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

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

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.

Study Overview

• Status: Completed
• Conditions: Mental Health Issue
• Intervention / Treatment: Behavioral: TMR-group; Behavioral: Treatment as usual

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Göteborg University

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2016
• Primary Completion (Actual): June 20, 2019
• Study Completion (Actual): June 20, 2019

Study Registration Dates

• First Submitted: March 12, 2021
• First Submitted That Met QC Criteria: March 16, 2021
• First Posted (Actual): March 19, 2021

Study Record Updates

• Last Update Posted (Actual): March 19, 2021
• Last Update Submitted That Met QC Criteria: March 16, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: TMR-study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No