A Feasibility Trial of Power Up

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

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.

Study Overview

• Status: Unknown
• Conditions: Emotional Difficulties
• Intervention / Treatment: Device: Power Up

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, E1 5NF
    • Recruiting
    • East London NHS Foundation Trust
    • Contact: Percy Aggett; Phone Number: 2400 020 7426 2375; Email: Percy.Aggett@elft.nhs.uk
  • London, United Kingdom, IG11 7LZ
    • Recruiting
    • North East London NHS Foundation Trust
    • Contact: Vivienne Okoh; Phone Number: 53261 0300 555 1035; Email: Vivienne.Okoh@nelft.nhs.uk
  • London, United Kingdom, NW3 5BA
    • Recruiting
    • The Tavistock and Portman NHS Foundation Trust
    • Contact: Emilios Lemoniatis; Phone Number: 020 8938 2429; Email: ELemoniatis@tavi-port.nhs.uk
    • Principal Investigator: Emilios Lemoniatis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Phase (No Power Up); 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); 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; Smartphone phone app

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Did Not Attends (DNAs)	Number of young person DNAs will be reported by the clinician.	3 months
Number of sessions attended	The number of sessions attended by the young person will be reported by the clinician.	3 months
Type of therapy / intervention received	The type of therapy / intervention received by the young person will be reported by the clinician.	3 months

Collaborators and Investigators

• Sponsor: University College, London
• Collaborators: Anna Freud National Centre for Children and Families; MindTech Healthcare Technology Co-operative; Common Room Consulting Ltd; Create Marketing
• Investigators: Principal Investigator: Miranda Wolpert, Professor, UCL & Anaa Freud National Centre for Children and Families

Publications and helpful links

General Publications

• Chapman L, Edbrooke-Childs J, Martin K, Webber H, Craven MP, Hollis C, Deighton J, Law R, Fonagy P, Wolpert M. A Mobile Phone App to Support Young People in Making Shared Decisions in Therapy (Power Up): Study Protocol. JMIR Res Protoc. 2017 Oct 30;6(10):e206. doi: 10.2196/resprot.7694.

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): August 1, 2017
• Study Completion (Anticipated): September 1, 2017

Study Registration Dates

• First Submitted: October 12, 2016
• First Submitted That Met QC Criteria: December 6, 2016
• First Posted (Estimate): December 9, 2016

Study Record Updates

• Last Update Posted (Estimate): December 9, 2016
• Last Update Submitted That Met QC Criteria: December 6, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 16/0087

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No