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

NCT04806542 | Completed

• 1 other identifier: TMR-study
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Mental Health Issue

Outcome Measures

Primary Outcomes (4)

• 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.

Study Arms (2)

TMR-group

EXPERIMENTAL

8-week program for schoolchildren called TMR (Training for Resilience and Mindfulness).

Behavioral: TMR-group

Treatment as Usual

ACTIVE COMPARATOR

Individual counselling.

Behavioral: Treatment as usual

Interventions

TMR-group BEHAVIORAL

A mindfulness-based 8 week program.

TMR-group

Treatment as usual BEHAVIORAL

Individual counselling.

Treatment as Usual

Eligibility Criteria

• Age: 9 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Göteborg University: lead

MeSH Terms

Interventions

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Study.

Study Record Dates

• First Submitted: March 12, 2021
• First Posted: March 19, 2021
• Study Start: January 29, 2016
• Primary Completion: June 20, 2019
• Study Completion: June 20, 2019
• Last Updated: March 19, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share