Intellectual DisabilityNCT04294082
Study of Mindfulness Course for Parents of Adults With Intellectual Disabilities
An observational study of Intellectual Disability, run by University of Edinburgh.
Trial summary
Being a parent to an adult person with learning disabilities can be very stressful, and can lead to experiencing mental health problems. Not much is known about what sort of support services should be offering to these parents; and not many options are available as a result. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intellectual Disability
- What is being tested?
- Mindfulness based intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2020to 1 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Parents of adults with IDs living in Aberdeenshire.
Who may be able to join
- All parents of adults (defined as individuals aged 16 years or above) with IDs, identified by the CLDT will be eligible.
- No formal diagnosis of IDs will be sought, as often service users do not have a formal diagnosis due to a lack of diagnostic services being available (either historically, or presently).
Who cannot join
- Parents of children (under 16 years old) with IDs. This includes family units comprised of both children and adults with IDs.
- Parents who are not sufficiently fluent in English, or who themselves have an IDs, such that they might be unable to undertake the intervention and complete the relative outcome measures.
- Parents that do not have capacity to consent to research at the time it is sought.
About this study
Official title: Evaluating a Brief Mindfulness-based Intervention for Parents of Adults With Intellectual Disabilities: a Case Series.
Being a parent to an adult person with learning disabilities can be very stressful, and can lead to experiencing mental health problems. Not much is known about what sort of support services should be offering to these parents; and not many options are available as a result. This study will try to find out if a short intervention, known as a mindfulness-based intervention (MBI), can be of help to these families. A mindfulness-based intervention is one that aims to increase someone's mindfulness, which is the ability to be aware of the present, in a non-judgemental fashion.
Simply put, what the investigators would like to find out from this study is: "Can a short course of MBI help improve the well-being of parents of adults with learning disabilities?"
Read more
To answer this question, the investigators will seek to invite parents to attend a mindfulness course of the duration of 4 sessions. Parents will be invited to participate by NHS staff at their local Community Learning Disabilities Team, who will hand out information sheets and consent forms. Parents will be informed that they may choose to withdraw from the study at any time without this having any negative effect. The investigators will also ask parents to provide feedback on their experience of the course using online questionnaires. Parents will be asked to complete the questionnaires at 6 points: 1 month before the start of the course, at the start of the course, at the end of the course, and at 3, 6 and 12 months after the course has ended. This way, the investigators will be able to track any changes in how parents rate their well-being; and if these changes persist in the long-term.
At the end of the study, participants will be offered information on the results.
Read the detailed description
A multitude of studies has established that parenting a child with intellectual disabilities (IDs) can negatively influence the psychological and physical wellbeing of primary caregivers. The same correlation between IDs and parental psychological distress exists in the parents of adults with IDs, with the transition from childhood to adulthood being particularly detrimental to the psychological wellbeing of the family. Carers of children with IDs often report increased levels of parental stress, a feature that is amplified in some categories of IDs, such as in autism spectrum disorder. Importantly, the effects of this especially demanding relationship are not limited to impacting the carers' wellbeing alone; they can also affect the carers' ability to respond to problematic child behaviour, and result in financial hardship.
In terms of psychological distress on the part of people with intellectual disabilities (PWIDs), this is most often observed in the form of challenging behaviour, which can be used by PWIDs to communicate their distress. Of interest to the present study, the complex and enduring pattern of difficulties observed within these families cannot be accounted for purely by the psychological distress of the carers, nor does it stem from challenging behaviour alone. Instead, it has been proposed that the relationship between parental stress and the child's challenging behaviour is bi-directional, and self-reinforcing, in that parental stress can increase challenging behaviour, just as challenging behaviour can induce stress, and other forms of psychological distress. This pattern has been observed in families with children, as well as in families with adults with IDs.
Given the link between challenging behaviour, parental stress, and their interdependent nature, there has recently been a focus on employing therapeutic modalities that are explicitly aimed at reducing stress, with third-wave cognitive behavioural therapies (CBT) at the forefront of such scrutiny. Among third-wave CBTs, mindfulness-based interventions (MBIs) have been employed with especially promising results, making them veritable candidates as effective interventions for what is a sizeable segment of the population.
MBI adaptations
It should be noted that the increased range of applicability derived from said universality can limit the scope and clarity of the MBIs' research base. Specifically, as observed in a recent review on the efficacy of MBIs in parents of children with disabilities, a plethora of different interventions and adaptations of MBIs are continuously being developed, from the classic programmes devised by Jon Kabat-Zinn and his team, to hybrid interventions that combine MBIs with other therapies, such as DBT or ACT. Such abundance of variation can limit the precision with which the various MBIs are comparable with one another, and frustrates the search for a definite analysis of precisely which mindfulness factors contribute to the self-reported decreases in psychological distress. In parallel, efforts are being made to distil the essential criteria a mindfulness intervention should be based on.
MBIs can also be adapted in relation to their structure, not just by intervention modality they incorporate. Shortened versions of MBIs have been devised and tested with positive results, with effect sizes for psychological outcomes comparable to those found in programmes of classic length. Shortened MBIs can cover the same content as their lengthier counterparts, within fewer sessions; or they may simply reduce the content they cover, and provide that within fewer sessions. In both instances, the literature suggests that there is no significant correlation between psychological outcomes and course length, indicating that shortened versions of MBIs may achieve the same psychological outcomes by the end of the programme, in clinical, as well as non-clinical populations.
Presently, no robust research exists on what intervention works best for parents of PWIDs, particularly within the realm of adults with IDs. To the author's knowledge, only one study has to date explored the effectiveness of a short MBI aimed specifically at parents of adults with a disability. It should be noted, however, that the study primarily evaluated parents of adults with a diagnosis of autism spectrum disorder (ASD). This limits the generalisability of the study to the ASD population, which represents but a section of the population with IDs. In addition, the authors of the study acknowledge that parents of adult children with IDs often find it difficult to commit to a course of MBI due to the time constrains dictated by their children's needs, and recommend the trialling of even shorter MBIs, with no studies to date having evaluated an MBI as brief as the one proposed herein. Finally, despite there being extensive research on the shorter-term effects of MBIs, no study to date has focussed with sufficient emphasis on the longer-term effects of MBI course. Advancing our understanding of whether MBIs retain their effect over time can lead to substantial improvements in terms of clinical applications.
Based on the premises that:
- shortened versions of MBIs have successfully generated psychological change in comparable populations; and
- theoretical models relating to children with disabilities suggest that parental stress negatively influences the caregiver-offspring dyad; it is hypothesized that a 4-week MBI course will achieve positive psychological outcomes in this population.
- Conditions
- Intellectual Disability
- Being tested
- Mindfulness based intervention
- Medical subject headings
- Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness based interventionBehavioural
A four session, 120 mins per session mindfulness based course delivered weekly oer the course of four weeks. The mindfulness sessions are based on the model delineated by Kabat-Zinn (1992) and will encompass:
- an introduction to mindfulness
- body-scan exercises
- sitting meditation
- mindful movement exercises
- individual and group reflections
- homework exercises
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness based intervention | A shortened version of a mindfulness-based intervention originally developed by Jon Kabat-Zinn for management of chronic pain. Receives: Behavioral: Mindfulness based intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental Stress Scale
Self-reported questionnaire measuring change in levels of stress in parents. Scores on scale range from 1 to 5, with higher values indicating lower parental stress.
Measured: Baseline (4 weeks before the start of the mindfulness course); Pre- (at the start of the mindfulness course); Post- (at the end of the mindfulness course; Time point: 4 weeks); Follow-ups (at 3, 6, 12 months from the end of the mindfulness course)
Secondary outcomes (3)
Warwick-Edinburgh Mental Well-Being Scale
Self-reported questionnaire measuring changes in psychological well-being. Scores on scale range from 1 to 5, with higher values indicating higher levels of well-being.
Measured: Baseline (4 weeks before the start of the mindfulness course); Pre- (at the start of the mindfulness course); Post- (at the end of the mindfulness course; Time point: 4 weeks); Follow-ups (at 3, 6, 12 months from the end of the mindfulness course)
Five-facet Mindfulness Questionnaire, Short Form. Scores on each questionnaire item range from 1 to 5, with higher values indicating higher levels of mindfulness.
Self-reported questionnaire measuring changes in levels of mindfulness
Measured: Baseline (4 weeks before the start of the mindfulness course); Pre- (at the start of the mindfulness course); Post- (at the end of the mindfulness course; Time point: 4 weeks); Follow-ups (at 3, 6, 12 months from the end of the mindfulness course)
Satisfaction with Life Scale. Scores range from 1 to 7, with a higher score indicating higher satisfaction with life.
Self-reported questionnaire measuring changes in satisfaction with life
Measured: Baseline (4 weeks before the start of the mindfulness course); Pre- (at the start of the mindfulness course); Post- (at the end of the mindfulness course; Time point: 4 weeks); Follow-ups (at 3, 6, 12 months from the end of the mindfulness course)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start1 Apr 2020 (estimated)
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Oct 2021 (estimated)
Why it stopped: Study stopped due to the outbreak of the covid-19 pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intellectual DisabilityStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Grampian
- Responsible party
- Sponsor
- Investigators
- Matteo Turco de Pretis-Cagnodo, MSc, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04294082
- Sponsor's protocol ID
- CAHSS1912/05
- Status last verified
- Mar 2020
- First submitted
- 21 Feb 2020
- Last updated
- 21 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Brief Mindfulness-based Intervention for Parents of Adults With Intellectual Disabilities: a Case Series.
- ClinicalTrials.gov ID
- NCT04294082
- Acronym / sponsor ID
- CAHSS1912/05
- Conditions
- Intellectual Disability
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study stopped due to the outbreak of the covid-19 pandemic.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Grampian
- Study start
- 1 Apr 2020 (estimated)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 3 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Being a parent to an adult person with learning disabilities can be very stressful, and can lead to experiencing mental health problems. Not much is known about what sort of support services should be offering to these parents; and not many options are available as a result. This study will try to find out if a short intervention, known as a mindfulness-based intervention (MBI), can be of help to these families. A mindfulness-based intervention is one that aims to increase someone's mindfulness, which is the ability to be aware of the present, in a non-judgemental fashion.
Simply put, what the investigators would like to find out from this study is: "Can a short course of MBI help improve the well-being of parents of adults with learning disabilities?"
To answer this question, the investigators will seek to invite parents to attend a mindfulness course of the duration of 4 sessions. Parents will be invited to participate by NHS staff at their local Community Learning Disabilities Team, who will hand out information sheets and consent forms. Parents will be informed that they may choose to withdraw from the study at any time without this having any negative effect. The investigators will also ask parents to provide feedback on their experience of the course using online questionnaires. Parents will be asked to complete the questionnaires at 6 points: 1 month before the start of the course, at the start of the course, at the end of the course, and at 3, 6 and 12 months after the course has ended. This way, the investigators will be able to track any changes in how parents rate their well-being; and if these changes persist in the long-term.
At the end of the study, participants will be offered information on the results.
Detailed description
A multitude of studies has established that parenting a child with intellectual disabilities (IDs) can negatively influence the psychological and physical wellbeing of primary caregivers. The same correlation between IDs and parental psychological distress exists in the parents of adults with IDs, with the transition from childhood to adulthood being particularly detrimental to the psychological wellbeing of the family. Carers of children with IDs often report increased levels of parental stress, a feature that is amplified in some categories of IDs, such as in autism spectrum disorder. Importantly, the effects of this especially demanding relationship are not limited to impacting the carers' wellbeing alone; they can also affect the carers' ability to respond to problematic child behaviour, and result in financial hardship.
In terms of psychological distress on the part of people with intellectual disabilities (PWIDs), this is most often observed in the form of challenging behaviour, which can be used by PWIDs to communicate their distress. Of interest to the present study, the complex and enduring pattern of difficulties observed within these families cannot be accounted for purely by the psychological distress of the carers, nor does it stem from challenging behaviour alone. Instead, it has been proposed that the relationship between parental stress and the child's challenging behaviour is bi-directional, and self-reinforcing, in that parental stress can increase challenging behaviour, just as challenging behaviour can induce stress, and other forms of psychological distress. This pattern has been observed in families with children, as well as in families with adults with IDs.
Given the link between challenging behaviour, parental stress, and their interdependent nature, there has recently been a focus on employing therapeutic modalities that are explicitly aimed at reducing stress, with third-wave cognitive behavioural therapies (CBT) at the forefront of such scrutiny. Among third-wave CBTs, mindfulness-based interventions (MBIs) have been employed with especially promising results, making them veritable candidates as effective interventions for what is a sizeable segment of the population.
MBI adaptations
It should be noted that the increased range of applicability derived from said universality can limit the scope and clarity of the MBIs' research base. Specifically, as observed in a recent review on the efficacy of MBIs in parents of children with disabilities, a plethora of different interventions and adaptations of MBIs are continuously being developed, from the classic programmes devised by Jon Kabat-Zinn and his team, to hybrid interventions that combine MBIs with other therapies, such as DBT or ACT. Such abundance of variation can limit the precision with which the various MBIs are comparable with one another, and frustrates the search for a definite analysis of precisely which mindfulness factors contribute to the self-reported decreases in psychological distress. In parallel, efforts are being made to distil the essential criteria a mindfulness intervention should be based on.
MBIs can also be adapted in relation to their structure, not just by intervention modality they incorporate. Shortened versions of MBIs have been devised and tested with positive results, with effect sizes for psychological outcomes comparable to those found in programmes of classic length. Shortened MBIs can cover the same content as their lengthier counterparts, within fewer sessions; or they may simply reduce the content they cover, and provide that within fewer sessions. In both instances, the literature suggests that there is no significant correlation between psychological outcomes and course length, indicating that shortened versions of MBIs may achieve the same psychological outcomes by the end of the programme, in clinical, as well as non-clinical populations.
Presently, no robust research exists on what intervention works best for parents of PWIDs, particularly within the realm of adults with IDs. To the author's knowledge, only one study has to date explored the effectiveness of a short MBI aimed specifically at parents of adults with a disability. It should be noted, however, that the study primarily evaluated parents of adults with a diagnosis of autism spectrum disorder (ASD). This limits the generalisability of the study to the ASD population, which represents but a section of the population with IDs. In addition, the authors of the study acknowledge that parents of adult children with IDs often find it difficult to commit to a course of MBI due to the time constrains dictated by their children's needs, and recommend the trialling of even shorter MBIs, with no studies to date having evaluated an MBI as brief as the one proposed herein. Finally, despite there being extensive research on the shorter-term effects of MBIs, no study to date has focussed with sufficient emphasis on the longer-term effects of MBI course. Advancing our understanding of whether MBIs retain their effect over time can lead to substantial improvements in terms of clinical applications.
Based on the premises that:
- shortened versions of MBIs have successfully generated psychological change in comparable populations; and
- theoretical models relating to children with disabilities suggest that parental stress negatively influences the caregiver-offspring dyad; it is hypothesized that a 4-week MBI course will achieve positive psychological outcomes in this population.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindfulness based intervention | – | Behavioral: Mindfulness based interventionA shortened version of a mindfulness-based intervention originally developed by Jon Kabat-Zinn for management of chronic pain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Parents of adults with IDs living in Aberdeenshire.
Key inclusion criteria (2 listed)
- All parents of adults (defined as individuals aged 16 years or above) with IDs, identified by the CLDT will be eligible.
- No formal diagnosis of IDs will be sought, as often service users do not have a formal diagnosis due to a lack of diagnostic services being available (either historically, or presently).
Key exclusion criteria (3 listed)
- Parents of children (under 16 years old) with IDs. This includes family units comprised of both children and adults with IDs.
- Parents who are not sufficiently fluent in English, or who themselves have an IDs, such that they might be unable to undertake the intervention and complete the relative outcome measures.
- Parents that do not have capacity to consent to research at the time it is sought.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness based interventionA four session, 120 mins per session mindfulness based course delivered weekly oer the course of four weeks. The mindfulness sessions are based on the model delineated by Kabat-Zinn (1992) and will encompass: * an introduction to mindfulness * body-scan exercises * sitting meditation * mindful movement exercises * individual and group reflections * homework exercises | Behavioural | Mindfulness based intervention |
Primary outcome
Parental Stress Scale
Time frame: Baseline (4 weeks before the start of the mindfulness course); Pre- (at the start of the mindfulness course); Post- (at the end of the mindfulness course; Time point: 4 weeks); Follow-ups (at 3, 6, 12 months from the end of the mindfulness course)
Self-reported questionnaire measuring change in levels of stress in parents. Scores on scale range from 1 to 5, with higher values indicating lower parental stress.
3 secondary outcomes
Warwick-Edinburgh Mental Well-Being Scale
Time frame: Baseline (4 weeks before the start of the mindfulness course); Pre- (at the start of the mindfulness course); Post- (at the end of the mindfulness course; Time point: 4 weeks); Follow-ups (at 3, 6, 12 months from the end of the mindfulness course)
Five-facet Mindfulness Questionnaire, Short Form. Scores on each questionnaire item range from 1 to 5, with higher values indicating higher levels of mindfulness.
Time frame: Baseline (4 weeks before the start of the mindfulness course); Pre- (at the start of the mindfulness course); Post- (at the end of the mindfulness course; Time point: 4 weeks); Follow-ups (at 3, 6, 12 months from the end of the mindfulness course)
Satisfaction with Life Scale. Scores range from 1 to 7, with a higher score indicating higher satisfaction with life.
Time frame: Baseline (4 weeks before the start of the mindfulness course); Pre- (at the start of the mindfulness course); Post- (at the end of the mindfulness course; Time point: 4 weeks); Follow-ups (at 3, 6, 12 months from the end of the mindfulness course)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matteo Turco de Pretis-Cagnodo, MSc principal investigator
University of Edinburgh
Questions about this trial
What is this clinical trial studying?
An observational study of Intellectual Disability, run by University of Edinburgh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental Stress Scale (time frame: Baseline (4 weeks before the start of the mindfulness course); Pre- (at the start of the mindfulness course); Post- (at the end of the mindfulness course; Time point: 4 weeks); Follow-ups (at 3, 6, 12 months from the end of the mindfulness course)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2020.