Navigating Challenges and Refining Methods for Randomized Controlled Trials Including Young People With Intellectual Disabilities: Empirical and Literature‐Informed Insights

ABSTRACT

People with intellectual disabilities experience poorer health than the general population, largely due to preventable non‐communicable diseases. Although randomized controlled trials (RCTs) are the gold standard for evaluating health promotion interventions, they are rarely conducted with young people with intellectual disabilities because of inadequate research procedures. This methodological paper draws empirical insights from a research program and relevant literature involving co‐design and an upcoming RCT of a digital health promotion intervention. Using the core RCT components, randomization, control, and trial procedures as an analytical framework, the paper integrates empirical experience and literature to examine challenges in conducting inclusive RCTs. Participation and accessibility emerged as overarching methodological considerations influencing recruitment, retention, engagement, statistical power, generalizability, and overall trial validity. Empirical experiences illustrated how relational, organizational, and methodological adaptations can address these challenges in practice. By combining evidence from the literature with empirically grounded strategies developed across the research program, this paper advances more inclusive and feasible RCT methodology for research involving young people with intellectual disabilities.