Two-year Follow-up of a Mindfulness-based Intervention in Children.

Study Overview
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Brief Summary
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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.

Official Title
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A Mindfulness-based Intervention Improves Resilience, Anxiety, Anger and Disruptive Behaviour in Children With Mental Health Problems: A 2-year Follow-up Study

Conditions
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Mental Health Issue

Intervention / Treatment
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* Behavioral: TMR-group
* Behavioral: Treatment as usual


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TMR-group<br>8-week program for schoolchildren called TMR (Training for Resilience and Mindfulness). | Behavioral: TMR-group<br>* A mindfulness-based 8 week program.<br>|
| Active Comparator: Treatment as Usual<br>Individual counselling. | Behavioral: Treatment as usual<br>* Individual counselling.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety, depression, anger, disruptive behaviour, self-concept according to Beck Youth Inventories. | The investigators used validated self-rating questionnaires called Beck Youth Inventories. Maximum score 300, minimum score 0. Higher values indicate worse outcome except on subscale measuring self-concept where higher score indicate better outcome . | Change from Baseline anxiety, depression, anger, disruptive behaviour and self-concept at 2 years. | 
| Resilience. | The investigators used a validated self-rating questionnaire called Resilience Scale 10. Maximum score 40, minimum score 10. Higher values indicate better outcome. | Change from Baseline Resilience at 2 years. | 
| Stress. | The investigators used a validated self-rating questionnaire called Stress in Children. Maximum score 92, minimum score 23. Higher values indicate better outcome. | Change from Baseline stress at 2 years. | 
| Mindfulness. | The investigators used a validated self-rating questionnaire called Child and Adolescent Mindfulness Measure (CAMM). Maximum score 40, minimum score 0. Higher values indicate better outcome. | Change from Baseline mindfulness at 2 years. |