The impact of measurement on clinical trials: Comparison of preliminary outcomes of a brief mobile intervention for autistic adults using multiple measurement approaches.
Annabelle M Mournet, Gabrielle Gunin, Jacqueline Shinall and 5 others
PMID 38321822WHAT IT FOUND
Autistic adults' anxiety and depression scores fell slightly after the plan and monitoring, but other scales did not change, weekly anxiety improved then worsened, and momentary use was linked to slower increases in sadness and agitation.
Key findings
01From baseline to post-monitoring, GAD-7 anxiety scores decreased slightly (p =.010, d =0.34) and PHQ-9 depression scores decreased slightly (p =.001, d =0.36), but ASR anxiety and depressive problems and EDI emotion dysregulation scores did not change significantly.
02Weekly GAD-7 scores decreased from week 1 through week 4 and then increased from week 4 through week 14, while weekly PHQ-9 scores showed no significant change over the study.
03In EMA surveys, using the ESP between assessments was not associated with reduced anxiety, but sadness and agitation increased at lower rates than when the ESP was not used.
STILL TO COME
How it was doneWhat they foundWhat it means for OTs
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What it does not show
Thirty-six people consented and 35 were analyzed, so the estimates are unstable. There was no comparison group, so symptom changes cannot be separated from natural fluctuation or the effect of repeated assessment. Only 14 participants did momentary assessments, and they were not randomly assigned. All outcomes were self-report, which can be influenced by participant expectations or reporting style. The authors combined two feasibility studies with different monitoring periods and clinician-guided and self-guided formats. Many analyses were exploratory and did not correct for multiple comparisons. Baseline anxiety and depression levels were fairly low, which may have made it harder to detect change. The plan was tested as a feasibility measure, not as a treatment efficacy trial.
Declared interests
The article text does not include an author conflicts of interest or funding declaration; the supplied publication types note non-U.S. government research support.
The easy way to misread this
Do not read the small GAD-7 and PHQ-9 reductions as proof that the plan alone works. It was a small, uncontrolled feasibility study, and participants also completed monitoring visits and questionnaires.