Clinical trial NCT06657014: Caregiver Mind-Mindedness Training to Alleviate Social Anxiety in Children
Official title: Caregiver Mind-Mindedness Training as an Early Intervention for Reducing Social Anxiety in Preschool-Aged Children: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Social Anxiety Disorder of Childhood
Keywords: Mind-Mindedness
Social Anxiety
intervention
Lead sponsor: Heriot-Watt University
Sponsor class: OTHER
First posted: 2024-10-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The Mind-Mindedness Training group will participate in three structured online sessions aimed at enhancing caregivers' ability to recognize and respond to their child's thoughts and feelings. This training seeks to improve caregivers' mentalization, which may help reduce social anxiety symptoms in children. Meanwhile, the Peer Support group will have access to a private online platform where caregivers can share experiences and coping strategies, creating a supportive environment without the structured intervention.

Data will be collected at baseline, immediately after the intervention, and during a three-month follow-up to assess changes in mind-mindedness, child social anxiety, attachment styles, and theory of mind. This parallel assignment model enables an effective evaluation of the intervention's impact on the target population while controlling for external variables through random assignment.
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial (RCT) aims to investigate the efficacy of Mind-Mindedness (MM) training for caregivers as an early intervention for preschool-aged children (4 to 7 years) exhibiting signs of social anxiety. The study posits that enhancing caregivers' ability to recognize and respond to their children's thoughts, feelings, and intentions-termed Mind-Mindedness-can foster secure attachments and improve socioemotional outcomes for children.

A total of 100 primary caregivers will be recruited from the United Kingdom and Iran, with participants randomly assigned to either an MM training intervention group or a peer support control group. The MM training will consist of three online sessions, each lasting one hour, focusing on strategies for implementing mind-minded comments and enhancing emotional understanding. The peer support group will provide caregivers with an online platform for sharing experiences related to their child's anxiety without receiving structured training.

Assessments of Mind-Mindedness, child social anxiety, attachment, and theory of mind will be conducted at baseline, post-intervention, and three months after the intervention using validated measures. This study aims to evaluate the effectiveness of MM training in reducing social anxiety symptoms in children while examining the potential mediating roles of attachment and theory of mind in this relationship.

By incorporating a cross-cultural approach, this research will contribute to understanding the influence of cultural contexts on the effectiveness of caregiver interventions. The anticipated findings could establish MM training as a valuable strategy for mitigating social anxiety in preschoolers and inform future clinical practices aimed at enhancing caregiver-child interactions.

Detailed description: This study aims to explore a new approach to support preschool children (ages 4 to 7) who struggle with social anxiety. The investigators believe that when caregivers, such as parents, understand and respond more effectively to their child's feelings and thoughts, it can help the child feel more secure and less anxious in social situations.

To test this idea, the investigators are inviting 100 caregivers from the UK and Iran to participate in our research. Participants will be randomly divided into two groups: one group will receive special training called Mind-Mindedness training, which consists of three online sessions designed to teach caregivers techniques for better understanding their child's emotions. The other group will participate in a peer support group where participants can share experiences with other caregivers, this group will not receive the training.

The investigators will assess the children's social anxiety before the training, immediately after it, and three months later to determine if the training has a positive impact. This study aims to demonstrate how enhancing caregiver awareness of their child's feelings can reduce anxiety and help children interact more confidently with others.

Eligibility criteria: Inclusion Criteria:

* Primary Caregiver Status: Participants must be the primary caregiver of a child aged 4 to 7 years.

Age of Caregiver: Caregivers must be between 18 and 60 years old. Geographical Location: Caregivers must reside in either the United Kingdom or Iran.

Social Anxiety Symptoms: Children must exhibit observable signs of social anxiety, which will be confirmed through a standardized screening tool.

Exclusion Criteria:

* Clinical Diagnosis: Children with a clinical diagnosis of another psychiatric disorder (e.g., autism spectrum disorder, ADHD) will be excluded.

Concurrent Support: Caregivers of children who are currently receiving any other form of psychological support or treatment for social anxiety will be excluded.

Primary outcomes:
measure: Child Social Anxiety Levels
timeFrame: Data will be collected at baseline, immediately after the intervention, and at a 3-month follow-up
Secondary outcomes:
measure: Mind-Mindedness of Caregivers
timeFrame: Data will be collected at baseline, immediately after the intervention, and at a 3-month follow-up.
Other outcomes:
measure: Attachment Security of Children
timeFrame: Data will be collected at baseline, immediately after the intervention, and at a 3-month follow-up.
measure: Theory of Mind Development in Children
timeFrame: Data will be collected at baseline, immediately after the intervention, and at a 3-month follow-up.
Locations:
city: Edinburgh
country: United Kingdom
facility: Heriot watt
Study officials:
affiliation: Herriot Watt University
name: Daniel Hale, Asst. Prof.
role: STUDY_DIRECTOR
References: