Caregiver Mind-Mindedness Training to Alleviate Social Anxiety in Children (CAMPS)

Caregiver Mind-Mindedness Training as an Early Intervention for Reducing Social Anxiety in Preschool-Aged Children: A Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Social Anxiety Disorder of Childhood
• Intervention / Treatment: Other: mind-mindedness

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hiva Javadian Javadian, PhD; Phone Number: 07456927219; Email: hj2015@hw.ac.uk
• Study Contact Backup: Name: Daniel Hale Hale, Asst. Prof.; Phone Number: 07456927219; Email: D.Hale@hw.ac.uk

Study Locations

• United Kingdom
  • Edinburgh, United Kingdom, EH14 4AS
    • Heriot watt
    • Contact: Daniel Hale, Asst. Prof.; Phone Number: 07456927219; Email: D.Hale@hw.ac.uk
    • Contact: Hiva Javadian, PhD Res; Phone Number: 07456927219; Email: hj2015@hw.ac.uk
    • Principal Investigator: Hiva Javadian, PhD Res

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mind-Mindedness Training Group; The Mind-Mindedness Training Group will involve 50 caregivers of preschool-aged children (ages 4 to 7) with social anxiety. Participants will attend three one-hour online sessions over three consecutive weeks. The training focuses on enhancing caregivers' ability to recognize and respond to their children's thoughts and emotions. Each session includes: Session 1:** Introduction to mind-mindedness, its importance, and caregiver roles in managing social anxiety.; Session 2:** Practical strategies for emotion coaching, including role-play exercises.; Session 3:** Advanced strategies addressing common challenges, with discussions and video examples. Participants will receive materials to support their learning. Effectiveness will be assessed through evaluations of mind-mindedness, child social anxiety, and related areas at baseline, post-intervention, and three months later.	Other: mind-mindedness; The Mind-Mindedness Training Intervention is a structured program designed specifically for primary caregivers of preschool-aged children (ages 4 to 7) who exhibit signs of social anxiety. This intervention is unique because it focuses on enhancing caregivers' understanding and responsiveness to their children's emotional and mental states through the concept of mind-mindedness.
Active Comparator: Peer Support Control Group; The Peer Support Control Group will consist of 50 primary caregivers of preschool-aged children (ages 4 to 7) exhibiting signs of social anxiety. Participants will not receive Mind-Mindedness training but will have access to a private online peer support platform. This group aims to provide a supportive environment for caregivers to share experiences, concerns, and coping strategies. Key features include: Peer Support Platform:A moderated online group for discussions and emotional support among caregivers. Resource Sharing: Opportunities for caregivers to share helpful articles, tips, and resources. Facilitated Discussions: Occasional prompts to encourage conversations about common challenges. Participants will complete assessments of mind-mindedness, social anxiety, attachment, and theory of mind at baseline, post-intervention, and three months later, similar to the Mind-Mindedness Training Group. This control group allows for comparisons of the effectiveness	Other: mind-mindedness; The Mind-Mindedness Training Intervention is a structured program designed specifically for primary caregivers of preschool-aged children (ages 4 to 7) who exhibit signs of social anxiety. This intervention is unique because it focuses on enhancing caregivers' understanding and responsiveness to their children's emotional and mental states through the concept of mind-mindedness.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child Social Anxiety Levels	Primary Outcome Measure Description: This measure will assess changes in social anxiety symptoms in preschool-aged children (4 to 7 years) as reported by caregivers, using the Spence Children's Anxiety Scale (SCAS), the parent versions. The SCAS scores range from a minimum of 0 to a maximum of 114. Higher scores on the SCAS indicate worse outcomes, reflecting higher levels of anxiety.	Data will be collected at baseline, immediately after the intervention, and at a 3-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mind-Mindedness of Caregivers	The assessment of mind-mindedness in caregivers will be conducted using the Mind-Mindedness Coding Manual(Meins, 2015). It evaluates caregivers' ability to understand and respond to their child's mental and emotional states. Scores on this scale typically range from 0 to 5, with higher scores indicating better outcomes, reflecting a greater level of mind-mindedness. A higher score signifies that the caregiver is more attuned to their child's emotional needs, which is associated with positive developmental outcomes for the child.	Data will be collected at baseline, immediately after the intervention, and at a 3-month follow-up.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attachment Security of Children	The assessment of attachment in caregivers will be conducted using the Attachment Insecurity Screening Inventory (AISI), developed by Spruit et al. (2018), allowing the evaluation of any changes in attachment security resulting from the intervention. This scale has a scoring range from 0 to 30, with higher scores indicating worse outcomes and greater attachment insecurity. Therefore, a higher score suggests that the caregiver exhibits more insecure attachment behaviours.	Data will be collected at baseline, immediately after the intervention, and at a 3-month follow-up.
Theory of Mind Development in Children	The Theory of Mind Task Battery (Hutchins et al., 2012) will be utilized to assess children's understanding of others' mental states, an important factor in social interactions and emotional regulation. Scores on this battery typically range from 0 to 30, with higher scores indicating better outcomes. A higher score reflects a greater ability for the child to understand and interpret the mental states of others, which is crucial for social interactions and emotional development.	Data will be collected at baseline, immediately after the intervention, and at a 3-month follow-up.

Collaborators and Investigators

• Sponsor: Heriot-Watt University
• Investigators: Study Director: Daniel Hale, Asst. Prof., Herriot Watt University

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2024
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: October 21, 2024
• First Submitted That Met QC Criteria: October 22, 2024
• First Posted (Actual): October 24, 2024

Study Record Updates

• Last Update Posted (Actual): October 24, 2024
• Last Update Submitted That Met QC Criteria: October 22, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Social Anxiety; intervention; Mind-Mindedness
• Additional Relevant MeSH Terms: Mental Disorders; Phobic Disorders; Phobia, Social; Anxiety Disorders
• Other Study ID Numbers: MM-SOCIALANXIETY-2024; Heriot watt university (Other Identifier: Heriot watt university)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Individual Participant Data will not be shared with other researchers for several reasons:

1. Participant Privacy: Protecting the privacy and confidentiality of participants is our highest priority. Sharing IPD could compromise their anonymity.
2. Data Sensitivity: The data collected during the trial may contain sensitive information that requires strict confidentiality measures.
3. Ethical Considerations: Ethical guidelines related to participant consent prohibit sharing identifiable data without explicit permission.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No