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

Not Applicable

Completed

• Conditions: Anxiety; Child, Only; Temperament; Depression
• Interventions: Behavioral: Mindfulness-based intervention

• Registration Number: NCT05179096
• Lead Sponsor: University of Pisa

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-20
• Primary Completion: 2021-10-31
• Study Completion: 2021-11-30
• Status Verified: 2021-12
• Study First Submitted: 2021-12-07
• Study First Submitted QC: 2021-12-20
• Last Update Submitted: 2021-12-20
• Study First Posted: 2022-01-05
• Last Update Posted: 2022-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness	Mindfulness-based intervention	Participants in the experimental group will undergo an 8-week mindfulness training program with weekly 60-minute group sessions

Primary Outcome Measures

Name	Time	Method
Temperament - Social Orientation (SO)	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 - Negative Emotionality (NE)	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
Temperament - Inhibition to Novelty (IN)	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)	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 - Positive Emotionality (PE)	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 - Motor Activity (MA)	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

Secondary Outcome Measures

Name	Time	Method
Anxiety	TAD for Anxiety is measured before and after the 8-week mindfulness intervention	Anxiety is measured using Anxiety and Depression Test in Childhood and Adolescence (TAD). Higher scores mean a worse outcome
Depression	TAD for Depression is measured before and after the 8-week mindfulness intervention	Depression is measured using Anxiety and Depression Test in Childhood and Adolescence (TAD). Higher scores mean a worse outcome

Trial Locations

Locations (1)

University of Pisa; 🇮🇹 Pisa, Italy