Effects of a Mindfulness Intervention on Temperament, Anxiety and Depression: the Mind the Child Study (MTC)
Primary Purpose
Child, Only, Temperament, Anxiety
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Mindfulness-based intervention
Sponsored by

About this trial
This is an interventional supportive care trial for Child, Only focused on measuring Child, Mindfulness, Temperament, Anxiety, Depression, Attention
Eligibility Criteria
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
Sites / Locations
- University of Pisa
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Mindfulness
Control
Arm Description
Participants in the experimental group will undergo an 8-week mindfulness training program with weekly 60-minute group sessions
The control group will follow routine daily school activities
Outcomes
Primary Outcome Measures
Temperament - Inhibition to Novelty (IN)
IN dimension of temperament is measured using Italian Questionnaires of Temperament (QUIT). Higher scores mean a worse outcome
Temperament - Attention (AT)
AT dimension of temperament is measured using Italian Questionnaires of Temperament (QUIT). Higher scores mean a better outcome
Temperament - Motor Activity (MA)
MA dimension of temperament is measured using Italian Questionnaires of Temperament (QUIT). No overall change is expected in MA scores
Temperament - Social Orientation (SO)
SO dimension of temperament is measured using Italian Questionnaires of Temperament (QUIT). Higher scores mean a better outcome
Temperament - Positive Emotionality (PE)
PE dimension of temperament is measured using Italian Questionnaires of Temperament (QUIT). Higher scores mean a better outcome
Temperament - Negative Emotionality (NE)
NE dimension of temperament is measured using Italian Questionnaires of Temperament (QUIT). Higher scores mean a worse outcome
Secondary Outcome Measures
Anxiety
Anxiety is measured using Anxiety and Depression Test in Childhood and Adolescence (TAD). Higher scores mean a worse outcome
Depression
Depression is measured using Anxiety and Depression Test in Childhood and Adolescence (TAD). Higher scores mean a worse outcome
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05179096
Brief Title
Effects of a Mindfulness Intervention on Temperament, Anxiety and Depression: the Mind the Child Study
Acronym
MTC
Official Title
Randomized Trial on the Effects of a Mindfulness Intervention on Temperament, Anxiety and Depression: a Multi-arm Psychometric Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
August 20, 2021 (Actual)
Primary Completion Date
October 31, 2021 (Actual)
Study Completion Date
November 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pisa
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child, Only, Temperament, Anxiety, Depression
Keywords
Child, Mindfulness, Temperament, Anxiety, Depression, Attention
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness
Arm Type
Experimental
Arm Description
Participants in the experimental group will undergo an 8-week mindfulness training program with weekly 60-minute group sessions
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group will follow routine daily school activities
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-based intervention
Intervention Description
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 Outcome Measure Information:
Title
Temperament - Inhibition to Novelty (IN)
Description
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
Title
Temperament - Attention (AT)
Description
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
Title
Temperament - Motor Activity (MA)
Description
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
Title
Temperament - Social Orientation (SO)
Description
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
Title
Temperament - Positive Emotionality (PE)
Description
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
Title
Temperament - Negative Emotionality (NE)
Description
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 Outcome Measure Information:
Title
Anxiety
Description
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
Title
Depression
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Poli, Psy.D.
Organizational Affiliation
University of Pisa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pisa
City
Pisa
ZIP/Postal Code
56126
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Raw data are available on request.
Learn more about this trial
Effects of a Mindfulness Intervention on Temperament, Anxiety and Depression: the Mind the Child Study
We'll reach out to this number within 24 hrs