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

NCT05179096 | Completed DMC

• 1 other identifier: MTC-01
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Child, Only; Temperament; Anxiety; Depression

Keywords

Child; Mindfulness; Temperament; Anxiety; Depression; Attention

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• Anxiety

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

• Depression

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

Study Arms (2)

Mindfulness

EXPERIMENTAL

Participants in the experimental group will undergo an 8-week mindfulness training program with weekly 60-minute group sessions

Behavioral: Mindfulness-based intervention

Control

NO INTERVENTION

The control group will follow routine daily school activities

Interventions

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

Mindfulness

Eligibility Criteria

• Age: 9 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Concurrent enrollment in other intervention trials
• Child or parent regularly practice complementary health interventions such as meditation

Sponsors & Collaborators

• University of Pisa: lead

Study Sites (1)

University of Pisa

Pisa, 56126, Italy

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Andrea Poli, Psy.D.

  University of Pisa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: January 5, 2022
• Study Start: August 20, 2021
• Primary Completion: October 31, 2021
• Study Completion: November 30, 2021
• Last Updated: January 5, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

IT (1)