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NCT Number: NCT05179096

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

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.

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Key information

Conditions

Child, Only Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Temperament

Age range

9 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pisa

Pisa, 56126, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness-based Intervention

Behavioral

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

Primary outcomes

  1. Temperament - Inhibition to Novelty (IN)

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

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

  2. Temperament - Attention (AT)

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

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

  3. Temperament - Motor Activity (MA)

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

    MA dimension of temperament is measured using Italian Questionnaires of Temperament (QUIT). No overall change is expected in MA scores

  4. Temperament - Social Orientation (SO)

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

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

  5. Temperament - Positive Emotionality (PE)

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

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

  6. Temperament - Negative Emotionality (NE)

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

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

Secondary outcomes

  1. Anxiety

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

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

  2. Depression

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

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

Sponsors and collaborators

Lead sponsor

University of Pisa

Other

Registry information

Official study title

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

Acronym: MTC

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 5, 2022
Registry last updated
Jan 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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