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A Feasibility Trial of Power Up

6 de diciembre de 2016 actualizado por: 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.

Descripción general del estudio

Estado

Desconocido

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

120

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Reino Unido
      • London, Reino Unido, E1 5NF
        • Reclutamiento
        • East London NHS Foundation Trust
        • Contacto:
      • London, Reino Unido, IG11 7LZ
        • Reclutamiento
        • North East London NHS Foundation Trust
        • Contacto:
      • London, Reino Unido, NW3 5BA
        • Reclutamiento
        • The Tavistock and Portman NHS Foundation Trust
        • Contacto:
        • Investigador principal:
          • Emilios Lemoniatis

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

11 años a 19 años (Niño, Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: 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.
Experimental: 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.
Dispositivo: Power Up
Smartphone phone app

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Shared Decision Making Questionnaire - 9 (SDM Q-9)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Patient Activation Measure - Mental Health (PAM - MH)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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.
Periodo de tiempo: 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

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Did Not Attends (DNAs)
Periodo de tiempo: 3 months
Number of young person DNAs will be reported by the clinician.
3 months
Number of sessions attended
Periodo de tiempo: 3 months
The number of sessions attended by the young person will be reported by the clinician.
3 months
Type of therapy / intervention received
Periodo de tiempo: 3 months
The type of therapy / intervention received by the young person will be reported by the clinician.
3 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University College, London

Colaboradores

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

Investigadores

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

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de septiembre de 2016

Finalización primaria (Anticipado)

1 de agosto de 2017

Finalización del estudio (Anticipado)

1 de septiembre de 2017

Fechas de registro del estudio

Enviado por primera vez

12 de octubre de 2016

Primero enviado que cumplió con los criterios de control de calidad

6 de diciembre de 2016

Publicado por primera vez (Estimar)

9 de diciembre de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

9 de diciembre de 2016

Última actualización enviada que cumplió con los criterios de control de calidad

6 de diciembre de 2016

Última verificación

1 de octubre de 2016

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 16/0087

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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