VA Capitol Network, Mental Illness Research, Education, and Clinical Center (MIRECC) and University of Maryland School of Medicine, Baltimore, MD
University of Pittsburgh School of Medicine, Pittsburgh, PA
Long Island Jewish Medical Center, NY
University of Pittsburgh, PA, USA
Correspondence: Alan S. Bellack, University of Maryland School of Medicine, 737 West Lombard St, Suite 551, Baltimore, MD 21201, USA; e-mail: abellack{at}umaryland.edu
Declaration of interest This research was supported in part by grants from the National Institute of Mental Health (MH41577 and MH39998) to A.S.B., and by the Department of Veterans Affairs Capitol Network, MIRECC.
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ABSTRACT |
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Aims To examine the effects of a behavioural family intervention and a family support programme on communication, problem solving and outcome in order to determine the impact of structured communication training.
Method Patients and family members participating in the Treatment Strategies in Schizophrenia study were videotaped engaging in 10-minute problem-solving conversations at baseline and after the conclusion of the family intervention. Tapes were subsequently evaluated for changes in communication patterns.
Results The intensive behavioural intervention did not produce differential improvement in communication, and change in communication was unrelated to patient outcomes.
Conclusions The data suggest that intensive behavioural family interventions may not be cost efficient, and that change in family communication patterns may only be important for a subset of families.
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INTRODUCTION |
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Background
Several family intervention approaches for schizophrenia have been
developed based on the general assumption that maladaptive interaction
patterns within the family produce high levels of stress for the patient and
lead to relapse (see reviews: Bellack &
Mueser, 1993; Dixon &
Lehman, 1995). These interventions have attempted to reduce the
risk of relapse either by altering communication and problem solving in the
home or by modifying family attitudes about the patient through education
about the illness. Although the effect of these interventions on relapse has
been quite positive, it is not clear that changes in parental attitudes and/or
communication patterns within the home are central to improved outcome. This
issue has important implications for the validity of the conceptual model
underlying the new family interventions, for the implementation of the
treatment and for our understanding of the role of the family in relapse.
The TSS study provided a unique opportunity to examine this issue. The protocol included an introductory psychoeducational workshop followed by random assignment to one of two family interventions (a behavioural family therapy conducted in the home and supplemented by monthly multi-family group meetings versus monthly multi-family group meetings only) and one of three maintenance pharmacological treatment strategies. Contrary to expectations, there was no overall difference in outcomes associated with either of the two family management conditions, and no family management by medication interaction effects on outcome (Schooler et al, 1997). However, the overall relapse rate for subjects in the active medication conditions was only 25% at the 2-year point, suggesting that exposure to family interventions made an appreciable contribution to the effects of the medication on clinical outcome.
The TSS study design did not include a family control condition, which might have shed more light on the specific effects of family intervention. Consequently, we conducted ancillary assessments in order to tease apart the contribution of the two family management approaches and to evaluate the effects of the extensive training in communication and problem-solving skills included in the behavioural condition. Patients and family members participated in a structured interaction, the Family Problem Solving Task (FPST), at each major assessment point. Developed by Bellack et al (1990, 1996), the FPST provides a standardised, reliable sample of patient and family behaviour during two 10-minute problem-solving discussions. The sample is subsequently coded to examine the occurrence of specific behaviour taught during home visits and/or thought to have an important effect on patient outcome. The following questions were addressed.
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METHOD |
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The AFM intervention was modelled after Falloon's Behavioural Family Therapy (BFT; Falloon et al, 1982, 1984). This is a manual-driven approach that provides structured training in communication and problem-solving skills that are intended to reduce family conflict, increase the ability of family members to communicate in a non-hostile manner and to assist all family members in achieving life goals. It was conducted in the home for 13 weekly sessions, followed by 13 bi-weekly sessions and then monthly sessions until 1 year after the patient had completed stabilisation. In addition, patients and family members were invited to attend monthly, multiple family support group meetings throughout the 2-year trial, and they received case management as needed. The SFM condition included monthly multiple family group meetings and case management as needed throughout the 2-year study period. Separate group meetings were held for participants in the two family management conditions.
Subjects
A total of 528 patients entered the TSS study. The current project was
initiated some time after the TSS study began, and 265 families had already
been enrolled. In addition, some FPSTs could not be coded due to technical
problems or procedural errors, and some families were not assessed at all time
points. This paper focuses on 77 cases who provided codable data at the
baseline and 1-year assessments (i.e. the conclusion of the home visit portion
of the AFM intervention). These 77 cases are highly representative of the
entire TSS sample. There were no significant differences between patients in
this sample and the remaining cohort on gender, age, race, severity of
illness, number of hospitalisations in the previous 12 months or age of first
psychiatric treatment (see Table
1). The FPST was conducted with the patient and the parent or
family member who served in loco parentis. In 68% of the cases that
person was the mother and in 11% it was the father. Family members in the
cohort of 77 were comparable to those in the full sample on most demographic
characteristics, but they had higher education and occupational achievement,
differences that should favour the highly verbal approach taught in the AFM
condition.
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Family Problem Solving Task
The primary measure of family communication was the FPST: a structured
conversational interaction that is videotaped for subsequent coding on a
variety of specific behavioural categories. Following a warmup activity
designed to acclimatise the dyad to problem-oriented discussion on videotape,
a family problem identified by either the patient or family member in a prior
interview was presented for discussion by a research assistant, who directed
the dyad to discuss the issue and attempt to reach some resolution. After 10
minutes of discussion, a second problem was presented and the procedure was
repeated. The FPST procedure draws on similar behavioural observation
assessment strategies used by Bellack
(Bellack et al, 1990),
Goldstein and colleagues (Miklowitz et
al, 1984; Doane et
al, 1985) and others. Miklowitz et al
(1984) and Strachan et
al (1986) found that
there were significant differences in the way parents with high and low
expressed emotion (EE) responded to their offspring with schizophrenia on this
type of task, and the general procedure has been shown to differentiate
distressed from non-distressed families and to be sensitive to treatment
effects.
Staff training
Staff who administered the FPST at the five TSS sites all received
extensive training from the first author (A.S.B.) via a twoday workshop, pilot
cases and conference calls. Each research assistant was
certified as meeting the criterion on the task before conducting
assessments on protocol cases. Videotapes from each research assistant were
reviewed by A.S.B. on a regular basis throughout the project to ensure
continued procedural standardisation.
Behavioural coding
The FPST coding system was designed to address the three major dimensions
that were a primary focus of treatment: communication skills; problem-solving
behaviour taught in the AFM treatment; and critical and overinvolved behaviour
(as per the concept of high EE) associated with relapse in schizophrenia. The
system included 12 behaviours coded using a 30-second time-sampling system and
7 global ratings based on five-point Likert-type scales for each 10-minute
discussion.
Separate principal component analyses were conducted on data from all patients and family members who participated in the FPST assessments at any one of the time points: baseline, 1 year or 2 years. Three equivalent factors were identified for each group of speakers (patients and family members) across each assessment point: criticality/intrusiveness; communication effectiveness; and problem-solving skills. In order to limit the number of statistical tests, all subsequent analyses were conducted on these six factor scores (three for patients and three for family members). The reader is referred to Bellack et al (1996) for behavioural definitions of the component codes, data on the individual behaviours and factor loadings.
Reliability and validity of the FPST
A complete report on the reliability and validity of the FPST in the
complete TSS sample is presented in Bellack et al
(1996). There was high
interrater agreement for the behavioural coding: intracluster correlation
coefficients and values on 25% of the sample were in the ranges
0.62-0.82 and 0.61-0.89, respectively. The data provided considerable support
for the internal consistency and construct validity of the coding system, and
there was evidence of good concurrent validity for behaviour exhibited during
the FPST discussions. Notably, critical and intrusive behaviours expressed by
relatives during the FPST were significantly correlated with criticism and
hostility about the patient expressed during Camberwell Family Interviews
(CFIs: Mueser et al,
1993) and subjective ratings of burden and feelings of rejection
toward the patient expressed in an interview about the patient's social
behaviour.
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RESULTS |
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Subjects in the two groups were equivalent in terms of ratings of global severity of illness (Clinical Global Impression, CGI; Guy, 1976), severity of negative symptoms (total of global items on the Scale for the Assessment of Negative Symptoms (SANS; Andreason, 1981)) and severity of psychotic symptoms (psychotic symptom scale from the Brief Psychiatric Rating Scale, BPRS; Overall & Gorham, 1962), age at onset and number of hospitalisations during the prior 12 months. There were no significant differences between the groups in the amount of face-to-face or telephone contact between patient and family in the year prior to entry into the study. There were no significant differences between the two treatment groups on any of the composite measures of communication at baseline (for either the patient or family member).
Change in communication patterns over time
We had a number of a priori hypotheses about the effects of family
management on communication and the relationship of changes in communication
patterns to outcome, but we did not have specific predictions about the impact
of medication condition or the family by medication interaction. Consequently,
we used a protected level of 0.01 to interpret any result involving
the medication factor.
Treatment effects on communication
A series of 2 x 3 x 2 (family management x medication
condition x time) repeated measures analyses of variance were conducted
separately for patients and family members in order to examine the effects of
the treatments on communication from baseline to 1 year. As summarised in
Table 2, there were no
significant main effects of family management, medication strategy or time for
either the patient or family member on any of the three communication
variables, and only one interaction effect approached the P<0.01
criterion for statistical significance: the three-way interaction of family
management, medication treatment and time on non-constructive
criticism/intrusiveness (F (71,2)=4.48, P<0.02).
Evaluation of the interaction via post hoc analyses did not identify
any predicted or consistent direction of effects among the three
variables.
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Attendance at AFM sessions and change in communication
One possible explanation for the lack of an AFM treatment effect could be
poor attendance at home visits. Overall, attendance was very good, with a mean
of 24 sessions attended out of a possible maximum of 32. A series of Pearson
correlations were conducted between attendance of patients and family members
and change in each communication composite. The correlations ranged from 0.01
to -0.28, with none reaching significance at the P<0.05 level.
Moderator effects of symptomatology on communication
To ascertain whether symptom severity influenced outcome on the
communication measures, we conducted a series of six analyses of variance and
covariance, with each of the communication composite change indices (computed
as deviation scores by regressing the baseline value for the composite on the
1-year value for the same measure) serving as the dependent variables. For
each of these analyses, medication condition and family management served as
the independent variables and baseline symptom measures were the covariates.
There were no direct or moderator effects of overall psychopathology (total
BPRS), positive symptoms (BPRS psychotic symptom scale) or negative symptoms
(total SANS) on any of the patient or family communication composites
(F (1,68)=0.11-3.11, P>0.05).
Clinical outcome
Time to rehospitalisation and time to first use of supplemental
medication
There were two primary clinical outcome variables evaluated in the TSS
study: time from initiation of double-blind medication to rehospitalisation;
and time to first use of supplemental (rescue) medication. We examined the
contribution of treatment and each of the communication indices to variance on
each of these outcome variables using Cox regression analyses. Two dummy drug
variables (indexing the contrast of the low dose versus the other two drug
conditions and the standard dose versus the other two drug conditions) were
entered in the first step, along with the family management assignment
variable. Standard dose predicted longer time to rehospitalisation (Wald=5.35,
d.f.=1, P<0.02). All six communication variables were then forced
into the equation on the second step. None of the communication variables
predicted time to rehospitalisation, and standard medication dose continued to
predict time to rehospitalisation (Wald=4.02, d.f.=1, P<0.04). A
similar pattern was found in logistic analyses conducted on time to first use
of supplemental (rescue) medication. Each of the two active drug treatment
strategies predicted time to first use of supplemental medication (Wald=12.02,
d.f.=1, P<0.001, and Wald=8.35, d.f.=1, P<0.004 for
each variable). Neither family management nor communication composites
predicted outcome on this index.
Symptomatology
A series of hierarchical multiple regression analyses were also conducted
to evaluate the contribution of treatment and each of the communication
measures to clinical outcome on key clinical symptomatology measures,
including overall psychopathology (total BPRS) and psychoticism (BPRS
psychotic symptom scale). Both drug and family treatment accounted for
significant amounts of variance in symptom outcomes, but neither patient nor
family communication variables predicted outcome at 1 year on any of the three
symptomatology measures.
Family constellation and face-to-face patient contact
To ascertain whether patients in families led by a single parent (mother
only) experienced worse outcomes, a dichotomous (single mother v.
family member) variable was entered along with the three treatment variables
and the family communication variables in a second set of regression analyses.
Family constellation did not contribute significantly to outcome. The mean
number of hours of face-to-face contact per week between family and patients
in the year prior to study entry were 37.3 (s.d.=30.7) and 40.9 (s.d.=26.5)
for the AFM and SFM groups, respectively. This difference was not significant
and amount of contact was not associated significantly with outcome.
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DISCUSSION |
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Potential limitations
These unexpected findings raise two questions about the internal validity
of our investigation. Was the FPST a valid technique for examining
communication patterns? Did TSS provide a fair test of AFM? Although there are
legitimate questions about the extent to which any analogue assessment
procedure accurately represents in vivo behaviour, measures of this
type generally reflect the most skillful performance that subjects
can manifest (Bellack, 1979;
Bellack et al, 1990).
It would be expected that interactions at home would be characterised by
greater stress and conflict and less inhibition than the structured,
videotaped interactions in the clinic. Consequently, both parents and patients
would be less likely to use the controlled, highly verbal AFM strategies
outside of the clinic than they would be to use them during the FPST
assessment. Moreover, the FPST was based on widely used procedures that have
demonstrated construct and concurrent validity in other studies (e.g.
Doane et al, 1985; Miklowitz et al,
1989; Mueser et al,
1993).
The second question about internal validity concerns how effectively AFM was administered. As discussed above, several steps were taken to ensure the competence of clinicians and their adherence to the protocol (Falloon et al, 1996). The intervention was guided by a detailed manual developed by Falloon and McGill. They conducted an initial training workshop with all clinicians and their on-site supervisors, and periodic follow-up workshops thereafter. Falloon or McGill certified the competence of each clinician before he or she was authorised to begin treating the protocol families. Clinicians received ongoing supervision from an on-site supervisor and participated in monthly conference calls with Falloon or McGill, who reviewed videotapes of sessions throughout the project. Liberman & Mintz (1998) argued that the trial was limited by the fact that most clinicians were not experienced behaviour therapists. However, it should be noted that the AFM intervention at the Philadelphia site was directed and supervised by A.S.B. and Kim Mueser, two highly experienced behaviour therapists who had expected AFM to produce better outcomes than SFM. Yet, there was no site effect or other indication that AFM had a greater impact on outcome or communication in Philadelphia. New interventions often are more effective in the hands of the originators than in other settings. The TSS project may not represent the best possible outcomes for the behavioural approach, but it can be viewed as a best case evaluation of effectiveness that can be achieved with careful dissemination.
Implications
Given that this study did have adequate internal validity, the findings
have important implications for both the content of family interventions and
for understanding the role of family communication patterns in outcome. First,
AFM and, by implication, Falloon's BFT did have a demonstrable clinical
benefit. However, the benefits were associated with aspects of the procedure
that were in common with the less intensive SFM, not to the home visits or
communication training. Given the cost of these components of AFM, the overall
equivalence of the two family interventions argues against their use.
Moreover, the interaction data reported in this paper lead us to question the
value of the focused communication and problem-solving training, even if it
could be implemented in a more cost-efficient manner. Most families either did
not learn the skills or did not apply them, and improved communication did not
result in better outcomes.
Consistent with our findings, several recent reviews and clinical trials have raised questions about the mechanism of action of family interventions and the importance of behavioural skills training (Halford, 1991; Penn & Mueser, 1996; Dixon et al, 2000). Tarrier et al (1988) did find superior patient outcomes with two variations of a behavioural approach compared to family education and routine treatment. However, the educational intervention consisted of only two sessions, and the advantage of the behavioural approach was limited to patients coming from families with high EE. In line with our findings, Zastowny et al (1992) did not find a behavioural approach to be superior to another active family intervention.
Expressed emotion has been shown to be a reliable indicator of risk of relapse, and reductions in EE are often associated with good treatment outcome, especially in families with high levels of face-to-face contact with the patient. However, the construct is also viewed as a form of stigma by many families, and its utility is limited by its dependence on the CFI. Consequently, TSS was not designed as an EE study. We did not assess EE or limit the sample to families with high levels of ongoing face-to-face contact between patients and relatives with high EE. As pointed out by one of the reviewers of this paper, the results may have been different if we had restricted the sample to such families and caution is advised in generalising from our study to that particular high-risk population. Conversely, Leff et al (1989) failed to find an advantage for the behavioural approach even with families with high EE and high contact, and recent findings have raised questions about whether EE is a correlate of the patient's symptomatology or a reflection of parental attributions about the patient, rather than a marker for meaningful parent-parent exchanges that play a central role in influencing the long-term course of schizophrenia (Halford, 1991; Barrowclough et al, 1994; Weardon et al, 2000). With the exception of McFarlane's multiple family approach (McFarlane et al, 1995), there is no evidence that any particular family approach is superior to another (Baucom et al, 1998; Dixon et al, 2000). Further research is required to explicate how family interventions produce their beneficial effects and to understand better the role of EE in relation to clinical improvement in the patient. In the interim, there seems to be little justification for the expense of including extensive communication training within a supportive psycho-educational family intervention.
CLINICAL IMPLICATIONS
LIMITATIONS
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ACKNOWLEDGMENTS |
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The Treatment Strategies in Schizophrenia (TSS) Cooperative Agreement Programme is a multicentre clinical trial carried out by five research teams in collaboration with the Division of Clinical Research of the NIMH, Rockville, MD. The NIMH principal collaborators are Nina R. Schooler, PhD, Samuel J. Keith, MD, Joanne B. Severe, MS and Susan M. Matthews. The NIMH principal collaborators for the Adjunctive Lithium Trial are S. Charles Schulz, MD and Carol L. Odbert. The principal investigators and co-principal investigators at the five sites are: Hillside Hospital-Long Island Jewish Medical Center, Glen Oaks, NY, U0I MH39992: John M. Kane, MD, Jeffrey A. Lieberman, MD and Margaret Woerner, PhD; Medical College of Pennsylvania at Eastern Pennsylvania Psychiatric Institute, Philadelphia, PA, U0I MH39998: Alan S. Bellack, PhD and George M. Simpson, MD; Cornell University Medical College and Payne Whitney Clinic, New York, NY, U0I MH40007: Ira D. Glick, MD and Allen J. Frances, MD; University of California at San Francisco and San Francisco General Hospital, San Francisco, CA, U0I MH400042: William A. Hargreaves, PhD and Marc Jacobs, MD; Emory University and Grady Memorial Hospital, Atlanta, GA, U0I MH40597: Philip T. Ninan, MD and Rosalind M. Mance, MD. Consultants for Applied Family Treatment are Ian R. H. Falloon, MD, Buckingham Hospital, Buckingham, UK and Christine W. McGill, PhD, University of California at San Francisco and San Francisco General Hospital, San Francisco, CA.
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Received for publication August 17, 1999. Revision received May 2, 2000. Accepted for publication May 9, 2000.