Healthy Parent Carers Feasibility Study
11 de septiembre de 2020 actualizado por: University of Exeter
Healthy Parent Carers Programme: Feasibility Study of a Peer-led Group-based Health Promotion Intervention for Parent Carers of Disabled Children Using a Parallel Group Randomised Controlled Trial Design
This study is a feasibility study of a peer-led group-based health promotion intervention for parent carers.
It will used a parallel group randomised controlled trial design to compare a group based intervention called Healthy Parent Carers, with online resources about improving health and wellbeing.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
The objectives of the study are:
- to evaluate whether the programme can be delivered in the community, and
- to provide information necessary to design a definitive randomised controlled trial.
The investigators aim to recruit at least 96 parent carers of children with special educational needs and disabilities aged up to 25 years in six sites in Devon, Cornwall and Somerset. Participants will be individually randomised, stratified by group delivery site when recruitment in each site is completed, to either take part in a group programme, which includes online Healthy Parent Carer programme materials (intervention), or to receive access to the online materials for self-study only (control).
The programme content is organised into 12 modules, which can be delivered over six longer (4-hour) sessions or 12 shorter (2-hour) sessions. Groups will consist of at least 6 parent carers. The participant materials will be provided online.
Demographics will be collected at baseline. Participants will complete measures of mental health, wellbeing, health-related quality of life, health behaviours, patient activation, protective factors, and resource use. These data will be collected before randomisation (baseline), at post-intervention (i.e. after the intervention arm completes the group programme), and at 6 months post-intervention.
Recruitment will be monitored in order to plan for a definitive trial. Facilitators' adherence to the Facilitator Manual and participant engagement will be monitored using a facilitator checklist at the end of the sessions and we will audio-record the training sessions and group sessions. Participants' will provide feedback on the programme to assess the acceptability of the outcome measures. The investigators will conduct interviews with a sample of participants in both study arms and a focus group with facilitators to provide insights into intervention content, delivery and experience.
Tipo de estudio
Intervencionista
Inscripción (Actual)
93
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.
Ubicaciones de estudio
-
-
Cornwall
-
Saint Austell, Cornwall, Reino Unido, PL26 6AZ
- Children's Hospice South West Little Harbour
-
-
Devon
-
Bideford, Devon, Reino Unido, EX39 2EY
- Learn Devon Bideford
-
Dawlish, Devon, Reino Unido, EX7 9SF
- Orchard Manor School
-
Plymouth, Devon, Reino Unido, PL6 5ES
- Woodlands School
-
Torquay, Devon, Reino Unido, TQ2 5QB
- Torbay Parent Carer Forum
-
-
Somerset
-
Minehead, Somerset, Reino Unido, TA24 5AP
- The Beach Hotel
-
-
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
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
a) Primary carers of children who identify that their children have additional needs and/or disabilities. Participants who self-identify as primary carers are eligible. The child should be up to 25 years old (this age range is consistent with the current UK Department of Health and Department of Education Special Educational Needs & Disability (SEND) legislation and The Children's Act);
b) Willing and able to attend the programme group meeting session(s) on arranged dates/times;
c) Able to access online information.
Exclusion Criteria:
- a) Not able to communicate in English.
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: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Group programme
Healthy Parent Carers group programme: A group-based peer led manualised programme called Healthy Parent Carers.
The programme content is organised into 12 modules, which can be delivered over six longer (4-hour) sessions or 12 shorter (2-hour) sessions.
|
Peer-led group-based weekly programme.
|
|
Comparador activo: Online resources
Healthy Parent Carers online resources: Online resources from the Healthy Parent Carers programme, including materials for 12 modules and related videos and audio files to illustrate the content.
|
Online resources related to health and wellbeing
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Warwick-Edinburgh Mental Well-being Scale
Periodo de tiempo: 6 months post-intervention
|
The Warwick-Edinburgh Mental Well-being Scale (WEMWBS) is a 14-item scale used to assess mental wellbeing in the general population and in evaluation of programmes aiming to improve mental wellbeing.
|
6 months post-intervention
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Warwick-Edinburgh Mental Well-being Scale
Periodo de tiempo: Baseline
|
The Warwick-Edinburgh Mental Well-being Scale (WEMWBS) is a 14-item scale used to assess mental wellbeing in the general population and in evaluation of programmes aiming to improve mental wellbeing.
|
Baseline
|
|
Warwick-Edinburgh Mental Well-being Scale
Periodo de tiempo: Immediately post-intervention (up to 12 weeks)
|
The Warwick-Edinburgh Mental Well-being Scale (WEMWBS) is a 14-item scale used to assess mental wellbeing in the general population and in evaluation of programmes aiming to improve mental wellbeing.
|
Immediately post-intervention (up to 12 weeks)
|
|
EQ-5D-5L
Periodo de tiempo: Baseline
|
The EuroQol-5 Dimensions (EQ-5D-5L) is a measure of health-related quality of life.
It consists of five items measuring five dimensions of health-related quality of life (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a vertical visual analogue scale measuring self-rated health.
|
Baseline
|
|
EQ-5D-5L
Periodo de tiempo: Immediately post-intervention (up to 12 weeks)
|
The EuroQol-5 Dimensions (EQ-5D-5L) is a measure of health-related quality of life.
It consists of five items measuring five dimensions of health-related quality of life (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a vertical visual analogue scale measuring self-rated health.
|
Immediately post-intervention (up to 12 weeks)
|
|
EQ-5D-5L
Periodo de tiempo: 6 months post-intervention
|
The EuroQol-5 Dimensions (EQ-5D-5L) is a measure of health-related quality of life.
It consists of five items measuring five dimensions of health-related quality of life (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a vertical visual analogue scale measuring self-rated health.
|
6 months post-intervention
|
|
PHQ-9
Periodo de tiempo: Baseline
|
The Patient Health Questionnaire-9 (PHQ-9) is a 9-item measure that rates the frequency of symptoms and is designed for screening, diagnosing, monitoring, and measuring the severity of depression.
|
Baseline
|
|
PHQ-9
Periodo de tiempo: Immediately post-intervention (up to 12 weeks)
|
The Patient Health Questionnaire-9 (PHQ-9) is a 9-item measure that rates the frequency of symptoms and is designed for screening, diagnosing, monitoring, and measuring the severity of depression.
|
Immediately post-intervention (up to 12 weeks)
|
|
PHQ-9
Periodo de tiempo: 6 months post-intervention
|
The Patient Health Questionnaire-9 (PHQ-9) is a 9-item measure that rates the frequency of symptoms and is designed for screening, diagnosing, monitoring, and measuring the severity of depression.
|
6 months post-intervention
|
|
Health Promoting Activities Scale
Periodo de tiempo: Baseline
|
The HPAS is an 8-item measure of a person's estimation of the frequency with which they participate in a range of activities that promote or maintain health and well-being.
|
Baseline
|
|
Health Promoting Activities Scale
Periodo de tiempo: Immediately post-intervention (up to 12 weeks)
|
The HPAS is an 8-item measure of a person's estimation of the frequency with which they participate in a range of activities that promote or maintain health and well-being.
|
Immediately post-intervention (up to 12 weeks)
|
|
Health Promoting Activities Scale
Periodo de tiempo: 6 months post-intervention
|
The HPAS is an 8-item measure of a person's estimation of the frequency with which they participate in a range of activities that promote or maintain health and well-being.
|
6 months post-intervention
|
|
Patient Activation Measure (PAM)
Periodo de tiempo: Baseline
|
The PAM is a 13-item measure that measures the spectrum of skills, knowledge, and confidence in patients and captures the extent to which people feel engaged and confident in managing their own health and care.
|
Baseline
|
|
Patient Activation Measure (PAM)
Periodo de tiempo: Immediately post-intervention (up to 12 weeks)
|
The PAM is a 13-item measure that measures the spectrum of skills, knowledge, and confidence in patients and captures the extent to which people feel engaged and confident in managing their own health and care.
|
Immediately post-intervention (up to 12 weeks)
|
|
Patient Activation Measure (PAM)
Periodo de tiempo: 6 months post-intervention
|
The PAM is a 13-item measure that measures the spectrum of skills, knowledge, and confidence in patients and captures the extent to which people feel engaged and confident in managing their own health and care.
|
6 months post-intervention
|
|
Parents' Assessment of Protective Factors
Periodo de tiempo: Baseline
|
The PAPF is a 36-item measure that assesses protective factors identified in the development of the Strengthening Families evidence-based parenting programme.
These protective factors are: parental resilience, social connections, concrete support in times of need, and support of children's social and emotional competence.
|
Baseline
|
|
Parents' Assessment of Protective Factors
Periodo de tiempo: Immediately post-intervention (up to 12 weeks)
|
The PAPF is a 36-item measure that assesses protective factors identified in the development of the Strengthening Families evidence-based parenting programme.
These protective factors are: parental resilience, social connections, concrete support in times of need, and support of children's social and emotional competence.
|
Immediately post-intervention (up to 12 weeks)
|
|
Parents' Assessment of Protective Factors
Periodo de tiempo: 6 months post-intervention
|
The PAPF is a 36-item measure that assesses protective factors identified in the development of the Strengthening Families evidence-based parenting programme.
These protective factors are: parental resilience, social connections, concrete support in times of need, and support of children's social and emotional competence.
|
6 months post-intervention
|
|
ICEpop CAPability measure for Adults (ICECAP-A)
Periodo de tiempo: Baseline
|
The ICECAP-A is a 5-item measure of capability, which includes the following aspects of wellbeing found to be important to adults in the UK: attachment, stability, achievement, enjoyment, and autonomy.
A set of UK utility values is available for the ICECAP-A, enabling it to be used in economic evaluations.
|
Baseline
|
|
ICEpop CAPability measure for Adults (ICECAP-A)
Periodo de tiempo: Immediately post-intervention (up to 12 weeks)
|
The ICECAP-A is a 5-item measure of capability, which includes the following aspects of wellbeing found to be important to adults in the UK: attachment, stability, achievement, enjoyment, and autonomy.
A set of UK utility values is available for the ICECAP-A, enabling it to be used in economic evaluations.
|
Immediately post-intervention (up to 12 weeks)
|
|
ICEpop CAPability measure for Adults (ICECAP-A)
Periodo de tiempo: 6 months post-intervention
|
The ICECAP-A is a 5-item measure of capability, which includes the following aspects of wellbeing found to be important to adults in the UK: attachment, stability, achievement, enjoyment, and autonomy.
A set of UK utility values is available for the ICECAP-A, enabling it to be used in economic evaluations.
|
6 months post-intervention
|
|
Service and Resource Use questionnaire
Periodo de tiempo: Baseline
|
We will develop a resource use questionnaire in collaboration with parent carers.
This will include health, social care, participant and broader societal resource use, and draw on measures in the Database of Instruments for Resource Use Management (DIRUM).
|
Baseline
|
|
Service and Resource Use questionnaire
Periodo de tiempo: Immediately post-intervention (up to 12 weeks)
|
We will develop a resource use questionnaire in collaboration with parent carers.
This will include health, social care, participant and broader societal resource use, and draw on measures in the Database of Instruments for Resource Use Management (DIRUM).
|
Immediately post-intervention (up to 12 weeks)
|
|
Service and Resource Use questionnaire
Periodo de tiempo: 6 months post-intervention
|
We will develop a resource use questionnaire in collaboration with parent carers.
This will include health, social care, participant and broader societal resource use, and draw on measures in the Database of Instruments for Resource Use Management (DIRUM).
|
6 months post-intervention
|
|
Programme Feedback Form
Periodo de tiempo: Immediately post-intervention (up to 12 weeks)
|
We will collect feedback from treatment and control arm participants about the Healthy Parent Carer materials and delivery via a feedback form.
All participants will be asked to complete the feedback form at 15 weeks post-randomisation.
|
Immediately post-intervention (up to 12 weeks)
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Chris Morris, DPhil, University of Exeter
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
- Borek AJ, McDonald B, Fredlund M, Bjornstad G, Logan S, Morris C. Healthy Parent Carers programme: development and feasibility of a novel group-based health-promotion intervention. BMC Public Health. 2018 Feb 20;18(1):270. doi: 10.1186/s12889-018-5168-4.
- Bjornstad G, Wilkinson K, Cuffe-Fuller B, Fitzpatrick K, Borek A, Ukoumunne OC, Hawton A, Tarrant M, Berry V, Lloyd J, McDonald A, Fredlund M, Rhodes S, Logan S, Morris C. Healthy Parent Carers peer-led group-based health promotion intervention for parent carers of disabled children: protocol for a feasibility study using a parallel group randomised controlled trial design. Pilot Feasibility Stud. 2019 Nov 23;5:137. doi: 10.1186/s40814-019-0517-3. eCollection 2019.
- Bjornstad G, Cuffe-Fuller B, Ukoumunne OC, Fredlund M, McDonald A, Wilkinson K, Lloyd J, Hawton A, Berry V, Tarrant M, Borek A, Fitzpatrick K, Gillett A, Rhodes S, Logan S, Morris C. Healthy Parent Carers: feasibility randomised controlled trial of a peer-led group-based health promotion intervention for parent carers of disabled children. Pilot Feasibility Stud. 2021 Jul 23;7:144. doi: 10.1186/s40814-021-00881-5. eCollection 2021.
Enlaces Útiles
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 (Actual)
29 de octubre de 2018
Finalización primaria (Actual)
4 de febrero de 2020
Finalización del estudio (Actual)
4 de febrero de 2020
Fechas de registro del estudio
Enviado por primera vez
10 de octubre de 2018
Primero enviado que cumplió con los criterios de control de calidad
10 de octubre de 2018
Publicado por primera vez (Actual)
15 de octubre de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
16 de septiembre de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
11 de septiembre de 2020
Última verificación
1 de septiembre de 2020
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- NIHR RfPB PB-PG-0317-20044
- 246169 (Otro identificador: IRAS)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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. .
Ensayos clínicos sobre Comportamiento de salud
-
University of Dublin, Trinity CollegeDesconocidoAtletas de élite retirados de Brain Health
-
Queens College, The City University of New YorkReclutamientoPublicación de artículos enviados al American Journal of Public HealthEstados Unidos
-
WestatPlasma Protein Therapeutics AssociationAún no reclutandoHealth Effects (Niveles de Ferritina, Niveles de PCR, Niveles de IgG, Salud Auto-reportada)Estados Unidos