Warwick, Jane, Bouliotis, Georgios, Wells, Philip, Yujin, Lee, Madan, Jason, Cannaway, Alastair, Tuomainen, Helena and Singh, Swaran P. (2019) Methodological issues in trials of youth mental health : what have we learnt during the MILESTONE study. In: International Clinical Trials Methodology Conference (ICTMC 2019), Brighton, UK, 6-9 Oct 2019. Published in: Trials, 20 (Supplement 3). doi:10.1186/s13063-019-3688-6 ISSN 1745-6215.

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Abstract

Introduction: Discontinuity of care at the child and adult mental health service boundary is present in many European countries. Young people of transition age (typically 16-18) who need ongoing mental health care may be poorly served by the gap between child and adolescent (CAMHS) to adult mental health services (AMHS), left without adequate care or support, at a time when they are undergoing great stress and change (leaving home, for example). We therefore developed a complex intervention, “Managed Transition”, to improve outcomes for young people at the child and adult mental health service (transition) boundary and undertook a cluster randomised controlled trial (cRCT) to assess the clinical and costeffectiveness of “Managed Transition” compared to standard care. Methods: Randomisation was 2:1 (control:intervention) and the cRCT was embedded within a longitudinal cohort study using a novel design. The primary outcome measure was the clinician reported Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) score at 15 months post-intervention. A range of secondary outcomes, including health and health economic measures, were also measured at 9 and 15 months post-intervention. Results: A total of 793 young people from 40 CAMHS in 8 countries were recruited into the trial; 241 to the intervention and 552 to the control arm. Follow-up was completed in September 2018 and the findings are already being used to inform policy and service development in Europe.
Discussion: During MILESTONE we faced many challenges. Aside from the usual barriers, recruitment, retention, compliance and so on, we faced a multitude of methodological problems arising from the novel trial design and unique clinical and geographical settings. In this presentation we share our experience of MILESTONE, using statistical and health-economic results, to illustrate what worked well and what did not, and to make recommendations for the design of future studies.

Item Type:	Conference Item (Poster)
Divisions:	Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School
Journal or Publication Title:	Trials
Publisher:	Biomed Central
ISSN:	1745-6215
Official Date:	22 October 2019
Dates:	Date Event 22 October 2019 Published 6 October 2019 Accepted
Volume:	20
Number:	Supplement 3
Article Number:	P-284
DOI:	10.1186/s13063-019-3688-6
Status:	Peer Reviewed
Publication Status:	Published
Access rights to Published version:	Restricted or Subscription Access
Description:	Meeting abstracts from the 5th International Clinical Trials Methodology Conference (ICTMC 2019) Brighton, UK. 06-09 October 2019
Conference Paper Type:	Poster
Title of Event:	International Clinical Trials Methodology Conference (ICTMC 2019)
Type of Event:	Conference
Location of Event:	Brighton, UK
Date(s) of Event:	6-9 Oct 2019
Related URLs:	Publisher

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