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
Total final enrolment
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
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 organizations
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
2020 results in https://doi.org/10.1007/s12671-020-01436-0 (added 10/07/2020)