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: Reference Bellack and MueserBellack & Mueser, 1993; Reference Dixon and LehmanDixon & 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 (Reference Schooler, Keith and SevereSchooler 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 (Reference Bellack, Morrison and Mueser1990, Reference Bellack, Haas and Tierney1996), 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.

1. (a) Did patients and family members in the behavioural family management condition learn the interpersonal skills targeted in treatment?

2. (b) Did patients and family members in the family control condition change their communication and problem-solving styles during the course of treatment?

3. (c) Did improved communication and problem solving lead to a better outcome for the patient?

TSS study design

Subject inclusion criteria were: DSM-III-R (American Psychiatric Association, 1987) schizophrenia, schizoaffective disorder or schizophreniform disorder; age between 18 and 55 years; having at least 4 h per week of face-to-face contact with the family of origin or a family member serving in loco parentis; and informed consent provided by both the patient and at least one family member. Exclusion criteria included pregnancy, epilepsy and drug or alcohol dependence. Patients were recruited during an acute episode of illness, after which their family members were invited to attend a multiple family psychoeducation workshop modelled after the Survival Skills Workshop developed by Anderson et al (Reference Anderson, Reiss and Hogarty1986). Patients then were assigned randomly to one of the two family management conditions, Applied Family Management (AFM) or Supportive Family Management (SFM). They then entered a 6-month (maximum) ‘stabilisation’ period, followed by randomisation to one of three maintenance pharmacological treatment strategies: standard dose (12.5-50 mg) fluphenazine decanoate, low-dose (2.5-10 mg) fluphenazine decanoate or targeted dose (placebo injections). The reader is referred to Schooler et al (Reference Schooler, Keith and Severe1997) for a more complete description of the procedure and for the results of the trial.

The AFM intervention was modelled after Falloon's Behavioural Family Therapy (BFT; Falloon et al, Reference Falloon, Boyd and McGill1982, Reference Falloon, Boyd and McGill1984). 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.

Table 1 Demographic and clinical characteristics of subjects by intervention group

	Applied Family Management (n=43)	Supportive Family Management (n=34)	All other TSS subjects (n=236)
Age, years (mean (s.d.))	31.3 (8.3)	27.1 (6.4)	29.6 (7.3)
Gender (n male (%))	29 (67)	27 (79)	151 (64)
Race (n, %)
Caucasian	21 (48.8)	15 (44.1)	88 (37.3)
African-American	19 (44.2)	15 (44.1)	123 (52.1)
Other	3 (7)	4 (11.8)	25 (10.6)
Marital status (n, %)
Never married	34 (79.1)	30 (88.2)	192 (75.4)
Educational achievement
College graduate	22 (52)	14 (41)	86 (36.4)
High school graduate	14 (33)	14 (41)	79 (33.5)
<High school graduate	7 (16)	6 (18)	71 (30.1)
Previous hospitalisations (n, %)
None	13 (30.2)	12 (35.3)	59 (25.0)
One or more	30 (69.8)	22 (64.7)	177 (75.0)
BPRS total score (mean (s.d.))	38.8 (11.6)	37.7 (10.5)	38.1 (10.5)
BPRS psychotic scale (mean (s.d.))	2.3 (1.4)	2.5 (1.0)	2.4 (1.2)
SANS total score (mean (s.d.))	11.9 (3.1)	11.9 (4.0)	11.8 (3.8)

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 (Reference Bellack, Morrison and MueserBellack et al, 1990), Goldstein and colleagues (Reference Miklowitz, Goldstein and FalloonMiklowitz et al, 1984; Reference Doane, Falloon and GoldsteinDoane et al, 1985) and others. Miklowitz et al (Reference Miklowitz, Goldstein and Falloon1984) and Strachan et al (Reference Strachan, Leff and Goldstein1986) 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.

Treatment group comparisons at baseline

Demographic characteristics of the sample for this trial are presented in Table 1. There were no differences between the two family management groups in terms of gender, race/ethnicity, marital status, educational attainment or occupational status of subjects. Patients in the SFM condition were younger (mean age 27.2 years) than patients in the AFM condition (mean age 31.3 years) (F (1,59)=4.11, P=0.05). The two groups were, in general, equivalent in terms of the socio-economic status of the patient's family of origin, although mothers of subjects assigned to the AFM condition had a lower mean level of occupational achievement than did the mothers of subjects assigned to the SFM condition (F (1,56)=6.94, P=0.01).

Subjects in the two groups were equivalent in terms of ratings of global severity of illness (Clinical Global Impression, CGI; Reference GuyGuy, 1976), severity of negative symptoms (total of global items on the Scale for the Assessment of Negative Symptoms (SANS; Reference AndreasonAndreason, 1981)) and severity of psychotic symptoms (psychotic symptom scale from the Brief Psychiatric Rating Scale, BPRS; Reference Overall and GorhamOverall & 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 α level of 0.01 to interpret any result involving the medication factor.

Treatment effects on communication

A series of 2 × 3 × 2 (family management × medication condition × 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.

Table 2 Multivariate effects for repeated measures analysis of variance for family × medication × time on communication composites for patient and family member subjects

Effect	Non-constructive criticism/intrusiveness	Problem solving	Communication effectiveness
Patient
Time effect	F (1,71)=3.25; P<0.08	F (1,71)=0.278; P>0.6	F (1,71)=4.93; P<0.03
Family × time	F (1,71)=0.22; P>0.6	F (1,71)=0.841; P>0.3	F (1,71)=0.50; P>0.8
Medication × time	F (1,71)=0.60; P>0.5	F (1,71)=1.86; P>0.1	F (1,71)=0.44; P>0.6
Family × medication × time	F (2,71)=4.48; P < 0.02	F (2,71)=0.369; P>0.6	F (2,71)=0.39; P>0.6
Family member
Time effect	F (1,71)=0.21; P>0.6	F (1,71)=0.096; P>0.7	F (1,71)=3.64; P<0.06
Family × time	F (1,71)=0.76; P>0.3	F (1,71)=0.431; P>0.8	F (1,71)=0.46; P>0.8
Medication × time	F (1,71)=0.86; P>0.4	F (1,71)=2.45; P<0.1	F (1,71)=0.85; P>0.4
Family × medication × time	F (2,71)=0.22; P>0.8	F (2,71)=0.361; P>0.6	F (2,71)=0.23; P>0.7

Clinical outcome

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 (Reference BellackBellack, 1979; Reference Bellack, Morrison and MueserBellack 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. Reference Doane, Falloon and GoldsteinDoane et al, 1985; Reference Miklowitz, Goldstein and DoaneMiklowitz et al, 1989; Reference Mueser, Bellack and WadeMueser 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 (Reference Falloon, McGill and MatthewsFalloon 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 (Reference Liberman and Mintz1998) 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 (Reference HalfordHalford, 1991; Reference Penn and MueserPenn & Mueser, 1996; Reference Dixon, Adams and LuckstedDixon et al, 2000). Tarrier et al (Reference Tarrier, Barrowclough and Vaughn1988) 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 (Reference Zastowny, Lehman and Cole1992) 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 (Reference Leff, Berkowitz and Shavit1989) 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 (Reference HalfordHalford, 1991; Reference Barrowclough, Johnston and TarrierBarrowclough et al, 1994; Reference Weardon, Zastowny and TarrierWeardon et al, 2000). With the exception of McFarlane's multiple family approach (Reference McFarlane, Lukens and LinkMcFarlane et al, 1995), there is no evidence that any particular family approach is superior to another (Reference Baucom, Shoham and MueserBaucom et al, 1998; Reference Dixon, Adams and LuckstedDixon 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

• ▪ Behavioural family interventions may not be effective in altering communication within the family.

• ▪ Psychoeducational family interventions need not produce changes in communication patterns to be effective.

• ▪ Home visits are not a cost-efficient addition to family psychoeducation and support.

LIMITATIONS

• ▪ These findings may not apply to families with high expressed emotion and high levels of face-to-face contact between patients and family.

• ▪ The sample of patients and families in the Treatment Strategies in Schizophrenia study may not be fully representative of patients with schizophrenia in the community.

• ▪ The analogue task used to assess communication does not completely reflect family interactions in the home.