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

Mental Health Issue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04806542
• Other study ID #: TMR-study
• Status: Completed
• Phase: N/A
• Start date: January 29, 2016
• Est. completion date: June 20, 2019

Study information

• Verified date: March 2021
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 20, 2019
• Est. primary completion date: June 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mental Health Issue

Intervention

Behavioral:
• TMR-group
A mindfulness-based 8 week program.
• Treatment as usual
Individual counselling.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Göteborg University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.