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Titolo:
Assessment in multisite randomized clinical trials of patients with autistic disorder: The autism RUPP network
Autore:
Arnold, LE; Aman, MG; Martin, A; Collier-Crespin, A; Vitiello, B; Tierney, E; Asarnow, R; Bell-Bradshaw, F; Freeman, PJ; Gates-Ulanet, P; Klin, A; McCracken, JT; McDougle, CJ; McGough, JJ; Posey, DJ; Scahill, L; Swiezy, NB; Ritz, L; Volkmar, F;
Indirizzi:
Indiana Univ, Bloomington, IN 47405 USA Indiana Univ Bloomington IN USA 47405 ana Univ, Bloomington, IN 47405 USA Johns Hopkins Univ, Kennedy Krieger Inst, Baltimore, MD 21218 USA Johns Hopkins Univ Baltimore MD USA 21218 r Inst, Baltimore, MD 21218 USA Ohio State Univ, Columbus, OH 43210 USA Ohio State Univ Columbus OH USA 43210 State Univ, Columbus, OH 43210 USA Univ Calif Los Angeles, Los Angeles, CA 90024 USA Univ Calif Los Angeles Los Angeles CA USA 90024 Los Angeles, CA 90024 USA Yale Univ, New Haven, CT 06520 USA Yale Univ New Haven CT USA 06520Yale Univ, New Haven, CT 06520 USA
Titolo Testata:
JOURNAL OF AUTISM AND DEVELOPMENTAL DISORDERS
fascicolo: 2, volume: 30, anno: 2000,
pagine: 99 - 111
SICI:
0162-3257(200004)30:2<99:AIMRCT>2.0.ZU;2-J
Fonte:
ISI
Lingua:
ENG
Soggetto:
PERVASIVE DEVELOPMENTAL DISORDERS; DIAGNOSTIC INTERVIEW; INFANTILE-AUTISM; DOUBLE-BLIND; WEIGHT-GAIN; FOLLOW-UP; CHILDREN; METHYLPHENIDATE; PERFORMANCE; RISPERIDONE;
Keywords:
autism; clinical trials; risperidone;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Social & Behavioral Sciences
Citazioni:
68
Recensione:
Indirizzi per estratti:
Indirizzo: Arnold, LE 479 S Galena Rd, Sunbury, OH 43074 USA 479 S Galena Rd SunburyOH USA 43074 Rd, Sunbury, OH 43074 USA
Citazione:
L.E. Arnold et al., "Assessment in multisite randomized clinical trials of patients with autistic disorder: The autism RUPP network", J AUTISM D, 30(2), 2000, pp. 99-111

Abstract

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 fora 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 individualchange 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 anew, 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 imperfectgoals. The assessment strategy developed is implemented in a RCT of risperidone (McDougle et al., 2000) for which the design and other methodologicalchallenges are described elsewhere (Scahill et al., 2000). Some of these problems and solutions are partially shared with RCTs of other treatments and other disorders.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 09/07/20 alle ore 18:57:12