Background: Conventional ADHD care yields robust short-term symptom reductions, yet gains in quality of life and participation are inconsistent. Neurodiversity-affirming practice centering autonomy, collaborative formulation, and environmental accommodations may enhance patient-valued outcomes without compromising safety.
Methods: We conducted a pragmatic, multicentre, cluster-randomized comparative-effectiveness trial (24-week follow-up) across outpatient child/adult mental-health and affiliated primary-care clinics. Sites were randomized 1: 1 to a neurodiversity-affirming bundle (collaborative assessment; identity-affirming psychoeducation; structured education/workplace accommodations; choice-sensitive use of medication and behavioral skills; clinician training) or guideline-concordant standard care. Participants were adolescents (12-17 y) and adults (18-55 y) with DSM-5-TR ADHD (N=390; bundle n=192; standard care n=198). Co-primary outcomes were change in health-related quality of life (0-100) and functional participation (standardized units). Key secondary outcomes were ADHD symptoms (SD units), therapeutic alliance (0-7), service engagement (≥75% session attendance), and safety. Analyses were intention-to-treat using mixed-effects models; non-inferiority for symptoms was pre-specified (margin 0. 2 SD) and superiority was tested for co-primary outcomes.
Results: The bundle outperformed standard care for quality of life (mean change +12. 4±18. 3 vs +6. 8±17. 9; Δ=+5. 6 points) and functional participation (+0. 62±0. 48 vs +0. 21±0. 44 SD; Δ=+0. 41 SD). Symptom improvement was substantial and met non-inferiority (bundle −0. 91 SD; standard care −0. 84 SD; Δ=−0. 07 SD). Alliance and engagement favored the bundle (alliance +1. 1 vs +0. 6; engagement 82. 0% vs 71. 5%). Safety was comparable with numerically fewer adverse events in the bundle (any AE 18. 2% vs 22. 7%; discontinuation due to AE 2. 6% vs 4. 5%). Benefits were observed in both adolescents and adults.
Conclusions: A structured neurodiversity-affirming intervention bundle yields superior gains in quality of life and functional participation, maintains non-inferior symptom reduction, and improves acceptability and engagement versus guideline-concordant standard care over 24 weeks.Implementing collaborative formulation, accommodation planning, and affirming communication alongside evidence-based medication and skills training represents a pragmatic, safety-compatible enhancement to routine ADHD services.