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This article was downloaded by: [UQ Library] On: 05 November 2014, At: 08:35 Publisher: Routledge Informa Ltd Registered in England and Wales Registered Number: 1072954 Registered office: Mortimer House, 37-41 Mortimer Street, London W1T 3JH, UK Journal of Clinical Child Psychology Publication details, including instructions for authors and subscription information: http://www.tandfonline.com/loi/hcap19 Development of a Multimethod Clinical Protocol for Assessing Stimulant Drug Response in Children With Attention Deficit Disorder Russell A. Barkley , Mariellen Fischer , Robert F. Newby & Michael J. Breen Published online: 07 Jun 2010. To cite this article: Russell A. Barkley , Mariellen Fischer , Robert F. Newby & Michael J. Breen (1988) Development of a Multimethod Clinical Protocol for Assessing Stimulant Drug Response in Children With Attention Deficit Disorder, Journal of Clinical Child Psychology, 17:1, 14-24, DOI: 10.1207/s15374424jccp1701_3 To link to this article: http://dx.doi.org/10.1207/s15374424jccp1701_3 PLEASE SCROLL DOWN FOR ARTICLE Taylor & Francis makes every effort to ensure the accuracy of all the information (the “Content”) contained in the publications on our platform. However, Taylor & Francis, our agents, and our licensors make no representations or warranties whatsoever as to the accuracy, completeness, or suitability for any purpose of the Content. Any opinions and views expressed in this publication are the opinions and views of the authors, and are not the views of or endorsed by Taylor & Francis. The accuracy of the Content should not be relied upon and should be independently verified with primary sources of information. Taylor and Francis shall not be liable for any losses, actions, claims, proceedings, demands, costs, expenses, damages, and other liabilities whatsoever or howsoever caused arising directly or indirectly in connection with, in relation to or arising out of the use of the Content. This article may be used for research, teaching, and private study purposes. Any substantial or systematic reproduction, redistribution, reselling, loan, sub-licensing, systematic supply, or distribution in any form to anyone is expressly forbidden. Terms & Conditions of access and use can be found at http:// www.tandfonline.com/page/terms-and-conditions

Development of a Multimethod Clinical Protocol for Assessing Stimulant Drug Response in Children With Attention Deficit Disorder

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Page 1: Development of a Multimethod Clinical Protocol for Assessing Stimulant Drug Response in Children With Attention Deficit Disorder

This article was downloaded by: [UQ Library]On: 05 November 2014, At: 08:35Publisher: RoutledgeInforma Ltd Registered in England and Wales Registered Number: 1072954 Registered office: Mortimer House,37-41 Mortimer Street, London W1T 3JH, UK

Journal of Clinical Child PsychologyPublication details, including instructions for authors and subscription information:http://www.tandfonline.com/loi/hcap19

Development of a Multimethod Clinical Protocol forAssessing Stimulant Drug Response in Children WithAttention Deficit DisorderRussell A. Barkley , Mariellen Fischer , Robert F. Newby & Michael J. BreenPublished online: 07 Jun 2010.

To cite this article: Russell A. Barkley , Mariellen Fischer , Robert F. Newby & Michael J. Breen (1988) Development of aMultimethod Clinical Protocol for Assessing Stimulant Drug Response in Children With Attention Deficit Disorder, Journal ofClinical Child Psychology, 17:1, 14-24, DOI: 10.1207/s15374424jccp1701_3

To link to this article: http://dx.doi.org/10.1207/s15374424jccp1701_3

PLEASE SCROLL DOWN FOR ARTICLE

Taylor & Francis makes every effort to ensure the accuracy of all the information (the “Content”) containedin the publications on our platform. However, Taylor & Francis, our agents, and our licensors make norepresentations or warranties whatsoever as to the accuracy, completeness, or suitability for any purpose of theContent. Any opinions and views expressed in this publication are the opinions and views of the authors, andare not the views of or endorsed by Taylor & Francis. The accuracy of the Content should not be relied upon andshould be independently verified with primary sources of information. Taylor and Francis shall not be liable forany losses, actions, claims, proceedings, demands, costs, expenses, damages, and other liabilities whatsoeveror howsoever caused arising directly or indirectly in connection with, in relation to or arising out of the use ofthe Content.

This article may be used for research, teaching, and private study purposes. Any substantial or systematicreproduction, redistribution, reselling, loan, sub-licensing, systematic supply, or distribution in anyform to anyone is expressly forbidden. Terms & Conditions of access and use can be found at http://www.tandfonline.com/page/terms-and-conditions

Page 2: Development of a Multimethod Clinical Protocol for Assessing Stimulant Drug Response in Children With Attention Deficit Disorder

Journal of Clinical Child Psychology 1988, Vol. 17, No. 1, 14-24

Copyright 1988 by Lawrence Erlbaum Associates, Inc.

Development of a Multimethod Clinical Protocol for Assessing Stimulant Drug Response in Children With Attention Deficit Disorder

Russell A. Barkley Department of Psychiatry

University of Massachusetts Medical Center

Mariellen Fischer, Robert F. Newby, and Michael J. Breen Department of Neurology

Medical College of Wisconsin

We developed a protocol for clinical assessment of stimulant drug response in children with attention deficit disorders (ADD) and used a triple-blind, placebo-controlled crossover design to assess the effects of two doses of Ritalin (.3 mg/kg and .5 mg/kg BID) and a placebo. The 1-hr assessment battery, administered at the end of each 1-week drug condition, consisted of parent and teacher ratings of ADD behaviors, problem settings, drug side effects, laboratory tests of vigilance and impulse control, and clinic playroom observations of ADD behaviors during academic performance. Twenty-three of twenty-eight 5- to 12-year-olds completed the entire study. Results demon- strated that most measures in the protocol were sensitive to both doses of medication. Eighty percent of the children were judged positive responders to medication. This quantitative, objective protocol for the clinical evaluation of stimulant drug response is feasible and cost-effective. It should represent a substantial improvement over the use of subjective impressions now common- place in clinical practice.

Stimulant drugs remain the most commonly recommended treatment for children with atten- tion deficit disorders (ADD), particularly for those ADD children in pediatric and child psychi- atry clinics (Barkley, 1981; Dulcan, 1985). Yet, the decision to medicate such children is often based solely on initial parental interviews and drug titration conducted via only telephone conversa- tions during the drug trial. Although many decry the unreliability of such sources of information in general (Ullman et al., 1981) and point to the need for more systematic and objective evaluations of drug responding specifically (Cantwell, 1980; D. M. Ross & S. Ross, 1982), an objective, multi- method, yet cost-effective assessment protocol

Portions of this article were presented at the meeting of the American Psychological Association, Los Angeles, August 1985.

We thank Kathy Schoendorf for her assistance with data collection and transcription and Lewis Bloomingdale for his comments on previous drafts of this article.

Requests for reprints should be sent to Russell A. Barkley, Department of Psychiatry, University of Massachusetts Med- ical Center, 55 Lake Avenue North, Worcester, MA 01605.

for use in clinical practice has remained elusive. Objective laboratory tests and direct observational methods for evaluating stimulant drug effects have been used for more than 15 years in the research literature (Barkley, 1977; CantwelI & Carlson, 1978), but they are expensive, cumber- some, or unavailable to clinicians. However, re- cent developments in direct behavioral observa- tion systems (Barkley, 1987a; Milich, Loney, & Landau, 1982) and in microcomputer technology (Gordon, 1983; Klee & Garfinkel, 1983) allow for the adaptation of these previously cumbersome research instruments to the efficient clinical assess- ment of inattention, impulsivity, and other ADD behaviors in children.

This article describes (a) the development of a protocol for the clinical assessment of ADD chil- dren and their stimulant drug responses and (b) use of this protocol with 28 clinic-referred ADD children. Varley and Trupin (1983) previously described a double-blind clinical protocol for eval- uating stimulant drug responding, but their pro- cedure employed only brief parent and teacher ratings of behavior. Kinsbourne and Swanson (see

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STIMULANT DRUG PROTOCOL

Dalby, IKinsbourne, Swanson, & Sobol, 1977) were probably the first to report the use of an obje:ctive: instrument for clinically assessing stim- ulant drug responses, but they relied solely on one measure (a paired-associate learning task) of only one type of behavior and typically conducted the evaluation of the chid within a single day. More relialble and valid information can be obtained fronn assessments that rely on different informa- tion sources (parent, teacher, clinician) from dif- ferent settings (home, school, community) using different methods (ratings, laboratory tests, direct behi~vioral observations) combined into a single protocol (Mash & Terdal, 1981) that examines drug responding over a more reasonable length of time:. After ireviewing the recent research litera- ture, we selected those methods demonstrating the most robust sensitivity to stimulant drug effects and requiring a minimum investment of time and resources for a clinical service.

The! Drug Evaluation Protocol

Twenty-eight 5- to 12-year-olds suspected of having ADD were referred to this drug assessment service. The .21 boys and 7 girls all were believed by r~eferring professionals to have ADD. Of these, 3 were not accepted for study for reasons to be described, artd 2 were prematurely discontinued during the evaluation due to the development of tic reactions to the medication. In both these 2 children, the tics subsided within several days after the medication was discontinued. Denckla, Bem~porad, and MacKay (1976) found that fewer than1 2% of a large number of ADD children receiiving medication in their clinical practice de- veloped tic reactions. Our results suggest that such reactions may be more common among ADD children exposed to stimulants than had previously been believecl. Clinicians should therefore ques- tion parents thoroughly during drug trials about such movement disturbances.

To be elig4ble for the drug evaluation, the chilclren bad to meet the following criteria:

1. Parlent and/or teacher complaints of poor sustained attention, impulsivity, and restless- ness.

2. Presence of these behavior problems for at least 12 months.

3. Onset of the problems by 6 years of age. 4. Scores an the Hyperactivity factor of either

the Conners Parent Rating Scale-Revised (CPRS-R) or the Conners Teaching Rating

Scale-Revised ((CTRS-R; Goyette, Conners, & Ulrich, 1978) of at least. 1.5 SD above the mean for same-age, normal children.

5. No history of mental retardation or signifi- cant developmental delay.

6. Absence of epilepsy, grobss brain damage, gross sensory deficitb, or severe emotional disturbance (autism, , sycliosis, etc:.).

7. No history of tic 4 'sorclers or 'Tourette's syndrome, cardiovas$ular problems, or pre- viously poor responsg to Ritalin afiter 5 years of age.

Procedures

After we received apprpval from the Human Research Review Committ(ee of the Medical Col- lege of Wisconsin, the qssessment service was advertised in letters sent tc/ all pediatiricjans, child psychiatrists, and child nelprologists in the greater Milwaukee area. Care was taken to explain the purpose and procetlul-es of tlie service and to assure area clinicians that ongoing pr~ofessional care of the ADD childrep would remain under their supervision. Cliniciqs wishing to refer chil- dren to the service plrovidqd a letter of referral, a separate letter authorizing schalol staff to adrnin- ister the noon dose of mepication (nirutdatory in Wisconsin public scliools), and a prescription for both doses of methjrlphen date (.3 and .5 mg/kg given twice daily).

I I

This prescription was sqnt to the pharmacy of an affiliated hospitad for preparation of the two doses and placebo. The ldctose placebo and ap- propriate dosages were prebareci to the nearest 2.5 mg using regular (5- and 10 mg size) Ritalin tablets that were then crushled an placed within orange opaque gelatin capsules ( 4 e 16, Ely Lilly Com- pany). Modal doses in the tudy were 7.5 and 12.5 mg twice daily. Caplsules isguised both the dif- ferences in doses across th three drug conditions as well as the distinct tas e differences between Ritalin and placebo. Pdth ugh each drug condi- tion lasted 1 week, extra ca sules were provided to permit the reschedullinjg o 1 the clinic visits when necessary (e.g., due to chi14 illness) without undue inconvenience in supplyi g families with more medication. Unused caj3sul s were returned to the clinic staff at the end of e ch week to allow for a convenient check on colmp iance to the tirug regi- men. 1

Children were initially sden for a 1%-hr evalua- tion consisting of thie lmealsures to be described. This screening was conlducfed to ensure that chil- dren referred for this serviqe were appropriate for such a drug trial. Of t;we+tt)r-eight 5- to 12-year olds referred to the service cluring its first 9

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BARKLEY, FISCHER, NEWBY, & BREEN

months, 3 were deemed inappropriate for the drug trial based on this initial evaluation. One child had a history of multiple-tic disorder and was not accepted for participation due to the possible stimulant-related increase in tics (Comings & Comings, 1984; Golden, 1982); a second child had a cerebral vascular accident 1 year earlier and was not accepted for participation due to the known cardiovascular pressor effects associated with Ritalin (Cantwell & Carlson, 1978; Hastings & Barkley, 1978); a third child was diagnosed as having only oppositional disorder of childhood without evidence of ADD.

Those children deemed eligible for the protocol were then scheduled for 3 weekly evaluations. Parents were provided with the first week's supply of the drug/placebo and with the telephone num- bers of the first author. If parents observed side effects of concern to them, they were instructed to contact the first author, who would then notify the referring physician and discuss whether to discon- tinue the drug trial. As already mentioned, 2 of the 28 children initially referred were discontinued due to the development of tic reactions to the medica- tion, Both had been given the .5-mg/kg dose. Children were randomly assigned to one of the six possible drug sequences of the placebo (P), low- dose (L), and high-dose (H) conditions: PLH, PHL, LHP, LPH, HPL, HLP.

The parents, children, the children's teachers, and the clinical assistant conducting the weekly drug evaluations were kept blipd to the child's drug condition and sequence until the end of the entire evaluation. At that time, the drug code was broken, and the pareats were informed of the sequence and dose levels. The children were al- ways evaluated an the last day of each drug conditi~n, and the clinical assistant ensured that the, children received a dose of Ritalin no more than 1 hr prior to the evaluation. After the final assessment, the findings of the entire evaluation were then reported to the referring physician, and the care of tho c;hild was returned to his or her clinical practice, Recomme,ni&tions for additional foms of treatment (e.$., parent training in be- havior man&gemant, mqrriage counseling, indi- vidual therapy f ~ r parents evidencing depression, referral of chid for sp~cibl educational assess- ments, etr;.) were occasionally made based on the findings of the initial clinic evaluation of the children and their parents.

Assessment Methods

Initial clidicbll evduation. The initial clinical evaluation consisted of the following measures:

1. Semistructured parental interview regarding present behavioral, emotional, and learning prob- lems; developmental, medical, and school histo- ries; and family history and current family prob- lems.

2. Vigilance and impulse control: These con- structs were assessed using the Gordon Diagnostic System (GDS; Gordon, 1983). The GDS used a small computer that permitted two tests to be administered to the child in a machine-paced fashion. The device was a metal box with a display screen on the front surface and a large blue button beneath it. Just above the screen were one red and one green light. The first test was a delay task believed to assess impulse control. It required that the child sit before the device, wait a short period of time, and then press the blue button. If the child waited a sufficient period of time (6 sec) and then pressed the button, the green light appeared and the child earned a point. Cumulative points were displayed on the screen. If the child did not wait an adequate period of time before pressing the blue button, the green light did not appear and no point was awarded. The children were not told by the experimenter how long to wait -only that if they waited long enough, they could earn a point. The task lasted 8 min, and the child's scores were the number of correct responses (successful de- lays), the total number of responses, and the ratio of correct responses to total responses (efficiency ratio), Gordon (1979) showed that the dday task significantly discriminates hyperactive from nonhyperactive clinic-refefred children and is sig- nificantly correlated with teacher ratings from the CTRS. This measure was included for experi- mental purposes, as no research has b ~ e n can- ducted on its sensitivity to stimulant drugs.

The second test w a ~ a measure af vigilance or sustained attention and was similar to tha contin- uous performance taslks used in stimulant drug research with ADD children (Biarkley, 1977). The child sat before the ddct:, and a series of numbers was shown on the screen at a rate of one per second. Each number was Bispllayad for 600 msec. The 6- to 12-year-alds were to press the blue button whenever the number 1 was fallowed im- mediately by 9. The 5-year-olds were told to watch only for the number 1 to appear and then to depress the button, The task lasted 9 &. The child's scores were the number of carrect re- sponses, the number of omisgions (missed target stimuli), and the number of commission errors. Normative data are available for 3- to 16-year-olds for both GDS tasks. Gordon (p&sanal ccrmmuni- cation, January 1986) reportad test-retest coeffi- cients for 90 normal children over a 30- to 45-day

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STIMULANT DRUG PROTOCOL

interval for the delay task of .77 for total re- sponses, .68 for number correct, and .60 for efficiency ratio; for the vigilance task, test-retest coefficients were .66 for total correct, .72 for errors of ~comlmission, and .80 for errors of omis- sion.

3. ADD behaviors during a restricted academic situation: Following the testing of the children, the experimenter took the mother and child to a 12- X 18-ft playroom equipped with a one-way mirror and intercom. The mother was asked to have her child perform a series of math problems. The child sat ait a small table away from his or her mother. The ]mother was seated on a sofa situated across the room; she read magazines. The mother was told t.o see to iit that the child remained at the table, did riot interrupt her, and completed the prob- lems. Three sets of math problems of varying difficulty levels were available. The problems were chosen from math workbooks commonly avail- able at local educational stores. The set most appropriate far the child's age was used. Sets were available for 5- to 6-year-olds, 7- to 8-year-olds, and '9- to 11-year-olds. Each set contained five pager; of math problems, which would ensure that the clhild did nlat finish the task before the 15 min of observatio~m were completed. Three different versions of each difficulty level were used to reduce the likelihood of practice effects over the 3 weeks.

During this 15-min period, the clinical assistant coded mother and child behavior. A tape recorder was used to cue the coder as to the occurrence of each 36-sec interval. During each interval, the coder scored the occurrence of each of eight behaviors. The category was checked as occurring only once, regardless of the frequency of its occurrence, during each 30-sec interval. The cate- gories were off-task, fidgets, vocalizes, talks to mother, plays with objects, out of seat, child negative, and mother commands. A single score was (derived for each category, this being the percentage occurrence of these behaviors relative to the: total porssible occurrences for that behavior. A total percentage occurrence for all behaviors was adso derived as a single total ADD behaviors score.

This observational system was selected to eval- uate those disruptive behaviors most frequently seen in ADD children during situations many ADD children find most difficult: situations in which1 they are required to accomplish sustained, boring tasks independently of adult assistance. Prior research has shown that a similar restricted academic situation and coding system not only discriiminated ADD children from normal children

but also discriminated ADD children from non- ADD conduct-problem childrein (Milich et al., 1982). A similar coding system allso showed signif- icant stability over a 2-year period for normal and clinic-referred children (MiPich, 1984; Milich, Loney, & Whitten, 1983) and significant correla- tions with teacher ratings of l~yperactivity and behavior problems.

The coder was trained to1 a level of 75% agree- ment with the first author psing prerecorded vid- eotapes of mothers and cqdren in this situation. Subsequently, intercoder rebability estimates were taken on 5 of the childrep by a second coder. Intercoder reliability was calculated using the number of agreements divided by the total pos- sible number of occu~rrenceS. Intercoder reliability averaged .77.

4. Parent ratings of chi1 belhavior: The child was being given the la~bo tory tasks while the

child's behavior:

$ mother completed several ratiing scides of her

a. The Child ~lelnavi~r Checklist (CBCL; Achenbach & Edelbroc , 19133) is a 118-item

lc rating scale having taro s ctioins-one assessing social competence anid t e other aissessing be- havior problems. The sc a le ~ i i s used because it provides a generally co@reh~ensive assessnnent of parent ratings of m st iolf the commonly occurring dimensions; o psychopathology in children and has lbeen s own to discriminate ADD from normal1 hildren ~(Edelbrock, Costello, & Kessler, 398 1 ). Normative data are available for 4- to 16-ye -olds of both sexes.

b. The CPRS-R. ((30 te et al., 1978) is a 48-item questionnaire co cerning various types of child behavior proble 1 s. Each item is scored on a 0-to-3 scale. The s ale can ble scored to yidd five factors: <:ondu t Pnoblems, Learning Problems, Psychoaomat'c, ! [mpulsive-Hyper- active, and Anxiety. Fac$or scores were calcu- lated by summing thr; pqints assigned to each item loading on that Picto . Thie originail version of this scale was sho to be sensitive to stimulant drug effects (B rkley, 195'7). The re- vised scale has no resear f on its drug sensitiv- ity, but it was ennplloy d here because it is similar to the original o m and because it required far less time b I the parents to com- plete. Although redunda4t with the GBCL in- formation as part of evaluation, the CPRS-R was used fin

the likelihood that its drug protocol would that might confound known to occur with rily develop between

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BARKLEY, FISCHER, NEWBY, & BREEN

istrators. Barkley (1987b) recommended that it be administered once before using it to assess treatment effects.

c. The Home Situations Questionnaire (HSQ; Barkley, 1981) is a rating scale that required parents to answer whether a child posed behavior problems in each of 16 situa- tions listed on the scale (i.e., while playing alone, when asked to do chores, in public places, etc.). If so, the parent indicated the severity of the problem using a scale ranging from mild (1) to severe (9). Two scores were obtained: the total number of problematic set- tings and the mean severity score. The scale differentiates ADD children from normal chil- dren (Barkley, 1981; Tarver-Behring, BarMey, & Karlsson, 1985) and is sensitive to stimulant drug effects (Barkley, Karlsson, Pollard, & Murphy, 1985). Norms are available for 4- to 1 1-year-olds (Barkley & Edelbrock, 1987). 5. Parent self-report measures: The children

completed the laboratory tests while their mothers completed the follawing questionnaires. This was to provide a more comprehensive description of each child's family. Previous research has demon- strated that parents of ADD children have signif- icantly more problems with stress, depression, and marital discord than those of normal children (Befera & Barkley, 1985).

a. The Parenting Stress Index (PSI; Burke & Abidin, 1980) is a 150-item multiple-choice questionnaire that yields six scores pertaining to child behavioral characteristics (e.g., distracti- bility, mpod, etc.), eight scores pertaining to maternal charxteristics (e.g., depression, sense of competencs as a parent, etc.), and two scores pertaining to situational and life stress events. These scores can be summed to yield three domain or summary scores: child domain, mother domain, and total stress.

b. The Beck Depression Inventory (BDI; Beck, 1967) is a 21-item multiple-choice ques- tionnaire designed to permit a quick assessment of self-reported levels of depression in the re- spondent. The total score is the sum of the number of credits ner item across all items. Higher scoras reflect greater depression. The ED1 was used because prior research showed that mothers; of ADD children may be more depressed than thoee of normal children (Befera & Barkley, 1985).

c. The Lqqke-Thomes Marital Adjustment Scale (Lacke & Thomes, 1980) is a brief, 19-item multiple-choice questiannaire designed to per- mit a quick assessment of marital discord. The score was the sum of the number of credits

assigned to each answer across all items. Lower scores reflect greater marital dissatisfaction. Previous research found mothers of ADD chil- dren, particularly those of boys, to have higher ratings of discord than mothers of normal chil- dren (Befera & Barkley, 1985). 6. Teacher ratings of child behavior: The

children's primary teachers were mailed a packet of rating scales to complete and return. This packet included:

a. The CBCL Teacher Report Form (Achenbach & Edelbrock, 1983) is a question- naire with two sections: The first deals with adaptive functioning at school, and the second deals with behavior problems. The adaptive functioning section can be scored for five scales (School Performance, Working Hard, Behaving Appropriately, Learning, and Happy) or two summary scores: one for school performance and the other for total adaptive functioning (sum of remaining four scales). The Behavior Problem scale has 113 items worded similarly to items on the CBCL Parent Report Form already described. Norms are available for 6- to 1 1-year- olds and 12- to 16-year-olds of each sex. The scales for 6- to 11-year-old boys are Anxious, Social-Withdrawal, Unpopular, Self-Destruc- tive, Obsessive-Compulsive, Inattentive, Ner- vous-Overactive, and Aggressive.

b. The CTRS-R (Goyette et al., 1978) is a 28-item questionnaire constructed similarly to the CPRS-R already described. Each item was scored on a 040-3 scale. The factors are Con- duct Problems, Hyperactivity, and Inattentive- Passive. Factor scores were calculated as the sum of the points for those items loading on that factor. The origiaal versioo of this rating scale (Conners, 1969) is one of the most widely used and sensitive measures of drug responding in ADD children (Barkley, 1977). Edelbrock, Greenbawn, and Conovex (1985) recently re- ported 1-week test-retest coeffiaients of $95 for Conduct Problems, .95 for Hyperactivity, .88 for Inattention, and .96 for the Hyperactivity Index. Again, as with the GPRS+R, this scale is redundant with infarmation from the CBCL Teacher Report Form. Because the CTRS-R has a significant practice effect between first and second administrations, however, it was given as part of the initial evaluafion to reduce the likelihood that practice effbcts on the scale would confound results when used in the re- peated drug assessment battery.

c. The School Situations Questionnaire (SSQ; Barkley, 1981) is a rating scale similar to the HSQ except that the settings to be rated deal

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STIMULANT DRUG PROTOCOL

witlh school situations most likely to be prob- lemlatic for ADD children. The scale lists 12 situations (i.e., during individual desk work, in the hallways, during large group work, etc.), andl the teacher was asked to indicate whether the child was a problem in each. If so, the teacher rated the problem on a scale ranging from mild (1) to severe (9). Two scores were derived: the number of problem settings and their mean severity rating. Norms are available for 6- to 11-year-old children (Barkley & Edelbrock, 1987).

Repeated drug evaluation battery. The vast majol-ity of the measures just described were repeated each week during the drug evaluation. Those not repeated were the parent and teacher versio~ns of the CBCL and the parent self-report measures (the PSI, the BDI, and the Locke- Thorr~es scale), These measures were not repeated because they have not been shown to be sensitive to stimulant drug effects and were not of interest in the 3-week drug assessment. They were used during the initial evaluation of each child as diagnostic aides or to evaluate various aspects of family functioning pertinent to determining future treatment recommendations for the child or fam- ily.

One measurie not used in the initial evaluation but repeated during each week of the drug trial was a rating scale of side effects. The Side Effects Rating Scale has been used in previous drug studies to obtain information about the occur- rence of 17 possible side effects known to occur with Ritalin (Rarkley, 1981). Parents or teachers answered yes or no as to whether each side effect was noted the previous week, and, if so, they rated its severity u s i~~g a scale ranging from mild (1) to severep (9). Two scores were derived from both the parent- and the teacher-completed scales: the number of sidle effects and their mean severity rating. These measures have been shown to be sensitive to dotre effects of Ritalin (Barkley et al., 1985).

Results

The initial characteristics ~f the 23 (17 male, 6 female) children completing the full evaluation and their parents are set forth in Table 1. These findings suggest that this sample was quite deviant from normal with respect to parent and teacher ratings of behavior and pervasiveness of the be- havior problems across situations. However, some children were identified as ADD (Hyperactivity factor score greater than 1.5 SD above the normal mean) by their teachers but not by their parents on

Table 1. Means, Standard lkviations, and Ranges of Variables Assessed in the Clinical Protocol

Measure

Age (in Years) Child's Education (in Yean;) Age of Onset of ADD (in Years) 'Mother's Age (in Years) Mother's Education (in Years) HSQ

Number of Problem Settings Mean Severity of Proble~ms

CPRS-R Conduct Problems Hyperactive-Impulsive Hyperactivity Index

CBCL (T Scores) Hyperactivity Delinquency Aggression

SSQ Number of Problems Mean Severity

CTRS-R Conduct Problems Hyperactivity Inattention

CBCL Teacher Report Fonn (T Scores)

Inattention Nervous-Overactive Aggression

BDI Locke-Thomes Scale PSI (Percentile)

Total Stress Domain Child Domain Mother Domain Parent Depression Scale

Range

5.4 to 12.9 0 to 6 1 to 6.9

27 to 44 11 to 18

2 to 16 1 to 6.8

3 to 27 0 to 12 5 to 26

56 to 85 56 to 86 55 to 88

2 to 12 2.7 to 7.5

6 to 23 2 to 21 6 to 24

56 to 87 55 to 86 55 to 83 1 to 27

38 to 160

30 to 100 65 to 100 10 to 95 10 to 95

the Conners scales, whereas others were so identi- fied by their parents bid by their teachers.

and Inatten-

both ADD and conduct (ems. Their mothers did not appear to be rno than normal, as indicate on the PSI, but did rep lems and stress with the Similarly, the mothers more depressed than having more marital ( Locke-Thomes scale, mended cutoff scores.

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These children had a mean performance that fell in the borderline range (between 5th and 10th percentile) on the delay task and made more errors than normal on both commission and omission errors on the vigilance task of the GDS. Behav- ioral observations during the restricted academic situation in the clinic playroom found that these children spend an average of 50Vo of their time en aged in off-task behavior and 35% in fidget- B ing. This is hardly surprising given the reasons for their referral, but it validates the success of this observational method at detecting these problems. The children engaged in vocal noises or self- directed speech 30% of the time and spoke to their mothers, even though they had been asked not to do so, approximately 25% of the time. The chil- dren engaged in fiegative behaviors such as whin- ing, refusal to do work, or tantrums approxi- mately 7% of the time, and their mothers initiated commands toward the children during 14% of the observations. Overall, ADD behaviors were noted during an average of 25% of the observational intervals.

Reliability of Measures

When utilizing measures in a repeated-assess- ment battery such as this, it is essential that the measures have satisfactory test-retest reliability between repeated administrations when no treat- ment occurred in the interim. To gain information about the test-retest reliability on the measures when such was lacking, scores from the initial assessment were correlated with those taken during the placebo condition. Such a method will likely yield lower estimates of reliability than the more traditional method of using fixed time inter- vals between two administrations of a measure in that both the number of weeks (1 to 3) and hence the number of repeat administrations of the meas- ures varied across participants (e.g., some children received placebo the first week, others the second, and others the third).

For the CPRS-R, coefficients across this 1- to 3-week interval were .65 for Conduct Problems, .57 for Impulsive-Hyperactive, and .53 for the Hyperactivity Index. For the HSQ, reliability was .66 for the number of problem settings and .62 for the mean severity rating. Coefficients for the same measures for the SSQ were .78 and .63, respec- tively. For the total ADD behaviors taken in the restricted academic situation, reliability was 36. All coefficients were statistically significant. Con- sidering that these are lower-bound estimates of reliability, the actual test-retest reliability of these measures Csing more traditional procedures would certainly prove higher. Hence, the reliability of all

measures seems quite adequate. No reliability was calculated for the Side Effects Rating Scale, as it was not administered as part of the initial evalua- tion of the children but only during the repeated drug evaluations.

Drug Effects

All dependent measures used in the repeated- assessment battery across the drug conditions were submitted to one-way (drug-condition) analyses of variance with repeated measures. The means, stan- dard deviations, and results of the statistical tests are set forth in Table 2. Significant main effects for drug condition were noted on 16 of the 31 dependent measures. The majority of these effects were found on the teacher ratings and on the behavioral observations taken in the clinic during the restricted academic situation. Surprisingly, significant drug effects were not noted on the percentage of math problems performed correctly during this playroom observation, but this may have resulted from the use of different types of math problems across the three testing conditions. The number and rated severity of side effects were also not significantly affected by these two doses of medication. In view of the many drug-related improvements in behavior, this suggests that the dose levels were well within a judicious therapeutic range for these children.

Pairwise comparisons were conducted on the 16 measures having significant main effects, and these results are shown in parentheses in Table 2. On the vast majority of these measures, the low and high doses were equally effective in improving the behavior of these children. Only on the behav- ioral category of "plays with objects" during the restricted academic situation was a significant dose effect noted for the high dose compared to the low dose. Although both doses resulted in a significant reduction in this behavior, the high dose p~oved more effective.

Although significant drug effects were noted on the vigilance task of the GDS, only the high dose of Ritalin r~sulted in significant improvements on both errors of commission and errors of omission.

At the end of each child's evaluation, the results were reviewed by the psychologist supervising the drug trial, and a recommendation was made to the referring physidan as to which dose level, if either, appeared to have been more effective for this child. All results entered into this clinical decisi~n, with that dose making the greatest changes in behavior acra$s tha most measures and with the least side effects being chosen, as the best dose for the child, As a result of these clinical judgmerits, 9 (20%) of the 25 children entering the protocol

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Tablle 2. Means, Standard Deviations, and Statistical Test Results on the Dependent A4easures for Each Drug Condition

Placebo Low Dose

Measure M SD M SD

HSQ Number of Problems 8 .O 4.5 7.4 4.2 Mean Severity 4.1 1.9 3.2 1.8

0' < H) CPRS-R

Cor~duct Problem 10.7 7.7 8.8 6.4 Hyperactive 7.0 3.3 5.0 3.2 (I' > L, P > H)

Index 13.3 6.9 10.8 6.1 Side E:ffects Rating Scale-Parent

Number 5 .O 4.0 5.1 3.9 Mean Severity 3.4 1.7 2.6 1.7

SSQ Nurnber of Problems 5.8 3.3 4.3 2.7

0' > L) Mean Severity 4.3 2.3 2.6 1.8

(I' > L, P > H) CTRS-R

Contduct Problem 7.2 6.0 4.2 4.4 (£'> L , P > H)

Hyperactivity 11.1 6.5 6.7 5.1 (I' > L, P > H)

Inattention 10.8 5.0 8 .O 4.7 (P > L , P > H)

Indtz 14.3 7.1 8.9 5.7 (E' > L, P > H)

Side Effects Rating Scale-Teacher Nunnber 3.8 3.3 3.3 2.8 Meam Severity 3 .O 2.3 2.6 2.1

GDS Delay Task Nunnber of Rewards 40.1 13.0 41.4 19.0 Nunnber of Responses 71.5 42.2 74.5 61.1 Efficiency Ratio 66.8 27.4 73.7 28.7

GDS Vigilance Nuanber Correct 40.8 18.9 39.3 15.6 Commission Errors 14.5 19.4 16.7 22.4

(F' > H, L > H) Omission Errors 10.0 12.1 9.6 15.5

(F' > N, L > H) Playroom Observations

(Percentage) Off Task 58.1 32.3 45.4 25.7

(P > L, P > H) Fidgets 38.3 25.4 27.4 20.8 Vocalizes 38.9 32.9 29.0 27.5 Tidks to Mother 26.5 33.3 19.3 26.5

(P > L, P > H) Plays With Object 14.8 20.3 7.2 13.4

(P > L , P > H) Out of Seat 12.6 24.7 5.4 16.4

(P > L, P > H, L > H) Child Negative 5.6 9.8 6.1 12.6 Mother Commands 15.8 25.6 9.7 19.4

(P > L, P > H) Total ADD Behavior 27.1 17.8 18.7 12.1

(P > L, P > H) Percentage Correct in

Math Problems 70.0 31.9 74.5 - 31.9

Note: ,Parentheses under the names of measures indicate the outcome of pairwise comparisons low dose, and H stands for high dose. *p < .05. **p < .01.

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BARKLEY, HSCHER, NEWBY, & BREEN

were not recommended for any medication (2 of these were the children discontinuing,prematurely due to tic reactions), 6 (24%) were recommended for the low dose, 8 (32%) were recommended for the high dose, and 6 (24%) were recommended for a moderate dose between the high and low doses. This latter recommendation was made when it was clear that both doses resulted in an effective drug response but that the high dose resulted in greater side effects for that particular child. Hence, 80% of the children entering the protocol were recom- mended for at feast some level of Ritalin following this drug/placebo evaluation. Comparisons on the initial evaluation measures of the responders and nonresponders were not undertaken, due to the inadequate sample sizes per group, to permit satisfactory statistical power in such comparisons.

Discussion

The results of this drug study suggest that an easily administered, cost-effective, multimethod assessment battery can be quite useful in the routine clinical evaluation of stimulant drug re- sponding in ADD children. Such a test battery draws on multiple sources and types of informa- tion using several methods of assessment and yields a wealth of clinically useful information on each case. The protocol can be administered in less than 1 hr per week, can be accomplished for a reasonable clinic fee (net cost for the 5 hr of evaluation for personnel, resources, drugs, and supplies was $120), and can be easily conducted by a paraprofessional having a short period of prior training in administering the tests (further en- hancing its cost-effectiveness).

The most useful measures for detecting stimu- lant drug effects were those derived from the teacher ratings and from the behavioral observa- tions of academic performance in the clinic play- room. Although some may be tempted to elimi- nate the use of the direct observational measures in favor of using only the more easily obtained teacher ratings, we recommend against it. First, the playroom measures proved equally if not more sensitive to the drug effects than did the teacher ratings of behavior in school. Second, it was our experience that such behavioral observations lent added credibility to the assessment protocol from the viewpoint of parents, teachers, and referring professionals in that they provided an objective assessment of the child's behavior apart from parent and teacher opinions. Third, when teacher ratings are not so readily obtained- teachers may not cooperate, they may be away during summer vacations, or their ratings may be believed to be unreliable- the clinic playroom measures are a

reasonable substitute. Finally, it is useful in such assessments to build in a modicum of redundancy across measures in order to corroborate the drug effects noted by one method applied in one setting with one source against those from a different method, setting, and source.

Similarly, although it would seem at first glance more efficient to dispense with the parent ratings because they were of little value in detecting drug or dose effects, this, too, would be a mistake. These measures were useful in the initial diagnosis of the children and provided a necessary vehicle for parents to inform clinic staff of their observa- tions across drug conditions. In some cases, these ratings revealed significant drug effects or side effects of use in further treatment planning. In fact, several parent ratings (hyperactive-impulsive behavior and mean severity score of problem behaviors) did show significant drug effects, par- ticularly at the high dose. Moreover, such ratings were valuable in providing ecologically valid as- sessments of behavior in an important setting (home) as reported by very important observers (parents) whose views in part resulted in the initial referral of the child. Nor should it be at all surprising that drug effects were limited on the parent-reported data, as parents have much less opportunity to observe drug effects given the short time course of the effects (6 to 7 hr), and such effects have often dissipated shortly after the child has returned home from school.

The failure of the GDS delay task to prove sensitive to drug effects was surprising in view of its purported evaluation of impulsivity-a be- havior typically responsive to stimulant drug ef- fects - and its previously demonstrated ability to differentiate clinic-referred ADD children from clinic-referred non-ADD children (Gordon, 1939). Perhaps practice effects develop on this measure over repeated administrations (Douglas, personal communication, Oct~ber 1985) such that a ceiling effect develops beyond which medication effects cannot be detected. This would suggest that varying the dday interval across the three repeated assessments and forewarning the child in each session that the waiting time between button presses is different from that of the previous week might help to overcome this effect. In its qurrent format, then, the delay task appears to have little utility in such a drug-assessment proto~iol.

Significant drug effects were noted on the GDS vigilance task for both errors of comdasion and errors of omi~lsion, but only at the hi@ dose of Ritalin. A simjlar result for this same m k u r e was found by Rapport, Stoner, DuPaul, Binpingham, and Tucker (1965). This is difficult to &plain considering that vigilance tasks of this sort are

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generally quite sensitive to lower doses of medica- tion in testing periods even shorter than that used here (Sykes, Douglas, Weiss, & Minde, 1971; Werry & Aman, 1975). Perhaps extending the length of this test - say from 9 to 12 min-might enhance its sensitivity to the lower doses of med- ication. Nevertheless, the considerable expense of the device and its insensitivity to the lower doses of medication may prevent it from being cost- effective in a clinical protocol such as this. How- ever, retention of some type of vigilance measure in the drug protocol is recommended for the time being, as it remains one of the few objective measures of sustained attention, and it has been shown to be dose-sensitive in many prior drug studies (Barkley, 1977).

The addition of a brief verbal learning and memory task to this protocol might enhance the sensitivity of the laboratory tasks to stimulant drug effects while providing a measure of drug effects in a different domain of cognitive ability not presently assessed yet of import to academic performance. Numerous prior stimulant drug studies have found the paired-associate learning task (PAL) to be sensitive to varying doses of stimulant medication (Dalby et al., 1977; Douglas, Barr,, 07Neill, & Britton, 1986; Rapport et al., 1985). The particular version of this task used by Douglas et al. (1986), or the children's version of the Selective Reminding Test (Taylor, 1985) ap- pears; to be the easiest and least time-consuming to administer, as well as the least expensive of these tasks.

The results of the present study encourage the development of regional drug evaluation clinics to which area professionals can refer ADD children for objective, multimethod, yet economical stim- ulant drug evaluations to replace the currently less reliable and more subjective approach employed in routine clinical practice. Many medical schools, hospitals, and mental health centers have the persoinnel and the financial and physical resources availi~ble to conduct these protocols easily and to return useful information rapidly to the referring professional for the ongoing care and manage- ment of ADD children, Moreover, the use of a relatively consistent protocol such as this one across numerous regional drug-assessment centers that then combine their findings could also greatly accelerate the collection of scientific information on much larger participant samples than has here- tofore been the case. The relatively high preva- lence of the disorder and the widespread use of stimulant drugs to treat it demand no less than the most objective, reliable* valid, and cost-effective routine clinical assessment protocol our present scientific knowledge and technology can provide.

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Received June 16, 1986 Revision received January 20, 1987

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