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

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 DECRYPT trial: study protocol for a phase II randomised controlled trial of cognitive therapy for post-traumatic stress disorder (PTSD) in youth exposed to multiple traumatic stressors

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e047600
Author(s):  
Leila Allen ◽  
Polly-Anna Ashford ◽  
Ella Beeson ◽  
Sarah Byford ◽  
Jessica Chow ◽  
...  
Keyword(s):  
Young People ◽  
Cognitive Therapy ◽  
Multiple Trauma ◽  
Traumatic Stress ◽  
Controlled Trial ◽  
Post Traumatic Stress ◽  
Children And Young People ◽  
Post Traumatic ◽  
Randomised Controlled ◽  
Post Randomisation

BackgroundPost-traumatic stress disorder (PTSD) is a distressing and disabling condition that affects significant numbers of children and adolescents. Youth exposed to multiple traumas (eg, abuse, domestic violence) are at particular risk of developing PTSD. Cognitive therapy for PTSD (CT-PTSD), derived from adult work, is a theoretically informed, disorder-specific form of trauma-focused cognitive–behavioural therapy. While efficacious for child and adolescent single-event trauma samples, its effectiveness in routine settings with more complex, multiple trauma-exposed youth has not been established. The Delivery of Cognitive Therapy for Young People after Trauma randomised controlled trial (RCT) examines the effectiveness of CT-PTSD for treating PTSD following multiple trauma exposure in children and young people in comparison with treatment as usual (TAU).Methods/designThis protocol describes a two-arm, patient-level, single blind, superiority RCT comparing CT-PTSD (n=60) with TAU (n=60) in children and young people aged 8–17 years with a diagnosis of PTSD following multiple trauma exposure. The primary outcome is PTSD severity assessed using the Children’s Revised Impact of Event Scale (8-item version) at post-treatment (ie, approximately 5 months post-randomisation). Secondary outcomes include structured interview assessment for PTSD, complex PTSD symptoms, depression and anxiety, overall functioning and parent-rated mental health. Mid-treatment and 11-month and 29-month post-randomisation assessments will also be completed. Process–outcome evaluation will consider which mechanisms underpin or moderate recovery. Qualitative interviews with the young people, their families and their therapists will be undertaken. Cost-effectiveness of CT-PTSD relative to TAU will be also be assessed.Ethics and disseminationThis trial protocol has been approved by a UK Health Research Authority Research Ethics Committee (East of England–Cambridge South, 16/EE/0233). Findings will be disseminated broadly via peer-reviewed empirical journal articles, conference presentations and clinical workshops.Trial registrationISRCTN12077707. Registered 24 October 2016 (http://www.isrctn.com/ISRCTN12077707). Trial recruitment commenced on 1 February 2017. It is anticipated that recruitment will continue until June 2021, with 11-month assessments being concluded in May 2022.

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. 561-576 ◽  
Author(s):  
S. Aldiss ◽  
R.M. Taylor ◽  
L. Soanes ◽  
R. Maguire ◽  
M. Sage ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Young People ◽  
Health Professionals ◽  
Controlled Trial ◽  
Phase 1 ◽  
Self Care ◽  
Alert System ◽  
Symptom Report ◽  
Mobile Phone Technology ◽  
Randomised Controlled

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.

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 Managing with Learning Disability and Diabetes: OK-Diabetes – a case-finding study and feasibility randomised controlled trial

2018 ◽  
Vol 22 (26) ◽  
pp. 1-328 ◽  
Author(s):  
Allan House ◽  
Louise Bryant ◽  
Amy M Russell ◽  
Alexandra Wright-Hughes ◽  
Liz Graham ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Observational Study ◽  
Learning Disability ◽  
Diabetes Management ◽  
Controlled Trial ◽  
Self Management ◽  
Feasibility Randomised Controlled Trial ◽  
The Mean ◽  
Randomised Controlled

BackgroundObesity and type 2 diabetes are common in adults with a learning disability. It is not known if the principles of self-management can be applied in this population.ObjectivesTo develop and evaluate a case-finding method and undertake an observational study of adults with a learning disability and type 2 diabetes, to develop a standardised supported self-management (SSM) intervention and measure of adherence and to undertake a feasibility randomised controlled trial (RCT) of SSM versus treatment as usual (TAU).DesignObservational study and an individually randomised feasibility RCT.SettingThree cities in West Yorkshire, UK.ParticipantsIn the observational study: adults aged > 18 years with a mild or moderate learning disability, who have type 2 diabetes that is not being treated with insulin and who are living in the community. Participants had mental capacity to consent to research and to the intervention. In the RCT participants had glycated haemoglobin (HbA1c) levels of > 6.5% (48 mmol/mol), a body mass index (BMI) of > 25 kg/m2or self-reported physical activity below national guideline levels.InterventionsStandardised SSM. TAU supported by an easy-read booklet.Main outcome measures(1) The number of eligible participants identified and sources of referral; (2) current living and support arrangements; (3) current health state, including level of HbA1c, BMI and waist circumference, blood pressure and lipids; (4) mood, preferences for change; (5) recruitment and retention in RCT; (6) implementation and adherence to the intervention; (7) completeness of data collection and values for candidate primary outcomes; and (8) qualitative data on participant experience of the research process and intervention.ResultsIn the observational study we identified 147 eligible consenting participants. The mean age was 54.4 years. In total, 130 out of 147 (88%) named a key supporter, with 113 supporters (77%) being involved in diabetes management. The mean HbA1clevel was 54.5 mmol/mol [standard deviation (SD) 14.8 mmol/mol; 7.1%, SD 1.4%]. The BMI of 65% of participants was > 30 kg/m2and of 21% was > 40 kg/m2. Many participants reported low mood, dissatisfaction with lifestyle and diabetes management and an interest in change. Non-response rates were high (45/147, 31%) for medical data requested from the primary care team. In the RCT, 82 participants were randomised. The mean baseline HbA1clevel was 56 mmol/mol (SD 16.5 mmol/mol; 7.3%, SD 1.5%) and the mean BMI was 34 kg/m2(SD 7.6 kg/m2). All SSM sessions were completed by 35 out of 41 participants. The adherence measure was obtained in 37 out of 41 participants. The follow-up HbA1clevel and BMI was obtained for 75 out of 82 (91%) and 77 out of 82 (94%) participants, respectively. Most participants reported a positive experience of the intervention. A low response rate and difficulty understanding the EuroQol-5 Dimensions were challenges in obtaining data for an economic analysis.LimitationsWe recruited from only 60% of eligible general practices, and 90% of participants were on a general practice learning disability register, which meant that we did not recruit many participants from the wider population with milder learning disability.ConclusionsA definitive RCT is feasible and would need to recruit 194 participants per arm. The main barrier is the resource-intensive nature of recruitment. Future research is needed into the effectiveness of obesity treatments in this population, particularly estimating the longer-term outcomes that are important for health benefit. Research is also needed into improving ways of assessing quality of life in adults with a learning disability.Trial registrationCurrent Controlled Trials ISRCTN41897033.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 22, No. 26. See the NIHR Journals Library website for further project information.

scholarly journals The DECRYPT trial: Study protocol for a phase II randomised controlled trial of cognitive therapy for post-traumatic stress disorder (PTSD) in youth exposed to multiple traumatic stressors.

2021 ◽  
Author(s):  
Leila Allen ◽  
Polly-Anna Ashford ◽  
Ella Beeson ◽  
Sarah Byford ◽  
Jessica Chow ◽  
...  
Keyword(s):  
Young People ◽  
Cognitive Therapy ◽  
Multiple Trauma ◽  
Traumatic Stress ◽  
Controlled Trial ◽  
Post Traumatic Stress ◽  
Children And Young People ◽  
Post Traumatic ◽  
Randomised Controlled ◽  
Post Randomisation

Background: Post-traumatic stress disorder (PTSD) is a distressing and disabling condition that affects significant numbers of children and adolescents. Youth exposed to multiple traumas (e.g. abuse, domestic violence) are at particular risk of developing PTSD. Cognitive-Therapy for PTSD (CT-PTSD), derived from adult work, is a theoretically-informed, disorder-specific form of trauma-focused cognitive-behavioural therapy (TF-CBT). While efficacious for child and adolescent single-event trauma samples, its effectiveness in routine settings with more complex, multiple-trauma exposed youth has not been established. The Delivery of Cognitive Therapy for Young People after Trauma (DECRYPT) randomised controlled trial (RCT) examines the effectiveness of CT-PTSD for treating PTSD following multiple trauma exposure in children and young people in comparison to treatment as usual (TAU). Methods/Design: This protocol describes a two-arm, patient-level, single blind, superiority RCT comparing CT-PTSD (n=60) to TAU (n=60) in children and young people aged 8-17 years with a diagnosis of PTSD following multiple trauma exposure. The primary outcome is PTSD severity assessed using the Children’s Revised Impact of Event Scale (8-item version) at post-treatment (i.e. approximately five months post-randomisation). Secondary outcomes include structured interview assessment for PTSD, complex PTSD symptoms, depression and anxiety, overall functioning and parent-rated mental health. Mid-treatment and 11- and 29-month post-randomisation assessments will also be completed. Process-outcome evaluation will consider which mechanisms underpin or moderate recovery. Qualitative interviews with the young people, their families and their therapists will be undertaken. Cost-effectiveness of CT-PTSD relative to TAU will be also be assessed.Ethics and dissemination: This trial protocol has been approved by a UK Health Research Authority (HRA) Research Ethics Committee (East of England – Cambridge South, 16/EE/0233). Findings will be disseminated broadly via peer-reviewed empirical journal articles, conference presentations, and clinical workshops.Trial registration: ISRCTN, ISRCTN12077707. Registered 24th October 2016, http://www.isrctn.com/ISRCTN12077707

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