跳至主要内容
临床试验/NCT01854333
NCT01854333已完成不适用

The Swedish Versions of ADOS and ADI-R: Psychometric Validation

Karolinska Institutet2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2011年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Diagnosis of Autism Spectrum Disorders

研究概览

简要总结

Autism spectrum disorders (ASD) are early onset chronic conditions coined by deficits in social reciprocity, communication and stereotypic interests and activities. Other functional impairments such as mental retardation, ADHD, known genetic syndromes and epilepsy are frequent coexisting problems. ASD cause considerable suffering for the affected individuals and burden for their families. With an estimated prevalence exceeding 1%, recent population-based studies suggest that ASD are no rare phenomena. Lifetime societal costs for services and support, together with the opportunity costs of lost productivity in a prototypic developed country are estimated SEK 15.6 million for someone with and SEK 10.3 million for a person without co-existing mental retardation. Despite ongoing efforts, no diagnostically informative biomarker has yet been identified for ASD. The development, refinement and evaluation of behavioral assessment tools has therefore been decisive to progress and quality assurance in ASD clinical practice and research. The most widely used and thoroughly evaluated instruments for ASD in international child mental health are the Autism Diagnostic Interview- Revised (ADI-R) and the Autism Diagnostic Observation Schedule (ADOS). The ADI-R and ADOS are deemed highly by the ASD expert community and thus commonly labeled as being the "gold standard" in ASD diagnostics. Although, Swedish translations of the ADI-R and ADOS exist, a Swedish standardization and cross-cultural validation is still lacking, impeding good clinical practice and research prerequisites for ASD in Sweden. The applied project seeks to broadly establish reliability and validity of the Swedish translations of the ADI-R and ADOS in order to enhance evidence-based clinical practice and stimulate internationally competitive ASD research in Sweden.

详细描述

Objectives:

The present study seeks to determine for the first time the reliability and validity of the Swedish versions of the Autism Diagnostic Interview-Revised (ADI-R)and Autism Diagnostic Observation Schedule (ADOS). The combination of these two assessments is deemed the "gold standard" of diagnosing ASD in international practice and research. ADI-R and ADOS are widely used (translated into 15 languages) and have been rigorously and convincingly evaluated in other countries. The Swedish translations of the ADI-R (interview schedule, algorithms) and ADOS (observation schedules, algorithms) have not yet been tested for scientific properties and feasibility, hampering best clinical practice, evidence-based diagnostics and research premises for ASD in Sweden. Therefore, this study aims at standardizing the Swedish forms of the ADI-R and ADOS to and ensure their cross-cultural validity and clinical utility. A particular objective of the study is to establish the agreement of ADI-R and ADOS with register-based diagnoses. The latter is of paramount importance for judging the significance and generalizability of findings from large scale register research, which is a specific strength of Swedish science.

Instruments:

The ADI-R is a clinical diagnostic instrument for assessing ASDs in children, adolescents and adults. The ADI-R provides a diagnostic algorithm for autism as described in both the ICD-10 and DSM-IV-TR and necessary information for making a diagnosis of other ASD in accord with the classification manuals. The ADI-R is appropriate for children and adults with mental ages from about 18 months and above. It is a standardized, semi-structured clinical review for caregivers of children, adolescents and adults. The interview contains 93 items on three content areas: quality of social interaction, communication and language, and repetitive, restricted and stereotyped interests and behavior. The measure also includes other items relevant for treatment planning, such as self-injury and over-activity. Responses are scored by the clinician based on the caregiver's description of the child's behavior. All questions ask about current behavior, with the exception of a few behaviors that only occur during specific age periods. In addition to asking about current behavior, each question focuses on the time period when the behaviors were likely to be most pronounced - generally, between the ages of 4 and 5 years. The interview starts with an introductory question followed by questions about the subject's early development. The next 41 questions cover verbal and nonverbal communication. Questions 50 through 66 ask about social development and play. The next 13 questions deal with interests and behaviors. The final 14 questions ask about "general behavior," including questions about memory skills, motor skills, over-activity and fainting.

The ADI-R interview generates scores in each of the three content areas. Elevated scores indicate problematic behavior in a particular area. Scores are based on the clinician's judgment following the caregiver's report of the child's behavior and development. For each item, the clinician gives a score ranging from 0 (not autistic) to 3 (severely autistic). A classification of autism is given when scores in all three content areas of communication, social interaction, and patterns of behavior meet or exceed the specified cutoffs, and onset of the disorder is evident by 36 months of age. For other ASD information from the ADI-R is used informally: e.g. a diagnosis of Asperger syndrome is indicated, if the criteria for autism are fulfilled in face of normal language development, or a diagnosis of PDD-NOS, if social interaction deficits and another behavior domain exceed the cut-offs. This interviewer-based instrument requires substantial training in administration and scoring. A trained clinician can administer the ADI-R to the parent of a child suspected of autism in approximately 2 ½ hours.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
Single (Investigator)

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

ADOS module 1-4, ADI-R

Other

Individuals recruited within clinical services in child psychiatry and child medicine in Stockholm county and Lund for whom assessments with ADOS module 1-4 or ADI-R are appropriate.

干预措施: ADOS module 1-4 or ADI-R (Other)

结局指标

主要结局

Diagnosis of Autism Spectrum Disorders

时间窗: The avarege time frame between the ADOS/ADI-R assessment and the final assessment of clinical diagnosis is one month.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sven Bölte

Professor, PhD

Karolinska Institutet

研究点 (2)

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