A Feasibility Trial of Power Up

Study Overview
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Brief Summary
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There is an increasing demand for digital tools to empower young people with mental health difficulties (NHS England, 2015). Digital information, advice and mood tracking tools are increasingly being used to support child mental health. Evidence suggests that young people want to be active participants in their care and involved in decisions about their treatment. However, there is a lack of digital shared decision making tools available to support young people in Child and Adolescent Mental Health Services (CAMHS). This study aims to develop Power Up, a smartphone app to empower young people in CAMHS to make their voice heard and to participate more in decisions around their care. The project will involve two phases: Development Phase -Developing Power Up according to the views and ideas expressed by young people, their parents/ carers, and clinicians in Patient and Public Involvement (PPI) sessions. -Conducting interviews and focus groups with 10 young people in CAMHS, 10 parents/ carers and 10 clinicians to review the acceptability of the content and format of Power Up. Feasibility testing Phase -Conducting a feasibility trial with 120 young people with emotional difficulties, aged 11-19 years, from three London CAMHS. 60 young people will receive treatment as usual and 60 will use Power Up alongside treatment as usual. Participant's ratings of empowerment, activation, and symptoms will be measured soon after their referral to the service. The same measures plus shared decision making questionnaires will be administered three months later. The findings will inform the planning of a prospective cluster controlled trial. More broadly this trial will contribute an understanding of the feasibility and acceptability of developing and implementing a shared decision making app into CAMHS.

Official Title
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A Feasibility Trial of Power Up: A Smartphone App to Support Young People to Make Shared Decisions in Therapy

Conditions
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Emotional Difficulties

Intervention / Treatment
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* Device: Power Up


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Recently been referred to CAMHS (pre - first appointment) Presenting with emotional difficulties Clinician will have confirmed that the young person does not have any vulnerability which would make taking part in the study inappropriate to their context

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Phase (No Power Up)<br>60 young people will receive CAMHS treatment as usual. Measures of empowerment, activation, and symptoms will be completed by participants soon after their referral to the service. The same measures plus shared decision making questionnaires will be administered three months later. | |
| Experimental: Intervention Phase (Power Up)<br>60 young people use Power Up alongside CAMHS treatment as usual. Measures of empowerment, activation, and symptoms will be completed by participants soon after their referral to the service. The same measures plus shared decision making questionnaires and a Power Up feedback form will be administered three months later. | Device: Power Up<br>* Smartphone phone app<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shared Decision Making Questionnaire - 9 (SDM Q-9) | This will be completed by young people at time two (three months into therapy). The SDM Q-9 is a nine item patient reported shared decision making questionnaire. | 3 months | 
| CollaboRATE | This will be completed by young people at time two (three months into therapy). CollaboRATE is a three item patient reported shared decision making measure. | 3 months | 
| Experience of Service Questionnaire (ESQ) | Four items from this questionnaire will be completed by young people at time two (three months into therapy) as a proxy measure of shared decision making. The ESQ is a self-completion questionnaire that assesses children and young people's views of services with respect to accessibility, humanity of care, organisation of care and environment. | 3 months | 
| Dyadic OPTION scale | This will be completed by clinicians at time two (three months into therapy). The Dyadic OPTION scale is a 12- item instrument to measure the extent to which patients have been involved in shared decision making from the viewpoint of the clinician. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Activation Measure - Mental Health (PAM - MH) | The PAM - MH will be completed by young people at time one (beginning of therapy) and time two (three months into therapy). The PAM - MH is a patient reported tool for measuring engagement in mental healthcare. | 3 months | 
| Strengths and Difficulties questionnaire (SDQ) | The SDQ will be completed by young people at time one (beginning of therapy) and time two (three months into therapy). The SDQ is a self-report behavioural screening questionnaire for children and adolescents measuring symptoms and functioning. | 3 months | 
| Youth Efficacy / Empowerment Scale - Mental Health (YES - MH) | The YES -MH will be completed by young people at time one (beginning of therapy) and time two (three months into therapy). The YES - MH assesses youth perceptions of efficacy with respect to managing their own mental health condition ('Self'), managing their own services and supports ('Service'), and using their experience and knowledge to help peers and improve service systems ('System'). | 3 months | 
| Client Receipt of Services Inventory (CSRI) - Children's Version. | The CSRI will be completed by parents at time one (beginning of therapy) and time two (three months into therapy). The CSRI provides information on service utilisation, as reported by the main carer of the child in the family. | 3 months |