergence of drug use and HIV/STI 20 months after baseline. There is a substantial literature linking disruptive behaviors (i.e., conduct disorder and attention deficit hyperactivity disorder) and mood instability (i.e., depressive disorders) and family conflict to the development of the Hispanic health disparities of drug use and HIV/STI. Conduct disorder (CD), attention deficit hyperactivity disorder (ADHD) and depressive disorders (DD) will be targets of treatment, as will be the family risk factors (e.g., poor parenting, family conflict) and acculturation-related stressors, all of which have been shown to place youth on a destructive trajectory toward deteriorating health.
详细描述
DESIGN AND METHODS. Overview. The first phase of the proposed study will include minor adaptations to the manual to enhance its "fit" with the specific characteristics of the target population, finalizing all assessment measures, finalizing the list of CTAU agencies and the referral mechanisms, conducting therapist training for the CIFTA conditions and assessor/interviewer training, and strengthening our connections with referral sources (months 1- 5). The team is experienced in all of these activities from previous treatment development and clinical trial projects. Immediately following this phase, the investigators will begin to recruit adolescents (11-14 years of age) who meet DSM-IV criteria for two of the following diagnoses (CD, DD, ADD) OR DSM-IV criteria for one diagnosis (CD, DD, ADD) and severe family conflict. Following screening, consent and assessment, the adolescents and their families will be randomly assigned to either the (1) Community Treatment as Usual Agency, or the (2) Culturally Informed Family Therapy for Adolescents. Assessments will be conducted at baseline (T1), post-treatment (T2- 4 months), follow-up 1 (T3- 12 months post baseline) and follow-up 2 (T4- 20 months post baseline). Data from service utilization and self-reports of therapeutic alliance will also be collected throughout the entire course of therapy. Longitudinal data analysis (growth curve modeling) will be used to test study hypotheses. Each of the specific components and procedures are described in detail below.
Design for Manualization of Refinements. The investigators and clinical team have experience in manualizing key treatment components. Although relatively minor, some of the specific refinements the investigators propose, based on our prior experience with CIFTA will include: 1) revising the parent training modules to be developmentally appropriate to middle school ages, 2) the establishment of healthy social activities that can shape the selection of prosocial peer groups and activities before ties to deviant peers are crystallized, 3) the creation of family session material that facilitates the parent-child discussion of country and culture of origin and helps to explore questions about the child's ethnic identity.
Manual Refinement meetings will include counselors and investigators and will be held to clarify the precise nature of the new material to be delivered, the therapeutic processes and procedures that are optimal for delivery of the material, and the interaction between these interventions and other intervention components. New manual entries/clarifications will be written together during the meeting so that the language is recommended and approved by both clinicians and investigators. The investigators have utilized this method in all of our treatment development efforts and the investigators have found that it leads to language that is user-friendly for clinicians. The team also agrees on adherence checklist items that reflect the nature of the intervention.
Therapist Selection, Training and Supervision. Two therapists (.3 FTE each) will deliver the CIFTA intervention. These therapists will be primarily selected from the Center for Family Studies, which has a cadre of therapists that have extensive experience with Hispanic youngsters and have had experience in delivering manualized treatments within a clinical research context. All therapists must also have at least a master's degree in counseling, psychology, social work or a related field. Therapists selected for this study must be bilingual (Spanish and English) to ensure that primarily Spanish-speaking family members can fully participate.
Therapist training. Training will follow the format the investigators have used over many years and also currently utilize in our Training Institute. The first phase of training will consist of a 3-day training workshop that includes the use of didactic material, the treatment manuals, and the presentation of videotaped sessions from our pilot work. The second phase will include intervention implementation with 1 pilot case. A therapist will be required to work with a pilot case for at least a one-month to be certified in that condition. The guidelines for certification the investigators will use are similar to those proposed by Carroll (1998) and will focus on the implementation of key aspects of the revised CIFTA treatment (parenting, skills modules, cultural modules, etc). Key aspects of therapy that receive poor ratings will require retraining. Interventions will be delivered over one month, a briefer period than is typical of the actual intervention in the trial, but will be sufficient to ensure comfort and competence in the key treatment components. There will be a 2 day workshop following the pilot phase to solidify any issues that remain and to incorporate any manual clarification that will assist in achieving high levels of competence and fidelity/adherence. The PI has extensive experience as a workshop trainer in family-oriented and substance abuse interventions.
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
- 11 Years 至 14 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •11-14 year old Hispanic youngsters meeting DISC-Predictives cut-off scores for two or more disorders (including CD, ADHD, and
- •DD [any of the depressive disorders]) and/or family conflict were included in the study along with their families.
排除标准
- •Participants who meet any of the following will be excluded:
- •History of any of the following DSM IV diagnoses - Developmental Disorders, Elective Mutism, Organic Mental Disorders (except Psychoactive Substance-Induced), Schizophrenia, Delusional (Paranoid) Disorder, Psychotic Disorder, and Bipolar Affective Disorder,
- •Any Substance Abuse or Dependence Disorder diagnosis (substance use that does not meet DSM IV diagnosis criteria will not excluded).
结局指标
主要结局
Diagnostic Interview Schedule for Children - Predictives Change Measure
时间窗: Baseline, T2 (4 months post baseline), T3 (12 months post baseline), and T4 (20 months post baseline)
The Diagnostic Interview Schedule for Children - Predictive Scales (DISC-P; Lucas et al., 1997) was used to evaluate psychiatric symptoms in a standardized manner consistent with DSM diagnostic criteria. For this study, the Attention Deficit Hyperactivity Disorder, Depression, Oppositional Defiant Disorder, and Conduct Disorder components of the measure were used. The DISC-P has been found to have a high degree of sensitivity with respect to the DISC for specific DPS scales. The DISC-P was administered to both parents and children.
Adolescent Risky Sexual Behaviors Change Measure
时间窗: Baseline, T2 (4 months post baseline), T3 (12 months post baseline), and T4 (20 months post baseline)
Questions from several instruments were combined into one gated instrument to assess a range of sexual risky situations and behaviors in the youth. Some questions from the Interview on Situations of Sexual Possibility- Booklet A (ISSP; Paikoff, 1995), a gated, structured interview about unsupervised peer activities, situations of sexual possibility, and other questions from the Sexual Behavior instrument (Jemmot, Jemmot, \& Fong, 1998), that assess the adolescent's sexual behavior, condom use, and existence of a sexually transmitted disease during their lifetime and in the past three months were combined. There was a total of 19 items in the questionnaire, however, the instrument is gated and not all questions were asked. Depending on the types of risky situations the adolescent had been involved in, the questions become more specific about risky sexual involvement or the instrument was discontinued if the adolescent had not been exposed to certain behaviors.
Child Behavior Checklist Change Measure
时间窗: Baseline, T2 (4 months post baseline), T3 (12 months post baseline), and T4 (20 months post baseline)
The Child Behavior Checklist (CBCL; Achenbach, 1991) was used as the parent report of youth's problem behaviors. Problem behaviors were scored along the dimensions of the super-ordinate domains of "internalizing" and "externalizing" behaviors. Smaller syndromes of behavior problems (e.g. delinquent behavior, aggressive behavior, anxious/depressed) were also available. The two syndromes that comprise the externalizing dimension, delinquent behavior and aggressive behavior were used as indicators of behavior problems, whereas the anxious/depressed dimension was used as an indicator of internalizing problems. Internal consistency reliabilities of each of the subscales ranged from .73 to .90.
Youth Self Report Change Measure
时间窗: Baseline, T2 (4 months post baseline), T3 (12 months post baseline), and T4 (20 months post baseline)
The Youth Self-Report (YSR; Achenbach, 1991) was used as the adolescent (11-18 years old) self-report instrument to assess problem behaviors, and the degree of functioning on three dimensions of Social Competence. Problem behaviors were scored along the dimensions of the super-ordinate domains of "internalizing" and "externalizing" behaviors. As with the CBCL, smaller syndromes of behavior problems (e.g. delinquent behavior, aggressive behavior, anxious/depressed) were also available. The two syndromes that comprised the externalizing dimension, delinquent behavior and aggressive behavior were used as indicators of behavior problems, whereas the anxious/depressed dimension was used as an indicator of internalizing problems. Internal consistency reliabilities of each of the subscales ranged from .72 to .90.
Substance Use and Attitudes Regarding Substance Use Change Measure
时间窗: Baseline, T2 (4 months post baseline), T3 (12 months post baseline), and T4 (20 months post baseline)
We combined items from several instruments. Items extracted from the Monitoring the Future Study (Johnston, O'Malley, \& Bachman, 2003) asked whether or not the adolescent had used cigarettes, alcohol, and other illegal substances. Adolescents who responded to using an illegal substance were asked to respond to the type of substance used, age of first use, and the frequency of use in the past 30 days. Items from the CSAP National Student Survey (1996), and the USC Health Behaviors Survey (Pentz, et al., 1989) measured attitudes toward tobacco, alcohol, and illegal substances, intentions regarding substance use, the degree to which adolescents care about how others would view them if they used drugs or alcohol, and perceptions of parents, peers, teachers approval/ disapproval of respondent's tobacco, alcohol, or other drug use. High internal consistency for the attitudes, intentions, and social norms subscales have been found (.92, .99, and .97, respectively).
次要结局
- Family Environment Scales Change Measure(Baseline, T2 (4 months post baseline), T3 (12 months post baseline), and T4 (20 months post baseline))
- Parenting Practices Questionnaire Change Measure(Baseline, T2 (4 months post baseline), T3 (12 months post baseline), and T4 (20 months post baseline))
- Parental Monitoring Change Measure(Baseline, T2 (4 months post baseline), T3 (12 months post baseline), and T4 (20 months post baseline))
- Parent Child Attachment Change Measure(Baseline, T2 (4 months post baseline), T3 (12 months post baseline), and T4 (20 months post baseline))
研究者
Daniel A. Santisteban, Ph.D.
Clinical Psychologist/Professor
University of Miami
