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Completed

NCT Number: NCT04806542

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

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.

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Key information

Conditions

Mental Health Issue

Age range

9 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TMR-group

Behavioral

A mindfulness-based 8 week program.

Treatment as Usual

Behavioral

Individual counselling.

Primary outcomes

  1. Anxiety, depression, anger, disruptive behaviour, self-concept according to Beck Youth Inventories.

    Time frame: 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 .

  2. Resilience.

    Time frame: 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.

  3. Stress.

    Time frame: 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.

  4. Mindfulness.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Mar 19, 2021
Registry last updated
Mar 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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