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

NCT01854333 | Completed DMC

• 1 other identifier: EvaluationADOS&ADI-R
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autism Spectrum Disorders

Keywords

Diagnostics; ADOS; ADI-R; Psychometrics; Autism spectrum disorders; Autism

Outcome Measures

Primary Outcomes (1)

• Diagnosis of Autism Spectrum Disorders

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

Study Arms (1)

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.

Other: ADOS module 1-4 or ADI-R

Interventions

ADOS module 1-4 or ADI-R OTHER

ADOS module 1-4, ADI-R

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• None

You may not qualify if:

• None

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska Institute Center for Neurodevelopmental Disorders

Stockholm, Stockholm County, 113 35, Sweden

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Sven Bölte, Professor, PhD

  Karolinska Institute Center for Neurodevelomental Disorders

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PhD

Study Record Dates

• First Submitted: May 8, 2013
• First Posted: May 15, 2013
• Study Start: January 1, 2011
• Primary Completion: October 1, 2014
• Study Completion: November 1, 2014
• Last Updated: June 24, 2015

Record last verified: 2015-06

Locations

SE (1)