Mindfulness as a Method of Improving the Well-being, Quality of Life and Health of Primary School Pupils

NCT03327714 | Active Not Recruiting

• 1 other identifier: 2016/299
• Study Type: interventional
• Target: 1,750
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the short and long-term effect of 5-10 minutes daily mindfulness and compassion training in school among children aged between 6-16 years old. The mindfulness intervention will last for 10 weeks and the results will be compared to children who do not perform mindfulness in school. Due to practical reasons, the study is not randomized; classes are instead placed in the mindfulness or control group. Anxiety, mental, physical and social health, quality of life, and school performance will be evaluated via questionnaires and school registries, before and after the intervention and thereafter once a year until the end of ninth grade (age 16 years). Long term health (diagnoses, medical consumption, and drug prescriptions) and family income (proxy for socioeconomic status) will be followed in regional and national registries until 25 years of age. The hypothesis of the study is that mindfulness can prevent mental disorders and anxiety, and increase well-being in children and adolescents. The primary aim is to subsequently evaluate if regular, daily, mindfulness and compassion training (5-10 minutes) prevents anxiety and mental disorders in children and adolescents. Secondary aims are to evaluate 1) the effect of mindfulness on daily life, quality of life, and health in school pupils; 2) the effect of mindfulness on school performance; 3) the effect of mindfulness and compassion on the class room environment; 4) the effect of potential individual, family, and school-level risk factors on mental health in children and adolescents; 5) the effect of mindfulness on these potential risk factors. Sessions are led by school teachers who have been educated in mindfulness. Their own levels of stress and mindfulness will be evaluated by a questionnaire and compared to teachers in control classes both before and after the intervention. The teachers will also be interviewed to evaluate the effect of mindfulness on the class room environment. In a sub-study, the effect of mindfulness on brain structure and function will be examined by magnetic resonance imaging in school pupils aged 15-16 year old. This will be preceded by a pilot study, in which feasibility of the method is tested in the target group. To achieve sufficient statistical power, taking into account a cluster effect to adjust for grouping of the pupils, 1750 children and adolescents will be recruited. Written informed consent is a prerequisite for participation.

Conditions

Anxiety; Depression

Keywords

mindfulness; children; anxiety; depression; mental disorder; risk factor

Outcome Measures

Primary Outcomes (1)

• Effect of mindfulness on change in anxiety and depression in children, grade 3-9, as measured by the Beck Depression Inventory for Youth and the Beck Anxiety Inventory for Youth.

  The primary aim is to evaluate if regular, daily, mindfulness and compassion practice (5-10 minutes) for 10 weeks prevents anxiety and depression in children, grade 3-9. Results will be compared within respective group (change from baseline) and between mindfulness and control group.

  Change from baseline depression and anxiety levels at 10 weeks

Secondary Outcomes (8)

• Effect of mindfulness on changes in daily life as measured by questions about school and leisure time (adapted from the Scania Public Health Survey).

  Change from baseline daily life status at 10 weeks

• Effect of regular mindfulness practice on school performance (data collected from school registers)

  Grade 0 (pupils aged 6-7 years) and will continue on a yearly basis until grade 9 (pupils aged 15-16).

• Effect of mindfulness on change in class room environment (evaluated by questionnaires, weekly schedule, and interviews with teachers).

  Change from baseline class room environment at 10 weeks

• Effect of risk factors on mental health: longitudinal follow-up study.

  Baseline, 10 weeks, 52 weeks. Thereafter yearly until 25 years of age.

• Effect of mindfulness on risk factors: longitudinal follow-up study.

  10 weeks, 52 weeks. Thereafter yearly until 25 years of age.

Study Arms (2)

Mindfulness and compassion

EXPERIMENTAL

Children aged between 6-16 years old will perform 5-10 minutes daily mindfulness and compassion training in school. The intervention will last for 10 weeks.

Behavioral: Mindfulness and compassion

Control group

NO INTERVENTION

The control group consists of children who do not perform mindfulness in school.

Interventions

Mindfulness and compassion BEHAVIORAL

Mindfulness and compassion

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• School pupils in grade 0-9

Sponsors & Collaborators

• Lund University: lead
• Region Skane: collaborator

Study Sites (1)

Center for Primary Health Care Research

Malmo, 20502, Sweden

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression; Mental Disorders

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jan Sundquist, PhD, MD

  Center for Primary Health Care Research, Institution of Clinical Sciences, Malmö, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Children in classes that perform regular mindfulness are compared to children in classes that do not.

Study Record Dates

• First Submitted: September 29, 2017
• First Posted: October 31, 2017
• Study Start: October 12, 2016
• Primary Completion: January 30, 2021
• Study Completion (Estimated): June 30, 2039
• Last Updated: March 17, 2025

Record last verified: 2025-03

Locations

SE (1)