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Healthy Parent Carers Feasibility Study

11 września 2020 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

The objectives of the study are:

  1. to evaluate whether the programme can be delivered in the community, and
  2. 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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

93

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Zjednoczone Królestwo
    • Cornwall
      • Saint Austell, Cornwall, Zjednoczone Królestwo, PL26 6AZ
        • Children's Hospice South West Little Harbour
    • Devon
      • Bideford, Devon, Zjednoczone Królestwo, EX39 2EY
        • Learn Devon Bideford
      • Dawlish, Devon, Zjednoczone Królestwo, EX7 9SF
        • Orchard Manor School
      • Plymouth, Devon, Zjednoczone Królestwo, PL6 5ES
        • Woodlands School
      • Torquay, Devon, Zjednoczone Królestwo, TQ2 5QB
        • Torbay Parent Carer Forum
    • Somerset
      • Minehead, Somerset, Zjednoczone Królestwo, TA24 5AP
        • The Beach Hotel

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko
  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Zapobieganie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Behawioralne: Healthy Parent Carers group programme
Peer-led group-based weekly programme.
Aktywny komparator: 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.
Behawioralne: Healthy Parent Carers online resources
Online resources related to health and wellbeing

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Warwick-Edinburgh Mental Well-being Scale
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Warwick-Edinburgh Mental Well-being Scale
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Exeter

Współpracownicy

University of Oxford

Śledczy

  • Główny śledczy: Chris Morris, DPhil, University of Exeter

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

29 października 2018

Zakończenie podstawowe (Rzeczywisty)

4 lutego 2020

Ukończenie studiów (Rzeczywisty)

4 lutego 2020

Daty rejestracji na studia

Pierwszy przesłany

10 października 2018

Pierwszy przesłany, który spełnia kryteria kontroli jakości

10 października 2018

Pierwszy wysłany (Rzeczywisty)

15 października 2018

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

16 września 2020

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

11 września 2020

Ostatnia weryfikacja

1 września 2020

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • NIHR RfPB PB-PG-0317-20044
  • 246169 (Inny identyfikator: IRAS)

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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