A feasibility trial of Power Up
| ISRCTN | ISRCTN77194423 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77194423 |
| Secondary identifying numbers | 31977 |
- Submission date
- 02/11/2016
- Registration date
- 07/11/2016
- Last edited
- 10/01/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Young people with mental health difficulties need support to ensure their voice is heard during therapy. Evidence suggests that young people want to be actively involved in their care and in decisions about their treatment (shared decision making), but this does not always happen in practice. There are a number of barriers to young people being involved in shared decision making in mental health services. The process of shared decision making is sometimes perceived as too time consuming by clinicians and there is also a lack of age appropriate resources to support the process. Many young people already use technology as an informal complement to treatment. More research is required to better understand how best to incorporate this type of technology into services. In response to this a smartphone app has been developed, which aims to support young people, aged 11 -19, who are in the initial stages of therapy. The Power Up app provides young people with six tools to use within and between sessions with Child and Adolescent Mental Health Services (CAMHS). The aim of these tools is to empower young people to be more actively engaged in their care and decisions about their care by supporting them to record their experiences, questions, opinions and tasks or actions related to their care. The aim of this study is to find out whether it would be feasible and acceptable to conduct a study looking at the effectiveness of Power Up within a CAMHS service.
Who can participate?
Young people (aged 11-19 years) who have recently been referred to a participating CAMHS with emotional difficulties who own a smartphone.
What does the study involve?
The study is made up of two phases. In the first phase of the study, 30 participants are recruited and asked to continue to receive treatment as usual from the CAMHS. At the start of this phase and then three months later, participants complete a number of questionnaires to measure shared decision making, empowerment, patient activation and symptoms of emotional and behavioural difficulties. In the second phase, 30 new participants are recruited and are given access to the Power Up app as well as their usual CAMHS sessions. The Power Up app includes a range of tools to use within and between CAMHS sessions. At the start of the phase and then three months later, participants complete a number of questionnaires to measure shared decision making, empowerment, patient activation and symptoms of emotional and behavioural difficulties.
What are the possible benefits and risks of participating?
There are no guaranteed benefits of taking part. One advantage is that young people will get to help shape a tool that clinicians, young people, and their families may use in future. Most people find taking part in research rewarding, as they contribute to the development of knowledge that may benefit other people in the future. There are no notable risks involved with participating.
Where is the study run from?
1. Tavistock and Portman CAMHS (UK)
2. Barking and Dagenham CAMHS (UK)
3. Tower Hamlets CAMHS (UK)
4. Central & North West London CAMHS (UK)
5. Barnet, Enfield & Haringey CAMHS (UK)
6. West London CAMHS (UK)
7. Hackney Children's Social Care
When is the study starting and how long is it expected to run for?
September 2015 to March 2018
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Dr Julian Edbrooke
Julian.Edbrooke-Childs@annafreud.org
Contact information
Scientific
Anna Freud Centre
4-8 Rodney Street
London
N1 9JH
United Kingdom
| Phone | +44 (0)20 7443 2275 |
|---|---|
| Julian.Edbrooke-Childs@annafreud.org |
Study information
| Study design | Multi-centre feasibility wait-list controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Community |
| Study type | Other |
| Participant information sheet | ISRCTN77194423_PIS_28Oct16_YP16-18_Phase2_V1.6.doc |
| Scientific title | A feasibility trial of UCL's Power Up: a smartphone app to support young people to make shared decisions in therapy |
| Study objectives | The aim of this study is to: 1. Develop a smartphone app, in collaboration with young people, parents and clinicians, which aims to support young people’s voice in Child and Adolescent Mental Health Services 2. Determine whether it is feasible and acceptable to study the effectiveness of Power Up using a cluster controlled trial |
| Ethics approval(s) | Queen Square NRES Committee, 15/06/2016, ref: 16/LO/0891 |
| Health condition(s) or problem(s) studied | Specialty: Mental Health, Primary sub-specialty: Anxiety - emotional; UKCRC code/ Disease: Mental Health/ Behavioural and emotional disorders with onset usually occurring in childhood and adolescence |
| Intervention | Current Interventions (as of 10/01/2018): The study is formed of two phases. 30 participants are recruited to take part in the first phase (control phase) and 30 are recruited to take part in the second phase (intervention phase). Control Phase (January 2017 – June 2017): Participants will receive treatment as usual for their presenting emotional difficulties. Participants will complete questionnaires measuring shared decision making, empowerment, activation and symptoms at the point of recruitment and again three months later. Intervention Phase (June 2017 – December 2017): Participants will use Power Up alongside their CAMHS sessions, where they will receive treatment as usual for their presenting emotional difficulties. Young people will download Power Up and are asked to use the app between and within these sessions to record diary entries, plans, questions, decisions and information about the sessions. Power Up is an app for young people, aged 11-19, in CAMHS to use independently. The Power Up app will provide young people with six tools to use within and between CAMHS sessions. The objective of these tools is to empower young people to be more actively engaged in their care and decisions about their care by supporting them to record their experiences, questions, opinions and tasks or actions related to their care. Users can enter information into the app using text, audio, video and photos. In ‘My Diary’, young people can record diary entries expressing their thoughts and feelings on their experiences. In ‘My Plans’, young people can record step by step plans for achieving goals or tackling difficulties. In ‘My Questions’, young people can record questions they would like to ask relevant others involved in their care (e.g. their CAMHS clinician), and then record their response. ‘My Decisions’ is a space for young people to work on decisions using a structured approach; by adding the pros and cons and weighting the importance of each one. Additionally, users will record a list of all the people in their support network, including their CAMHS clinician, in My People when they first download the app. As Power Up users add entries to the app, they will be reminded to consider if they want to talk to any of the individuals in My People about their entry. Finally, the Help and Support tool will signpost young people to other relevant resources giving information and advice. Young people will be able to add their own links and phone numbers to the list. Participants will complete questionnaires measuring shared decision making, empowerment, activation and symptoms at the point of recruitment and again three months later. Previous Interventions: The study is formed of two phases. Sixty participants are recruited to take part in the first phase (control phase) and sixty are recruited to take part in the second phase (intervention phase). Control Phase (September 2016 – February 2017): Participants will receive treatment as usual for their presenting emotional difficulties. Participants will complete questionnaires measuring shared decision making, empowerment, activation and symptoms at the point of recruitment and again three months later. Intervention Phase (March 2017 – August 2017): Participants will use Power Up alongside their CAMHS sessions, where they will receive treatment as usual for their presenting emotional difficulties. Young people will download Power Up and are asked to use the app between and within these sessions to record diary entries, plans, questions, decisions and information about the sessions. Power Up is an app for young people, aged 11-19, in CAMHS to use independently. The Power Up app will provide young people with six tools to use within and between CAMHS sessions. The objective of these tools is to empower young people to be more actively engaged in their care and decisions about their care by supporting them to record their experiences, questions, opinions and tasks or actions related to their care. Users can enter information into the app using text, audio, video and photos. In ‘My Diary’, young people can record diary entries expressing their thoughts and feelings on their experiences. In ‘My Plans’, young people can record step by step plans for achieving goals or tackling difficulties. In ‘My Questions’, young people can record questions they would like to ask relevant others involved in their care (e.g. their CAMHS clinician), and then record their response. ‘My Decisions’ is a space for young people to work on decisions using a structured approach; by adding the pros and cons and weighting the importance of each one. Power Up users can choose to ‘flag up’ the diary entries, plans, questions and decisions which they wish to discuss with relevant others involved in their care. There will also be a space for the young person to record their own notes, tasks or actions from CAMHS appointments in ‘My Sessions’. Finally ‘My Library’ will consist of a list of links, signposting young people to other relevant resources giving information and advice, to which the young person can add. Users of the Power Up app will not be able to digitally share information that they enter. Participants will complete questionnaires measuring shared decision making, empowerment, activation and symptoms at the point of recruitment and again three months later. |
| Intervention type | Other |
| Primary outcome measure | Young people: Shared decision making is measured using CollaboRATE, Shared Decision Making Questionnaire – 9, and four items of the ESQ (proxy measure) at baseline and 3 months (for each phase). Clinicians: Shared decision making in young people is assessed using the Dyadic OPTION Scale at baseline and 3 months (for each phase). |
| Secondary outcome measures | 1. Empowerment is measured using the Youth Empowerment Scale – Mental Health 2. Patient activation is measured using the Patient Activation Scale – Mental Health 3. Symptoms of emotional difficulties are measured using the Strengths and Difficulties Questionnaire 4. Service use is measured using the Client Service Receipt Inventory – Children’s Version (parent report) 5. Number of sessions attended, number of Did Not Attends, type of intervention and type of presenting problems will also be reported by clinicians for each participant at three months All measures are taken at baseline (during initial sessions) and three months later unless otherwise stated. |
| Overall study start date | 01/09/2015 |
| Completion date | 31/03/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 11 Years |
| Upper age limit | 19 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 60; UK Sample Size: 60 |
| Key inclusion criteria | Current inclusion criteria (as of 10/08/2018): 1. Recent referral to CAMHS at the point of recruitment 2. Aged 11-19 years 3. Presenting to CAMHS with emotional difficulties, such as anxiety or depression (Strengths and Difficulties Questionnaire score of ≥ 7) 4. Able to understand English sufficiently to provide informed consent 5. Own a smartphone Previous inclusion criteria: 1. Recent referral to CAMHS at the point of recruitment 2. Aged 11-19 years 3. Presenting to CAMHS with emotional difficulties, such as anxiety or depression (Strengths and Difficulties Questionnaire score of ≥ 7) 4. Able to understand English sufficiently to provide informed consent 5. Own an iPhone |
| Key exclusion criteria | Clinician identifies a reason why the young person's vulnerabilities would make them inappropriate to participate |
| Date of first enrolment | 01/01/2017 |
| Date of final enrolment | 31/12/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
NHS Foundation Trust Tavistock Centre
120 Belsize Lane
London
NW3 5BA
United Kingdom
The Child and Family Centre
79 Axe Street
Barking
IG11 7LZ
United Kingdom
11 Gill Street
Poplar
London
E14 8HQ
United Kingdom
London
W9 2NW
United Kingdom
Burnt Oak Broadway
Edgware
London
HA8 0AD
United Kingdom
Hounslow
London
TW3 3EL
United Kingdom
1 Hillman Street
London
E8 1DY
United Kingdom
Sponsor information
Hospital/treatment centre
Joint Research Office UCL
1st Floor, Maple House – Suite B
149 Tottenham Court Road
London
W1T 7DN
England
United Kingdom
"ROR" |
https://ror.org/02jx3x895 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/12/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Findings of both phases will be disseminated through a publication in a high impact peer reviewed journal, an internal report, and conference presentations. Results will also be published (in age-appropriate language) on the UCL, AFC and NHS Hospital/CAMHS websites. |
| IPD sharing plan | The current data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version V1.6 | 28/10/2016 | 07/11/2016 | No | Yes |
| Participant information sheet | version V1.6 | 28/10/2016 | 07/11/2016 | No | Yes |
| Participant information sheet | version V1.6 | 28/10/2016 | 07/11/2016 | No | Yes |
| Participant information sheet | version V1.6 | 28/10/2016 | 07/11/2016 | No | Yes |
| Participant information sheet | version V1.6 | 28/10/2016 | 07/11/2016 | No | Yes |
| Participant information sheet | version V1.6 | 28/10/2016 | 07/11/2016 | No | Yes |
| Protocol article | protocol | 30/10/2017 | Yes | No | |
| HRA research summary | 26/07/2023 | No | No |
Additional files
- ISRCTN77194423_PIS_28Oct16_YP16-18_Phase2_V1.6.doc
- Uploaded 07/11/2016
- ISRCTN77194423_PIS_28Oct16_Parental_YP1-15_Phase2_V1.6.doc
- Uploaded 07/11/2016
- ISRCTN77194423_PIS_28Oct16_YP11-15_Phase1_V1.6.doc
- Uploaded 07/11/2016
- ISRCTN77194423_PIS_28Oct16_YP11-15_Phase2_V1.6.doc
- Uploaded 07/11/2016
- ISRCTN77194423_PIS_28Oct16_YP16-18_Phase1_V1.6.doc
- Uploaded 07/11/2016
- ISRCTN77194423_PIS_28Oct16_Parental_YP11-15_Phase1_V1.6.doc
- Uploaded 07/11/2016
Editorial Notes
10/01/2018: The following changes were made:
1. Interventions and participant inclusion criteria were updated
2. Target number of participants was changed from 150 to 60.
3. Recruitment start date was changed from 01/09/2016 to 01/01/2017.
4. Recruitment end date was changed from 31/08/2017 to 31/12/2017.
5. Four trial participating centres were added.
01/11/2017: Publication reference added.
07/11/2016: Participant information sheets uploaded.
