TOPS-UK logo
The TOPS-UK Study was funded by a grant from the National Institute for Health and Care Research Research for Patient Benefit and ran from December 2016 to March 2019. The Chief Investigator, Dr Anna Adlam, is a clinical psychologist and an associate professor at the University of Exeter. The Peninsula Clinical Trials Unit (PenCTU) undertook trial and data management for the study. The study was conducted in collaboration with colleagues at the University of Exeter Medical School, Professor Shari Wade from Cincinnati Children’s Hospital, Ohio, USA, the Child Brain Injury Trust, UK, and sponsored by the Royal Devon University Healthcare NHS Foundation Trust.


Brain injuries (through illness or accident) during childhood are common, and may lead to serious long term disability and problems which can impact on the whole family. Such problems may affect thinking, emotion, behaviour and relationships, An online problem solving programme was developed for adolescents in the USA where it was shown to be beneficial and adapted for use in the UK.

Aims and objectives

Our aim was to test the processes for a larger trial, specifically to see if doctors could identify potential participants, whether families felt able to give consent and complete questionnaires online, what they felt about the online intervention, how many completed the study, and to estimate of the costs of a full trial.


Participants: 12 adolescents who had survived a brain injury, and their parent, were recruited to the study, half of whom were randomly allocated to continue to receive their usual treatment and access to the online intervention, supported by weekly video-conference calls with a therapist, while half continued to receive their usual treatment only.

Trail and Data Management

This was the first study to be managed entirely online with no face-to-face contact with any researcher. PenCTU built a bespoke website for the study allowing the adolescent and parent participants to access study information, give online consent and complete study measures at a time and place convenient to them. Research nurses used the website to enter clinical research data and to follow the progress of their participants. The website was stored in a secure, encrypted SQL server (a database management system with restricted access, which maintains confidentiality). The intervention was provided via a website at Cincinnati Children’s Hospital, and the US-based TOPS treatment content was edited to include British spelling, narration and video clips, and UK resource links. The original content was also adapted to be appropriate for young people with all types of brain injuries.

Key findings

Hospital doctors found it difficult to identify potential participants because many adolescents had already been discharged, and around half of those who approached did not respond. Of the 12 adolescents who did take part, 11 completed follow-up questionnaires and took part in interviews. These suggested that the intervention was acceptable (most reported it as enjoyable) and changes to the study procedure were suggested to help future studies.

Dissemination, outputs and impact

The research team will publish findings in peer-reviewed journals and these will also be available on the University of Exeter and other relevant websites. The results will help researchers plan a future study with the aim of facilitating the online intervention to be available through the NHS in future.

Further information

If you would like any further information about the TOPS-UK Study, or about the TOPS-UK intervention, please contact Professor Anna Adlam by email: