Healthy Parent Carers Feasibility Study
11 сентября 2020 г. обновлено: 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.
Обзор исследования
Статус
Завершенный
Условия
Подробное описание
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.
Тип исследования
Интервенционный
Регистрация (Действительный)
93
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Cornwall
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Saint Austell, Cornwall, Соединенное Королевство, PL26 6AZ
- Children's Hospice South West Little Harbour
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Devon
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Bideford, Devon, Соединенное Королевство, EX39 2EY
- Learn Devon Bideford
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Dawlish, Devon, Соединенное Королевство, EX7 9SF
- Orchard Manor School
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Plymouth, Devon, Соединенное Королевство, PL6 5ES
- Woodlands School
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Torquay, Devon, Соединенное Королевство, TQ2 5QB
- Torbay Parent Carer Forum
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Somerset
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Minehead, Somerset, Соединенное Королевство, TA24 5AP
- The Beach Hotel
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Да
Полы, имеющие право на обучение
Все
Описание
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.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: 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.
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Peer-led group-based weekly programme.
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Активный компаратор: 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.
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Online resources related to health and wellbeing
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Warwick-Edinburgh Mental Well-being Scale
Временное ограничение: 6 months post-intervention
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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.
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6 months post-intervention
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Warwick-Edinburgh Mental Well-being Scale
Временное ограничение: Baseline
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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.
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Baseline
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Warwick-Edinburgh Mental Well-being Scale
Временное ограничение: 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.
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Immediately post-intervention (up to 12 weeks)
|
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EQ-5D-5L
Временное ограничение: 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.
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Baseline
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EQ-5D-5L
Временное ограничение: Immediately post-intervention (up to 12 weeks)
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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.
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Immediately post-intervention (up to 12 weeks)
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EQ-5D-5L
Временное ограничение: 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.
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6 months post-intervention
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PHQ-9
Временное ограничение: Baseline
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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.
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Baseline
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PHQ-9
Временное ограничение: 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.
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Immediately post-intervention (up to 12 weeks)
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PHQ-9
Временное ограничение: 6 months post-intervention
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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.
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6 months post-intervention
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Health Promoting Activities Scale
Временное ограничение: Baseline
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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.
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Baseline
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Health Promoting Activities Scale
Временное ограничение: Immediately post-intervention (up to 12 weeks)
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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.
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Immediately post-intervention (up to 12 weeks)
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Health Promoting Activities Scale
Временное ограничение: 6 months post-intervention
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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.
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6 months post-intervention
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Patient Activation Measure (PAM)
Временное ограничение: Baseline
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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.
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Baseline
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Patient Activation Measure (PAM)
Временное ограничение: Immediately post-intervention (up to 12 weeks)
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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.
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Immediately post-intervention (up to 12 weeks)
|
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Patient Activation Measure (PAM)
Временное ограничение: 6 months post-intervention
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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.
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6 months post-intervention
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Parents' Assessment of Protective Factors
Временное ограничение: Baseline
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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.
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Baseline
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Parents' Assessment of Protective Factors
Временное ограничение: Immediately post-intervention (up to 12 weeks)
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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.
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Immediately post-intervention (up to 12 weeks)
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Parents' Assessment of Protective Factors
Временное ограничение: 6 months post-intervention
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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.
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6 months post-intervention
|
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ICEpop CAPability measure for Adults (ICECAP-A)
Временное ограничение: Baseline
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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.
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Baseline
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ICEpop CAPability measure for Adults (ICECAP-A)
Временное ограничение: Immediately post-intervention (up to 12 weeks)
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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.
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Immediately post-intervention (up to 12 weeks)
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ICEpop CAPability measure for Adults (ICECAP-A)
Временное ограничение: 6 months post-intervention
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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.
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6 months post-intervention
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Service and Resource Use questionnaire
Временное ограничение: Baseline
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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).
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Baseline
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Service and Resource Use questionnaire
Временное ограничение: 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).
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Immediately post-intervention (up to 12 weeks)
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Service and Resource Use questionnaire
Временное ограничение: 6 months post-intervention
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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).
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6 months post-intervention
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Programme Feedback Form
Временное ограничение: Immediately post-intervention (up to 12 weeks)
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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.
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Immediately post-intervention (up to 12 weeks)
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Соавторы
Следователи
- Главный следователь: Chris Morris, DPhil, University of Exeter
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- 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.
Полезные ссылки
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
29 октября 2018 г.
Первичное завершение (Действительный)
4 февраля 2020 г.
Завершение исследования (Действительный)
4 февраля 2020 г.
Даты регистрации исследования
Первый отправленный
10 октября 2018 г.
Впервые представлено, что соответствует критериям контроля качества
10 октября 2018 г.
Первый опубликованный (Действительный)
15 октября 2018 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
16 сентября 2020 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
11 сентября 2020 г.
Последняя проверка
1 сентября 2020 г.
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- NIHR RfPB PB-PG-0317-20044
- 246169 (Другой идентификатор: IRAS)
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
Клинические исследования Поведение в отношении здоровья
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University of Colorado, DenverEunice Kennedy Shriver National Institute of Child Health and Human Development... и другие соавторыЗавершенныйПрофилактические медицинские услуги (PREV HEALTH SERV)Соединенные Штаты
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Seattle Children's HospitalEunice Kennedy Shriver National Institute of Child Health and Human Development... и другие соавторыЕще не набираютПрофилактические медицинские услуги (PREV HEALTH SERV)Соединенные Штаты
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Hopital MontfortChildren's Hospital of Eastern Ontario Research InstituteРекрутингНарушения теплового стресса | Первая медицинская помощь | Воздействие окружающей среды | Поведение по снижению риска | Здравоохранение | Тепловое воздействие | Изменение климата | Профилактические медицинские услуги (PREV HEALTH SERV) | Хитли СубъектыКанада
Клинические исследования Healthy Parent Carers group programme
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University of California, San FranciscoЗавершенныйСиндром дефицита внимания и гиперактивностиСоединенные Штаты