Substance Abuse Clinical Trial
Official title:
Building Outcomes With Observation-Based Supervision: An FFT Effectiveness Trial
The proposed effectiveness study examines differences in treatment outcomes of an observation-based supervision (BOOST) versus supervision as usual (SAU). The study will be implemented within 16 teams delivering FFT services at 11 sites in the California Institute of Mental Health (CIMH) system. The 16 FFT therapist teams will be randomly assigned either to BOOST or SAU. Each team will have 3 therapists who will treat 6 families for a total of 18 families per team. Thus, each condition will include 24 therapists who will treat 144 families. The project will be implemented in four staggered waves to establish a more even rate of data collection and treatment implementation to enhance the feasibility of the study by keeping staffing and project costs more constant across the 5-year project. Each wave will involve 4 FFT teams, 2 receiving BOOST and 2 receiving SAU. Teams will be randomized to supervision conditions. Outcome assessments of parents and adolescents will be conducted at baseline and at 4 months and 16 months after treatment initiation.
The proposed study is designed to evaluate two distinct approaches to therapist supervision
in the implementation of Functional Family Therapy (FFT), an EBT for adolescent substance
abuse and delinquent/behavior problems. The impetus for the proposed research emerged from a
large scale dissemination study conducted by the Washington State Institute for Public
Policy. The study identified two key findings: (1) Only half the therapists were actually
implementing the FFT model in a competent manner, and (2) positive outcomes, i.e. reductions
in felony recidivism, were evident only for therapists implementing the model competently.
For the subset of competent FFT therapists, the financial benefits of the dissemination were
estimated at $7.50 for each dollar of program cost. Based on the accumulated evidence
supporting FFT, interest in disseminating the FFT treatment model has skyrocketed.
Currently, the dissemination organization, FFT LLC, has trained more than 270 local, state,
national and international organizations. Over 1100 FFT therapists have served over 12,000
families around the globe, with large scale multi-site implementations ongoing in
California, Washington, Pennsylvania, New York, Florida, and the Netherlands.
To address the key issue of enhancing treatment competence, FFT LLC recently developed and
implemented a sophisticated web-based application designed to monitor highly structured FFT
therapist progress notes, as well as supervisor and client ratings of therapist competence.
The process helps to maximize sustainability for community programs by limiting costs.
Hence, the supervision process involves feedback to therapists based on the progress notes
and therapist-supervisor discussions of therapist performance. The impact of this
supervision process on therapist competence and treatment outcomes is unknown. By contrast,
Miller and his colleagues found that supervision involving active feedback and/or coaching
based on supervisor review of therapy sessions to observe therapist behaviors directly
results in improved model fidelity. Such observation-based supervision has been the hallmark
in the development of family therapy models and in fidelity monitoring processes in efficacy
trials evaluating family therapy and addictions treatments. By eliminating this practice, it
is possible that FFT dissemination efforts may unwittingly be omitting one of the most
important components needed for effective transfer of treatment.
During this early period of research on dissemination, it is vital to identify the specific
procedures most likely to maximize effective translation of efficacious treatments into
community settings. Observation-based supervision of family therapy has played a critical
role both in the development of clinical practices and in efficacy trials which have
established positive effects on youth outcomes. Hence, a key first step in effectiveness
research is to examine the extent to which supervision practices involving therapist report
and observation of therapist behaviors during sessions influence therapist competence and
subsequent treatment outcomes. The costs associated with supervision based on a direct
review of therapy session recordings are often viewed as prohibitive for community
implementation of EBTs. However, the potential sustainability of community implementations
must be considered in the context of empirical evidence for the procedures in relation to
outcomes achieved. If more intensive supervision practices were to enhance competence and
produce superior outcomes, then economic analyses evaluating supervision cost, cost
effectiveness, and cost-benefit would be essential. Such analyses would ultimately drive
policy considerations with respect to funding EBTs at the community level to maximize the
long-term financial and societal benefits.
Study Aims
The purpose of the proposed study is to examine the effects of observation-based supervision
(BOOST) versus the standard supervision as usual (SAU) approach currently used by FFT LLC on
therapist competence and adolescent outcomes in a community-based sample of adolescents
receiving FFT. The study will be implemented with 16 FFT teams affiliated with the
California Institute of Mental Health (CIMH), the coordinating center for stakeholders
implementing FFT in community agencies in California. Of these 16 teams, 14 teams will be
from 10 community-based agencies affiliated with CIMH and 2 teams will be FFT teams within
Los Angeles County Probation. Participants will include three therapists from each of the 16
FFT teams (n=48) and 6 adolescents/families per therapist (n=288). All of the adolescents
referred to participate in the study by the FFT teams within Los Angeles County Probation
will be youth who are "home on probation." In addition, some of the youth referred to the
study by community-based organizations will include "home on probation" youths (e.g., Star
View Behavioral Health) and some will not (e.g., Long Beach Adolescent Program). Similarly,
youths referred by some community-based organizations to participate in the study may have
child welfare involvement. Therapist teams will be randomly assigned to either BOOST or SAU.
The aims of the study are as follows:
Specific Aim 1: To examine differences between BOOST and SAU in improving treatment
outcomes. Specifically, we hypothesize that BOOST will be associated with significantly
greater reductions in adolescent substance use (Aim 1a) and conduct disturbance/delinquent
behaviors (Aim 1b) than SAU.
Specific Aim 2: To examine differences between BOOST and SAU in improving engagement and
retention in treatment. Specifically, we hypothesize that BOOST will be associated with
significantly higher rates of engagement and retention in treatment.
Family therapy interventions are based largely on the premise that dysfunctional family
processes play a central role in the development of adolescent problem behaviors such as
substance use and delinquency. Family therapy is aimed at mitigating the dysfunctional
processes. The success of family therapy in improving family functioning and youth outcomes,
as noted above, depends on the fidelity of treatment implementation in general and on
therapist competent adherence to the treatment model in particular. Thus:
Specific Aim 3: To examine differences between BOOST and SAU in improving therapist
competence and family functioning. Specifically, we hypothesize that BOOST will be
associated with significantly greater rates of therapist competence (Aim 3a) and
improvements in family functioning (Aim 3b) than SAU.
Exploratory Aim 4: To explore potential mediating effects of therapist competence and family
functioning on treatment outcomes. Specifically, we will explore whether therapist
competence mediates (Aim 4a) the association between supervision condition and youth
outcomes (substance use, conduct/delinquent behaviors), improvements in family functioning,
and greater rates of engagement and retention in treatment. We also will explore whether
improvements in family functioning (Aim 4b) mediate the link between supervision condition
and youth outcomes (substance use, conduct/delinquent behaviors).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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