Culturally Informed Family Based Treatment of Adolescents: A Randomized Trial
Culturally Informed Family Based Treatment of Adolescents: A Randomized Trial
This Stage II randomized trial tests Culturally Informed & Flexible Family Based Treatment
 for Adolescents (CIFFTA) developed as part of a Stage I treatment development effort and
 yielding 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 capable of addressing these issues 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. CIFFTA
 integrates innovative culturally-based, individually-based, and family-based components to:
 1) reduce maladaptive family processes (e.g., poor parenting practices, family conflict) and
 increase family protective factors (e.g., strong parent-child attachment), 2) teach
 adolescents skills to effectively manage interpersonal conflicts and stressors and to
 increase motivation to change, 3) deliver psycho-educational and culturally congruent
 material (e.g., modules on immigration stressors) to youth and parents both separately and
 together, and 4) deliver the intervention using a flexible treatment manual that allows the
 clinician to tailor the treatment (e.g., by selecting the most relevant psycho-educational
 modules and themes) to the unique characteristics and needs of the Hispanic family.

 This Stage II randomized 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, in a larger and more
 rigorous Stage II trial. Assessments occur at baseline, 4 months post baseline (end of
 treatment), 10 months post baseline and 16 months post baseline. 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.
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.

 Screening and Assessment Procedures. Study personnel are trained to identify substance
 abusing youth and families and to explain the research study in detail. Those interested will
 be asked to sign an informed consent that allows the screening of inclusion/exclusion
 criteria. Those individual who meet screening criteria go on to the baseline part of the
 assessment. Participants that do not meet criteria will receive another set of placement
 referrals. Participants will be randomized immediately after baseline testing and will be
 given the name of the therapist that will be contacting them to schedule the first therapy
 session. All participants will be assessed 4 months after baseline (post-treatment - T2), 10
 months after baseline (Follow-up 1 or T3) and 16 months after baseline (Follow-up 2 - T4).
 All assessments will be administered by highly trained and competent Master's level research
 assistants who are bilingual in English and Spanish. Our assessors have worked on multiple
 projects using the same types of self-report and interview measures proposed in this study.
 All measures and consents will be available in both English Spanish to ensure that primarily
 Spanish-speaking adolescents or parents are not excluded.

 Each assessment interview lasts approximately 3 hours and consists of three parts: an
 individual interview with the adolescent, an individual interview with each parent, and a
 family interview session. To ensure participation at the T2-T4 assessments, families will be
 paid $40 for T2 and $75 for T3 and $100 for T4, for completed assessments. The fees may be
 slightly higher than other projects that work only with individual participants because our
 assessments include multiple family members (typically an adolescent and two caregivers). The
 fee is meant to compensate 3 participants X approximately 3 hours each or 9 total hours of
 assessment time per time-point. All assessment data are entered directly into a web-based
 Velos system.

 Therapist Supervision and Adherence Monitoring. Separate weekly clinical meetings are held
 for the CIFFTA and TFT condition therapists. Each therapist will receive formal supervision
 in these meetings, in addition to consults as needed. Recorded sessions will be reviewed, the
 clinical complexity of cases will be discussed, and good manual implementation will be
 emphasized. These meetings help to ensure that manualized interventions are delivered
 competently. The independent adherence rater will randomly select 20% of the sessions from
 each condition at different treatment phases (early, mid, and late) for adherence ratings.
 These rating 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 focus for that dimension and if
 necessary, re-training. Adherence raters will be trained using the established adherence
 checklists for the two study conditions which have been developed and used successfully in
 previous studies. The condition supervisors 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.

 Prevention of Dropouts from the study. To ensure retaining as much of the sample as possible,
 each participant will have contact with the same assessment specialist over the entire course
 of the study. Additional procedures that we have established to retain Ss in the study, and
 ensure follow-up assessments, include: 1) conducting assessments at convenient locations for
 the families including their homes when necessary, 2) paying families for their participation
 in assessments, 3) conducting additional service utilization phone interviews at points
 between the formal assessment points that is, at 6, 8, 12, and 14 months post-baseline, 4)
 updating all contact information at regular intervals, and 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).

 Treatment Conditions:

 Traditional Family Therapy (TFT). The TFT condition is intended to control for many of the
 factors present in CIFFTA except for the systematic integration of individual level work and
 psycho-educational modules within a flexible treatment package. This is the same control
 intervention that was used in the Stage I study with one exception. In that Stage I study we
 tested the "add on" effect of the new treatment components and flexibility, to investigate
 whether such additions would lead to a significant boost in treatment effects. The dosages of
 the two interventions were not equal. To provide a more rigorous test of the intervention by
 having equivalent dosages in the two conditions, we have added to the TFT intervention used
 in the Stage I study, an additional hour per week. The additional weekly hour consists of
 drug education and risky sexual behavior/STI/HIV information delivered to the youth in a
 group format. This additional hour per week per client of intervention was selected after
 consultation with the director of one of the largest local community treatment agencies that
 uses this approach as a standard of care. The Traditional Family Therapy (TFT) condition
 intervention is rooted in the Structural Family Therapy work of Salvador Minuchin. TFT is
 designed to: 1) target behavior problems and substance abuse; and 2) target youth who were
 unwilling to seek treatment on their own. The typical length of intervention for TFT is 4
 months of weekly family sessions. An important assumption underlying this and other
 family-oriented models is that the family therapist can spend only a limited number of hours
 with participants, but by changing the family system (parents, extended family, non-blood
 kin), the family context becomes a force that will positively influence the youth on an
 around the clock basis.

 Culturally Informed and Flexible Family-Based Treatment for Adolescents (CIFFTA). The CIFFTA
 treatment model has three major components - Family Therapy, Individual Therapy, and
 Psycho-educational Modules - delivered over 16 weeks in a two session (60 minutes each) per
 week format. One session will typically be a family session which may include Family Therapy
 or Psycho-educational modules designed for the family or parents alone. The other session is
 typically with the adolescent alone, which may include individual treatment or
 Psycho-educational modules designed for the adolescent. CIFFTA is a flexible manual because
 it allows for the selection of psycho-educational modules that address specific family and
 adolescent clinical and cultural issues that are central to that lives of that family. CIFFTA
 is an outpatient treatment. Home visits although infrequent, may be critically important at
 times when a key member has disengaged from therapy and must be re-engaged. Visits to
 schools, courts, and other important institutions in the adolescent's ecology are also
 allowed as needed (usually a maximum of 2-3 such visits per family).

 Individual characteristics that are targeted for modification by CIFFTA include: a) impulsive
 involvement in unhealthy behaviors such as drug use, risky sexual behavior, and criminal
 activity, and b) co-occurring psychiatric disorders.

 Individual level factors that support healthy development and are promoted by revised CIFFTA
 will be: 1) increased motivation to work toward healthy development, 2) life skills
 acquisition, 3) goal setting, 4) knowledge of short and long term drug effects and HIV risk,
 and 4) improved decision making.

 Family characteristics that will be targeted for modification by CIFFTA include: a)
 maladaptive responses to immigration and acculturation processes and stresses, b) parental
 neglect, c) verbal or physical violence, and d) interactions that reward/reinforce
 maladaptive behaviors (i.e., coercive processes).

 Family level factors that support healthy development and are promoted by revised CIFFTA will
 be improvements in: 1) parenting practices, 2) parent-adolescent attachment, 3) parental
 guidance and leadership, 4) stability of home environment, 5) directness and clarity of
 communication, and 6) positive/supportive family interactions.

 Individual and family level targets of change must be specifically able to address the
 ecological factors as well. For example, parenting practices may be improved to better
 monitor the adolescent's peers; parental leadership and guidance may focus on taking a more
 active role in advocacy in schools; and adolescent skills may become important in better
 addressing peer pressure in the peer context.

 CIFFTA Thematic Psycho-Educational Modules Component The thematic modules component of CIFFTA
 provides parents and adolescents with focused information/educational sessions on specific
 areas that are relevant to the family. Content and process are both emphasized during the
 session, however content is more heavily emphasized in modules while process work (e.g.,
 shaping better communication, deepening their understanding of each other, processing past
 traumas) is more heavily emphasized in family sessions.
Inclusion Criteria:

 -  The adolescent has a substance abuse disorder,

 -  The adolescent is 14 to 17 years old, and

 -  The adolescent is living with at least one family member of an older generation born
 in a Spanish-speaking country such as a parent or grandparent

 Exclusion Criteria:

 -  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

 -  Bipolar Affective Disorder