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

Not Applicable

Completed

• Conditions: Mental Health Issue

• Registration Number: NCT04806542
• Lead Sponsor: Göteborg University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-29
• Primary Completion: 2019-06-20
• Study Completion: 2019-06-20
• Status Verified: 2021-03
• Study First Submitted: 2021-03-12
• Study First Submitted QC: 2021-03-16
• Last Update Submitted: 2021-03-16
• Study First Posted: 2021-03-19
• Last Update Posted: 2021-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Anxiety, depression, anger, disruptive behaviour, self-concept according to Beck Youth Inventories.	Change from Baseline anxiety, depression, anger, disruptive behaviour and self-concept at 2 years.	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 .
Resilience.	Change from Baseline Resilience at 2 years.	The investigators used a validated self-rating questionnaire called Resilience Scale 10. Maximum score 40, minimum score 10. Higher values indicate better outcome.
Stress.	Change from Baseline stress at 2 years.	The investigators used a validated self-rating questionnaire called Stress in Children. Maximum score 92, minimum score 23. Higher values indicate better outcome.
Mindfulness.	Change from Baseline mindfulness at 2 years.	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.