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

Depression Clinical Trial

— MTC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05179096
• Other study ID #: MTC-01
• Status: Completed
• Phase: N/A
• Start date: August 20, 2021
• Est. completion date: November 30, 2021

Study information

• Verified date: December 2021
• Source: University of Pisa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: November 30, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Child, Only
• Depression
• Depressive Disorder
• Temperament

Intervention

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

Locations

Country	Name	City	State
Italy	University of Pisa	Pisa

Sponsors (1)

Lead Sponsor	Collaborator
University of Pisa

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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