Condition category
Not Applicable
Date applied
12/09/2018
Date assigned
21/09/2018
Last edited
23/10/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims:
Family carers (especially parents) of children and adults with intellectual disability (ID) are twice as likely as other carers to experience stress and mental health problems. There is no high quality research about effective and cost-effective ways to support parents. This study aims to find out if an online mindfulness course (Be Mindful) might help parents of children and adults with ID to look after their emotional well-being.

Who can participate?
Family carers (maternal or paternal caregivers) of children or adults of any age with ID who are living with their family carer(s)

What does the study involve?
Be Mindful is a 10-session course, and is an online version of the Mindfulness-Based Cognitive Therapy (MBCT) programme that is recommended in the NICE clinical guideline for depression (NICE, 2009). Thirty family carers will be randomly selected to receive Be Mindful, and 30 will receive Be Mindful plus telephone coaching support from trained parents who themselves have children with ID (Be Mindful+). All 60 family carers will be asked to complete some measures of things that might change after they have finished Be Mindful or Be Mindful+. The questionnaires will include questions about the family carers’ well-being, the family carers’ mental health, approaches to parenting, relationships with their partner (if they have one) and child with ID.

What are the possible benefits and risks of participating?
The Be Mindful programme has been successful in improving the well-being of participants who are not family carers of a child with learning disability. Because Be Mindful has not yet been tested with family carers who have a child with learning disability, we do not know yet if it will benefit participants. The questionnaires, Be Mindful programme, and additional telephone support sessions include positive things, but will also ask family carers to reflect on challenges they may face with their child. However, we do not think that taking part in the study will pose any risk to family carers or their children.

Where is the study run from?
University of Warwick (UK)

When is the study starting and how long is it expected to run for?
April 2018 to November 2019

Who is funding the study?
The Baily Thomas Charitable Fund (UK)

Who is the main contact?
Samantha Flynn
s.flynn.1@warwick.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Ms Samantha Flynn

ORCID ID

http://orcid.org/0000-0003-3466-9506

Contact details

CEDAR
New Education Building
Westwood Campus
University of Warwick
Coventry
CV4 7AL
United Kingdom
+44 7823 362152
s.flynn.1@warwick.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

Scientific title

Mindfulness Online STress intervention for family carers of children and adults with Intellectual Disability (MOST-ID): A feasibility study of Be Mindful.

Acronym

MOST-ID

Study hypothesis

To examine the feasibility of conducting a definitive trial of the BeMindful online mindfulness programme to reduce stress in parents of children or adults with intellectual disabilities

Ethics approval

University of Warwick Humanities and Social Science Research Ethics Committee (HSSREC), 09/02/2018, 58/17-18

Study design

Interventional randomised controlled feasibility study incorporating a process evaluation

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Internet

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Well-being in parents of children/adults with intellectual disabilities

Intervention

Parents will be randomised to receive BeMindful or BeMindful plus telephone coaching support (BeMindful+) on a 1:1 basis, using minimisation (via the free Minim randomisation programme) – balancing the age of the child with intellectual disabilities between the two arms of the trial (child under 10 years, child 10-18 years, adult >18 years).
BeMindful is an online mindfulness training programme. The course guides participants through all the elements of MBCT. Ten easy-to-follow online sessions, featuring videos and interactive exercises, are presented by qualified mindfulness trainers, and the course can be completed in as little as 4 weeks (although longer is typical). The course is highly accessible and can be followed from any device with a web browser and internet connection, such as mobile ‘phones and tablets, including being saved as a web-app on the devices homepage. Twelve assignments to practise in daily life are included, along with six downloadable course hand-outs and online self-reporting tools to enable participants to chart progress with reducing stress, depression, and anxiety (measures different to those we propose to use as outcomes to ensure no overlap). Users also receive auto-generated supporting motivational emails.
Trained parent mentors will offer, arrange and deliver 3 guided support sessions for each of the 30 parents randomised to the BeMindful+ arm of the trial.
The intervention can be completed in 4 weeks, but most people take between 6 and 8 weeks to complete it. Recruitment will last for between 6 and 8 months from September 2018. The follow-up periods will be 12 weeks post-baseline and 6 months post-baseline.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Parent psychological well-being, assessed using the Warwick-Edinburgh Mental Well-Being Scale at the baseline, after 12 weeks and after 6 months.

Secondary outcome measures

The following will be assessed at the baseline, after 12 weeks and after 6 months:
1. Parental anxiety and depression, assessed using the Hospital Anxiety and Depression Scale (HADS)
2. Parental health-related quality of life, assessed using the EQ-5D-5L
3. Parent relationship with partner, assessed using:
3.1. Happiness of Relationship Scale
3.2. Disagreement over issues related to parenting/care of the child (from the Millennium Cohort Study Wave 2, 2003-2005)
4. Perception of family functioning/quality of life, assessed using the Family APGAR Scale
5. Parenting efficacy, assessed using 7 items from the Parenting Sense of Competence Scale (PSOC)
6. Parental perceptions of the positive impact of their child, assessed using the Positive Gain Scale
7. Parenting relationship, assessed using the Child-Parent Relationship Scale (CPRS)

Overall trial start date

01/04/2018

Overall trial end date

01/11/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 23/10/2018:
Parents of children or adults of any age with intellectual disabilities who are living with their parent(s) for the majority of time (intellectual disabilities will be defined administratively, by parents reporting that the child or adult has received a diagnosis and/or is in receipt of UK learning disability services).

Previous inclusion criteria:
Parents of children or adults of any age with intellectual disabilities who are living with their parent(s) (intellectual disabilities will be defined administratively, by parents reporting that the child or adult has received a diagnosis and/or is in receipt of UK learning disability services)

Participant type

Carer

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

Parents concurrently receiving an individual or group therapy for stress, well-being, or mental health problems (including other mindfulness-based interventions).
We will gather information on parents’ previous use of any mindfulness-based interventions, but this will not be an exclusion criterion.

Recruitment start date

10/08/2018

Recruitment end date

31/01/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Centre for Educational Development, Appraisal and Research (CEDAR)
New Education Building, University of Warwick
Coventry
CV4 7AL
United Kingdom

Sponsor information

Organisation

University of Warwick

Sponsor details

University Road
Coventry
CV4 7AL
United Kingdom

Sponsor type

University/education

Website

www.warwick.ac.uk

Funders

Funder type

Not defined

Funder name

Baily Thomas Charitable Fund

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The findings from the research will be published in high-impact, peer-reviewed journals.

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date

Intention to publish date

01/01/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

23/10/2018: The participant inclusion criteria have been changed.