Effects of a Mindfulness Intervention on Temperament, Anxiety and Depression: the Mind the Child Study

Study Overview
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Brief Summary
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Background and study aims: Mindfulness is a mental state that can be achieved through meditation. So far, studies have shown that practicing mindfulness on a consistent and regular basis can improve attentional functions and emotional well-being. Mindfulness has recently begun to be used in the field of child development. The aim of this study is to assess if a mindfulness program may help primary school students in reducing anxiety and depression while also improving their temperament. Who can participate? Students attending the fourth or fifth year of primary school What does the study involve? Participants will be randomly assigned to the experimental and control groups. Participants in the experimental group will undergo an 8-week mindfulness training program with weekly 60-minute group sessions, while the control group will follow routine daily school activities. Questionnaires will be used to assess temperament, anxiety and depression before and after the intervention. What are the possible benefits and risks of participating? Benefits of participating in the study may include a lowering of anxiety and depression levels, as well as an improvement of temperament.

Official Title
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Randomized Trial on the Effects of a Mindfulness Intervention on Temperament, Anxiety and Depression: a Multi-arm Psychometric Study

Conditions
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Child, Only, Temperament, Anxiety, Depression

Intervention / Treatment
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* Behavioral: Mindfulness-based intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged 9 to 11 years Children have reasonable comprehension of spoken language and can follow simple instructions Children and their parents are willing to attend all intervention sessions Children and parents have an adequate understanding of English Exclusion Criteria: Concurrent enrollment in other intervention trials Child or parent regularly practice complementary health interventions such as meditation

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness<br>Participants in the experimental group will undergo an 8-week mindfulness training program with weekly 60-minute group sessions | Behavioral: Mindfulness-based intervention<br>* The program consists of a series of awareness practices: the exercises are presented in progression, starting from the awareness of the external environment, then the self-awareness in the environment, the awareness of the body and the five senses, the awareness of the interconnection among the various forms of life and, eventually, meditation exercises that characterize the awareness of the cognitive processes<br>|
| No Intervention: Control<br>The control group will follow routine daily school activities | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Temperament - Inhibition to Novelty (IN) | IN dimension of temperament is measured using Italian Questionnaires of Temperament (QUIT). Higher scores mean a worse outcome | QUIT-IN is measured before and after the 8-week mindfulness intervention | 
| Temperament - Attention (AT) | AT dimension of temperament is measured using Italian Questionnaires of Temperament (QUIT). Higher scores mean a better outcome | QUIT-AT is measured before and after the 8-week mindfulness intervention | 
| Temperament - Motor Activity (MA) | MA dimension of temperament is measured using Italian Questionnaires of Temperament (QUIT). No overall change is expected in MA scores | QUIT-MA is measured before and after the 8-week mindfulness intervention | 
| Temperament - Social Orientation (SO) | SO dimension of temperament is measured using Italian Questionnaires of Temperament (QUIT). Higher scores mean a better outcome | QUIT-SO is measured before and after the 8-week mindfulness intervention | 
| Temperament - Positive Emotionality (PE) | PE dimension of temperament is measured using Italian Questionnaires of Temperament (QUIT). Higher scores mean a better outcome | QUIT-PE is measured before and after the 8-week mindfulness intervention | 
| Temperament - Negative Emotionality (NE) | NE dimension of temperament is measured using Italian Questionnaires of Temperament (QUIT). Higher scores mean a worse outcome | QUIT-NE is measured before and after the 8-week mindfulness intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety | Anxiety is measured using Anxiety and Depression Test in Childhood and Adolescence (TAD). Higher scores mean a worse outcome | TAD for Anxiety is measured before and after the 8-week mindfulness intervention | 
| Depression | Depression is measured using Anxiety and Depression Test in Childhood and Adolescence (TAD). Higher scores mean a worse outcome | TAD for Depression is measured before and after the 8-week mindfulness intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Child, Mindfulness, Temperament, Anxiety, Depression, Attention