- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03705221
Healthy Parent Carers Feasibility Study
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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Cornwall
-
Saint Austell, Cornwall, Vereinigtes Königreich, PL26 6AZ
- Children's Hospice South West Little Harbour
-
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Devon
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Bideford, Devon, Vereinigtes Königreich, EX39 2EY
- Learn Devon Bideford
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Dawlish, Devon, Vereinigtes Königreich, EX7 9SF
- Orchard Manor School
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Plymouth, Devon, Vereinigtes Königreich, PL6 5ES
- Woodlands School
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Torquay, Devon, Vereinigtes Königreich, TQ2 5QB
- Torbay Parent Carer Forum
-
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Somerset
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Minehead, Somerset, Vereinigtes Königreich, TA24 5AP
- The Beach Hotel
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
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.
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Peer-led group-based weekly programme.
|
Aktiver 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.
|
Online resources related to health and wellbeing
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Warwick-Edinburgh Mental Well-being Scale
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Warwick-Edinburgh Mental Well-being Scale
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Chris Morris, DPhil, University of Exeter
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- NIHR RfPB PB-PG-0317-20044
- 246169 (Andere Kennung: IRAS)
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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