Lessons learned from two clinical trials on nutritional supplements to reduce aggressive behaviour.

ABSTRACT:

Background

Setting up and conducting a randomised controlled trial (RCT) has many challenges-particularly trials that include vulnerable individuals with behavioural problems or who reside in facilities that focus on care as opposed to research. These populations are underrepresented in RCTs.

Approach

In our paper, we describe the challenges and practical lessons learned from two RCTs in two care settings involving long-stay psychiatric inpatients and people with intellectual disabilities. We describe five main difficulties and how these were overcome: (1) multisite setting, (2) inclusion of vulnerable participants, (3) nutritional supplements and placebos, (4) assessment of behavioural outcomes, and (5) collecting bio samples.

Conclusions

By sharing these practical e

SUBMITTER: de Bles NJ 

PROVIDER: S-EPMC9543803 | biostudies-literature | 2022 Aug

REPOSITORIES: biostudies-literature