Making Mindfulness Matter© (M3) for Mindfulness

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Epilepsy Southwestern Ontario, London, Canada
Mindfulness+3 More
Making Mindfulness Matter© (M3) - Behavioral
Eligibility
< 18
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a mindfulness-based intervention can improve quality of life and mental health for children with epilepsy and their parents.

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Eligible Conditions

  • Mindfulness
  • Epilepsy in Children
  • Quality of Life (QOL)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Making Mindfulness Matter© (M3) will improve 1 primary outcome and 10 secondary outcomes in patients with Mindfulness. Measurement will happen over the course of Throughout the study enrollment period and over the 8 weeks of intervention..

Week 8
Feasibility of Making Mindfulness Matter© (M3) as a family treatment for children with epilepsy and their parents
Week 17
Does M3 have a positive effect on children's adaptive skills
Does M3 have a positive effect on children's executive function
Does M3 have a positive effect on children's externalizing problems
Does M3 have a positive effect on children's internalizing problems
Does M3 have a positive effect on children's severity of epilepsy
Does M3 have a positive effect on parents' anxiety
Does M3 have a positive effect on parents' depression
Does M3 have a positive effect on parents' stress
Effect of M3 on Health Related Quality of Life of children with epilepsy
Effect of M3 on Health Related Quality of Life of parents

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Intervention Group
1 of 1
Experimental Treatment

This trial requires 100 total participants across 1 different treatment group

This trial involves a single treatment. Making Mindfulness Matter© (M3) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Intervention Group
Behavioral
Child-parent dyads will undergo a standardized 8-week course of Making Mindfulness Matter© (M3). The program will be delivered online using live, interactive sessions to groups of 4 to 8, for 1.5 hours each week for the parent group and 1 hour each week for the child group. Children and parents will attend separate on-line sessions and at the end of each child session, the parent will be asked to join their child on-line for a shared mindful exercise. Once 4 to 8 dyads are assigned to the intervention group, participants will be given the baseline questionnaires and start the intervention in the following week.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 8 weeks, 17 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline, 8 weeks, 17 weeks for reporting.

Closest Location

Epilepsy Southwestern Ontario - London, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
No age restriction on parent participating in parent/child dyad
Children aged 4 to 10 years diagnosed with epilepsy a minimum of 6 months ago, as per the International League Against Epilepsy (ILAE) 2014 operational definition*
Children have reasonable comprehension of spoken language and can follow simple instructions
Children with epilepsy and their parents** are willing to attend all intervention sessions
Children with epilepsy and parents have an adequate understanding of English
At least two unprovoked (or reflex) seizures occurring>24 h apart, or One unprovoked (or reflex) seizure and a probability of further seizures similar to the general recurrence risk (at least 60%) after two unprovoked seizures, occurring over the next 10 years, or Diagnosis of an epilepsy syndrome
Parents: refers to parent or guardian self-identifying as most responsible for child's day-to-day care

Patient Q&A Section

What are common treatments for aura?

"In this article the most common treatments for aura are discussed, some of them as well described in the literature. We discuss what are common treatments for patients with visual aura before is treated. This article also discusses all current treatments and treatments for aura and the literature for each treatment. Patients with visual aura can benefit from an evaluation of their condition. They may also benefit from treatment and consultation and if so a referral to their physician can be considered." - Anonymous Online Contributor

Unverified Answer

What are the signs of aura?

"Data from a recent study of this meta-analysis show that more than half of people with a clinically significant history of pre-morbid psychiatric conditions report having experienced an aura when they had a first transient focal neurological presentation, which may be of clinical relevance for both patients and clinicians." - Anonymous Online Contributor

Unverified Answer

What is aura?

"Aura is a symptom experienced by many women who have had a prior uncomplicated pregnancy. The symptoms generally resolve after the delivery of the baby. The diagnosis of a serious obstetric problem is made by measuring the fetal heart rate during labor rather than by feeling the mother's abdomen. Because of the ambiguity of its original meaning, [aura] became [varying, undefined, indeterminate] when it was introduced into English dictionaries in 1663. The first published use of the word "aura" was in 1474, literally "an omen", from Latin "avis avellana" and "avis avellanella", literally an "avowel" or "avowel bird"." - Anonymous Online Contributor

Unverified Answer

How many people get aura a year in the United States?

"Approximately 10% of the US population experiences aura at some point during the year. It is the most common presentation of a migraine during the year." - Anonymous Online Contributor

Unverified Answer

What causes aura?

"There is disagreement between the auras reported by syncope sufferers and those of other members of the population; the auras experienced by syncope syndromes and by the general population cannot be easily explained by a specific disease or disorder." - Anonymous Online Contributor

Unverified Answer

Can aura be cured?

"There is considerable confusion over how to define and treat auras in clinical practice. Results from a recent clinical trial offers a clear definition of an aura-free state and draws a clear boundary around which treatments can be safely used." - Anonymous Online Contributor

Unverified Answer

Is making mindfulness matter© (m3) safe for people?

"We conclude that this intervention is safe for people with severe and disabling panic symptoms, with an effect at 12 weeks longer than treatment as usual." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets aura?

"The majority of people report getting an aura during their lifetime which is very unusual considering all of the evidence of only a few people knowing about this experience, but this number is quite small. The average age people get an aura is 30." - Anonymous Online Contributor

Unverified Answer

How serious can aura be?

"There is a misconception that one type of severe aura is more troubling than another type. The seriousness of a particular type of aura may vary with time. For example, visual symptoms such as flushing and tingling tend to be more debilitating in the morning. To be safe, consider any new headache symptom as [symptomatic] rather than [serious] when evaluating or diagnosing or choosing treatment for an episodic headache." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating aura?

"There has been no significant advancement in the research. Studies on aura treatment to date have mainly focused on treating the symptoms. However, some evidence also exists that aura may indeed have a link with migraines. More research should be carried out to see if aura treatment is effective in preventing migraines. There have been attempts to trial a topical treatment for treating aura, but more research is needed to know how effective this treatment would be. [Power (https://www.withpower." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for aura?

"Patients' beliefs, attitudes, and experiences on aura and the effect of aura are important, because whether or not they think symptoms of aura should be attributed to real disease is important for patient decisions. Patients should be informed about the risk of false positives and false negatives of aura as well as the possibility of not having a positive effect from the trial. Physicians should discuss this issue with patients and communicate to them that a false-positive result is normal and that the risk of not finding treatment for real disease is greater in patients who are worried about the results." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of aura?

"As defined by the [Merck Manual], aura is the condition of fear, excitement, unease, discomfort, discomfort, or distress in a situation that has no known physical cause. This condition, though commonly associated with migraine, may be quite nonspecific (e.g., due to stress or anxiety) and occurs without any aura in 20% of patients with episodic migraine without aura. This may be in part due to the heterogeneity of the condition and the use of misleading definitions of aura. A major issue with the definition of aura in the [Merck Manual] is that it implies that the patient was aware of the aura. While common, this assumption is questionable." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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