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

University of Pisa41 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Child, Only Temperament

Interventions

Mindfulness-based interventionBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 9 YearsMax age: 11 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Children aged 9 to 11 years 2. Children have reasonable comprehension of spoken language and can follow simple instructions 3. Children and their parents are willing to attend all intervention sessions 4. Children and parents have an adequate understanding of English Exclusion Criteria: 1. Concurrent enrollment in other intervention trials 2. Child or parent regularly practice complementary health interventions such as meditation

Outcomes

Primary Outcomes

Temperament - Inhibition to Novelty (IN)

IN dimension of temperament is measured using Italian Questionnaires of Temperament (QUIT). Higher scores mean a worse outcome

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: QUIT-NE is measured before and after the 8-week mindfulness intervention

Secondary Outcomes

Anxiety

Anxiety is measured using Anxiety and Depression Test in Childhood and Adolescence (TAD). Higher scores mean a worse outcome

Time frame: 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

Time frame: TAD for Depression is measured before and after the 8-week mindfulness intervention