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

NCT ID: NCT04806542

Last Updated: 2021-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-29

Study Completion Date

2019-06-20

Brief Summary

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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.

Detailed Description

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Conditions

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Mental Health Issue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Study.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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TMR-group

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

Group Type EXPERIMENTAL

TMR-group

Intervention Type BEHAVIORAL

A mindfulness-based 8 week program.

Treatment as Usual

Individual counselling.

Group Type ACTIVE_COMPARATOR

Treatment as usual

Intervention Type BEHAVIORAL

Individual counselling.

Interventions

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TMR-group

A mindfulness-based 8 week program.

Intervention Type BEHAVIORAL

Treatment as usual

Individual counselling.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

9 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Göteborg University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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TMR-study

Identifier Type: -

Identifier Source: org_study_id

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