Clinical trial NCT05179096: Effects of a Mindfulness Intervention on Temperament, Anxiety and Depression: the Mind the Child Study
Official title: Randomized Trial on the Effects of a Mindfulness Intervention on Temperament, Anxiety and Depression: a Multi-arm Psychometric Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child, Only
Temperament
Anxiety
Depression
Keywords: Child
Mindfulness
Temperament
Anxiety
Depression
Attention
Lead sponsor: University of Pisa
Sponsor class: OTHER
First posted: 2022-01-05
Enrollment: 41
Sex: ALL
Minimum age (years): 9
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Temperament - Inhibition to Novelty (IN)
timeFrame: QUIT-IN is measured before and after the 8-week mindfulness intervention
measure: Temperament - Attention (AT)
timeFrame: QUIT-AT is measured before and after the 8-week mindfulness intervention
measure: Temperament - Motor Activity (MA)
timeFrame: QUIT-MA is measured before and after the 8-week mindfulness intervention
measure: Temperament - Social Orientation (SO)
timeFrame: QUIT-SO is measured before and after the 8-week mindfulness intervention
measure: Temperament - Positive Emotionality (PE)
timeFrame: QUIT-PE is measured before and after the 8-week mindfulness intervention
measure: Temperament - Negative Emotionality (NE)
timeFrame: QUIT-NE is measured before and after the 8-week mindfulness intervention
Secondary outcomes:
measure: Anxiety
timeFrame: TAD for Anxiety is measured before and after the 8-week mindfulness intervention
measure: Depression
timeFrame: TAD for Depression is measured before and after the 8-week mindfulness intervention
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: University of Pisa
Study officials:
affiliation: University of Pisa
name: Andrea Poli, Psy.D.
role: PRINCIPAL_INVESTIGATOR
References: