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A Feasibility Trial of Power Up

6. december 2016 opdateret af: University College, London

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:

  • 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.

Studieoversigt

Status

Ukendt

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

120

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • London, Det Forenede Kongerige, E1 5NF
        • Rekruttering
        • East London NHS Foundation Trust
        • Kontakt:
      • London, Det Forenede Kongerige, IG11 7LZ
        • Rekruttering
        • North East London NHS Foundation Trust
        • Kontakt:
      • London, Det Forenede Kongerige, NW3 5BA
        • Rekruttering
        • The Tavistock and Portman NHS Foundation Trust
        • Kontakt:
        • Ledende efterforsker:
          • Emilios Lemoniatis

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

11 år til 19 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • 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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Control Phase (No Power Up)
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.
Eksperimentel: Intervention Phase (Power Up)
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.
Smartphone phone app

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Shared Decision Making Questionnaire - 9 (SDM Q-9)
Tidsramme: 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.
3 months
CollaboRATE
Tidsramme: 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.
3 months
Experience of Service Questionnaire (ESQ)
Tidsramme: 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.
3 months
Dyadic OPTION scale
Tidsramme: 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.
3 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patient Activation Measure - Mental Health (PAM - MH)
Tidsramme: 3 months
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.
3 months
Strengths and Difficulties questionnaire (SDQ)
Tidsramme: 3 months
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.
3 months
Youth Efficacy / Empowerment Scale - Mental Health (YES - MH)
Tidsramme: 3 months
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').
3 months
Client Receipt of Services Inventory (CSRI) - Children's Version.
Tidsramme: 3 months
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.
3 months

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Did Not Attends (DNAs)
Tidsramme: 3 months
Number of young person DNAs will be reported by the clinician.
3 months
Number of sessions attended
Tidsramme: 3 months
The number of sessions attended by the young person will be reported by the clinician.
3 months
Type of therapy / intervention received
Tidsramme: 3 months
The type of therapy / intervention received by the young person will be reported by the clinician.
3 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Miranda Wolpert, Professor, UCL & Anaa Freud National Centre for Children and Families

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2016

Primær færdiggørelse (Forventet)

1. august 2017

Studieafslutning (Forventet)

1. september 2017

Datoer for studieregistrering

Først indsendt

12. oktober 2016

Først indsendt, der opfyldte QC-kriterier

6. december 2016

Først opslået (Skøn)

9. december 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

9. december 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. december 2016

Sidst verificeret

1. oktober 2016

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 16/0087

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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