Child, OnlyMTCNCT05179096
Effects of a Mindfulness Intervention on Temperament, Anxiety and Depression: the Mind the Child Study
A study testing Mindfulness-based intervention in people with Child, Only and Temperament, run by University of Pisa at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 9 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Child, Only, Temperament, Anxiety
- What is being tested?
- Mindfulness-based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteItaly
- Study dates
- 20 Aug 2021to 30 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Concurrent enrollment in other intervention trials
- Child or parent regularly practice complementary health interventions such as meditation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- Mindfulness-based intervention
- Keywords
- Child, Mindfulness, Temperament, Anxiety, Depression, Attention
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based interventionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness | Experimental | Participants in the experimental group will undergo an 8-week mindfulness training program with weekly 60-minute group sessions Receives: Behavioral: Mindfulness-based intervention |
| Control | No intervention | The control group will follow routine daily school activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temperament - Inhibition to Novelty (IN)
IN dimension of temperament is measured using Italian Questionnaires of Temperament (QUIT). Higher scores mean a worse outcome
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: QUIT-NE is measured before and after the 8-week mindfulness intervention
Secondary outcomes (2)
Anxiety
Anxiety is measured using Anxiety and Depression Test in Childhood and Adolescence (TAD). Higher scores mean a worse outcome
Measured: 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
Measured: TAD for Depression is measured before and after the 8-week mindfulness intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start20 Aug 2021
- Primary completion31 Oct 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child, OnlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Poli, University of Pisa
- Investigators
- Andrea Poli, Psy.D., Principal investigator, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05179096
- Sponsor's protocol ID
- MTC-01
- Acronym
- MTC
- Status last verified
- Dec 2021
- First submitted
- 7 Dec 2021
- Last updated
- 5 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Raw data are available on request.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial on the Effects of a Mindfulness Intervention on Temperament, Anxiety and Depression: a Multi-arm Psychometric Study
- ClinicalTrials.gov ID
- NCT05179096
- Acronym / sponsor ID
- MTC / MTC-01
- Conditions
- Child, Only, Temperament, Anxiety, Depression
- Keywords
- Child, Mindfulness, Temperament, Anxiety, Depression, Attention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Study start
- 20 Aug 2021 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 5 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness | Experimental | Behavioral: Mindfulness-based interventionParticipants in the experimental group will undergo an 8-week mindfulness training program with weekly 60-minute group sessions |
| Control | No intervention | –The control group will follow routine daily school activities |
Who may qualify
- Ages
- 9 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Concurrent enrollment in other intervention trials
- Child or parent regularly practice complementary health interventions such as meditation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based interventionThe 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 | Behavioural | Mindfulness |
Primary outcome
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
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
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
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
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
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
2 secondary outcomes
Anxiety
Time frame: TAD for Anxiety is measured before and after the 8-week mindfulness intervention
Depression
Time frame: TAD for Depression is measured before and after the 8-week mindfulness intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2022.
- Individual participant dataSharing planned: Yes. Raw data are available on request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Poli, Psy.D. principal investigator
University of Pisa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based intervention in people with Child, Only and Temperament, run by University of Pisa at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Temperament - Inhibition to Novelty (IN) (time frame: QUIT-IN is measured before and after the 8-week mindfulness intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2022.