Analysis of single-double blind procedures, maintenance of placebo effects, and drug-induced dyskinesia with mentally retarded persons

Applied Research in MemalRetardation, Vol. 1, pp. 175-192, 1 9 8 0 Printed in the USA. A|I rights reserved.

0270-3092/80/030175-18502.00/0 Copyright © 1981 Pergamnn Press Ltd

Analysis of Single-Double Blind Procedures, Maintenance of Placebo Effects, and Drug-Induced Dyskinesia with Mentally Retarded Persons Stephen E. Breuning, Donald G. Ferguson, and Salvatore Cullari Coldwater Regional Center for Developmental Disabilities

The present study examined the importance o f reliability checks, placebo conditions, and double blind conditions in assessing medication effects with ten institutionalized mentally retarded persons. In addition, a procedure f o r discontinuing the use o f placebo and double blind conditions was explored and all residents received weekly assessments and one year follow-up o f withdrawal and persistent dyskinesia. The results empirically demonstrate the importance o f using reliability checks, placebo conditions, and double blind conditions. The procedure f o r discontinuing placebo-double blind conditions was effective and is discussed in terms o f ethical and practical issues concerning their use in institutions. Placebo effects were observed to last 12 or more weeks and are discussed in terms o f being maintained via operant variables. Withdrawal dyskinesius were present in nine o f the ten residents and a 1.5 year follow-up showed persistent dyskinesias present in six o f the ten residents. Lip-mouth and tongue movements were the primary dyskinesias. Key words: Double blind procedures, Placebo effects, Dyskinesia, Mentally retarded persons.

Recent surveys have shown that approximately 50-60% of the institutionalized mentally retarded persons in the United States are receiving psychotropic (neuroleptic) medications for the management of behavior problems (Lipman, 1970; Sprague, 1977). These surveys have also shown that medication dosages exceeding manufacturer's recommendations are Preparation of this manuscript was partially supported by Grant MH 32206 from the National Institute of Mental Health. Reprint requests to: Dr. Stephen E. Breuning, Psychologicaland Research Services, Coldwater Regional Center for Developmental Disabilities, Coldwater, Michigan 49036. 175

176

S. E. Breuning, D. G. Ferguson, and S. Cullari

often used. This widespread use and abuse of psychotropic medication has lead to increasing public concern, press coverage, and litigation and legislation. One paramount issue resulting from current litigation and legislation relates to the assessment of medication effects. For example, Standard 22 of the landmark case of Wyatt v. Stickney (1972, p. 400) states that "Residents" records shall state the effects o f psychoactive medication on the resident. When dosages o f such are changed or other psychoactive medications are prescribed, a notation shall be made in the resident's record concerning the effect o f the new medication or new dosages and the behavior changes, i f any, which occur.'" This issue is paramount because many of the accepted criteria for assessing medication effects are not routinely employed in institutional settings. Based on reports suggesting criteria to be met in order to adequately assess medication effects in experimental situations (e.g., Sprague & Werry, 1971; Sulzbacher, 1973; Sprague & Baxley, 1978), there appear to be five criteria applicable to an institutional (applied) setting. First, the behavior of the individual should be measured in observable and measurable terms beginning 15-30 days prior to a medication change, preferably in terms of actual frequency of occurrence; second, independent reliability checks should be performed on the recording of the target behavior; third, placebo conditions should be employed; fourth, double blind conditions should be used; and fifth, there should be a comparison of medications to alternative treatment. The importance of two of these five criteria in the assessment of medication effects is well documented. First, Sulzbacher (1973) has shown that medication effects are much less pronounced when target behaviors are defined in observable and measurable terms, particularly when frequency counts are used. Second, Breuning, Regan, and Davis (Note 1), Breuning, O'Neill, and Ferguson (Note 2), and McConahey, Thompson, and Zimmerman (1977) have all shown that behavior management is often more effective than medications with mentally retarded persons. To date, there have been no empirical demonstrations of the importance of reliability checks, placebo conditions, and double blind conditions with mentally retarded persons in drug research. The present study was designed to examine the importance of these three issues in assessing medication effects with institutionalized mentally retarded persons. Six conditions were employed. These were: (1) resident on medication; (2) staff told medication is a placebo; (3) resident blind; (4) staff blind; (5) both resident and staff blind; and (6) neither resident nor staff blind. In the last four conditions the residents were off all medication.

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177

In addition, a procedure for discontinuing the use of placebo and double blind conditions was explored and all residents received weekly assessments and a one year follow-up of withdrawal and persistent dyskinesia. METHOD

Subjects Ten institutionalized mentally retarded persons (residents) participated in the study. Each was from a different living unit (ward). Residents were selected according to four criteria. First, the resident had to be emitting physical aggression, property destruction-disruption, a n d / o r yellingscreaming at a frequency of at least 20 times per day. These behaviors were selected because they are the most common inappropriate behaviors that medication was prescribed for and they are easily defined in observable and measurable terms. Second, the resident had to be receiving a single medication to control a specific inappropriate behavior for at least two years. Residents were receiving Thioridazine (Mellaril), Chlorpromazine (Thorazine), or Haloperidol (Haldol). Third, the resident had to be determined for discontinuation of the medication by an interdisciplinary team (typically because of no evidence that the medication was controlling the inappropriate behavior). And fourth, informed consent for the resident to participate in the study had to be obtained. The age, sex, IQ, medication, medication dosage, years on current medication, and consecutive years on medication (major tranquilizers) for each resident are presented in Table 1.

Setting and Staff Data were collected in the living unit of each resident. The living units measured approximately 20.6 m by 12.7 m and were divided into two discrete areas, a day area measuring approximately 12.4 m by 12.7 m and a sleeping area measuring approximately 8.2 m by 12.7 m. There were between 9 and 13 residents and two or three nondegreed staff in each living unit on the A.M and P.M. shifts and one staff on the midnight shift. Staff worked a given living unit on a routine basis. All staff had previously received approximately 20 hours of training in behavior analysis and 100 hours of general in-service training. In total, 74 staff recorded resident inappropriate behaviors at least once. Thirty-eight of the staff were male and 36 were female. The mean age of the staff was 34 with a range of 18 to 62. The mean number of years of employment as living unit staff was 12 years with a range of seven months to 41 years.

34 19 25 71 25 22 28 17 24 49

1 2 3 4 5 6 7 8 9 10

M M F M F F F M M F

Sex 45 74 19 58 63 14 37 47 27 34

IQ Chlorpromazine Thioridazine Chlorpromazine Chlorpromazine Thioridazine Haloperidol Thioridazine Haloperidol Thioridazine Thioridazine

Medication 300 BID 250 BID 150 QID 200 BID 200 QID 4 QID 150 BID 2 TID 350 TID 100 QID

mg 12.74 6.82 12.17 6.41 14.49 .27* 5.87 .09* 14.68 7.13

mg/kg 1.6 3.5 .4 2.3 1.2 1.9 .7 2.7 1.6 .6

Medication

Years on Current

*.27 mg/kg and .09 mg/kg have Chlorpromazine equivalences of 13.49 mg/kg and 4.53 mg/kg, respectively.

Age

Resident

Medication Dosage

6.4 12.4 5.4 3.0 8.3 3.2 3.4 2.7 4.1 12.9

on Medication

Consecutive Years

TABLE 1 Age, Sex, IQ, Medication, Medication Dosage, Years on Current Medication, and Consecutive Years on Medication for the Residents

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179

Procedure Conditions. The residents were randomly assigned to one of a number of sequences of treatment presentations with the restriction that each sequence have two residents. The first four sequences were designed to examine placebo effects and the fifth sequence was designed to examine the effectiveness o f a procedure for discontinuing placebo and double blind conditions. Each of the five sequences consisted of a combination of the following conditions. 1. Drug (D). The residents were receiving the medication and dosage outlined in Table 1. 2. Staff tom medication is placebo (PD). The residents were receiving the medication and dosage outlined in Table 1. Staff were informed that the resident was off medication but was receiving a placebo similar to the medication in taste and appearance. 3. Residents blind (RB). The residents were off medication, but were receiving a placebo. Staff were informed that a placebo had replaced the medication. 4. Staff blind (SB). The residents were o f f medication and were not receivi n g a placebo. Staff were informed that a new type of medication was being used and that it was administered in the resident's food. 5. Neither resident nor staff blind (NB). The residents were off medication and were not receiving a placebo. Staff were informed that the resident was no longer on medication. 6. Both resident and staff blind (RSB). The residents were off medication and were receiving a placebo. Staff were not informed that the resident was no longer on medication. Table 2 summarizes the sequence of conditions presented each resident. Residents 1-8 were initially receiving medication (D). After four weeks, residents 1-4 began the PD condition. Residents 5-8 remained in the D condition for an additional four weeks. Beginning week 13, residents 1-8 again received the RSB condition. This was done to verify mean frequencies of inappropriate behavior obtained in the initial RSB conditions. Residents 9-10 received medication for the first four weeks and were then switched to the RSB condition. The RSB condition lasted 12 weeks. Residents 9-10 then received the RB condition for four weeks followed by the NB condition for the remaining eight weeks. Medication and Placebo. Residents 1-8 received medication for the first eight weeks of the study. Residents 9-10 received medication for the first four weeks of the study. Each resident was abruptly withdrawn from medication with the last administration occurring at the scheduled time on the last day of week eight for residents 1-8 and last day of week four for

180

S. E. Breuning, D. G. Ferguson, and S. Cullari TABLE 2 S u m m a r y of Conditions

Sequence

Residents

1 2 3 4 5

1-2 3-4 5-6 7-8 9-10

•

Conditions per Four Week Interval D D D D D

PD PD D D RSB

RB RSB NB SB RSB

RSB RB SB NB RSB

SB NB RB RSB RB

NB SB RSB RB NB

RSB RSB RSB RSB NB

D = drug condition, medication being received; PD = medication being received, staff told medication is placebo; RB = resident blind; SB = staff blind; NB = neither resident nor staff blind; RSB = both resident and staff blind. Italicized conditions were randomly counterbalanced.

residents 9-10. Throughout the remainder of the study the ten residents were off all medication. Drug conditions in which placebos were administered followed procedures identical to those used during medication conditions including abrupt withdrawal. The clinic nurse (LPN) typically administered the medication. If absent, medication was administered by the shift supervisor. The nurse and supervisor were unaware of the study and received the same condition information presented to the living unit staff. All medications and placebos were similar in taste and appearance and were supplied in identical packages by the pharmacist and physician. One package contained enough medication or placebos for four weeks. Data collection a n d reliability. As stated earlier, the three target behaviors were physical aggression, property destruction-disruption, and yelling-screaming. Physical aggression was defined as any hitting, kicking biting, shoving, or pulling hair of another resident or staff. Attempts to hit, etc. another person were counted. Property destruction was defined as furniture shoving, chair tipping, object throwing, clothes tearing, window breaking, or similar behavior. Yelling-screaming was defined as any raising of the voice for more than 3 seconds and that was not part of conversation. For example, loud talking for the sake of being heard was not counted. Frequencies of inappropriate behaviors were recorded by the living unit staff in 30 minute intervals, 24 hours per day. Staff counted and charted in alternate intervals. Frequencies of each of the three target behaviors were recorded separately and totaled per interval. Interval totals were compiled at the end of each shift by a living unit staff. Reliability checks were made on a random selection of four 30 minute intervals per day. Two intervals during the A.M. shift and two during the P.M. shift. Reliability checks were not conducted on the midnight shift because less than 2% of the occur-

Single-Double Blind Procedures

181

rences of inappropriate behaviors were on this shift. The reliability checks were conducted by two trained observers who were unaware of the conditions in the study or that a study was taking place. Each observer independently checked the same interval. To help insure objectivity, the observers recorded the behavior of four residents at one time and were unaware that one of the four residents was part of the study. Living unit staff were unaware of the reliability checks. Reliability was computed as percentage of agreement per interval between the observers and between the observers and staff. Only intervals in which observers and living unit staff recorded the occurrence of an inappropriate behavior were counted. Intervals in which neither observers nor staff recorded the occurrence of an inappropriate behavior were not counted in computing agreement (scored interval technique, Hawkins & Dotson, 1975). Reliability on each behavior as well as the interval total were computed. Since the recorded frequencies had to match exactly to be counted as an agreement and nonoccurrences were excluded, the reliability measures were quite stringent. Placebo-double blind discontinuation. Following the RSB condition for residents 9-10, the living unit and clinic nursing staff involved with these residents were presented with the procedures used and data collected during the D and RSB conditions. The results were explained and the staff were told that the residents were going to continue to receive the placebo. At this point a differential reinforcement (DRO) procedure was introduced. The living unit and nursing staff were instructed to begin administering the placebo as rapidly and unemotionally as possible and that attention to the resident was to be minimal at medication time. In addition, the living unit staff were instructed to deliver as much attention and praise as possible for appropriate behavior during the 20 minute period preceding medication time. Only social reinforcers were used. Simultaneous with the DRO procedures the use of placebos was gradually reduced. For resident 9, one placebo was discontinued after the 10th day, one after the 20th day, and the last on the 28th day of the RB condition. For resident 10, one placebo was discontinued on the 7th, 14th, 21st, and 28th day of the RB condition. The NB condition was as described above. Assessment ofdyskinesia. All residents were assessed for dyskinesia three days prior to the discontinuation of medication (baseline) and at one week intervals following discontinuation of the medication. The weekly assessments continued throughout the remainder of the study. Assessments were completed independently by two registered nurses (RN) using the Withdrawal Emergent Symptom Checklist (WESC; Engelhardt, Note 3). The use of two nurses allowed for reliability checks on the WESC.

182

S. E. Breuning, D. G. Ferguson, and S. Cullari

RESULTS Figure 1 shows the mean daily frequencies of inappropriate behaviors of residents 1-8 in one week blocks across conditions. Data for residents 1-2, 3-4, 5-6, and 7-8 are presented in the upper to lower panels respectively. Responding for residents 1-8 followed a similar pattern across all conditions except SB. During the D condition the frequencies of inappropriate behaviors were relatively stable with no upward or downward trends. During the PD (residents 1-4), RB, and NB conditions the frequencies were 15 % to 47 % (mean of 32.8 %) higher than those obtained during the D condition. During the first RSB condition the frequencies were 3% to 29% (mean of 9.8%) lower than those obtained during the D condition. Responding for these eight residents had stabilized by the third week in this condition. Similar frequencies were obtained during the second RSB condition. During the SB condition the inappropriate behaviors of residents 1, 2, 3, and 5 were stable at frequencies similar to those obtained during the PD, RB, and NB conditions (14% to 39% - mean 27.4%, greater than during the D condition). Frequencies for residents 4, 6, and 7 were initially similar to those obtained during the PD, RB, and NB conditions but rapidly decreased across the SB condition. The frequency for resident 8 was initially similar to the frequency obtained during the D condition and showed a slow decrease throughout the condition. Figure 2 shows the mean daily frequencies of inappropriate behaviors of residents 9-10 in one week blocks across conditions. The patterns of responding for residents 9-10 were very similar across the four conditions. During the D condition the frequencies of inappropriate behaviors were relatively stable. As with residents 1-8, there were no upward or downward trends. At the beginning of the RSB condition the frequencies were similar (within 2 %) to those obtained during the D condition. Across the condition there was a gradual decrease in frequencies with stabilization occurring by the end of the RSB condition. Frequencies remained stable at the lower frequencies (44% to 62%) throughout the RB and NB conditions. The effectiveness of the placebo-double blind discontinuation procedure was replicated with residents 1-8 following their second RSB condition. These data are not presented because they mirror the data obtained during the RB and NB conditions for residents 9-10. Figure 3 shows the mean reliability between observers and between observers and living unit staff on frequencies of inappropriate behaviors that were totaled per interval. These data are presented separately for residents 1-8 and 9-10 per condition. Reliability was computed by counting the number of total interval frequency agreements, dividing by the number of intervals compared, and multiplying by 100. Mean reliability between observers on the interval total frequencies for

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FIGURE 1. Mean dally frequencies of inappropriate behaviors of residents 1-8 in one week blocks across conditions. Data for residents 1-2, 3-4, 5-6, and 7-8 are presented in the upper to lower panel respectively. During the D condition the residents received medication, dudng the PD condition the residents received medi. cation but staff were told the medication was a placebo, during the RB condition the residents were blind, during the SB condition the staff were blind, during the NB con. dition neither the residents nor staff were blind, and during the RSB condition both the residents and staff were blind. The dotted vertical fines separate the conditions.

184

S. E. Breuning, D. G. Ferguson, and S. Cullari

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FIGURE 2. Mean daily frequencies of inappropriate behaviors of residents 9-10 in one week blocks across conditions during the placebo-double blind discontinuation procedure. During the D condition the residents received medication, during the RSB condition both the residents and staff were blind, during the RB condition the residents were blind, and during the NB condition neither the residents nor staff were blind. The dotted vertical lines separate the conditions.

t [] B E T W E E N 1OO • B E T W E E N

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Single-Double Blind Procedures

185

residents 1-8 was 94.2, 90.1, 92.8, 84.6, 87.4, 86.1, and 95.3 for the D, PD, RB, SB, NB, and two RSB conditions respectively. Between the observers and living unit staff the mean reliability was 90.3, 33.8, 41.6, 88.7, 87.6, 91.1, and 93.8 respectively for the seven conditions. For residents 9-10, mean reliability between observers and 90.3, 87.9, 90.1, and 93.4 for the D, RSB, RB, and NB conditions respectively. Mean reliability between the observers and living unit staff for these four conditions was 83.6, 96.4, 89.7, and 85.8 respectively. The reliability between observers and living unit staff was between 87.6 %0 and 93.8% across all conditions except the PD and RB conditions for residents 1-8. During these conditions the frequencies of inappropriate behaviors recorded by the living unit staff were substantially higher than the frequencies recorded by the observers. Since reliability between the observers remained above 90 % during the PD and RB conditions the frequencies recorded by the living unit staff appeared inaccurately higher. A projection of the mean daily frequencies of inappropriate behaviors bears this out. Figure 4 is identical to Figure 1 except that the slopes of projected mean daily frequencies for the PD and RB conditions have been added. These projected frequencies were derived using a regression equation described by Guilford and Fruchter (1973). By entering the mean interval frequencies recorded by the observers into the equation it was possible to predict the true frequencies of inappropriate behaviors during the PD and RB conditions. It can be seen in Figure 4 that the projected true frequencies for the PD and RB conditions (residents 1-8) were within 8 %0 of the D conditions and 36% to 62% (mean of 46.8%) lower than the frequencies recorded by the living unit staff. The projected frequencies were validated by using the regression equation to project frequencies that had already been determined to be reliable (i.e., agreement between observers and living unit staff above 90 %0). Fifty projections were made with 41 being within 9%, 6 being within 12%, and the remaining 3 being within 17% of the reliable frequencies. Table 3 summarizes the WESC findings prior to discontinuation of medication (baseline) and 1, 4, 8, 14, and 28 weeks following discontinuation. Findings on these WESC assessments were representative of changes occurring on the weekly assessments. For each WESC category, the number of residents recorded by both RNs as having mild, moderate, or severe symptoms are presented. During the baseline assessment choreoathetoid and myoclonic movements were not recorded for any resident. By the 1st week after

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FIGURE 4i Mean daily frequencies of inappropriate behaviors and projected frequencies during the PD and RB conditions for residents 1-8. Data are presented in one week blocks across conditions in the upper to lower panel for residents 1-2, 3-4, 5-6, and 7-8 respectively. During the D conditions the residents received medication, during the PD condition the residents received medication but staff were told the medication was a placebo, during the RB condition the residents were blind, during the SB condition the staff were blind, during the NB condition neither the residents nor staff were blind, and during the RSB conditions both the residents and staff were blind. The dotted vertical lines separate the conditions.

1

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M, M, S = Mild, Moderate, Severe, respectively. Numbers represent the n u m b e r of residents scored by both nurses per WESC category.

Euphoria, elation

1

1

2

5

Anorexia

1

2

2

2

3

1

Weight loss

Vomiting

Increased perspiration

Hypertonia

Terminal tremor volition

Disturbance of balance

1

2

Tongue Movements

1

1

4

Posturing

2

3

1

Lip - - mouth movements, f a c i a l t i c s

1

1

2

2

2

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Myoclonic m o v e m e n t s of limbs, head, trunk

Week 1 M M S 2

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Coreathetoid m o v e m e n t s of limbs, head, trunk

WESC Categories

TABLE 3 Summary of WESC Findings

188

S. E. Breuning, D. G. Ferguson, and S. Cullari

medication discontinuation residents 3 and 7, and, 2 and 9 had mild and moderate myoclonic movements respectively. By the 4th week residents 3 and 9 had shown no change in myoclonic movements but now had moderate coreoathetoid movements. Residents 2 and 7 no longer had myoclonic movements but did have mild coreoathetoid movements. By the 8th week only resident 9 remained with myoclonic and coreoathetoid movement. These were of moderate intensity and were still present on the 28th week. Mild and moderate l i p - m o u t h and tongue movements were recorded for residents 1 and 5 respectively on the baseline assessment. Resident 8 had mild tongue movements. During the four weeks following medication discontinuation there was an increase in l i p - m o u t h and tongue movements for 9 of the 10 residents. These movements slowly decreased across the next 12 weeks. By the 16th week, residents 3 and 6, 1, 5 and 8, and 9 had mild, moderate, and severe l i p - m o u t h and tongue movements respectively. Resident 9 also had moderate dyskinetic posturing. There were no additional changes by the 28th week. Vomiting, weight loss, and anorexia were not recorded for any resident on the baseline assessment. By the 1st week, residents 3 and 5 had mild and resident 6 had moderate vomiting and anorexia. By the 4th week residents 5 and 6 had a mild weight loss and resident 4 had a moderate weight loss. Resident 6 also had mild anorexia. By the 8th week, residents 5 and 6 had mild and moderate weight loss respectively. There were no occurrences of vomiting, weight loss or anorexia after the 8th week. Throughout the WESC assessments there were no occurrences of disturbance of balance, terminal-tremor (volition), hypertonia, increased perspiration, or euphoriaelation. A one year followup (1.5 years after medication discontinuation) revealed that residents 1, 3, 5, 6, 8, and 9 were still exhibiting the posturing lip-mouth, and tongue movements present 28 weeks after discontinuation of their medication (see Table 3). Reliability of the WESC findings was determined by comparing each of the assessments completed by the RNs. Comparisons were made on each of the 13 WESC categories for the ten residents across the 29 assessments (baseline and 28 weekly). This resulted in a total of 3770 comparisons (13 x 10 x 29). Complete agreement between the RNs was obtained on 3167 (84 %) of the comparisons. On 490 (13 %) of the comparisons the RNs were within one intensity level (e.g., mild to moderate) of each other. Separate comparisons were made on all categories where residents were reported to have dyskinetic symptoms. This was done to determine whether the categories where none of the residents had dyskinetic symptoms resulted in a biased total percentage of agreement between the RNs. Complete agreement was obtained on 1484 of 1809 comparisons (82%).

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DISCUSSION The results empirically demonstrate the importance of using reliability checks, placebo conditions, and double blind conditions in assessing medication effects with mentally retarded persons. Without the placebo and double blind conditions there was an unreliable increase in the recorded frequencies of the resident's inappropriate behaviors during the PD and RB conditions and a reliable increase in the frequencies recorded during the SB and NB conditions. These increases are due to variables other than the medication being discontinued. The increase in frequencies during the PD and RB conditions are most easily explained in terms of expectancy effects by staff (e.g., Rosenthal, 1968). It has been repeatedly demonstrated that when experimenters, teachers, and data collectors have preconceived notions of what behavior changes should occur, there is a very high probability that the expected changes do indeed occur. As an adjunct to the present study the living unit staff were individually polled concerning what happens when medication is discontinued. Seventy of the 74 staff said that the residents would become much worse, three said they did not know, and one said we would have to see. The increases in frequencies during the SB and NB conditions appear to be due to operant variables. During the SB and NB conditions, residents 1, 2, 3, 5, 7, and 8 emitted true increases in frequencies of inappropriate behaviors. Examination of these increases per 30 minute intervals revealed that for these six residents, 93 % of the increases occurred within 15 minutes of the time (typically following) they had previously received medication. During subsequent RSB conditions, the frequencies of inappropriate behaviors were approximately 65% lower and were maintained at these lower frequencies during the placebo-double blind discontinuation procedure. This suggests that the higher frequencies during the SB and NB conditions were maintained by the attention received for emitting the inappropriate behaviors. During the SB and NB conditions, residents 4 and 6 showed initial increases in frequencies that gradually decreased across the conditions. The trends resembled a typical extinction curve. For these two residents, the gradual decreases in frequencies occurred within 30 minutes of the times they had been receiving medication. This suggests that they did not receive sufficient attention to maintain the increase in inappropriate behaviors. The increases in frequencies for these seven residents are not related to discontinuation of the medication. Consistent changes occurred regardless of whether the SB and NB conditions appeared immediately or eight weeks following medication discontinuation.

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These findings have important implications for institution staff responsible for assessing medication effects. In a typical institutional setting reliability checks and placebo-double blind conditions are not employed. The present results show that without placebo-double blind conditions, increases in inappropriate behaviors will be recorded. However, these increases are often unreliable and not related to medication effects. Thus, in many cases physicians and other interdisciplinary team members are discussing the effects of medication based on erroneous data. Once a physician is informed of an increase in inappropriate behavior there is a tendency to increase the medication. If the increases in inappropriate behavior are unreliable or due to variables other than medication, an increase in medization may be a violation of the resident's right to habilitative treatment. For example, the "Minimum Constitutional Standards for Adequate Habilitation of the Mentally Retarded" (Wyatt v Stickney, 1972) states that "Residents shah have a right to be f r e e f r o m unnecessary or excessive medication" (Standard 22, page 400).

Previous research with phenothiazines reports placebo effects ranging up to 70°-/0 improvement with effects present up to six weeks (e.g., Adamson, Nellis, Runge, Cleland, & Killian, 1958). In the present study, the lowest frequencies of inappropriate behaviors of all 10 residents occurred during the RSB conditions with the placebo-double blind effects still present after 12 weeks (residents 9-10). In addition, it was demonstrated that it is possible to implement and gradually discontinue placebo-double blind conditions (see Procedure section). This is important because the results clearly indicate the importance of these conditions (even with severely and profoundly mentally retarded persons), but it would not be functionally possible to maintain these conditions indefinitely. Together with the findings of Adamson et al. (1958) the present findings refute the notion that placebo-double blind conditions should not be used in institutional settings because of ethical and practical reasons. Withdrawal dyskinesias were present in nine of the 10 residents and persistent dyskinesias were present in six of the 10 residents. Lip-mouth and tongue movements were the primary dyskinesias. Resident 9 was the only resident to have persistent dyskinesias of severe intensity. These were lip-mouth and tongue movements. While the small number of subjects did not allow for formal analyses (e.g., multiple correlation), informal analyses suggest no relationship between age, sex, IQ, type of medication, years on current medication, consecutive years on medication, history of medication (drug) holidays and intensity of dyskinesias. However, with the exception of resident 8, daily dosage and mg/kg dosage appear to be related to intensity of dyskinesias. For example, resident 9 had severe, residents 5 and 8 had moderate, and

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resident 1, 3, and 6 had mild persistent dyskinesias. The daily and mg/kg dosages were 1050-14.68,800-14.49, 300-4.53 (Chlorpromazine equivalent), 600-12.74, 600-12.17, and 800-13.49 (Chlorpromazine equivalent) respectively. While this finding is probably of little surprise to most investigators, and at best preliminary in nature, it reiterates the need for caution in increasing medication dosages and suggests that medication effects with mentally retarded persons be analyzed in terms of both daily and mg/kg dosages. Such analyses would be useful because an individual can be on a relatively low daily dosage, yet a relatively high mg/kg dosage. REFERENCE NOTES 1. Breuning, S. E., Regan, J. T. & Davis, V. J. Behavioralalternatives to drug control: Comparison o f drug, DRO, token economy, and response cost procedures with hyperkinetic elementary school children and institutionalized retarded adults. 1980, under review. 2. Breuning, S. E., O'Neill, M. J. & Ferguson, D. G. Comparison ofpsychotropic drug, response cost, and psychotropic drug plus response cost procedures f o r controlling institutionalized retarded persons. 1980, under review. 3. Engelhardt, D. A. WESC - Withdrawal Emergent Symptoms Checklist. Unpublished manuscript, 1974. Available from Dr. David A. Engelhardt, Department of Psychiatry/Psychopharmacology, Downstate Medical Center, State University of New York, 450 Clarkson Avenue, Brooklyn, New York 11203.

REFERENCES Adamson, W. C., Nellis, B. P., Runge, G., Cleland, C. & Killian, E. Use of tranquilizers for mentally deficient patients. A.M.A. Journal o f Diseases o f Children, 1958, 96, 159-164. Guilford, J. P. & Fruchter, B. Fundamental Statistics in Psychology and Education (Fifth Edition). New York: McGraw Hill, 1973. Hawkins, R. P. & Dotson, V. A. Reliability scores that delude: An Alice in Wonderland trip through the misleading characteristics of interobserver agreement scores in interval recording. In E. Ramp & G. Semb (Eds.), Behavioral Analysis: Areas o f Research and Applications. Englewood Cliffs, New Jersey: Prentice Hall, 1975. Lipman, R. S. The use of psychopharmacological agents in residential facilities for the retarded. In F. J. Menolacino (Ed.), Psychiatric Approaches to Mental Retardation. New York: Basic Books, 1970. McConahey, O. L., Thompson, T. & Zimmerman, R. A token system for retarded women: behavior therapy, drug administration, and their combination. In T. Thompson and J. Grabowski (Eds.), Behavior Modification o f the Mentally Retarded (Second Edition). New York: Oxford University Press, 1977. Rosenthal, R. A. Self-fulfilling prophecy. Psychology Today, September, 1968, 46-51. Sprague, R. L. Overview of psychopharmacology for the retarded in the United States. In P. Mittler (Ed.), Research to Practice in Mental Retardation - Biomedical Aspects, Vol. III. Baltimore: University Park Press, 1977. Sprague, R. L. & Baxley, G. B. Drugs for behavior management, with coment on some legal aspects. In J. Wortis (Ed.), Mental Retardation and Developmental Disabilities, Vol. X. New York: Bruner/Mazel, 1978.

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Sprague, R. L. & Werry, J. S. Methodology of psychopharmacological studies with the retarded. In N. R. Ellis (Ed.), InternationalReview of Research in MentaIRetardation, Vol. 5. New York: Academic Press, 1971. Sulzbacher, S. I. Psychotropic medication with children: An evaluation of procedural bias in results of reported studies. Pediatrics, 51(3), March 1973, 513-517. Wyatt v Stickney, 344 F. Supp. 387 (1972).