Review: Working in collaboration with young people and health professionals: a staged approach to the implementation of a randomised controlled trial

2010 ◽  
Vol 16 (6) ◽  
pp. 577-578
Author(s):  
Denis Anthony
2010 ◽  
Vol 16 (6) ◽  
pp. 561-576 ◽  
Author(s):  
S. Aldiss ◽  
R.M. Taylor ◽  
L. Soanes ◽  
R. Maguire ◽  
M. Sage ◽  
...  

ASyMS© is an Advanced Symptom Management System utilising mobile phone technology to monitor chemotherapy-related symptoms and promote self-care. It was first developed with an adult cancer population and is now being evaluated with young people through an iterative development process. ASyMS© involves patients recording and sending symptom reports to the hospital and receiving tailored self-care advice. Health professionals are alerted when severe symptoms are reported. Three phases of the ASyMS©-YG (young people) study are complete. Phase 1 involved young people identifying the symptoms to be assessed. Phase 2 involved young people testing the symptom report system, and ascertaining young people’s, parents’ and professionals’ perceptions of ASyMS©-YG. This paper reports on Phase 3, in which the system was developed further in preparation for a randomised controlled trial (RCT). Health professionals devised an alert system based on risk modelling side-effect severity, and young people and professionals developed self-care advice. A pilot study was conducted to test the alert system and study design in readiness for a definitive RCT. The contribution young people and professionals have made to this project is invaluable in evaluating the practical effectiveness of ASyMS©-YG and ensuring the intervention is acceptable and works in everyday practice.


2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Laura Williams ◽  
Charlotte L. Hall ◽  
Sue Brown ◽  
Boliang Guo ◽  
Marilyn James ◽  
...  

Abstract Background Medication for attention deficit hyperactivity disorder (ADHD) should be closely monitored to ensure optimisation. There is growing interest in using computerised assessments of ADHD symptoms to support medication monitoring. The aim of this study was to assess the feasibility and acceptability of a randomised controlled trial (RCT) to evaluate the efficacy of one such computerised assessment, the Quantified Behavior (Qb) Test, as part of medication management for ADHD. Methods This feasibility multi-site RCT conducted in child and adolescent mental health and community paediatric settings recruited participants aged 6–15 years diagnosed with ADHD starting stimulant medication. Participants were randomised into one of two arms: experimental (QbTest protocol) where participants completed a QbTest at baseline and two follow-up QbTests on medication (2–4 weeks and 8–10 weeks later) and control where participants received treatment as usual, including at least two follow-up consultations. Measures of parent, teacher, and clinician-rated symptoms and global functioning were completed at each time point. Clinicians recorded treatment decision-making and health economic measures were obtained. Data were analysed using multi-level modelling and participants (children and parents) and clinicians were interviewed about their experiences, resulting data were thematically analysed. Results Forty-four children and young people were randomised. Completion of study outcome measures by care-givers and teachers ranged from 52 to 78% at baseline to 47–65% at follow-up. Participants reported the questionnaires to be useful to complete. SNAP-IV inattention scores showed greater reduction in the intervention than the control group (− 5.85, 95% CI − 10.33, − 1.36,). Engagement with the intervention ranged from 100% at baseline, to 78% follow-up 1 and 57% follow-up 2. However, only 37% of QbTests were conducted in the correct time period. Interview data highlighted that the objectivity of the QbTest was appreciated by clinicians and parents. Clinicians commented that the additional time and resources required meant that it is not feasible to use QbTest for all cases. Conclusion The trial design and protocol appear to be feasible and acceptable but could be improved by modifying QbTest time periods and the method of data collection. With these changes, the protocol may be appropriate for a full trial. Adding QbTest may improve symptom outcome as measured by SNAP-IV. Trial registration ClinicalTrials.gov, NCT03368573, prospectively registered, 11th December 2017, and ISRCTN, ISRCTN69461593, retrospectively registered, 10th April 2018


2018 ◽  
Vol 18 (1) ◽  
Author(s):  
Elanor C. Hinton ◽  
Laura A. Birch ◽  
John Barton ◽  
Jeffrey M. P. Holly ◽  
Kalina M. Biernacka ◽  
...  

2021 ◽  
Author(s):  
Michelle H Lim ◽  
Lily Thurston ◽  
Robert Eres ◽  
Thomas L Rodebaugh ◽  
Mario Alvarez-Jimenez ◽  
...  

Abstract Background: Young people are vulnerable to experiencing problematic levels of loneliness which can lead to poor mental health outcomes. Loneliness is a malleable treatment target and preliminary evidence has shown that it can be addressed with digital platforms. Peer Tree is a strengths-based digital smartphone application aimed at reducing loneliness. The study aim is to reduce loneliness, and assess the acceptability, usability, and feasibility of Peer Tree in young people enrolled at university. Methods: This will be a pilot randomised controlled trial (RCT) comparing a strengths-based digital smartphone application (Peer Tree) with a treatment as usual (TAU) condition. Forty-two young people enrolled at university will be recruited for this pilot RCT. Participants with suicidality risk, acute psychiatric symptoms in the past month, or a current diagnosis of a mood or social anxiety disorder will be excluded. Allocation will be made on a 1:1 ratio and will occur after the initial baseline assessment. Assessments are completed at baseline, post-intervention, and at follow-up. Participants in the TAU condition complete the same three assessment sessions. The primary outcomes of the study will be self-reported loneliness as well as the acceptability, usability, feasibility and safety of Peer Tree. Depression, social anxiety, and quality of life variables will also be measured as secondary outcomes. Discussion: This trial will report the findings of implementing Peer Tree, a smartphone application aimed at reducing loneliness in university students. Findings from this trial will highlight the initial efficacy, acceptability and feasibility of using digital positive psychology interventions to reduce subthreshold mental health concerns. Findings from this trial will also describe the safety of Peer Tree as a digital tool. Results will contribute evidence for positive psychology interventions to address mental ill-health.Trial registration: Australian New Zealand Clinical Trial Registry, ACTRN12619000350123. Registered 6th March 2020


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