
Conducting a Clinical Trial during COVID-19
Our team were excited to launch a new study this year, a clinical trial exploring whether combining an established social learning therapy–the parent delivered Early Start Denver Model (ESDM)–would be enhanced by pairing it with a nasal spray. In this randomised placebo-controlled double-blind study, all participants receive one-on-one coaching with an Early Start Denver Model therapist for 12 weeks. While all participants receive a nasal spray, for 50%, this is a placebo, enabling us to compare the group results. This study is for children aged 3-5 years and their parent/caregiver.
Introducing social-distancing due to COVID-19 part-way through the study has been a challenge requiring flexibility from our team (particularly our wonderful parent coaches and participants). Under the guidance of Dr Sally Rogers and with support from our partners at the Brain and Mind Institute, University of Sydney, our p-ESDM therapy is going online! Using video technology, our therapists have been able to “meet” participants in their own home. This has involved using the live video to watch parents working with their children, and coaching them in their familiar environment. Although not the original plan, there might be benefits to this approach. Parents and children can feel comfortable in their home environment, skills might generalise more easily when taught in a familiar setting, and it saves travel time onto campus.
A number of challenges remain for us while continuing this study. While we have succeeded in taking the intervention online, the stringent eligibility assessments are currently paused until it is safe to see new participants face to face again. Understandably, we are unable to take participants for a medical check with the study doctor until the pressure is taken off our health system. So, during COVID-19, our team will continue taking expressions of interest from new families interested in hearing more about the trial, staying in touch with families who have already expressed interest and are waiting for their assessments, and learning all we can from this new and unique time. This is another example of how COVID-19 has challenged us, yet brought us together to enhance our cooperation and collaboration, creativity, and flexibility.
If you have a child on the spectrum aged 3-5 years and are interested in this study, please ontact Dr Rachel Jellett
OTstudy@latrobe.edu.au Ph: 9479 5421