Emotional DifficultiesNCT02987608
A Feasibility Trial of Power Up
A study testing Power Up in people with Emotional Difficulties, run by University College, London at 3 sites in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 11 to 19 years
- Conditions the study is for
- Emotional Difficulties
- What is being tested?
- Power Up
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Sep 2016to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites, 3 recruiting
- Recruiting
East London NHS Foundation Trust
London, E1 5NF
Percy Aggett, 020 7426 2375 ext. 2400, Percy.Aggett@elft.nhs.uk
- Recruiting
North East London NHS Foundation Trust
London, IG11 7LZ
Vivienne Okoh, 0300 555 1035 ext. 53261, Vivienne.Okoh@nelft.nhs.uk
- Recruiting
The Tavistock and Portman NHS Foundation Trust
London, NW3 5BA
Emilios Lemoniatis, 020 8938 2429, ELemoniatis@tavi-port.nhs.uk
Emilios Lemoniatis
About this study
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:
Read more
- 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.
- Conditions
- Emotional Difficulties
- Being tested
- Power Up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Power UpDevice
Smartphone phone app
| Study group | Role | What they receive |
|---|---|---|
| Control Phase (No Power Up) | No intervention | 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. |
| Intervention Phase (Power Up) | Experimental | 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. Receives: Device: Power Up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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').
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study startSep 2016
- Primary completionAug 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emotional DifficultiesStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Anna Freud National Centre for Children and Families, MindTech Healthcare Technology Co-operative, Common Room Consulting Ltd, Create Marketing
- Responsible party
- Sponsor
- Investigators
- Miranda Wolpert, Professor, Principal investigator, UCL & Anaa Freud National Centre for Children and Families
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02987608
- Sponsor's protocol ID
- 16/0087
- Status last verified
- Oct 2016
- First submitted
- 12 Oct 2016
- Last updated
- 9 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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.
PubMed 29084708
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Trial of Power Up: A Smartphone App to Support Young People to Make Shared Decisions in Therapy
- ClinicalTrials.gov ID
- NCT02987608
- Acronym / sponsor ID
- 16/0087
- Conditions
- Emotional Difficulties
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Anna Freud National Centre for Children and Families, MindTech Healthcare Technology Co-operative, Common Room Consulting Ltd, Create Marketing
- Study start
- Sep 2016
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 9 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Phase (No Power Up) | No intervention | –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. |
| Intervention Phase (Power Up) | Experimental | Device: Power Up60 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. |
Who may qualify
- Ages
- 11 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Power UpSmartphone phone app | Device | Intervention Phase (Power Up) |
Primary outcome
Shared Decision Making Questionnaire - 9 (SDM Q-9)
Time frame: 3 months
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.
CollaboRATE
Time frame: 3 months
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.
Experience of Service Questionnaire (ESQ)
Time frame: 3 months
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.
Dyadic OPTION scale
Time frame: 3 months
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.
4 secondary outcomes
Patient Activation Measure - Mental Health (PAM - MH)
Time frame: 3 months
Strengths and Difficulties questionnaire (SDQ)
Time frame: 3 months
Youth Efficacy / Empowerment Scale - Mental Health (YES - MH)
Time frame: 3 months
Client Receipt of Services Inventory (CSRI) - Children's Version.
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2016.
- Derived from this study: PubMed 29084708Chapman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miranda Wolpert, Professor principal investigator
UCL & Anaa Freud National Centre for Children and Families
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Power Up in people with Emotional Difficulties, run by University College, London at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Louise N Chapman (020 7443 2205, louise.chapman@annafreud.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shared Decision Making Questionnaire - 9 (SDM Q-9) (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02987608, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2016.