scholarly journals Protocol investigating the clinical utility of an objective measure of activity and attention (QbTest) on diagnostic and treatment decision-making in children and young people with ADHD—‘AssessingQbTestUtility inADHD’ (AQUA): a randomised controlled trial

BMJ Open ◽  
2014 ◽  
Vol 4 (12) ◽  
pp. e006838 ◽  
Author(s):  
Charlotte L Hall ◽  
Gemma M Walker ◽  
Althea Z Valentine ◽  
Boliang Guo ◽  
Catherine Kaylor-Hughes ◽  
...  
Keyword(s):  
Decision Making ◽  
Randomised Controlled Trial ◽  
Young People ◽  
Clinical Utility ◽  
Controlled Trial ◽  
Objective Measure ◽  
Treatment Decision ◽  
Children And Young People ◽  
Treatment Decision Making ◽  
Randomised Controlled

scholarly journals Optimising medication management in children and young people with ADHD using a computerised test (QbTest): a feasibility randomised controlled trial

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Laura Williams ◽  
Charlotte L. Hall ◽  
Sue Brown ◽  
Boliang Guo ◽  
Marilyn James ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Young People ◽  
Controlled Trial ◽  
Medication Management ◽  
Control Group ◽  
Global Functioning ◽  
Children And Young People ◽  
Link Type ◽  
Randomised Controlled

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

scholarly journals Optimising medication management in children and young people with ADHD using a computerised test (QbTest): a feasibility randomised controlled trial

2020 ◽  
Author(s):  
Laura Williams ◽  
Charlotte L Hall ◽  
Sue Brown ◽  
Boliang Guo ◽  
Marilyn James ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Young People ◽  
Stimulant Medication ◽  
Controlled Trial ◽  
Medication Management ◽  
Control Group ◽  
Global Functioning ◽  
Children And Young People ◽  
Randomised Controlled

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); participants completed a QbTest at baseline and two follow-up QbTests on medication (2-4 weeks and 8-10 weeks later). Control; 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 52-78% 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, p=0.01). 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: Prospectively registered with Clinicaltrials.gov (NCT03368573, 11th December 2017, https://clinicaltrials.gov/ct2/show/NCT03368573) and retrospectively with ISRCTN (ISRCTN69461593, 10th April 2018, http://www.isrctn.com/ISRCTN69461593).

scholarly journals Developing and evaluating a child-centred intervention for diabetes medicine management using mixed methods and a multicentre randomised controlled trial

2014 ◽  
Vol 2 (8) ◽  
pp. 1-442 ◽  
Author(s):  
Jane P Noyes ◽  
Lesley Lowes ◽  
Rhiannon Whitaker ◽  
Davina Allen ◽  
Cynthia Carter ◽  
...  
Keyword(s):  
Decision Making ◽  
Blood Glucose ◽  
Young People ◽  
Diabetes Management ◽  
Controlled Trial ◽  
Self Care ◽  
Self Management ◽  
Children And Young People ◽  
Age Appropriate ◽  
Randomised Controlled

AimTo develop and evaluate an individually tailored age-appropriate diabetes diary and information pack for children and young people aged 6–18 years with type 1 diabetes to support decision-making and self-care with a specific focus on insulin management and blood glucose monitoring, compared with available resources in routine clinical practice.DesignFour-stage study following the Medical Research Council framework for designing and evaluating complex interventions. Stage 1: context – brief review of reviews and mixed-method systematic review; updating of database of children’s diabetes information; children’s diabetes information quality assessment and diabetes guideline analysis; and critical discourse analysis. Stage 2: intervention development – working with expert clinical advisory group; contextual qualitative interviews and focus groups with children and young people to ascertain their information preferences and self-care practices; ongoing consultation with children; development of intervention programme theory. Stage 3: randomised controlled trial (RCT) to evaluate the diabetes diaries and information packs in routine practice. Stage 4: process evaluation.FindingsThe RCT achieved 100% recruitment, was adequately powered and showed that the Evidence into Practice Information Counts (EPIC) packs and diabetes diaries were no more effective than receiving diabetes information in an ad hoc way. The cost per unit of producing the EPIC packs and diabetes diaries was low. Compared with treatment as usual information, the EPIC packs fulfilled all NHS policy imperatives that children and young people should receive high-quality, accurate and age-appropriate information about their condition, self-management and wider lifestyle and well-being issues. Diabetes guidelines recommend the use of a daily diabetes diary and EPIC diaries fill a gap in current provision. Irrespective of allocation, children and young people had a range of recorded glycated haemoglobin (HbA1c) levels, which showed that as a group their diabetes self-management would generally need to improve to achieve the HbA1clevels recommended in National Institute for Health and Care Excellence guidance. The process evaluation showed that promotion of the EPIC packs and diaries by diabetes professionals at randomisation did not happen as intended; the dominant ‘normalisation’ theory underpinning children’s diabetes information may be counterproductive; risk and long-term complications did not feature highly in children’s diabetes information; and children and young people engaged in risky behaviour and appeared not to care, and most did not use a diabetes diary or did not use the information to titrate their insulin as intended.LimitationsRecruitment of ‘hard to reach’ children and young people living away from their families was not successful. The findings are therefore more relevant to diabetes management within a family context.ConclusionsThe findings indicate a need to rethink context and the hierarchical relationships between children, young people, parents and diabetes professionals with regard to ‘partnership and participation’ in diabetes decision-making, self-care and self-management. Additional research, implementation strategies and service redesign are needed to translate available information into optimal self-management knowledge and subsequent optimal diabetes self-management action, including to better understand the disconnection between children’s diabetes texts and context; develop age-appropriate Apps/e-records for recording blood glucose measurements and insulin management; develop interventions to reduce risk-taking behaviour by children and young people in relation to their diabetes management; reconsider what could work to optimise children’s self-management of diabetes; understand how best to reorganise current diabetes services for children to optimise child-centred delivery of children’s diabetes information.Study registrationCurrent Controlled Trials ISRCTN17551624.FundingThe National Institute for Health Research Health Services and Delivery Research programme.

scholarly journals Optimising medication management in children and young people with ADHD using a computerised test (QbTest): a feasibility randomised controlled trial

2020 ◽  
Author(s):  
Laura Williams ◽  
Charlotte L Hall ◽  
Susan Brown ◽  
Boliang Guo ◽  
Marilyn James ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Young People ◽  
Stimulant Medication ◽  
Controlled Trial ◽  
Medication Management ◽  
Control Group ◽  
Global Functioning ◽  
Children And Young People ◽  
Randomised Controlled

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): participants completed a QbTest at baseline and two follow-up QbTests on medication (2-4 weeks and 8-10 weeks later). Control: 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 caregivers and teachers ranged from 52-78% 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, p=0.01). 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.

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