A Feasibility Trial of Power Up

NCT02987608 | Unknown DMC

• 1 other identifier: 16/0087
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Emotional Difficulties

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Secondary Outcomes (4)

• Patient Activation Measure - Mental Health (PAM - MH)

  3 months

• Strengths and Difficulties questionnaire (SDQ)

  3 months

• Youth Efficacy / Empowerment Scale - Mental Health (YES - MH)

  3 months

• Client Receipt of Services Inventory (CSRI) - Children's Version.

  3 months

Other Outcomes (3)

• Did Not Attends (DNAs)

  3 months

• Number of sessions attended

  3 months

• Type of therapy / intervention received

  3 months

Study Arms (2)

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.

Device: Power Up

Interventions

Power Up DEVICE

Smartphone phone app

Intervention Phase (Power Up)

Eligibility Criteria

• Age: 11 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• University College, London: lead
• Anna Freud National Centre for Children and Families: collaborator
• MindTech Healthcare Technology Co-operative: collaborator
• Common Room Consulting Ltd: collaborator
• Create Marketing: collaborator

Study Sites (3)

East London NHS Foundation Trust

London, E1 5NF, United Kingdom

RECRUITING

North East London NHS Foundation Trust

London, IG11 7LZ, United Kingdom

RECRUITING

The Tavistock and Portman NHS Foundation Trust

London, NW3 5BA, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 29084708 DERIVED

Study Officials

• Miranda Wolpert, Professor

  UCL & Anaa Freud National Centre for Children and Families

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Louise N Chapman

CONTACT

020 7443 2205; louise.chapman@annafreud.org

Julian Edbrooke - Childs

CONTACT

020 7443 2275; julian.edbrooke-childs@annafreud.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2016
• First Posted: December 9, 2016
• Study Start: September 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: September 1, 2017
• Last Updated: December 9, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)