Social Anxiety Disorder of ChildhoodCAMPSNCT06657014
Caregiver Mind-Mindedness Training to Alleviate Social Anxiety in Children
A study testing mind-mindedness in people with Social Anxiety Disorder of Childhood, run by Heriot-Watt University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Social Anxiety Disorder of Childhood
- What is being tested?
- mind-mindedness
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2024to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Heriot watt
Edinburgh, EH14 4AS
Daniel Hale, Asst. Prof., 07456927219, D.Hale@hw.ac.uk
Hiva Javadian, PhD Res, 07456927219, hj2015@hw.ac.uk
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Social Anxiety Disorder of Childhood
- Being tested
- mind-mindedness
- Keywords
- Mind-Mindedness, Social Anxiety, intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mind-mindednessOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: mind-mindedness |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Data will be collected at baseline, immediately after the intervention, and at a 3-month follow-up
Secondary outcomes (1)
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.
Measured: Data will be collected at baseline, immediately after the intervention, and at a 3-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Social Anxiety Disorder of ChildhoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heriot-Watt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hiva Javadian, Heriot-Watt University
- Investigators
- Daniel Hale, Asst. Prof., Study director, Herriot Watt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06657014
- Sponsor's protocol ID
- MM-SOCIALANXIETY-2024
- Other IDs
- Heriot watt university
- Acronym
- CAMPS
- Status last verified
- Oct 2024
- First submitted
- 21 Oct 2024
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 40982456
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caregiver Mind-Mindedness Training as an Early Intervention for Reducing Social Anxiety in Preschool-Aged Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06657014
- Acronym / sponsor ID
- CAMPS / MM-SOCIALANXIETY-2024
- Conditions
- Social Anxiety Disorder of Childhood
- Keywords
- Mind-Mindedness, Social Anxiety, intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Heriot-Watt UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 24 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Mind-Mindedness Training Group | Experimental | Other: mind-mindednessThe 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. |
| Peer Support Control Group | Active comparator | Other: mind-mindednessThe 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mind-mindednessThe 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. | Other | Mind-Mindedness Training Group, Peer Support Control Group |
Primary outcome
Child Social Anxiety Levels
Time frame: Data will be collected at baseline, immediately after the intervention, and at a 3-month follow-up
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.
1 secondary outcome
Mind-Mindedness of Caregivers
Time frame: Data will be collected at baseline, immediately after the intervention, and at a 3-month follow-up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- Derived from this study: PubMed 40982456Javadian 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Hale, Asst. Prof. study director
Herriot Watt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mind-mindedness in people with Social Anxiety Disorder of Childhood, run by Heriot-Watt University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hiva Javadian Javadian, PhD (07456927219, hj2015@hw.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Social Anxiety Levels (time frame: Data will be collected at baseline, immediately after the intervention, and at a 3-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06657014, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2024.