Two-year Follow-up of a Mindfulness-based Intervention in Children. (NCT04806542) | Clinical Trial Compass
CompletedNot Applicable
Two-year Follow-up of a Mindfulness-based Intervention in Children.
34 participantsStarted 2016-01-29
Plain-language summary
The primary aim of this study was to determine whether an 8-week mindfulness-based intervention, called Training for Mindfulness and Resilience (TMR), mitigates moderate mental health symptoms and increases resilience during a 2-year follow-up.
Methods
The participants were 34 schoolchildren in age range of 9-14 years, reporting moderate mental health problems. Participants were randomised into either TMR intervention group (N=22) or control group, receiving best current practice (N=12). The investigators used validated self-rating questionnaires to measure anxiety, depression, anger, disruptive behaviour, self-concept, resilience, stress and mindfulness before treatment with either TMR or control, as well as at 6 months, 1 year and 2 years after treatment period.
Who can participate
Age range
9 Years – 14 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* F32.0 Mild depressive episode
* F32.1 Moderate depressive episode
* F41 Anxiety disorders
* F43 Reactions to stress
* F51 Nonorganic sleep disorders
* F93 Emotional disorders with onset specific to childhood
* F94.8 Other childhood disorders of social functioning
* F94.9 Other childhood disorder of social functioning, unspecified
Exclusion Criteria:
* Ongoing treatment for severe psychiatric disorders (F20-29, F31-F33.3)
* Cognitive disorders
* Difficulties in understanding Swedish
* Neuropsychiatric considerations and diagnosis
* Learning disabilities with difficulties in verbal understanding
* Ongoing parental conflict in conjunction with separation/divorce.
* Attending less than 5 of the 8 sessions of the TMR program.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Anxiety, depression, anger, disruptive behaviour, self-concept according to Beck Youth Inventories.
Timeframe: Change from Baseline anxiety, depression, anger, disruptive behaviour and self-concept at 2 years.
2
Resilience.
Timeframe: Change from Baseline Resilience at 2 years.
3
Stress.
Timeframe: Change from Baseline stress at 2 years.
4
Mindfulness.
Timeframe: Change from Baseline mindfulness at 2 years.