Evaluation of clinical assessments of social abilities for use in autism clinical trials by the autism biomarkers consortium for clinical trials.

Researchers tested eight different assessment tools used to measure social skills in autistic children during clinical trials. They studied nearly 400 children (280 autistic, 119 neurotypical) aged 6-11. All tools could tell the difference between autistic and non-autistic children. The tools varied in how consistent they were over time and how well they agreed with each other. This research helps identify which assessment tools work best for different purposes in autism research studies.

The Autism Biomarkers Consortium for Clinical Trials evaluated eight common clinical assessment instruments for measuring social abilities in autism research. The study included 280 autistic children and 119 neurotypical children aged 6-11 years. All instruments successfully distinguished between autistic and neurotypical groups with high data acquisition rates (>95%). The assessments showed varying levels of intercorrelation and stability over 6 weeks, with some demographic differences noted.

Short-term stability ranged from moderate to excellent, suggesting different instruments may be suitable for different trial purposes - either identifying clinical subgroups or serving as outcome measures.

This research provides evidence-based guidance for selecting appropriate assessment instruments in autism clinical trials. The varying stability profiles suggest different tools may be optimal for different research purposes - some for participant characterization and others for measuring treatment outcomes. High completion rates support feasibility in research settings.

Limited to children aged 6-11 years with IQ scores 60-150. Six-week follow-up period may not capture longer-term stability. Demographic differences across instruments were noted but not fully detailed. Sample may not represent the full autism spectrum diversity.

Clinical trials in autism spectrum disorder (ASD) often rely on clinician rating scales and parent surveys to measure autism-related features and social behaviors. To aid in the selection of these assessments for future clinical trials, the Autism Biomarkers Consortium for Clinical Trials (ABC-CT) directly compared eight common instruments with respect to acquisition rates, sensitivity to group differences, equivalence across demographic sub-groups, convergent validity, and stability over a 6-week period. The sample included 280 children diagnosed with ASD (65 girls) and 119 neurotypical children (36 girls) aged from 6 to 11 years. Full scale IQ for ASD ranged from 60 to 150 and for neurotypical ranged from 86 to 150.

Instruments measured clinician global assessment and autism-related behaviors, social communication abilities, adaptive function, and social withdrawal behavior. For each instrument, we examined only the scales that measured social or communication functioning. Data acquisition rates were at least 97.5% at T1 and 95.7% at T2. All scales distinguished diagnostic groups.

Some scales significantly differed by participant and/or family demographic characteristics. Within the ASD group, most clinical instruments exhibited weak (≥ |0.1|) to moderate (≥ |0.4|) intercorrelations. Short-term stability was moderate (ICC: 0.5-0.75) to excellent (ICC: >0.9) within the ASD group. Variations in the degree of stability may inform viability for different contexts of use, such as identifying clinical subgroups for trials versus serving as a modifiable clinical outcome.

All instruments were evaluated in terms of their advantages and potential concerns for use in clinical trials.