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document
Assessment in multisite randomized clinical trials of patients with autistic disorder : the Autism RUPP Network . Research Units on Pediatric Psychopharmacology . Assessment of autistic disorder ( autism ) symptoms , primary and secondary , poses more challenging problems than ordinarily found in multisite randomized clinical trial ( RCT ) assessments . For example , subjects may be uncommunicative and extremely heterogeneous in problem presentation , and current pharmacological treatments are not likely to alter most core features of autism . The Autism Research Units on Pediatric Psychopharmacology ( RUPP Autism Network ) resolved some of these problems during the design of a risperidone RCT in children/adolescents . The inappropriateness of the usual anchors for a Clinical Global Impression of Severity ( CGI-S ) was resolved by defining uncomplicated autism without secondary symptoms as a CGI-S of 3 , mildly ill . The communication problems , compromising use of the patient as an informant , were addressed by several strategies , including careful questioning of care providers , rating scales , laboratory tests , and physical exams . The broad subject heterogeneity requires outcome measures sensitive to individual change over a wide spectrum of treatment response and side effects . The problems of neuropsychologically testing nonverbal , lower functioning , sometimes noncompliant subjects requires careful instrument selection/adaptation and flexible administration techniques . The problems of assessing low-end IQs , neglected by most standardized test developers , was resolved by an algorithm of test hierarchy . Scarcity of other autism-adapted cognitive and neuropsychological tests and lack of standardization required development of a new , specially adapted battery . Reliability on the Autism Diagnostic Interview ( currently the most valid diagnostic instrument ) and other clinician instruments required extensive cross-site training ( in-person , videotape , and teleconference sessions ) . Definition of a treatment responder required focus on individually relevant target symptoms , synthesis of possible modest improvements in many domains , and acceptance of attainable though imperfect goals . The assessment strategy developed is implemented in a RCT of risperidone ( McDougle et al. , 2000 ) for which the design and other methodological challenges are described elsewhere ( Scahill et al. , 2000 ) . Some of these problems and solutions are partially shared with RCTs of other treatments and other disorders .
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Intervention_Pharmacological
risperidone RCT
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Intervention_Pharmacological
risperidone
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Outcome_Physical
autistic disorder
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Outcome_Physical
autistic disorder ( autism ) symptoms , primary and secondary
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Outcome_Physical
communication problems
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Outcome_Physical
careful questioning of care providers
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Outcome_Other
rating scales
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Outcome_Other
laboratory tests
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Outcome_Other
physical exams
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Outcome_Other
response
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Outcome_Adverse-effects
side effects .
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Outcome_Physical
low-end IQs
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Outcome_Physical
Autism Diagnostic Interview
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Participant_Condition
autistic disorder
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Participant_Age
children/adolescents
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Participant_Condition
autism