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

Agren, KA, Henriksson, P, Johansson, S, Tyrberg, MJ, Ineland, J, Chadwick, D ORCID: 0000-0002-4963-0973 and Mussener, U (2026) Navigating Challenges and Refining Methods for Randomized Controlled Trials Including Young People With Intellectual Disabilities: Empirical and Literature-Informed Insights. Journal of Policy and Practice in Intellectual Disabilities, 23 (2). ISSN 1741-1122

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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.

Item Type:	Article
Uncontrolled Keywords:	co-design; digital health interventions; eHealth; health promotion; inclusive research; intellectual disability; randomized controlled trials; co-design; digital health interventions; eHealth; health promotion; inclusive research; intellectual disability; randomized controlled trials; 44 Human Society; 5204 Cognitive and Computational Psychology; 4409 Social Work; 52 Psychology; Prevention; Intellectual and Developmental Disabilities (IDD); Behavioral and Social Science; Clinical Trials and Supportive Activities; Brain Disorders; Clinical Research; Social Determinants of Health; Health Disparities; Health Disparities and Racial or Ethnic Minority Health Research; Mental Health; 8.4 Research design and methodologies (health services); Generic health relevance; 3 Good Health and Well Being; 1607 Social Work; 1701 Psychology; 4203 Health services and systems; 4409 Social work; 5201 Applied and developmental psychology
Subjects:	B Philosophy. Psychology. Religion > BF Psychology H Social Sciences > HV Social pathology. Social and public welfare. Criminology > HV697 Protection, assistance and relief > HV888 Children with disabilities H Social Sciences > HV Social pathology. Social and public welfare. Criminology > HV697 Protection, assistance and relief > HV1551 People with disabilities
Divisions:	Psychology (from Sep 2019)
Publisher:	Wiley
Date of acceptance:	9 June 2026
Date of first compliant Open Access:	3 July 2026
Date Deposited:	03 Jul 2026 12:18
Last Modified:	03 Jul 2026 12:18
DOI or ID number:	10.1111/jppi.70066
URI:	https://researchonline.ljmu.ac.uk/id/eprint/28937

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