Study of Mindfulness Course for Parents of Adults With Intellectual Disabilities

NCT04294082 | Withdrawn DMC

• 1 other identifier: CAHSS1912/05
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Intellectual Disability

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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.

  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.

  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)

Study Arms (1)

Mindfulness based intervention

A shortened version of a mindfulness-based intervention originally developed by Jon Kabat-Zinn for management of chronic pain.

Behavioral: Mindfulness based intervention

Interventions

Mindfulness based intervention BEHAVIORAL

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

Mindfulness based intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Parents of adults with IDs living in Aberdeenshire.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Edinburgh: lead
• NHS Grampian: collaborator

MeSH Terms

Conditions

Intellectual Disability

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Matteo Turco de Pretis-Cagnodo, MSc

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2020
• First Posted: March 3, 2020
• Study Start: April 1, 2020
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: August 21, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share