NCT06657014

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 24, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

October 24, 2024

Status Verified

October 1, 2024

Enrollment Period

2 months

First QC Date

October 21, 2024

Last Update Submit

October 22, 2024

Conditions

Keywords

Mind-MindednessSocial Anxietyintervention

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Mind-Mindedness of Caregivers

    Data will be collected at baseline, immediately after the intervention, and at a 3-month follow-up.

Other Outcomes (2)

  • Attachment Security of Children

    Data will be collected at baseline, immediately after the intervention, and at a 3-month follow-up.

  • Theory of Mind Development in Children

    Data will be collected at baseline, immediately after the intervention, and at a 3-month follow-up.

Study Arms (2)

Mind-Mindedness Training Group

EXPERIMENTAL

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

Peer Support Control Group

ACTIVE COMPARATOR

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

Interventions

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.

Mind-Mindedness Training GroupPeer Support Control Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heriot watt

Edinburgh, EH14 4AS, United Kingdom

Location

Related Publications (1)

  • Javadian H, Stewart ME, Mathews M, Williams AJ, Hale D. Caregiver mind-mindedness training as an early intervention for social anxiety in children: A protocol for a randomised controlled trial. PLoS One. 2025 Sep 22;20(9):e0315150. doi: 10.1371/journal.pone.0315150. eCollection 2025.

Study Officials

  • Daniel Hale, Asst. Prof.

    Herriot Watt University

    STUDY DIRECTOR

Central Study Contacts

Hiva Javadian Javadian, PhD

CONTACT

Daniel Hale Hale, Asst. Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctoral Researcher

Study Record Dates

First Submitted

October 21, 2024

First Posted

October 24, 2024

Study Start

November 1, 2024

Primary Completion

December 30, 2024

Study Completion

April 30, 2025

Last Updated

October 24, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

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.

Locations