scholarly journals Correction: An App to Help Young People Self-Manage When Feeling Overwhelmed (ReZone): Protocol of a Cluster Randomized Controlled Trial

10.2196/10018 ◽  
2018 ◽  
Vol 7 (3) ◽  
pp. e10018
Author(s):  
Julian Edbrooke-Childs ◽  
Jaime Smith ◽  
Jessica Rees ◽  
Chloe Edridge ◽  
Ana Calderon ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Young People ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Randomized Controlled ◽  
Cluster Randomized ◽  
Feeling Overwhelmed

scholarly journals An App to Help Young People Self-Manage When Feeling Overwhelmed (ReZone): Protocol of a Cluster Randomized Controlled Trial

2017 ◽  
Vol 6 (11) ◽  
pp. e213 ◽  
Author(s):  
Julian Edbrooke-Childs ◽  
Jaime Smith ◽  
Jessica Rees ◽  
Chloe Edridge ◽  
Ana Calderon ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Young People ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Randomized Controlled ◽  
Cluster Randomized ◽  
Feeling Overwhelmed

scholarly journals An mHealth Intervention (ReZone) to Help Young People Self-Manage Overwhelming Feelings: Cluster-Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Chloe Edridge ◽  
Miranda Wolpert ◽  
Jessica Deighton ◽  
Julian Edbrooke-Childs
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Young People ◽  
Outcome Measurement ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Mhealth Intervention ◽  
Randomized Controlled ◽  
Mental Health Difficulties ◽  
Cluster Randomized

BACKGROUND Mental health difficulties in young people are increasing, and there is a need for evidence on the effectiveness of digital interventions to increase opportunities for supporting mental health in young people. Such studies are complicated due to issues of implementation and adoption, outcome measurement, and appropriate study designs. OBJECTIVE The objective of this study was to examine the effectiveness of an mHealth intervention (ReZone) in reducing mental health difficulties in young people. METHODS The cluster-randomized controlled trial enrolled 409 participants aged 10-15 years, and classes were allocated to ReZone or management as usual. Self-reported questionnaires were completed at baseline and 3-month follow-up. RESULTS There were no significant differences between the ReZone condition and management as usual in the self-reported outcome measures. However, there were 3467 usage sessions, which corresponds to 16.9 times per student (total of 205 students) in classes allocated to ReZone. CONCLUSIONS It is essential to publish studies that do not show significant differences, as these findings can still contribute to the literature, help in learning, and inform the direction of future work. The results reported in this paper could be due to a range of reasons, including whether ReZone has the scope to impact change or limitations related to the setting, context, and appropriateness of an RCT. The findings of this study suggest that ReZone was implemented and adopted. INTERNATIONAL REGISTERED REPORT RR2-10.2196/resprot.7019

scholarly journals Assessing the Feasibility of a Multicenter Transition Intervention Model Across Adolescent Secure Services in England (MOVING FORWARD): Protocol for a Feasibility Cluster Randomized Controlled Trial

10.2196/29273 ◽  
2021 ◽  
Vol 10 (10) ◽  
pp. e29273
Author(s):  
Maria Livanou ◽  
Rebecca Lane
Keyword(s):  
Randomized Controlled Trial ◽  
Young People ◽  
Transitional Care ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Intervention Model ◽  
Randomized Controlled ◽  
Transition Intervention ◽  
Cluster Randomized ◽  
Transition Preparation

Background Young people moving from adolescent secure inpatient units to adult care in the United Kingdom have multiple and complex needs and are more likely to experience poor transition outcomes. Poorly managed transitions can lead to enduring use and dependency on mental health services. However, there is a lack of knowledge about the feasibility of transitional care models. Objective This paper presents the protocol for a study that aims to test a feasibility cluster randomized controlled trial for young people transitioning from adolescent secure services to adult-oriented settings. The overarching aim of the MOVING FORWARD study is to provide a preliminary estimate of the effectiveness and cost-effectiveness of a new transition intervention model and to inform a future full-scale cluster randomized controlled trial. Methods The design of the study is a 3-arm feasibility cluster randomized controlled trial comparing the MOVING FORWARD intervention against standard transition preparation conducted at 6 adolescent secure services, of which 4 units will receive the intervention and 2 will serve as controls. Eligible young people between 17-19 years, their parents/carers, and key workers will be invited to participate. Young people and parents/carers will be allocated to two conditions (young people alone and young people with a parent/carer) and will receive 4 transition preparation workshops across 6 months. Six adolescent secure hospitals will be randomly allocated, stratified by area and service type. Data will be collected at 3 time points: baseline (T0), 6-12 months postintervention (T1), and 18-24 months postbaseline (T2). Primary and secondary outcomes will be based on assessment measures and interviews conducted at T1 and T2. Results A total of 13 young people and 17 staff members have contributed to the intervention design through online advisory groups on the design of the study and important themes for transition. We have also consulted members of the public (a steering group) including 2 young people who have transitioned to the community and 2 parents/carers. Common identified themes included appropriateness of module content and support during delayed transitions. The content of the intervention will be finalized during the first 6 months of the study. Participants will be recruited over the course of 6 months. An intraclass correlation coefficient will be calculated to inform the power of the sample size for a further large-scale trial. With a sample size of 50, we will be able to estimate a dropout rate of 80% (95% CI –11% to 11%). Conclusions This research will provide practitioners and policy makers with an evidence-based framework of how training and familiarization with the prospective transitions can yield positive outcomes. This study will test whether a psychosocial intervention can be implemented in adolescent secure hospitals. The results will identify barriers and facilitators to the proposed intervention and will enable services to reflect on the quality of transitional care delivery. International Registered Report Identifier (IRRID) PRR1-10.2196/29273

scholarly journals Assessing the Feasibility of a Multicenter Transition Intervention Model Across Adolescent Secure Services in England (MOVING FORWARD): Protocol for a Feasibility Cluster Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Maria Livanou ◽  
Rebecca Lane
Keyword(s):  
Randomized Controlled Trial ◽  
Young People ◽  
Transitional Care ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Intervention Model ◽  
Randomized Controlled ◽  
Transition Intervention ◽  
Cluster Randomized ◽  
Transition Preparation

BACKGROUND Young people moving from adolescent secure inpatient units to adult care in the United Kingdom have multiple and complex needs and are more likely to experience poor transition outcomes. Poorly managed transitions can lead to enduring use and dependency on mental health services. However, there is a lack of knowledge about the feasibility of transitional care models. OBJECTIVE This paper presents the protocol for a study that aims to test a feasibility cluster randomized controlled trial for young people transitioning from adolescent secure services to adult-oriented settings. The overarching aim of the MOVING FORWARD study is to provide a preliminary estimate of the effectiveness and cost-effectiveness of a new transition intervention model and to inform a future full-scale cluster randomized controlled trial. METHODS The design of the study is a 3-arm feasibility cluster randomized controlled trial comparing the MOVING FORWARD intervention against standard transition preparation conducted at 6 adolescent secure services, of which 4 units will receive the intervention and 2 will serve as controls. Eligible young people between 17-19 years, their parents/carers, and key workers will be invited to participate. Young people and parents/carers will be allocated to two conditions (young people alone and young people with a parent/carer) and will receive 4 transition preparation workshops across 6 months. Six adolescent secure hospitals will be randomly allocated, stratified by area and service type. Data will be collected at 3 time points: baseline (T0), 6-12 months postintervention (T1), and 18-24 months postbaseline (T2). Primary and secondary outcomes will be based on assessment measures and interviews conducted at T1 and T2. RESULTS A total of 13 young people and 17 staff members have contributed to the intervention design through online advisory groups on the design of the study and important themes for transition. We have also consulted members of the public (a steering group) including 2 young people who have transitioned to the community and 2 parents/carers. Common identified themes included appropriateness of module content and support during delayed transitions. The content of the intervention will be finalized during the first 6 months of the study. Participants will be recruited over the course of 6 months. An intraclass correlation coefficient will be calculated to inform the power of the sample size for a further large-scale trial. With a sample size of 50, we will be able to estimate a dropout rate of 80% (95% CI –11% to 11%). CONCLUSIONS This research will provide practitioners and policy makers with an evidence-based framework of how training and familiarization with the prospective transitions can yield positive outcomes. This study will test whether a psychosocial intervention can be implemented in adolescent secure hospitals. The results will identify barriers and facilitators to the proposed intervention and will enable services to reflect on the quality of transitional care delivery. INTERNATIONAL REGISTERED REPORT PRR1-10.2196/29273

scholarly journals An mHealth Intervention (ReZone) to Help Young People Self-Manage Overwhelming Feelings: Cluster-Randomized Controlled Trial

10.2196/14223 ◽  
2020 ◽  
Vol 22 (7) ◽  
pp. e14223
Author(s):  
Chloe Edridge ◽  
Miranda Wolpert ◽  
Jessica Deighton ◽  
Julian Edbrooke-Childs
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Young People ◽  
Outcome Measurement ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Mhealth Intervention ◽  
Randomized Controlled ◽  
Mental Health Difficulties ◽  
Cluster Randomized

Background Mental health difficulties in young people are increasing, and there is a need for evidence on the effectiveness of digital interventions to increase opportunities for supporting mental health in young people. Such studies are complicated due to issues of implementation and adoption, outcome measurement, and appropriate study designs. Objective The objective of this study was to examine the effectiveness of an mHealth intervention (ReZone) in reducing mental health difficulties in young people. Methods The cluster-randomized controlled trial enrolled 409 participants aged 10-15 years, and classes were allocated to ReZone or management as usual. Self-reported questionnaires were completed at baseline and 3-month follow-up. Results There were no significant differences between the ReZone condition and management as usual in the self-reported outcome measures. However, there were 3467 usage sessions, which corresponds to 16.9 times per student (total of 205 students) in classes allocated to ReZone. Conclusions It is essential to publish studies that do not show significant differences, as these findings can still contribute to the literature, help in learning, and inform the direction of future work. The results reported in this paper could be due to a range of reasons, including whether ReZone has the scope to impact change or limitations related to the setting, context, and appropriateness of an RCT. The findings of this study suggest that ReZone was implemented and adopted. International Registered Report Identifier (IRRID) RR2-10.2196/resprot.7019

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