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

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

Study Overview

• Status: Completed
• Conditions: Depression; Anxiety; Child, Only; Temperament
• Intervention / Treatment: Behavioral: Mindfulness-based intervention

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Pisa, Italy, 56126
    • University of Pisa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 11 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness; Participants in the experimental group will undergo an 8-week mindfulness training program with weekly 60-minute group sessions	Behavioral: Mindfulness-based intervention; 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
No Intervention: Control; The control group will follow routine daily school activities

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Pisa

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2021
• Primary Completion (Actual): October 31, 2021
• Study Completion (Actual): November 30, 2021

Study Registration Dates

• First Submitted: December 7, 2021
• First Submitted That Met QC Criteria: December 20, 2021
• First Posted (Actual): January 5, 2022

Study Record Updates

• Last Update Posted (Actual): January 5, 2022
• Last Update Submitted That Met QC Criteria: December 20, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Depression; Child; Anxiety; Mindfulness; Attention; Temperament
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Anxiety Disorders
• Other Study ID Numbers: MTC-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Raw data are available on request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No