NCT03705221

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 15, 2018

Completed
14 days until next milestone

Study Start

First participant enrolled

October 29, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2020

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

1.3 years

First QC Date

October 10, 2018

Last Update Submit

September 11, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Warwick-Edinburgh Mental Well-being Scale

    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

Secondary Outcomes (24)

  • Warwick-Edinburgh Mental Well-being Scale

    Baseline

  • Warwick-Edinburgh Mental Well-being Scale

    Immediately post-intervention (up to 12 weeks)

  • EQ-5D-5L

    Baseline

  • EQ-5D-5L

    Immediately post-intervention (up to 12 weeks)

  • EQ-5D-5L

    6 months post-intervention

  • +19 more secondary outcomes

Study Arms (2)

Group programme

EXPERIMENTAL

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.

Behavioral: Healthy Parent Carers group programme

Online resources

ACTIVE COMPARATOR

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.

Behavioral: Healthy Parent Carers online resources

Interventions

Peer-led group-based weekly programme.

Group programme

Online resources related to health and wellbeing

Online resources

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • a) Not able to communicate in English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Children's Hospice South West Little Harbour

St Austell, Cornwall, PL26 6AZ, United Kingdom

Location

Learn Devon Bideford

Bideford, Devon, EX39 2EY, United Kingdom

Location

Orchard Manor School

Dawlish, Devon, EX7 9SF, United Kingdom

Location

Woodlands School

Plymouth, Devon, PL6 5ES, United Kingdom

Location

Torbay Parent Carer Forum

Torquay, Devon, TQ2 5QB, United Kingdom

Location

The Beach Hotel

Minehead, Somerset, TA24 5AP, United Kingdom

Location

Related Publications (3)

  • 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.

    PMID: 29458355BACKGROUND
  • 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.

    PMID: 31788323BACKGROUND
  • 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.

Related Links

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Chris Morris, DPhil

    University of Exeter

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2018

First Posted

October 15, 2018

Study Start

October 29, 2018

Primary Completion

February 4, 2020

Study Completion

February 4, 2020

Last Updated

September 16, 2020

Record last verified: 2020-09

Locations