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

Sponsor
Göteborg University (Other)
Overall Status
Completed
CT.gov ID
NCT04806542
Collaborator
(none)
34
Enrollment
2
Arms
40.7
Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: TMR-group
  • Behavioral: Treatment as usual
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
34 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized Controlled Study.Randomized Controlled Study.
Masking:
None (Open Label)
Primary Purpose:
Other
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
Actual Study Start Date :
Jan 29, 2016
Actual Primary Completion Date :
Jun 20, 2019
Actual Study Completion Date :
Jun 20, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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 .

  2. 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.

  3. 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.

  4. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
9 Years to 14 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Göteborg University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Göteborg University
ClinicalTrials.gov Identifier:
NCT04806542
Other Study ID Numbers:
  • TMR-study
First Posted:
Mar 19, 2021
Last Update Posted:
Mar 19, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 19, 2021