Schizophrenia Elsevier
Research,
3 (1990) 187-200
187
SRS 00099
A randomized clinical trial of inpatient family intervention IV. Followup
results for subjects with schizophrenia*
Ira D. Glick, James H. Spencer, Jr., John F. Clarkin, Gretchen L. Haas, Alfred B. Lewis, Joanne Peyser, Nancy DeMane, Marcie Good-Ellis, Elizabeth Harris and Veronica Lestelle Seventh Floor Unit, Payne Whitney Clinic, The New York Hospital, (Received
6 July 1989, revised received
20 November
Cornell University Medical College, New York, U.S.A. 1989, accepted
27 November
1989)
This is the last of a series of four papers, here focussing on schizophrenia, which report followup data up to 18 months from a randomized clinical trial of a psychoeducational family intervention (IFI), which was added to medication and limited to the inpatient phase of treatment, after which post-hospital care was not controlled. Our data suggested that patients with poor prehospital functioning (i.e., the chronic patients) may benefit from inpatient family intervention, but this therapeutic effect appears to be limited to females and does not appear until 18 months postadmission. Families of patients with schizophrenia also show benefit from having received IFI, the effect is seen earlier than with the patients, and is associated with achieving the goals of IFI. The results in the IF1 group could not be accounted for by improved posthospital medication compliance, but they may be related to this group’s greater tendency to obtain further family treatment after discharge. Key words: Family
therapy;
Psychoeducation;
(Schizophrenia)
INTRODUCTION
Some form of family therapy combined with drug treatment has been recommended as part of the treatment package for hospitalized patients with schizophrenia. But is the addition of family intervention to inpatient treatment more effective than treatment without it? The only controlled study in the literature (Wallace and Liberman, 1985) addressed inpatient family treatment only as a minor component of an inpatient social skills training program. The present paper reports 6 and 18 month followup results for the schizophrenic patients in a clinical trial of family intervention in which the treatment phase was limited to the Correspondence to: I.D. Glick, The Payne Whitney Clinic, Cornell University Medical College, 525 East 68th Street, New York, NY 10021, U.S.A. * Read, in part, at the Annual Meeting of the American Psychiatric Association, Montreal, May, 1988.
0920-9964/90/$03.50
0
1990 Elsevier Science Publishers
period of hospitalization. Earlier reports examined effects for the total sample at discharge (Haas et al., 1988) and followup (Spencer et al., 1988). A companion paper reports followup results for patients with affective disorder (Clarkin et al., 1990). Research has shown that family environment influences the course of illness in patients with schizophrenia (Brown et al., 1962, 1972; Leff, 1976; Vaughn and Leff, 1976; Vaughn et al., 1984). Family treatment reduces rates of relapse for a year or more when the treatment is provided in a continuing outpatient program for weeks or months after a hospitalization (Goldstein et al., 1978; Falloon et al., 1982, 1985; Leff et al., 1982; Hogarty et al., 1986) but as yet there is no data to demonstrate that inpatient family treatment has a carry-over effect on the post-hospital course of schizophrenics. While inpatient family treatment is widely recommended (Anderson, 1977; Lansky, 1981; Anderson and Reiss, 1982; Harbin, 1982;
B.V. (Biomedical
Division)
188
McFarlane, 1982; Group for the Advancement of Psychiatry, 1985) for hospitalized patients, most hospitals cannot, or do not, provide the kind of sustained, long-term outpatient care which has been evaluated in previous studies (Goldstein et al., 1978; Leff et al., 1982; Falloon et al., 1982, 1985; Hogarty et al., 1986). Typically, at the time of discharge from hospital, various kinds of outpatient treatment are recommended (medications, day programs, psychotherapy, family therapy, etc.), but the hospital has no control over how and whether most patients make use of the facilities available to them. Our study aimed to replicate this typical condition, so we did not include control of postdischarge treatment as part of the design. Hospital psychiatrists hope, despite the lack of research evidence, that inpatient family work results in change in the family and/or begins a constructive process that affects the postdischarge course through variables that continue to act long after the inpatient treatment is completed and the patient leaves the hospital (e.g., improved family support for medication compliance, less family stress). We hypothesized that this kind of effect could be found at 6 and 18 months after discharge. Our research studied an inpatient treatment rather than aftercare, and it differed from the studies cited above (Goldstein et al., 1978; Falloon et al., 1982, 1985; Leff et al., 1982; Hogarty et al., 1986) in other ways: (1) its design evaluated separately two groups of schizophrenic patients who differed in preadmission level of functioning; (2) it included more females; and (3) it was not limited to families with high expressed emotion or under other specific stress. Our results should therefore add to knowledge gained from the earlier studies.
METHODS Study design The patients discussed in this report participated in an outcome study which also included a group of major affective disorders and a residual group of ‘other’ diagnoses. Its methodology has been described in more detail in previous reports (Haas et al., 1988; Spencer et al., 1988) - here we focus on methodology as it relates to the schizophrenic subsample. Patients with an admission diagnosis of DSM-III schizophrenia, schizoaffective or schizo-
phreniform disorder were selected for the study if the patient lived with or had regular contact with family and met one or more criteria from a set of indications for family therapy (Haas et al., 1987). Both patients and families signed informed consent, and the patients were stratified on the basis of functional impairment as measured by the Role Performance Treatment Scale (RPTS) (Spencer et al., 1988; Good-Ellis et al., 1987). The RPTS is an instrument developed for this study which rates patient functioning in a number of roles (work or other primary occupation such as housewife, family, social, leisure) over a time period of up to 18 months, based on information gathered in a semistructured interview with the patient and family, and from medical records. It focusses on functional impairment, independent of symptom severity. It has been shown in separate studies (Good-Ellis et al., 1987) to be reliable (interrater reliability >0.90) and valid in comparisons with other accepted psychosocial rating scales, the Katz Adjustment Scale (Katz and Lyerly, 1963) and the Social Adjustment Scale (Weissman et al., 1981). A cutting score of 3.5 (midpoint) on this scale distinguished two groups by average level of functioning (LOF) over the 18 months prior to admission: (a) LOF 1: schizophrenic/schizophreniform disorder with ‘good’ prehospital functioning (n = 38, with 13 in IF1 and 25 in the comparison group); and (b) LOF2: schizophrenic/schizophreniform disorder with ‘poor’ prehospital functioning (n = 54, with 24 in IF1 and 30 in the comparison group). We elected to block patients on prehospital level of functioning, rather than using the groups as a covariate because chronicity is the most important prognostic variable, and we wanted to be certain we recruited approximately equal numbers of subjects in each cell. Within each LOF group, patients were randomly assigned to either standard, multimodal hospital treatment with inpatient family intervention (IFI), or the same without family intervention (comparison treatment). Standard hospital treatment included medication, individual supportive psychotherapy, occupational therapy, and other activities common to hospital treatment (Haas et al., 1988). IF1 is a brief (mean number of sessions= 8.6, mode= 6) family treatment with an
189
emphasis on psychoeducation (Haas et al., 1988). The patient and family members met once or twice a week during the hospitalization with the patient’s primary therapist and a social worker trained and experienced in doing IF1 with hospital patients. IF1 is described in a manual developed for the study (Clarkin et al., 1981). Its goals in general are: patient/family acceptance and understanding of the illness, identification and amelioration of family stresses which may play a part in the illness, and understanding of the need for continued treatment after discharge. Specific goals for each family are articulated at the beginning of treatment in a Goals of ZFZ Rating Scale, and their degree of attainment rated at discharge. The comparison group received the same standard, multimodal hospital treatment as the IF1 group but without the family work. There was a moderate increase in individual psychotherapy time for the comparison group and a parallel decrease for the IF1 group in an attempt to equalize the total time in contact with a therapist (Haas et al., 1988). A partially fixed drug regimen was used successfully to assure that patients in each treatment group received comparable and adequate amounts of medication. The mean neuroleptic dose/day was 1334 mg CPZ equivalent, with a range of 150-2920 mg/day. The average length of stay for patients in the study was 51.1 (SDk29.4) days, with no significant difference between the two treatment groups. Posthospital treatment was not controlled for reasons discussed later. Outcome measures reported here include: the Global Assessment Scale (GAS) (Endicott et al., 1976) and the Psychiatric Evaluation Form (PEF) (Endicott and Spitzer, 1972), which assess global outcome and symptoms in patients; the Role Performance Treatment Scale (RPTS) described above; and a Family Attitude Inventory (FAI) (Haas et al., 1988; Levitt, 1982), which measures family attitudes to treatment, social support, the patient, and family burden. One of the subscales of the FAI is a modified version of Kreisman’s (personal communication, 1980) Patient Rejection Scale (Kreisman et al., 1979) which provides an approximation to a score on one of the expressed emotion (EE) subscales (hostility), in the families of schizophrenics. PEF symptom ratings were reduced to scores on symptom clusters (Endicott and Spitzer, 1972). For all patients in the study, the initial assign-
ment to diagnostic group was necessarily made on the basis of information available at admission using DSM-III criteria. However, since longitudinal course is critical for correct diagnosis, we used the approach advocated by the developers of RDC and by the current NIMH collaborative project on the study of depression. The final research diagnosis for each patient was made at 18 months, using all information available at that point (Spencer et al., 1988). All data analyses are based on these research diagnoses. Patient characteristics Demographic and clinical characteristics of the overall schizophrenic sample and the two level of functioning (LOF) subgroups are presented in Table 1. In general, the two level-of-functioning groups showed few demographic differences with the exception of a greater preponderance of lower SES (Weiss and Weiss, 1979) cases (based on status and achievements of relatives) in the poor prehospita1 functioning group (x2 = 12.66, df = 4, P < 0.01) (Table 1). Our two level-of-functioning groups are distinguished by degree of impairment during 18 months prior to hospitalization: the mean RPTS level-offunctioning score for the LOFl patients was 2.93 on a six-point scale, similar to the mean score for a sample of major affective disorder patients (2.90); the LOF2 mean was 4.67, a considerably lower level of functioning. The LOFl group included patients with acute first episodes, but also many patients with chronic or recurrent illness for periods up to 10 years who had been able to sustain a relatively high level of functioning. The two LOF groups did not differ in composition with regard to sex, age, or race. Relatively more LOFl patients were married and LOF2 patients divorced or separated, but the numbers were small and the majority of patients in both groups were single. Among the LOF2 patients, there were many more patients living with their parents. The LOF2 patients also had more previous episodes and hospital admissions. Schizophrenic results at discharge Let us first summarize results reported in earlier papers. At discharge, examination of means for each diagnosis, and gender by diagnosis group, revealed that the positive effect of IF1 was largest
190 TABLE
1
Demographic and baseline characteristics of IFI schizophrenic patiems AN patients
Good prehospital schizophrenics
Poor prehospital schizophrenics
Age:
Mean SD
26.1 8.2
21.5 8.9
26.2 7.8
Sex (%):
Male Female
53.3 46.1
52.6 47.4
53.1 46.3
Race (%):
White Black Hispanic Other
71.4 18.7 6.6 3.3
71.1 18.4 5.3 5.3
11.1 18.9 7.5 1.9
SES* (%):
1 (High) 2 3 4 (Low) 5
2.2 5.4 52.2 13.0 21.2
2.6 5.3 65.8 18.4 1.9
1.9 5.6 42.6 9.3 40.7
Single Married Div/Sep
13.9 20.7 5.4
68.4 23.1 7.9
77.8 18.5 3.7
Married w/chldn. Married, no chldn. Single w/chldn. Single, alone Single w/parents
6.5 6.5 5.4 26.1 55.4
10.5 7.9 1.9 34.2 39.5
3.1 5.6 3.1 20.4 66.7
Marital
status
Living situation
(%):
(%):
Prior episodes:
Mean SD
2.1 2.2
1.6 1.7
2.5 2.5
Previous
Mean SD
2.0 2.1
1.1 1.7
2.6 3.1
Mean SD
4.0 1.2
2.9 0.7
4.1 1.0
Mean SD
25.0 6.2
26.6 5.9
23.8 6.2
Overall
admissions:
role functioning:
GAS score:
*SES= Socioeconomic
Status
(from Weiss and Weiss (30), based on Hollingshead
for females and primarily attributable to females in the major affective disorder group, although it was present to a lesser extent in the good prehospital functioning group (Haas et al., 1988). For this reason, our followup data analysis strategy was to run a three-way (TA by Sex by Dx) analysis of variance. For the total sample we found a positive effect of IF1 for both patients and their families (Spencer et al., 1988). We now present more complete details of the followup analyses. Attrition and missing data 92 schizophrenic patients and their families
com-
Scale).
pleted the inpatient treatment phase of the study: 38 in the higher functioning group (13 IFI; 25 Comp); 54 in the lower functioning group (24 IFI; 30 Comp). As discussed, the admitting diagnosis (on which entry into the study and randomization was based) was revised for some patients when the final research diagnosis was made at the end of 18 months (Spencer et al., 1988); this accounts for the apparent imbalances in treatment assignment. The attrition rate was low: data were obtained at six months on all patients and all but one family, and at 18 months on all but two patients and all but eight families.
191
Data analysis A strategy for analyzing multiple subject samples and multiple dependent measures has been described (Haas et al., 1988; Spencer et al., 1988) and is used in this report as in a previous report (Spencer et al., 1988). (1) Results for individual patient and family outcome measures are presented, in terms of effect sizes (Cohen, 1965; Rosenthal and Rosnow, 1984). Significant findings in the type of higher-order analysis (described below) can help ‘protect’ these results on individual measures against the risk of type I error inherent in multiple significance tests (Cohen and Cohen, 1975). For reasons discussed by Cohen (1965) and by Rosenthal and Rubin (1985), we report findings which attained statistical significance at the P< 0.10 level (although we recognize that this makes it more likely the findings are due to chance). (2) Three-way (treatment assignment x sex x level of function) analyses of covariance with composite outcome measures (Beutler and Hamblin, 1986) were performed on the entire sample of schizophrenic patients. (In earlier experiment-wide analyses (Haas et al., 1988; Spencer et al., 1988) the two schizophrenic Level of Functioning samples were treated as separate ‘Diagnosis’ groups. In the present report the term ‘LOF’ replaces ‘Diagnosis’ in referring to these groups). These analyses aimed to test general treatment effects and treatment interaction effects and to provide sample-wide control of significance testing on the individual outcome measures (Cohen and Cohen, 1975). The composite measures were: Patient Global Outcome/ Symptoms (PCOMPI) and Role Functioning (PCOMP2); Family Attitude Toward Treatment/ Social Support (FCOMPI) and Patient Rejection/ Burden (FCOMP2). They were derived from principal component analyses of outcome measures, but they also have clinical face validity: PCOMPl expresses the degree to which the patient is ‘sick’ or ‘disturbed’, with an emphasis on symptoms and the kind of global illness rating provided by the GAS (Endicott et al., 1976); PCOMP2 on the other hand expresses the degree to which a patient can function in community roles independent of severity of symptoms, an important factor in the long-term course of many schizophrenic patients. FCOMPl expresses the family’s attitude toward and ability/willingness to make use of outside support of
different sorts in dealing with the patient. FCOMP2 expresses the family’s attitude toward the patient and the degree to which they perceive him/her as a burden.
RESULTS
For both patient and family measures, we present results of tests on the individual outcome measures, followed by results of the higher order analyses. Groups examined include (in the following order): (1) all schizophrenic patients combined, (2) good prehospital functioning patients, and (3) poor prehospital functioning patients. Treatment eflects on patient outcomes For all patients combined (Table 2), we found only two treatment effects-patients treated with IF1 showed superior outcome in terms of functioning in the family, as measured on the RPTS (P < 0.05) and better global outcome as measured on the Overall Severity Scale of the PEF (PC O.lO)---with both effects manifest at the 18 month followup only. The majority of treatment effects were specific to females and showed better outcome with IFI: better global outcome at 6 months, as measured on the GAS (PC 0.10) and better global outcome at 18 months as measured on both the Overall Severity Scale of the PEF (PcO.01) and the GAS (PcO.10). Consistent with results on global measures at 18 months, we found specific treatment effects for females (favoring IFI) on social withdrawal as measured on the PEF (PC 0.05) and role functioning as measured on RPTS scales including family (P < 0.05) and social (P < 0.10) functioning. For good prehospital functioning schizophrenic patients (Table 3) we found few treatment effects on individual outcome measures; what effects were found were gender-specific. For females we found treatment effects favoring IFI, including a trend for less subjective distress (P
Research,
3 (1990) 187-200
187
SRS 00099
A randomized clinical trial of inpatient family intervention IV. Followup
results for subjects with schizophrenia*
Ira D. Glick, James H. Spencer, Jr., John F. Clarkin, Gretchen L. Haas, Alfred B. Lewis, Joanne Peyser, Nancy DeMane, Marcie Good-Ellis, Elizabeth Harris and Veronica Lestelle Seventh Floor Unit, Payne Whitney Clinic, The New York Hospital, (Received
6 July 1989, revised received
20 November
Cornell University Medical College, New York, U.S.A. 1989, accepted
27 November
1989)
This is the last of a series of four papers, here focussing on schizophrenia, which report followup data up to 18 months from a randomized clinical trial of a psychoeducational family intervention (IFI), which was added to medication and limited to the inpatient phase of treatment, after which post-hospital care was not controlled. Our data suggested that patients with poor prehospital functioning (i.e., the chronic patients) may benefit from inpatient family intervention, but this therapeutic effect appears to be limited to females and does not appear until 18 months postadmission. Families of patients with schizophrenia also show benefit from having received IFI, the effect is seen earlier than with the patients, and is associated with achieving the goals of IFI. The results in the IF1 group could not be accounted for by improved posthospital medication compliance, but they may be related to this group’s greater tendency to obtain further family treatment after discharge. Key words: Family
therapy;
Psychoeducation;
(Schizophrenia)
INTRODUCTION
Some form of family therapy combined with drug treatment has been recommended as part of the treatment package for hospitalized patients with schizophrenia. But is the addition of family intervention to inpatient treatment more effective than treatment without it? The only controlled study in the literature (Wallace and Liberman, 1985) addressed inpatient family treatment only as a minor component of an inpatient social skills training program. The present paper reports 6 and 18 month followup results for the schizophrenic patients in a clinical trial of family intervention in which the treatment phase was limited to the Correspondence to: I.D. Glick, The Payne Whitney Clinic, Cornell University Medical College, 525 East 68th Street, New York, NY 10021, U.S.A. * Read, in part, at the Annual Meeting of the American Psychiatric Association, Montreal, May, 1988.
0920-9964/90/$03.50
0
1990 Elsevier Science Publishers
period of hospitalization. Earlier reports examined effects for the total sample at discharge (Haas et al., 1988) and followup (Spencer et al., 1988). A companion paper reports followup results for patients with affective disorder (Clarkin et al., 1990). Research has shown that family environment influences the course of illness in patients with schizophrenia (Brown et al., 1962, 1972; Leff, 1976; Vaughn and Leff, 1976; Vaughn et al., 1984). Family treatment reduces rates of relapse for a year or more when the treatment is provided in a continuing outpatient program for weeks or months after a hospitalization (Goldstein et al., 1978; Falloon et al., 1982, 1985; Leff et al., 1982; Hogarty et al., 1986) but as yet there is no data to demonstrate that inpatient family treatment has a carry-over effect on the post-hospital course of schizophrenics. While inpatient family treatment is widely recommended (Anderson, 1977; Lansky, 1981; Anderson and Reiss, 1982; Harbin, 1982;
B.V. (Biomedical
Division)
188
McFarlane, 1982; Group for the Advancement of Psychiatry, 1985) for hospitalized patients, most hospitals cannot, or do not, provide the kind of sustained, long-term outpatient care which has been evaluated in previous studies (Goldstein et al., 1978; Leff et al., 1982; Falloon et al., 1982, 1985; Hogarty et al., 1986). Typically, at the time of discharge from hospital, various kinds of outpatient treatment are recommended (medications, day programs, psychotherapy, family therapy, etc.), but the hospital has no control over how and whether most patients make use of the facilities available to them. Our study aimed to replicate this typical condition, so we did not include control of postdischarge treatment as part of the design. Hospital psychiatrists hope, despite the lack of research evidence, that inpatient family work results in change in the family and/or begins a constructive process that affects the postdischarge course through variables that continue to act long after the inpatient treatment is completed and the patient leaves the hospital (e.g., improved family support for medication compliance, less family stress). We hypothesized that this kind of effect could be found at 6 and 18 months after discharge. Our research studied an inpatient treatment rather than aftercare, and it differed from the studies cited above (Goldstein et al., 1978; Falloon et al., 1982, 1985; Leff et al., 1982; Hogarty et al., 1986) in other ways: (1) its design evaluated separately two groups of schizophrenic patients who differed in preadmission level of functioning; (2) it included more females; and (3) it was not limited to families with high expressed emotion or under other specific stress. Our results should therefore add to knowledge gained from the earlier studies.
METHODS Study design The patients discussed in this report participated in an outcome study which also included a group of major affective disorders and a residual group of ‘other’ diagnoses. Its methodology has been described in more detail in previous reports (Haas et al., 1988; Spencer et al., 1988) - here we focus on methodology as it relates to the schizophrenic subsample. Patients with an admission diagnosis of DSM-III schizophrenia, schizoaffective or schizo-
phreniform disorder were selected for the study if the patient lived with or had regular contact with family and met one or more criteria from a set of indications for family therapy (Haas et al., 1987). Both patients and families signed informed consent, and the patients were stratified on the basis of functional impairment as measured by the Role Performance Treatment Scale (RPTS) (Spencer et al., 1988; Good-Ellis et al., 1987). The RPTS is an instrument developed for this study which rates patient functioning in a number of roles (work or other primary occupation such as housewife, family, social, leisure) over a time period of up to 18 months, based on information gathered in a semistructured interview with the patient and family, and from medical records. It focusses on functional impairment, independent of symptom severity. It has been shown in separate studies (Good-Ellis et al., 1987) to be reliable (interrater reliability >0.90) and valid in comparisons with other accepted psychosocial rating scales, the Katz Adjustment Scale (Katz and Lyerly, 1963) and the Social Adjustment Scale (Weissman et al., 1981). A cutting score of 3.5 (midpoint) on this scale distinguished two groups by average level of functioning (LOF) over the 18 months prior to admission: (a) LOF 1: schizophrenic/schizophreniform disorder with ‘good’ prehospital functioning (n = 38, with 13 in IF1 and 25 in the comparison group); and (b) LOF2: schizophrenic/schizophreniform disorder with ‘poor’ prehospital functioning (n = 54, with 24 in IF1 and 30 in the comparison group). We elected to block patients on prehospital level of functioning, rather than using the groups as a covariate because chronicity is the most important prognostic variable, and we wanted to be certain we recruited approximately equal numbers of subjects in each cell. Within each LOF group, patients were randomly assigned to either standard, multimodal hospital treatment with inpatient family intervention (IFI), or the same without family intervention (comparison treatment). Standard hospital treatment included medication, individual supportive psychotherapy, occupational therapy, and other activities common to hospital treatment (Haas et al., 1988). IF1 is a brief (mean number of sessions= 8.6, mode= 6) family treatment with an
189
emphasis on psychoeducation (Haas et al., 1988). The patient and family members met once or twice a week during the hospitalization with the patient’s primary therapist and a social worker trained and experienced in doing IF1 with hospital patients. IF1 is described in a manual developed for the study (Clarkin et al., 1981). Its goals in general are: patient/family acceptance and understanding of the illness, identification and amelioration of family stresses which may play a part in the illness, and understanding of the need for continued treatment after discharge. Specific goals for each family are articulated at the beginning of treatment in a Goals of ZFZ Rating Scale, and their degree of attainment rated at discharge. The comparison group received the same standard, multimodal hospital treatment as the IF1 group but without the family work. There was a moderate increase in individual psychotherapy time for the comparison group and a parallel decrease for the IF1 group in an attempt to equalize the total time in contact with a therapist (Haas et al., 1988). A partially fixed drug regimen was used successfully to assure that patients in each treatment group received comparable and adequate amounts of medication. The mean neuroleptic dose/day was 1334 mg CPZ equivalent, with a range of 150-2920 mg/day. The average length of stay for patients in the study was 51.1 (SDk29.4) days, with no significant difference between the two treatment groups. Posthospital treatment was not controlled for reasons discussed later. Outcome measures reported here include: the Global Assessment Scale (GAS) (Endicott et al., 1976) and the Psychiatric Evaluation Form (PEF) (Endicott and Spitzer, 1972), which assess global outcome and symptoms in patients; the Role Performance Treatment Scale (RPTS) described above; and a Family Attitude Inventory (FAI) (Haas et al., 1988; Levitt, 1982), which measures family attitudes to treatment, social support, the patient, and family burden. One of the subscales of the FAI is a modified version of Kreisman’s (personal communication, 1980) Patient Rejection Scale (Kreisman et al., 1979) which provides an approximation to a score on one of the expressed emotion (EE) subscales (hostility), in the families of schizophrenics. PEF symptom ratings were reduced to scores on symptom clusters (Endicott and Spitzer, 1972). For all patients in the study, the initial assign-
ment to diagnostic group was necessarily made on the basis of information available at admission using DSM-III criteria. However, since longitudinal course is critical for correct diagnosis, we used the approach advocated by the developers of RDC and by the current NIMH collaborative project on the study of depression. The final research diagnosis for each patient was made at 18 months, using all information available at that point (Spencer et al., 1988). All data analyses are based on these research diagnoses. Patient characteristics Demographic and clinical characteristics of the overall schizophrenic sample and the two level of functioning (LOF) subgroups are presented in Table 1. In general, the two level-of-functioning groups showed few demographic differences with the exception of a greater preponderance of lower SES (Weiss and Weiss, 1979) cases (based on status and achievements of relatives) in the poor prehospita1 functioning group (x2 = 12.66, df = 4, P < 0.01) (Table 1). Our two level-of-functioning groups are distinguished by degree of impairment during 18 months prior to hospitalization: the mean RPTS level-offunctioning score for the LOFl patients was 2.93 on a six-point scale, similar to the mean score for a sample of major affective disorder patients (2.90); the LOF2 mean was 4.67, a considerably lower level of functioning. The LOFl group included patients with acute first episodes, but also many patients with chronic or recurrent illness for periods up to 10 years who had been able to sustain a relatively high level of functioning. The two LOF groups did not differ in composition with regard to sex, age, or race. Relatively more LOFl patients were married and LOF2 patients divorced or separated, but the numbers were small and the majority of patients in both groups were single. Among the LOF2 patients, there were many more patients living with their parents. The LOF2 patients also had more previous episodes and hospital admissions. Schizophrenic results at discharge Let us first summarize results reported in earlier papers. At discharge, examination of means for each diagnosis, and gender by diagnosis group, revealed that the positive effect of IF1 was largest
190 TABLE
1
Demographic and baseline characteristics of IFI schizophrenic patiems AN patients
Good prehospital schizophrenics
Poor prehospital schizophrenics
Age:
Mean SD
26.1 8.2
21.5 8.9
26.2 7.8
Sex (%):
Male Female
53.3 46.1
52.6 47.4
53.1 46.3
Race (%):
White Black Hispanic Other
71.4 18.7 6.6 3.3
71.1 18.4 5.3 5.3
11.1 18.9 7.5 1.9
SES* (%):
1 (High) 2 3 4 (Low) 5
2.2 5.4 52.2 13.0 21.2
2.6 5.3 65.8 18.4 1.9
1.9 5.6 42.6 9.3 40.7
Single Married Div/Sep
13.9 20.7 5.4
68.4 23.1 7.9
77.8 18.5 3.7
Married w/chldn. Married, no chldn. Single w/chldn. Single, alone Single w/parents
6.5 6.5 5.4 26.1 55.4
10.5 7.9 1.9 34.2 39.5
3.1 5.6 3.1 20.4 66.7
Marital
status
Living situation
(%):
(%):
Prior episodes:
Mean SD
2.1 2.2
1.6 1.7
2.5 2.5
Previous
Mean SD
2.0 2.1
1.1 1.7
2.6 3.1
Mean SD
4.0 1.2
2.9 0.7
4.1 1.0
Mean SD
25.0 6.2
26.6 5.9
23.8 6.2
Overall
admissions:
role functioning:
GAS score:
*SES= Socioeconomic
Status
(from Weiss and Weiss (30), based on Hollingshead
for females and primarily attributable to females in the major affective disorder group, although it was present to a lesser extent in the good prehospital functioning group (Haas et al., 1988). For this reason, our followup data analysis strategy was to run a three-way (TA by Sex by Dx) analysis of variance. For the total sample we found a positive effect of IF1 for both patients and their families (Spencer et al., 1988). We now present more complete details of the followup analyses. Attrition and missing data 92 schizophrenic patients and their families
com-
Scale).
pleted the inpatient treatment phase of the study: 38 in the higher functioning group (13 IFI; 25 Comp); 54 in the lower functioning group (24 IFI; 30 Comp). As discussed, the admitting diagnosis (on which entry into the study and randomization was based) was revised for some patients when the final research diagnosis was made at the end of 18 months (Spencer et al., 1988); this accounts for the apparent imbalances in treatment assignment. The attrition rate was low: data were obtained at six months on all patients and all but one family, and at 18 months on all but two patients and all but eight families.
191
Data analysis A strategy for analyzing multiple subject samples and multiple dependent measures has been described (Haas et al., 1988; Spencer et al., 1988) and is used in this report as in a previous report (Spencer et al., 1988). (1) Results for individual patient and family outcome measures are presented, in terms of effect sizes (Cohen, 1965; Rosenthal and Rosnow, 1984). Significant findings in the type of higher-order analysis (described below) can help ‘protect’ these results on individual measures against the risk of type I error inherent in multiple significance tests (Cohen and Cohen, 1975). For reasons discussed by Cohen (1965) and by Rosenthal and Rubin (1985), we report findings which attained statistical significance at the P< 0.10 level (although we recognize that this makes it more likely the findings are due to chance). (2) Three-way (treatment assignment x sex x level of function) analyses of covariance with composite outcome measures (Beutler and Hamblin, 1986) were performed on the entire sample of schizophrenic patients. (In earlier experiment-wide analyses (Haas et al., 1988; Spencer et al., 1988) the two schizophrenic Level of Functioning samples were treated as separate ‘Diagnosis’ groups. In the present report the term ‘LOF’ replaces ‘Diagnosis’ in referring to these groups). These analyses aimed to test general treatment effects and treatment interaction effects and to provide sample-wide control of significance testing on the individual outcome measures (Cohen and Cohen, 1975). The composite measures were: Patient Global Outcome/ Symptoms (PCOMPI) and Role Functioning (PCOMP2); Family Attitude Toward Treatment/ Social Support (FCOMPI) and Patient Rejection/ Burden (FCOMP2). They were derived from principal component analyses of outcome measures, but they also have clinical face validity: PCOMPl expresses the degree to which the patient is ‘sick’ or ‘disturbed’, with an emphasis on symptoms and the kind of global illness rating provided by the GAS (Endicott et al., 1976); PCOMP2 on the other hand expresses the degree to which a patient can function in community roles independent of severity of symptoms, an important factor in the long-term course of many schizophrenic patients. FCOMPl expresses the family’s attitude toward and ability/willingness to make use of outside support of
different sorts in dealing with the patient. FCOMP2 expresses the family’s attitude toward the patient and the degree to which they perceive him/her as a burden.
RESULTS
For both patient and family measures, we present results of tests on the individual outcome measures, followed by results of the higher order analyses. Groups examined include (in the following order): (1) all schizophrenic patients combined, (2) good prehospital functioning patients, and (3) poor prehospital functioning patients. Treatment eflects on patient outcomes For all patients combined (Table 2), we found only two treatment effects-patients treated with IF1 showed superior outcome in terms of functioning in the family, as measured on the RPTS (P < 0.05) and better global outcome as measured on the Overall Severity Scale of the PEF (PC O.lO)---with both effects manifest at the 18 month followup only. The majority of treatment effects were specific to females and showed better outcome with IFI: better global outcome at 6 months, as measured on the GAS (PC 0.10) and better global outcome at 18 months as measured on both the Overall Severity Scale of the PEF (PcO.01) and the GAS (PcO.10). Consistent with results on global measures at 18 months, we found specific treatment effects for females (favoring IFI) on social withdrawal as measured on the PEF (PC 0.05) and role functioning as measured on RPTS scales including family (P < 0.05) and social (P < 0.10) functioning. For good prehospital functioning schizophrenic patients (Table 3) we found few treatment effects on individual outcome measures; what effects were found were gender-specific. For females we found treatment effects favoring IFI, including a trend for less subjective distress (P
