Internalising DisordersPower UpNCT02552797
The Development and Piloting of 'Power Up': a Tool for Young People with Internalising/emotional Disorders to Make Shared Decisions in Child and Adolescent Mental Health Services (CAMHS)
A study testing Shared Decision Making tool in people with Internalising Disorders and Anxiety, run by University College, London.
Trial summary
Patients should be able to have a say in their care and treatment, but how this should work for children and young people with mental health difficulties is unknown. For example, how and when do young people want to be involved in decision making, and what is important to them, their parents/guardians and healthcare… Read more about this study
- Who is it for?
- Ages 11 years and older
- Conditions the study is for
- Internalising Disorders, Anxiety, Depression
- What is being tested?
- Shared Decision Making tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Jul 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- A young person between 11 and 16 years of age with an emotional/internalising disorder who is accessing CAMHS.
- A parent/guardian of a young person between 11 and 16 years of age with an emotional/internalising disorder who is accessing CAMHS.
- A clinician in a participating CAMHS site.
- Only those providing consent will be included. Where potential participants are under 16 parents/legal guardians will also have to provide consent.
Who cannot join
- Any individual who is not accessing a participating CAMHS site.
- Given there are no additional resources for an interpreter, children or parents who are not comfortable with English may not be included
- Young people under the age of 11, or over the age of 16 would not be included.
- Parents/guardians of young people with SEN (special educational needs) will not be included
- Those who do not consent.
About this study
Patients should be able to have a say in their care and treatment, but how this should work for children and young people with mental health difficulties is unknown. For example, how and when do young people want to be involved in decision making, and what is important to them, their parents/guardians and healthcare professionals? This project will address these questions and will develop a tool known as 'Power Up' to help young people with mental health difficulties make decisions about their own care and treatment.
This project will run for 24 months and will:
Read more
- Understand the beliefs, experiences, and values of young people, their parents/guardians and clinicians around shared decision making (SDM) in mental health.
- Use these responses to develop 'Power Up'; a tool to help young people make decisions about their care or treatment in mental health services.
- Pilot 'Power 'Up' in child and adolescent mental health services to estimate the number of patients who would want to use Power Up and to see whether patients can be recruited and followed up with measures. The pilot study would investigate randomisation, see how clinicians cooperate, and identify barriers to collaboration and ways of overcoming these.
Forty five young people, parents and clinicians will be recruited for interviews and focus groups to inform tool development. Sixty young people aged 1116 will be recruited for the pilot/feasibility study. Measurements will be collected at baseline, session by session, and at the end of treatment.
Read the detailed description
TOOL DEVELOPMENT All potential information about the project can be given verbally (this will be over the phone in the first instance). For CYP (children and young people) that are under 16, parental consent will also be needed. After the phone call, if individuals are interested in taking part, age appropriate information sheets will be posted out to both the CYP and guardians/parents outlining the details of the study. The researcher will discuss any questions potential participants may have over the telephone, and both will have as long as they need to decide whether to take part. If they decide to take part the participants will be invited to take part if they meet study inclusion criteria. For clinicians, the researcher will come to staff meetings, outline the study and leave contact details/expression of interest forms so that those who are interested can get in contact to find out more. For young people and families, clinician's will briefly outline the study and interested participants will fill out an expression of interest form. After the researcher receives the contact details participants will be contacted by a researcher so that further information researcher will then arrange a time to meet with them for an interview or when they may be available for a focus group, and consent forms will be signed. Clinicians, parents/guardians and those aged 16 will also have the opportunity to have the interview conducted over the phone if they prefer (in which case consent forms will be posted). During interviews participants will speak about their previous experiences and beliefs about SDM as well as view and discuss the few existing SDM tools used with young people within CAMHS to use as a baseline for further development. After the interview participants will be debriefed, and be given the opportunity to validate themes that emerge from the data once analysed.
USING POWER UP IN CAMHS SERVICES Clinicians For clinicians, the researcher will be come to staff meetings, outline the study and leave contact details/expression of interest forms so that those who are interested can get in contact to find out more. After the researcher receives the clinicians contact details they will be contacted by a researcher so that further information about the project can be given verbally (this will be over the phone in the first instance). The researcher will then meet with those who are interested an outline the study to them (including randomisation). The researcher will discuss any questions potential participants may have over the telephone, and both will have as long as they need to decide whether to take part. Those who want to take part will be asked to sign a consent form, and will be allocated to use 'Power Up' or continue as TAU with their patients.
CYP/ Families Young people and their families will be invited to take part if they meet the study criteria. Clinicians will briefly outline the study and interested participants will fill out an expression of interest form. After the researcher receives the contact details patients and their families will be contacted by a researcher so that further information about the project can be given verbally (this will be over the phone in the first instance). For CYP's that are under 16, parental consent will also be needed. After the phone call, if individuals are interested in taking part, age appropriate information sheets will be posted out to both the CYP and Guardians/Parents outlining the details of the study. The researcher will discuss any questions potential participants may have over the telephone, and both will have as long as they need to decide whether to take part.
If they decide to take part the researcher will then arrange a time to meet with them at the CAMHS service and complete any baseline assessments (week 1) for clinical symptomology (e.g. Revised Child Anxiety and Depression Scale , Strengths and Difficulties Questionnaire) if these are not routinely collected by the CAMHS service. Randomisation will occur at clinician level and participants will be made aware of this in the information sheets. Throughout the course of treatment session by session measures at weeks 2, 4 and 8) will be completed. Participants and clinicians will also be asked if they consent to the researcher observing one appointment session when the tool is being used (this is optional and will last up to 30 mins, but will likely be week 2 or 3) to understand how the tool is being used in clinical settings.
At the end of treatment (approximately week 8) clinical symptomology, therapeutic alliance, level of shared decision making, and experience of care will be collected. Participants will be invited for an interview to hear their views and experiences about the 'Power Up tool' which like other interviews will take place at a time of their choosing and abide by SOPs (standard operating procedures). Participants will exit the trial and any further treatment will be discussed between them and their healthcare professional.
- Conditions
- Internalising Disorders, Anxiety, Depression
- Being tested
- Shared Decision Making tool
- Keywords
- Shared Decision Making, CAMHS
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shared Decision Making toolBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Using Power Up | Experimental | Participants will use 'Power Up' to help them make shared decisions about their treatment or care Receives: Behavioral: Shared Decision Making tool |
| Not using Power Up | No intervention | Participants will continue treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shared Decision Making Questionnaire (CollaboRATE)
A measure of SDM - this consists of three questions related to shared decision making on a 9 point likert scale ranging from 0 'no effort was made' to 9 'every effort was made'.
Measured: Level of Shared Decision Making at end of treatment (this will be at approximately week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
Why it stopped: Changes to scope of project and funding
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 Internalising DisordersStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julian Edbrooke-Childs, PhD, Principal investigator, University College London and Anna Freud Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02552797
- Sponsor's protocol ID
- 15/0340
- Acronym
- Power Up
- Status last verified
- Sep 2015
- First submitted
- 27 Aug 2015
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Edbrooke-Childs J, Edridge C, Averill P, Delane L, Hollis C, Craven MP, Martin K, Feltham A, Jeremy G, Deighton J, Wolpert M. A Feasibility Trial of Power Up: Smartphone App to Support Patient Activation and Shared Decision Making for Mental Health in Young People. JMIR Mhealth Uhealth. 2019 Jun 4;7(6):e11677. doi: 10.2196/11677.
PubMed 31165709
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development and Piloting of 'Power Up': a Tool for Young People with Internalising/emotional Disorders to Make Shared Decisions in Child and Adolescent Mental Health Services (CAMHS)
- ClinicalTrials.gov ID
- NCT02552797
- Acronym / sponsor ID
- Power Up / 15/0340
- Conditions
- Internalising Disorders, Anxiety, Depression
- Keywords
- Shared Decision Making, CAMHS
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Changes to scope of project and funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 17 Sep 2015 (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.
Patients should be able to have a say in their care and treatment, but how this should work for children and young people with mental health difficulties is unknown. For example, how and when do young people want to be involved in decision making, and what is important to them, their parents/guardians and healthcare professionals? This project will address these questions and will develop a tool known as 'Power Up' to help young people with mental health difficulties make decisions about their own care and treatment.
This project will run for 24 months and will:
- Understand the beliefs, experiences, and values of young people, their parents/guardians and clinicians around shared decision making (SDM) in mental health.
- Use these responses to develop 'Power Up'; a tool to help young people make decisions about their care or treatment in mental health services.
- Pilot 'Power 'Up' in child and adolescent mental health services to estimate the number of patients who would want to use Power Up and to see whether patients can be recruited and followed up with measures. The pilot study would investigate randomisation, see how clinicians cooperate, and identify barriers to collaboration and ways of overcoming these.
Forty five young people, parents and clinicians will be recruited for interviews and focus groups to inform tool development. Sixty young people aged 1116 will be recruited for the pilot/feasibility study. Measurements will be collected at baseline, session by session, and at the end of treatment.
Detailed description
TOOL DEVELOPMENT All potential information about the project can be given verbally (this will be over the phone in the first instance). For CYP (children and young people) that are under 16, parental consent will also be needed. After the phone call, if individuals are interested in taking part, age appropriate information sheets will be posted out to both the CYP and guardians/parents outlining the details of the study. The researcher will discuss any questions potential participants may have over the telephone, and both will have as long as they need to decide whether to take part. If they decide to take part the participants will be invited to take part if they meet study inclusion criteria. For clinicians, the researcher will come to staff meetings, outline the study and leave contact details/expression of interest forms so that those who are interested can get in contact to find out more. For young people and families, clinician's will briefly outline the study and interested participants will fill out an expression of interest form. After the researcher receives the contact details participants will be contacted by a researcher so that further information researcher will then arrange a time to meet with them for an interview or when they may be available for a focus group, and consent forms will be signed. Clinicians, parents/guardians and those aged 16 will also have the opportunity to have the interview conducted over the phone if they prefer (in which case consent forms will be posted). During interviews participants will speak about their previous experiences and beliefs about SDM as well as view and discuss the few existing SDM tools used with young people within CAMHS to use as a baseline for further development. After the interview participants will be debriefed, and be given the opportunity to validate themes that emerge from the data once analysed.
USING POWER UP IN CAMHS SERVICES Clinicians For clinicians, the researcher will be come to staff meetings, outline the study and leave contact details/expression of interest forms so that those who are interested can get in contact to find out more. After the researcher receives the clinicians contact details they will be contacted by a researcher so that further information about the project can be given verbally (this will be over the phone in the first instance). The researcher will then meet with those who are interested an outline the study to them (including randomisation). The researcher will discuss any questions potential participants may have over the telephone, and both will have as long as they need to decide whether to take part. Those who want to take part will be asked to sign a consent form, and will be allocated to use 'Power Up' or continue as TAU with their patients.
CYP/ Families Young people and their families will be invited to take part if they meet the study criteria. Clinicians will briefly outline the study and interested participants will fill out an expression of interest form. After the researcher receives the contact details patients and their families will be contacted by a researcher so that further information about the project can be given verbally (this will be over the phone in the first instance). For CYP's that are under 16, parental consent will also be needed. After the phone call, if individuals are interested in taking part, age appropriate information sheets will be posted out to both the CYP and Guardians/Parents outlining the details of the study. The researcher will discuss any questions potential participants may have over the telephone, and both will have as long as they need to decide whether to take part.
If they decide to take part the researcher will then arrange a time to meet with them at the CAMHS service and complete any baseline assessments (week 1) for clinical symptomology (e.g. Revised Child Anxiety and Depression Scale , Strengths and Difficulties Questionnaire) if these are not routinely collected by the CAMHS service. Randomisation will occur at clinician level and participants will be made aware of this in the information sheets. Throughout the course of treatment session by session measures at weeks 2, 4 and 8) will be completed. Participants and clinicians will also be asked if they consent to the researcher observing one appointment session when the tool is being used (this is optional and will last up to 30 mins, but will likely be week 2 or 3) to understand how the tool is being used in clinical settings.
At the end of treatment (approximately week 8) clinical symptomology, therapeutic alliance, level of shared decision making, and experience of care will be collected. Participants will be invited for an interview to hear their views and experiences about the 'Power Up tool' which like other interviews will take place at a time of their choosing and abide by SOPs (standard operating procedures). Participants will exit the trial and any further treatment will be discussed between them and their healthcare professional.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Using Power Up | Experimental | Behavioral: Shared Decision Making toolParticipants will use 'Power Up' to help them make shared decisions about their treatment or care |
| Not using Power Up | No intervention | –Participants will continue treatment as usual |
Who may qualify
- Ages
- 11 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- A young person between 11 and 16 years of age with an emotional/internalising disorder who is accessing CAMHS.
- A parent/guardian of a young person between 11 and 16 years of age with an emotional/internalising disorder who is accessing CAMHS.
- A clinician in a participating CAMHS site.
- Only those providing consent will be included. Where potential participants are under 16 parents/legal guardians will also have to provide consent.
Key exclusion criteria (5 listed)
- Any individual who is not accessing a participating CAMHS site.
- Given there are no additional resources for an interpreter, children or parents who are not comfortable with English may not be included
- Young people under the age of 11, or over the age of 16 would not be included.
- Parents/guardians of young people with SEN (special educational needs) will not be included
- Those who do not consent.
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 |
|---|---|---|
| Shared Decision Making tool | Behavioural | Using Power Up |
Primary outcome
Shared Decision Making Questionnaire (CollaboRATE)
Time frame: Level of Shared Decision Making at end of treatment (this will be at approximately week 8)
A measure of SDM - this consists of three questions related to shared decision making on a 9 point likert scale ranging from 0 'no effort was made' to 9 'every effort was made'.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Derived from this study: PubMed 31165709Edbrooke-Childs J, Edridge C, Averill P, Delane L, Hollis C, Craven MP, Martin K, Feltham A, Jeremy G, Deighton J, Wolpert M. A Feasibility Trial of Power Up: Smartphone App to Support Patient Activation and Shared Decision Making for Mental Health in Young People. JMIR Mhealth Uhealth. 2019 Jun 4;7(6):e11677. doi: 10.2196/11677.
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.
Julian Edbrooke-Childs, PhD principal investigator
University College London and Anna Freud Centre
Questions about this trial
What is this clinical trial studying?
A study testing Shared Decision Making tool in people with Internalising Disorders and Anxiety, run by University College, London.
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 4 inclusion and 5 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: withdrawn, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shared Decision Making Questionnaire (CollaboRATE) (time frame: Level of Shared Decision Making at end of treatment (this will be at approximately week 8)). 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 NCT02552797, 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 4 Dec 2024.