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A Feasibility Trial of Power Up

6. desember 2016 oppdatert av: 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.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Forventet)

120

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Storbritannia
      • London, Storbritannia, E1 5NF
        • Rekruttering
        • East London NHS Foundation Trust
        • Ta kontakt med:
      • London, Storbritannia, IG11 7LZ
        • Rekruttering
        • North East London NHS Foundation Trust
        • Ta kontakt med:
      • London, Storbritannia, NW3 5BA
        • Rekruttering
        • The Tavistock and Portman NHS Foundation Trust
        • Ta kontakt med:
        • Hovedetterforsker:
          • Emilios Lemoniatis

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

11 år til 19 år (Barn, Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: 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.
Eksperimentell: 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.
Enhet: Power Up
Smartphone phone app

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University College, London

Samarbeidspartnere

Anna Freud National Centre for Children and Families
MindTech Healthcare Technology Co-operative
Common Room Consulting Ltd
Create Marketing

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. september 2016

Primær fullføring (Forventet)

1. august 2017

Studiet fullført (Forventet)

1. september 2017

Datoer for studieregistrering

Først innsendt

12. oktober 2016

Først innsendt som oppfylte QC-kriteriene

6. desember 2016

Først lagt ut (Anslag)

9. desember 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

9. desember 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. desember 2016

Sist bekreftet

1. oktober 2016

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 16/0087

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Nei

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