Emotional Difficulties Clinical Trial
Official title:
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.
| Status | Recruiting |
| Enrollment | 120 |
| Est. completion date | September 2017 |
| Est. primary completion date | August 2017 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 11 Years to 19 Years |
| Eligibility |
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 |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | East London NHS Foundation Trust | London | |
| United Kingdom | North East London NHS Foundation Trust | London | |
| United Kingdom | The Tavistock and Portman NHS Foundation Trust | London |
| Lead Sponsor | Collaborator |
|---|---|
| University College, London | Anna Freud National Centre for Children and Families, Common Room Consulting Ltd, Create Marketing, MindTech Healthcare Technology Co-operative |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Did Not Attends (DNAs) | Number of young person DNAs will be reported by the clinician. | 3 months | No |
| Other | Number of sessions attended | The number of sessions attended by the young person will be reported by the clinician. | 3 months | No |
| Other | Type of therapy / intervention received | The type of therapy / intervention received by the young person will be reported by the clinician. | 3 months | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Primary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |