Condition category
Mental and Behavioural Disorders
Date applied
02/11/2016
Date assigned
07/11/2016
Last edited
07/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

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 an iPhone.

What does the study involve?
The study is made up of two phases. In the first phase of the study, 60 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, 60 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)

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Julian Edbrooke

ORCID ID

Contact details

Anna Freud Centre
4-8 Rodney Street
London
N1 9JH
United Kingdom
+44 20 7443 2275
Julian.Edbrooke-Childs@annafreud.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

31977

Study information

Scientific title

A feasibility trial of UCL's Power Up: A smartphone app to support young people to make shared decisions in therapy

Acronym

Study hypothesis

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

Queen Square NRES Committee, 15/06/2016, ref: 16/LO/0891

Study design

Multi-centre feasibility wait-list controlled trial

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Community

Trial type

Other

Patient information sheet

See additional files

Condition

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

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/09/2015

Overall trial end date

31/03/2018

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 150; UK Sample Size: 150

Participant exclusion criteria

Clinician identifies a reason why the young person's vulnerabilities would make them inappropriate to participate.

Recruitment start date

01/09/2016

Recruitment end date

31/08/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Tavistock and Portman CAMHS
The Tavistock and Portman NHS Foundation Trust Tavistock Centre 120 Belsize Lane
London
NW3 5BA
United Kingdom

Trial participating centre

Barking and Dagenham CAMHS
Child and family consultation service The Child and Family Centre 79 Axe Street
Barking
IG11 7LZ
United Kingdom

Trial participating centre

Tower Hamlets CAMHS
Emmanuel Miller Centre 11 Gill Street Poplar
London
E14 8HQ
United Kingdom

Sponsor information

Organisation

University College London

Sponsor details

Joint Research Office UCL
1st Floor
Maple House – Suite B
149 Tottenham Court Road
London
W1T 7DN
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

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.

Intention to publish date

01/12/2018

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

not available

Publication citations

Editorial Notes

07/11/2016: Participant information sheets uploaded.