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 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 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 Fidelity of delivery and contextual factors influencing children’s level of engagement with an online behavioural intervention for tics: Process evaluation of the ORBIT trial (Preprint)

2020 ◽  
Author(s):  
Kareem Khan ◽  
Chris Hollis ◽  
Charlotte L Hall ◽  
Elizabeth Murray ◽  
E Bethan Davies ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Contextual Factors ◽  
Controlled Trial ◽  
Parental Engagement ◽  
Tic Disorders ◽  
Behavioural Intervention ◽  
High Fidelity ◽  
Factor Scores ◽  
Randomized Controlled ◽  
Factors Influencing

BACKGROUND The Online Remote Behavioural Intervention for Tics (ORBIT) study was a multicentre randomized controlled trial of a complex intervention that consisted of an online behavioural intervention for children and young people (CYP) with tic disorders. In this first part of a two-stage process evaluation, we conducted a mixed-methods study exploring reach, dose, and fidelity of the intervention and contextual factors influencing engagement with the intervention. OBJECTIVE This study aims to explore the fidelity of delivery and the contextual factors underpinning the ORBIT intervention. METHODS Baseline study data and intervention usage metrics from participants in the intervention arm were used as quantitative implementation data (n=112). The experiences of being in the intervention were explored by semi-structured interviews with children (n=20) and parent (n=20) participants, therapists (n=4), and referring clinicians (n=6). A principal components analysis was used to create a comprehensive, composite measure of CYP’s engagement with the intervention. Engagement factor scores reflected relative uptake as assessed by a range of usage indices including chapters accessed, number of pages visited and number of logins. RESULTS The intervention was implemented with high fidelity, and participants deemed the intervention acceptable and satisfactory. Engagement and adherence were high with child participants completing an average of 7.5/10 chapters and 100/112 (89.3%) participants completed a minimum of 4 chapters: the pre-defined threshold for effective dose. Compared to the total population of children with tic disorders, the sample tended to have more educated parents and live in more economically advantaged areas but socioeconomic factors were not related to engagement factor scores. Factors associated with higher engagement factor scores included participants enrolled at the London site vs. the Nottingham site (P=.011), self-referred vs. clinic-referred (P=.041), higher parental engagement as evidenced by number of parental chapters completed (ρ=0.73, n=111, P<.001) and more therapist time for parent (ρ=0.46, n=111, P<.001). A multiple linear regression indicated that parents’ chapter completion (β=.69, t110=10.18, P<.001) and therapist time for parent (β=.19, t110=2.95, P=.004) were the only significant independent predictors of engagement factor scores. CONCLUSIONS Overall, the intervention had high fidelity of delivery and was evaluated positively by participants, although reach may have been constrained by the nature of the randomized controlled trial. Parental engagement and therapist time for parent were strong predictors of intervention implementation which has important implications for the design and implementation of digital therapeutic interventions into Child and Adolescent Mental Health Services. CLINICALTRIAL International Standard Randomized Controlled Trial Number (ISRCTN) 70758207; https://doi.org/10.1186/ISRCTN70758207 and ClinicalTrials.gov NCT03483493; https://clinicaltrials.gov/ct2/show/NCT03483493 INTERNATIONAL REGISTERED REPORT RR2-https://doi.org/10.1186/s13063-019-3974-3

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 Effect of Stepped Care on Sexual Interest and Enjoyment in Distressed Patients with Head and Neck Cancer: A Randomized Controlled Trial

2021 ◽  
Vol 9 (1) ◽  
pp. 100304
Author(s):  
Laura E.R. Schutte ◽  
Heleen C. Melissant ◽  
Femke Jansen ◽  
Birgit I. Lissenberg-Witte ◽  
C. René Leemans ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Head And Neck Cancer ◽  
Head And Neck ◽  
Neck Cancer ◽  
Sexual Interest ◽  
Controlled Trial ◽  
Stepped Care ◽  
Randomized Controlled
Sign in / Sign up

Export Citation Format

Share Document