Culturally Informed Family Based Treatment of Adolescents: A Randomized Trial

This Stage II randomized trial provides a more rigorous test for Culturally Informed & Flexible Family Based Treatment for Adolescents (CIFFTA) which was developed as part of a Stage I treatment development effort and yielded promising preliminary findings. Drug use rates are highest among Hispanic middle school youth and to date no treatments have met criteria for "Well Established" in the treatment of substance abuse in Hispanic adolescents. Further treatment for Hispanic youth and families is complicated by the fact that these families often differ from mainstream populations in culture-related values, beliefs and behaviors that can directly impact engagement, retention, and efficacy/effectiveness of drug treatment. Our efforts to develop a more powerful treatment began with a Stage 1 study that led to the development of a multi-component treatment that includes a flexible manual that allows treatment tailoring to the unique characteristics of individual families. The current Stage II trial randomizes 220 Hispanic adolescents ages 14-17 who meet DSM-IV criteria for Substance Abuse to a 4-month treatment of either CIFFTA or Traditional Family Therapy. The study tests CIFFTA's efficacy in impacting drug use, risky sexual behavior, and other severe behavior problems, and hypothesized mechanisms of change. Should this line of research continue to be successful, it has the potential to contribute to the field a highly innovative and efficacious treatment for Hispanic drug abusing adolescents, a better understanding of mechanisms of treatment efficacy, and also a framework for future flexible and tailored treatments that can be used to better address the unique needs of other special populations.

Design and Methods: The study is divided into three phases. The first phase (months 1- 5) prior to the initiation of the randomized trial focused on: 1) clarifying manual sections and finalizing all assessment measures, 2) hiring and training therapists and assessors, and 3) setting up the web-based data collection system. The second phase (months 6-47) includes the implementation of the randomized trial and the delivery of all clinical treatments. Beginning in month 6 we began to recruit 220 Hispanic adolescents (14-17 years of age) who meet DSM-IV criteria for Substance Abuse or Dependency. Following screening, consent and assessment, the adolescents and their families will be randomly assigned to either the (1) Culturally Informed and Flexible Family-Based Treatment for Adolescents (CIFFTA) or to our Traditional Family Therapy (TFT). The two conditions will be tested as a four month intervention with two sessions per week. The participation of adolescents and families in clinical services will end at approximately month 48 of the grant. The third phase (months 48-60) will focus on the completion of all follow-up assessments, data cleaning and logic checks, data base locks, and the analysis, interpretation and reporting of findings. Assessments will be conducted at baseline, termination (4 months), 6 month follow-up (10 months post baseline), and 12 month follow-up (16 months post baseline). Data from urine analyses, self-reports of therapeutic alliance and data on service utilization outside of the program, will also be collected throughout the entire course of therapy and service utilization will continue during periods between follow-up assessments. Longitudinal data analysis (growth curve modeling) will be used to test study hypotheses. More detail on the details of the randomized trial procedures is provided below.

Randomized Study Design. This is a randomized clinical trial in which 220 14-17 year old Hispanic adolescents meeting DSM-IV criteria for Substance Abuse, and their families will be assessed at baseline, randomized to one of two outpatient conditions (CIFFTA or TFT) in which they will receive treatment twice weekly for four months, and assessed again following termination, 6 months following termination (T3) and 12 months following termination (T4). Randomization will be stratified by gender, number of comorbid psychiatric disorders, whether or not they were mandated to treatment, and whether or not they are taking medication upon entry into the program.

Inclusion of Family members in the study. The target adolescents and parents/guardians are asked to participate in all assessments and in treatment. All other family members living in the household of the target adolescent will be invited to participate in the family treatment but not in assessments. 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. In our Stage I project we were successful at engaging family members into treatment as indicated by the fact that we had an average of three family members per participant household participating in the family intervention component.

Participant Recruitment Plan: We have a strong partnership with the Miami Behavioral Health Center which runs the Miami-Dade County Juvenile Addiction Receiving Facility in which all youth meet DSM-IV criteria for drug abuse and for which approximately 80% of the youth are Hispanic. Our previous research projects received many referrals from the JARF and this is bound to increase now that it is located at our partner agency. In our currently NCMHD prevention study with 11-14 year old Hispanic youth and their parents we have been very successful at recruiting from community clinics, middle school counselors, trust counselors and directly from the community. One highly successful strategy was to conduct an interview about the research program on Spanish language television. This strategy used at the initiation of randomization produced a large wave of interested families to the project and facilitated the prompt filling of all slots. Similar interventions on Spanish radio have been equally effective. These strategies will be utilized if participation rates are low.