scholarly journals Protocol for the Process Evaluation of the Online Remote Behavioural Intervention for Tics (ORBIT) Randomised Controlled Trial for children and young people

2019 ◽  
Author(s):  
Kareem Khan ◽  
Chris Hollis ◽  
Charlotte L Hall ◽  
E Bethan Davies ◽  
David Mataix-Cols ◽  
...  
Keyword(s):  
Young People ◽  
Process Evaluation ◽  
Qualitative Data ◽  
Controlled Trial ◽  
Clinical Care ◽  
Complex Interventions ◽  
Behavioural Intervention ◽  
Main Trial ◽  
Children And Young People ◽  
Standard Clinical Practice

Abstract Background Process evaluations are an important component in the interpretation and understanding of outcomes in trials. The ‘Online Remote Behavioural Intervention for Tics’ (ORBIT) study is a randomized controlled trial evaluating the effectiveness of an internet delivered behavioural intervention (called BIP TIC) compared to an internet delivered education program aimed at children and young people with tics. A process evaluation will be undertaken alongside the main trial to determine precisely how the behavioural intervention works and ascertain whether, and if so, how, the intervention could be successfully implemented in standard clinical practice. This protocol paper describes the rationale, aims, and methodology of the ORBIT trial process evaluation. Methods The process evaluation will use a mixed-methods design following the UK Medical Research Council’s 2015 guidelines, comprising of both quantitative and qualitative data collection. This will include: analyzing data usage of participants in the intervention arm; purposively sampled, semi-structured interviews of parents and children, therapists and supervisors, and referring clinicians of the ORBIT trial, as well as analysis of qualitative comments input into the online therapy platform by participants at the end of treatment. Qualitative data will be analyzed thematically. Quantitative and qualitative data will be integrated in a triangulation approach, to provide an understanding of how the intervention works, and what resources are needed for effective implementation, uptake and use in routine clinical care. Discussion This process evaluation will explore the experiences of participants, therapists and supervisors, and referring clinicians of a complex online intervention. By contextualising trial efficacy results, this will help understand how and if the intervention worked and what may be required to sustain the implementation of the treatment long-term. The findings will also aid in our understanding of factors that can affect the success of complex interventions. This will enable future researchers developing online behavioural interventions for children and young people with mental health and neurological disorders to gain invaluable information from this process evaluation.

scholarly journals Protocol for the Process Evaluation of the Online Remote Behavioural Intervention for Tics (ORBIT) Randomised Controlled Trial for children and young people

2019 ◽  
Author(s):  
Kareem Khan ◽  
Chris Hollis ◽  
Charlotte L Hall ◽  
E Bethan Davies ◽  
David Mataix-Cols ◽  
...  
Keyword(s):  
Young People ◽  
Process Evaluation ◽  
Qualitative Data ◽  
Controlled Trial ◽  
Clinical Care ◽  
Complex Interventions ◽  
Behavioural Intervention ◽  
Main Trial ◽  
Children And Young People ◽  
Standard Clinical Practice

Abstract Background Process evaluations are an important component in the interpretation and understanding of outcomes in trials. The ‘Online Remote Behavioural Intervention for Tics’ (ORBIT) study is a randomized controlled trial evaluating the effectiveness of an internet delivered behavioural intervention (called BIP TIC) compared to an internet delivered education program aimed at children and young people with tics. A process evaluation will be undertaken alongside the main trial to determine precisely how the behavioural intervention works and ascertain whether, and if so, how, the intervention could be successfully implemented in standard clinical practice. This protocol paper describes the rationale, aims, and methodology of the ORBIT trial process evaluation. Methods The process evaluation will use a mixed-methods design following the UK Medical Research Council’s 2015 guidelines, comprising of both quantitative and qualitative data collection. This will include: analyzing data usage of participants in the intervention arm; purposively sampled, semi-structured interviews of parents and children, therapists and supervisors, and referring clinicians of the ORBIT trial, as well as analysis of qualitative comments input into the online therapy platform by participants at the end of treatment. Qualitative data will be analyzed thematically. Quantitative and qualitative data will be integrated in a triangulation approach, to provide an understanding of how the intervention works, and what resources are needed for effective implementation, uptake and use in routine clinical care. Discussion This process evaluation will explore the experiences of participants, therapists and supervisors, and referring clinicians of a complex online intervention. By contextualising trial efficacy results, this will help understand how and if the intervention worked and what may be required to sustain the implementation of the treatment long-term. The findings will also aid in our understanding of factors that can affect the success of complex interventions. This will enable future researchers developing online behavioural interventions for children and young people with mental health and neurological disorders to gain invaluable information from this process evaluation.

scholarly journals Protocol for the Process Evaluation of the Online Remote Behavioural Intervention for Tics (ORBIT) randomized controlled trial for children and young people

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
K. Khan ◽  
C. Hollis ◽  
C. L. Hall ◽  
E. B. Davies ◽  
D. Mataix-Cols ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Young People ◽  
Process Evaluation ◽  
Qualitative Data ◽  
Controlled Trial ◽  
Clinical Care ◽  
Behavioural Intervention ◽  
Main Trial ◽  
Children And Young People ◽  
Randomized Controlled

Abstract Background Process evaluations are an important component in the interpretation and understanding of outcomes in trials. The Online Remote Behavioural Intervention for Tics (ORBIT) study is a randomized controlled trial evaluating the effectiveness of an Internet-delivered behavioural intervention (called BIP TIC) compared to an Internet-delivered education programme aimed at children and young people with tics. A process evaluation will be undertaken alongside the main trial to determine precisely how the behavioural intervention works and ascertain whether, and if so, how, the intervention could be successfully implemented in standard clinical practice. This protocol paper describes the rationale, aims, and methodology of the ORBIT trial process evaluation. Methods The process evaluation will have a mixed-methods design following the UK Medical Research Council 2015 guidelines, comprising both quantitative and qualitative data collection. This will include analysing data usage of participants in the intervention arm; purposively sampled, semi-structured interviews of parents and children, therapists and supervisors, and referring clinicians of the ORBIT trial, as well as analysis of qualitative comments put into the online therapy platform by participants at the end of treatment. Qualitative data will be analysed thematically. Quantitative and qualitative data will be integrated in a triangulation approach, to provide an understanding of how the intervention works, and what resources are needed for effective implementation, uptake and use in routine clinical care. Discussion This process evaluation will explore the experiences of participants, therapists and supervisors and referring clinicians of a complex online intervention. By contextualising trial efficacy results, this will help understand how and if the intervention worked and what may be required to sustain the implementation of the treatment long term. The findings will also aid in our understanding of factors that can affect the success of complex interventions. This will enable future researchers developing online behavioural interventions for children and young people with mental health and neurological disorders to gain invaluable information from this process evaluation. Trial registration International Standard Randomised Controlled Trials Number, ISRCTN70758207. Registered on 20 March 2018. ClinicalTrials.gov, NCT03483493. Registered on 30 March 2018.

scholarly journals Therapist-Supported Online Interventions for Children and Young People With Tic Disorders: Lessons Learned From a Randomized Controlled Trial and Considerations for Future Practice (Preprint)

2020 ◽  
Author(s):  
Liam R Chamberlain ◽  
Charlotte L Hall ◽  
Per Andrén ◽  
E Bethan Davies ◽  
Joseph Kilgariff ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Young People ◽  
Controlled Trial ◽  
Clinical Care ◽  
Lessons Learned ◽  
Tic Disorders ◽  
Stepped Care ◽  
Behavioural Intervention ◽  
Children And Young People ◽  
Randomized Controlled

UNSTRUCTURED In recent years, research into internet-based cognitive behavioral therapy (iCBT) has suggested that therapist-guided digital interventions have greater engagement, adherence, and effectiveness than self-directed digital therapies. While research has focused on the effectiveness of, and adherence to, these interventions, less attention has been paid to their implementation in practice and what aspects of the therapist role support success. An understanding of the key factors related to the therapist role and intervention delivery is required if these iCBTs are to be applied in routine clinical care and outcomes optimized. In light of the coronavirus disease 2019 (COVID-19) pandemic, there is greater emphasis on allowing patients access to remote therapies. We report the experiences and reflections of 4 therapists and their 2 supervisors in delivering an online, therapist-supported intervention in a randomized controlled trial for children and young people with tic disorders (the Online Remote Behavioural Intervention for Tics [ORBIT] trial). Themes discussed include the importance of training, supervision, creating support documents/manuals, and record keeping. Alongside this are communication strategies used by therapists to encourage patient adherence and treatment effectiveness. These include rapport building, treatment personalization, and suggestions for overcoming non-engagement. These reflections offer important considerations for the delivery of iCBTs as well as implications associated with the implementation of these interventions in existing services and future research studies. We share thoughts on where iCBTs may sit in a stepped care model, how services may deal with comorbid conditions, and the potential role of iCBTs in collecting clinical data.

scholarly journals Therapist-Supported Online Interventions for Children and Young People With Tic Disorders: Lessons Learned From a Randomized Controlled Trial and Considerations for Future Practice

10.2196/19600 ◽  
2020 ◽  
Vol 7 (10) ◽  
pp. e19600 ◽  
Author(s):  
Liam R Chamberlain ◽  
Charlotte L Hall ◽  
Per Andrén ◽  
E Bethan Davies ◽  
Joseph Kilgariff ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Young People ◽  
Controlled Trial ◽  
Clinical Care ◽  
Lessons Learned ◽  
Tic Disorders ◽  
Stepped Care ◽  
Behavioural Intervention ◽  
Children And Young People ◽  
Randomized Controlled

In recent years, research into internet-based cognitive behavioral therapy (iCBT) has suggested that therapist-guided digital interventions have greater engagement, adherence, and effectiveness than self-directed digital therapies. While research has focused on the effectiveness of, and adherence to, these interventions, less attention has been paid to their implementation in practice and what aspects of the therapist role support success. An understanding of the key factors related to the therapist role and intervention delivery is required if these iCBTs are to be applied in routine clinical care and outcomes optimized. In light of the coronavirus disease 2019 (COVID-19) pandemic, there is greater emphasis on allowing patients access to remote therapies. We report the experiences and reflections of 4 therapists and their 2 supervisors in delivering an online, therapist-supported intervention in a randomized controlled trial for children and young people with tic disorders (the Online Remote Behavioural Intervention for Tics [ORBIT] trial). Themes discussed include the importance of training, supervision, creating support documents/manuals, and record keeping. Alongside this are communication strategies used by therapists to encourage patient adherence and treatment effectiveness. These include rapport building, treatment personalization, and suggestions for overcoming non-engagement. These reflections offer important considerations for the delivery of iCBTs as well as implications associated with the implementation of these interventions in existing services and future research studies. We share thoughts on where iCBTs may sit in a stepped care model, how services may deal with comorbid conditions, and the potential role of iCBTs in collecting clinical data.

scholarly journals Planning implementation and scale-up of physical activity interventions for people with walking difficulties: study protocol for the process evaluation of the ComeBACK trial

Trials ◽  
2022 ◽  
Vol 23 (1) ◽  
Author(s):  
Siobhan Wong ◽  
Leanne Hassett ◽  
Harriet Koorts ◽  
Anne Grunseit ◽  
Allison Tong ◽  
...  
Keyword(s):  
Physical Activity ◽  
Process Evaluation ◽  
Text Messaging ◽  
Quantitative Data ◽  
Qualitative Data ◽  
Controlled Trial ◽  
Scale Up ◽  
Complex Interventions ◽  
Trial Registration ◽  
Physical Activity Interventions

Abstract Background There is currently little evidence of planning for real-world implementation of physical activity interventions. We are undertaking the ComeBACK (Coaching and Exercise for Better Walking) study, a 3-arm hybrid Type 1 randomised controlled trial evaluating a health coaching intervention and a text messaging intervention. We used an implementation planning framework, the PRACTical planning for Implementation and Scale-up (PRACTIS), to guide the process evaluation for the trial. The aim of this paper is to describe the protocol for the process evaluation of the ComeBACK trial using the framework of the PRACTIS guide. Methods A mixed methods process evaluation protocol was developed informed by the Medical Research Council (MRC) guidance on process evaluations for complex interventions and the PRACTIS guide. Quantitative data, including participant questionnaires, health coach and administrative logbooks, and website and text message usage data, is being collected over the trial period. Semi-structured interviews and focus groups with trial participants, health coaches and health service stakeholders will explore expectations, factors influencing the delivery of the ComeBACK interventions and potential scalability within existing health services. These data will be mapped against the steps of the PRACTIS guide, with reporting at the level of the individual, provider, organisational and community/systems. Quantitative and qualitative data will elicit potential contextual barriers and facilitators to implementation and scale-up. Quantitative data will be reported descriptively, and qualitative data analysed thematically. Discussion This process evaluation integrates an evaluation of prospective implementation and scale-up. It is envisaged this will inform barriers and enablers to future delivery, implementation and scale-up of physical activity interventions. To our knowledge, this is the first paper to describe the application of PRACTIS to guide the process evaluation of physical activity interventions. Trial registration Australian and New Zealand Clinical Trials Registry (ANZCTR) Registration date: 10/12/2018.

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.

scholarly journals Development of a Pathway for Multidisciplinary Neurodevelopmental Assessment and Diagnosis in Children and Young People

Children ◽  
2021 ◽  
Vol 8 (11) ◽  
pp. 1033
Author(s):  
Marion Rutherford ◽  
Donald Maciver ◽  
Lorna Johnston ◽  
Susan Prior ◽  
Kirsty Forsyth
Keyword(s):  
Young People ◽  
Lived Experience ◽  
Waiting Times ◽  
Complex Interventions ◽  
Assessment Tools ◽  
Advisory Group ◽  
Children And Young People ◽  
Implementation Team ◽  
Scottish Government ◽  
Assessment And Diagnosis

There is a variable standard of access to quality neurodevelopmental assessment and diagnosis. People may have negative experiences, encountering lengthy waiting times, and inconsistent practices. Practitioners need guidance on standards and practices for assessment and diagnosis matched to new ways of working. In this paper, we present a new pathway and recommendations for multidisciplinary neurodevelopmental assessment and diagnosis for children and young people (<19 years), developed by the Scottish Government funded National Autism Implementation Team (NAIT). Our research used the Medical Research Council guidance for the development of complex interventions and included several iterative stages. Stage 1: n = 44 stakeholders attended an event on developing new practices for diagnosis and assessment. Stage 2: a literature synthesis was completed by the research team of clinical guidelines and diagnosis and assessment tools. Stage 3: an event with n = 127 stakeholders included discussion and debate of the data from stages 1 and 2. Recommendations and a draft pathway were written. Stage 4: successive drafts of recommendations and the pathway documentation were circulated among an advisory group, including multidisciplinary clinical experts and people with lived experience, until the final pathway was agreed upon. The finalised pathway includes guidance on terminology, assessment, diagnosis, triage, time standards and engagement of people with lived experience. The new pathway has been adopted by the Scottish Government. The pathway and associated documentation are freely available online for use by others.

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