Preventing Health Disparities in Hispanic Youth
Condition: ADHD; Conduct Disorder; Depression; Family Dysfunction
MeSH terms: Conduct Disorder
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.

      Therapist Supervision and Adherence Monitoring. Weekly clinical meetings will be held for the
      CIFTA therapists. Dr. Santisteban will supervise the team and provide formal supervision to
      all project team members. All sessions will be videotaped and these will be reviewed. The
      clinical complexity of cases will be discussed and good culturally-competent and clinical
      implementation will be emphasized.

      Adherence raters will be trained using the established adherence checklists for the two study
      conditions. The condition supervisor will be held as the gold-standard for inter-rater
      reliability on adherence ratings and raters will be trained to achieve an intra-class
      correlation coefficient of .70 or higher, and at least 80% agreement across items.
      Inter-rater reliability will be checked regularly to avoid drift. Specifically, an
      independent adherence rater will randomly select 10% of the video-taped sessions from each
      condition at different treatment phases (early, mid, and late) for adherence ratings. These
      ratings will document the adequacy with which treatment sessions follow specific manual
      interventions and treatment strategies. Ratings that fall below adequacy on any
      dimension/component will trigger increased supervision focused for that dimension and if
      necessary, re-training.

      Participants for the randomized trial. 200 11-14 year old Hispanic youngsters meeting DSM-IV
      criteria for multiple child disorders (including CD, ADHD, and DD [any of the depressive
      disorders}) will be included in the study along with their families. Participants will be
      recruited from the community in general as well as from the Dade County Public School System,
      the University of Miami Institute for Individual and Family Counseling, and MBHC/Spectrum
      Programs. The investigators will work intensively with referral sources to ensure full
      representation of both males and females (goal will be to obtain 50%/50% split in boys and
      girls) and a diverse mix of Hispanic subgroups that are prominent in the South Florida area
      (e.g., Mexican, Central American, South American, Puerto Rican, and Cuban). Randomization
      will be stratified by gender, symptom profile, and years residing in U.S.

      Participants will go through a screening to evaluate if they meet criteria for the study and
      then will complete baseline (T1) and randomization. Assessments will be conducted again at
      post-treatment (T2- 4 months), follow-up 1 (T3- 12 months post baseline) and follow-up 2 (T4-
      20 months post baseline). The 4, 12 and 20 month assessments have been selected to coincide
      with the termination of treatment, follow-up 12 months after baseline, and 20 months after
      baseline.

      Participant Recruitment Plan. The Center for Family Studies has fostered a collegial and
      continuous relationship with many of the referral sources in the community. Given this
      relationship, in our last studies the investigators surpassed the number of participants
      originally proposed. In addition, the investigators have had experience recruiting and
      assessing youth from these sources (Santisteban, Coatsworth, et al., 1997; Santisteban,
      Dillon, et al., 2005). The main referral sources for our proposed study will be the community
      in general as well as the Dade County Public School Sytem, the University of Miami Institute
      for Individual and Family Counseling and MBHC/Spectrum Programs. These clinics are very
      active, with a large percentage of Hispanic families and fully capable of referring a large
      number of cases per week (only approximately 5 cases per month are needed). The investigators
      have strong referral relationships with the Dade County school system counselors who referred
      the large majority of the cases for the Santisteban et al. (1997) study which was a precursor
      to the current study, and with the Miami Behavioral Health Center which is the main agency
      treating mental health issues in the Hispanic population. Because our Center has a history of
      leadership on Hispanic issues, the investigators are looked upon for culturally competent
      treatment of youth and families.

      Throughout the study the investigators plan to conduct meetings in the schools with the
      school counselors and at the Institute for Individual and Family Counseling Clinic with the
      therapists to explain the specifics of this new study. Throughout the life of the study, the
      assessors will participate in the staffing meetings to consult with staff as needed at the
      Insititute for Individual and Family Counseling on a weekly basis, as well as maintain weekly
      contacts with school counselors to obtain referrals. We will encourage counselors from the
      schools and clinicians from the Institute for Individual and Family Counseling Clinic to call
      the Study Assessor in the presence of the family, once they have introduced the study to the
      family and they expressed interest in the study. The assessor will then make an appointment
      with the family for study consent and initial screening. In the case the assessor is not
      available, the counselors will ask for the family's permission to give the assessor their
      phone number to be contacted at a later time. The same process will be used at MBHC/Spectrum
      Programs. As mentioned before, this referral process has been very successful in past
      studies; thus we anticipate similar success in the proposed study. We will also meet with
      individuals involved with the media and radio and any other community referral source that
      would be appropriate as a referral source. In addition, we have created a brochure with
      important information about the research study to be given to referral agencies/sites via
      e-mail and/or in person and for potential participants. We will also run ads in several
      community based newspaper in order to assist in the recruitment of participants.

      Inclusion criteria. To be included in the study, the youngster/families must meet the
      following criteria: (a) be between the ages of 11 to 14 years old, (b) be born in a Spanish
      speaking country or have parents born in Spanish speaking countries, (c) be living with at
      least one family member of an older generation such as a parent or grandparent; and all
      family members of the household (including the youngster and at least one adult) must agree
      to be present during the assessment and treatment sessions, and (d) 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.

      Exclusion criteria. Participants who meet any of the following will be excluded: (a) history
      of any of the following DSM IV diagnoses - Pervasive Developmental Disorders, Elective
      Mutism, Organic Mental Disorders (except Psychoactive Substance-Induced), Schizophrenia,
      Delusional (Paranoid) Disorder, Psychotic Disorder, and Bipolar Affective Disorder, (b) Any
      Substance Abuse or Dependence Disorder diagnosis (substance use that does not meet DSM IV
      diagnosis criteria will not excluded).

      Inclusion of family members in the study. Youth and both parents are scheduled for
      assessment. All family members living in the household of the target adolescent will be
      invited to participate. Decisions are made on a case by case basis regarding the inclusion of
      very young children (younger than 10). In addition, individuals who are not blood relatives
      but have significant roles in raising the adolescent will also be invited. Parental figures
      will be asked to complete the parent version of the assessment battery. Our previous projects
      have been very successful at identifying and engaging family members into treatment as well
      as in retaining them throughout the course of the treatment (Santisteban et al., 1996;
      Szapocznik et al., 1988).

      Screening and Assessment Procedures. Families that are interested will have the research
      study explained to them, and will be asked to sign an informed consent that explains the
      study. Research assessors will be trained to conduct the initial screening using the
      Diagnostic Interview Schedule for Children (DISC) and the Family Environment Scale - Conflict
      Scale. All participants included in the study will complete a Baseline assessment and will be
      randomized after testing. Assessments will be conducted again at post-treatment (T2- 4
      months), follow-up 1 (T3- 12 months post baseline) and follow-up 2 (T4- 20 months post
      baseline). A trained Master's-level research assistant who is bilingual in English and
      Spanish will administer all assessments. Our assessors have worked on multiple projects using
      the self-reports and interview measures proposed in this study. All measures and consents
      will be available in Spanish to ensure that primarily Spanish-speaking adolescents or parents
      are not excluded.

      Each assessment interview will last approximately 3 hours and consist of three components: an
      individual interview with the adolescent, an individual interview with each parent/guardian,
      and a family interview session.

      Prevention of Dropouts from the study. To ensure capturing and maintaining as much of the
      sample as possible, each participant will have contact with the same assessment specialist
      during the entire course of the study. Having the same assessor follow a given family
      throughout the study will provide personal continuity, and thus improve participation and
      retention in the study. Additional procedures that we have established to retain participants
      in prior studies, and ensure follow-up assessments, include: 1) conducting assessments at
      convenient locations for the families including their homes when necessary, 2) providing
      compensation to families for their participation in assessments, 3) conducting the service
      utilization phone interviews at baseline and 4, 8, 12, 16, and 20 months post-baseline, 4)
      updating all contact information at regular intervals, 5) obtaining the names of three
      contact persons who are close to family members and who may be contacted by the Assessment
      Specialist in the event that the family is unreachable at the assessment time-points (this is
      included in the consent form), and 6) sending out birthday and holiday cards to all
      participants. In our experience, the utilization of standard operating procedures for
      tracking and contacting participants dramatically increase retention rates in the study. The
      PI and research team has solid experience with tracking families for follow-up related
      activities. In our last federally funded treatment development grant we were able to track
      families six weeks after the adolescent was discharged from an Addictions Receiving Facility
      at a success rate of 96%.

      AIM I: To refine/adapt the CIFTA treatment manual to meet the unique clinical and
      developmental characteristics of youth 11-14 years of age, while at the same time targeting
      existing psychiatric, behavioral and family problems (CD, ADHD, DD, family dysfunction) via a
      "flexible" treatment manual that can tailor the intervention package to youth and their
      families.

      AIM II: To test, using a randomized clinical trial, the efficacy of CIFTA compared to a
      Community Treatment-as-Usual (CTAU) in reducing symptoms of CD, ADHD, DD, and family
      dysfunction.

      AIM III: To test the ability of CIFTA, compared to CTAU, to prevent health disparities
      conditions (drug use andHIV/STI) over a period of 20 months post baseline.

      AIM IV: To empirically (using cluster analysis) identify subtypes of profiles on
      acculturation and immigration-related factors, and to investigate the relationship of these
      culture-related subtypes to problem behavior profiles and to responses to the CIFTA
      treatment.

      AIM V: To investigate the relationship of CIFTA's hypothesized mechanisms of treatment change
      (parenting practices, parent-school interactions, child utilization of skills, etc) to CIFTA
      treatment outcome on the existing problems (CD, ADHD, DD, family dysfunction).
    

Intervention name(s): Culturally Informed Family Treatment for Adolescents; Individual Treatment
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Family Therapy, Psycho-educational Modules, Individual therapy sessions; Cognitive Behavior Therapy, Interpersonal psychotherapy, social skills training, anger control training, problem solving skills, assertiveness training, and the Empty chair technique from Gestalt therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Family Therapy; Substance abuse prevention; Minority; randomized trials; outcome research; adolescent treatment