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.

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