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

Not Applicable

Completed

• Conditions: Mental Health Issue
• Interventions: Behavioral: TMR-group; Behavioral: Treatment as usual

• 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

Arm && Interventions

Group	Intervention	Description
TMR-group	TMR-group	8-week program for schoolchildren called TMR (Training for Resilience and Mindfulness).
Treatment as Usual	Treatment as usual	Individual counselling.

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.