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Trial registered on ANZCTR


Registration number
ACTRN12622001292763
Ethics application status
Approved
Date submitted
20/09/2022
Date registered
5/10/2022
Date last updated
5/10/2022
Date data sharing statement initially provided
5/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of feasibility and effectiveness of the Mindgardens Functional Neurological Symptom Disorders (FND) Tic program for children and adolescents.
Scientific title
Evaluation of feasibility and effectiveness of the Mindgardens Functional Neurological Symptom Disorders (FND) Tic program for children and adolescents.
Secondary ID [1] 308011 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Tics Disorders 327682 0
Tourette Syndrome 327683 0
Condition category
Condition code
Mental Health 324769 324769 0 0
Other mental health disorders
Neurological 324789 324789 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mindgardens Functional Neurological Symptom Disorders (FND) Tic program is a new dedicated service designed to provide support to children and adolescents with a diagnosed Tic Disorder.

For children and adolescent participants to be allocated into a Stream (either Stream 1 or Stream 2), screening tools will be administered and will be required to be completed before the initial assessment.

Stream 1
This stream will include children and adolescents aged between 12-18 years who have a diagnosis of a Functional Tic Disorder (diagnosed by a GP or Specialist such as a Pediatrician, Psychiatrist or Neurologist).

Participants will receive 10 x individual sessions over 10 weeks. Each one-on-one session will take approximately 50 minutes and the individual sessions will be run by a registered psychologist who runs each session weekly. Participants will be asked to complete online surveys on four different occasions. This will include completing a set of questionnaires before the completion of the program (4 questionnaires will be completed) and 8 questionnaires on 2 occasions after the child/adolescent completes the program (after the child’s first comprehensive assessment, and at 3 months post-assessment) (9 questionnaires will be completed).

There will be 88 participants that will receive one-on-one individual sessions. An attendance checklist will be taken prior to starting each session to monitor adherence to the program.

Sessions will be offered to participants either face-to-face or remotely, e.g. via videoconferencing platform. The participant will advise the format as to how they would like to attend these sessions. If the participant chooses to attend sessions remotely via video teleconferencing platform a link to the session will be provided to both the adolescent and the parent/career of the adolescent prior to the session.

An interview guide has been developed to support individual sessions with adolescents. The guide provides instructions on how the individual sessions will be run and the types of open-ended questions asked to stimulate discussion in the sessions.

Facilitator role

The facilitator will:

• observe and listen
• consider participant availability and the importance of time management (ensuring that each session starts and finishes on time)
• ensure all questions are covered
• keep the questions on the topic
• reassure each participant that their confidentiality will be maintained
• providing appropriate feedback to management.

The facilitator will adhere to the guidelines outlined in this Individual Session Guide in conducting the proceedings associated with each of the individual sessions. The facilitator will be required to reflect and create their own set of written notes following the completion of each session.

Format

The psychologist will introduce the individual session’s purpose and expected outcomes. Below will be the suggested format that will be employed for each of the individual sessions:

• introductions
• confidentiality
• questioning (e.g. engagement, exploration, exit questions)
• summary of themes
• next steps.

The final individual session (session 10) will finish with ‘next steps’ as this will be important for participants to understand what happens with their comments and feedback after the final individual session (session number 10), how their comments will be presented and to who, and when they will hear back about a plan of action.

Participant guidelines

The psychologist will:

• ask each participant, prior to the start of each individual session, to switch off or silence their mobile devices
• advise participants that there are no right or wrong answers, each view shared will be respected and while it will be appropriate to respectfully disagree, be mindful of the words that they choose to show their disagreement.
• encourage participants to rephrase statements using “I” such as “I hear what you are saying, but I think…” instead of “you’re wrong”.
Questioning

Age-appropriate, simple, and short questions will be the most important tool the psychologistwill employ to engage with this young cohort to ascertain outcomes for the individual session discussions. The psychologist will have a prepared list of open-ended questions. Examples of questions will include:


• Have you had motor tics (e.g. facial twitch, blinking, jerking parts of the body) or other unusual movements or habits?
• If YES, how old were you when your motor tics began?
• Have you ever found yourself involuntarily making noises or voices (e.g. grunting, throat clearing, coughing, sniffing)?
• What was the first tic, habit or mannerism you developed?
• Can you tell me about your current tic(s), habit or manerisms?
• Did you feel worried or upset about anything around the time your tics started/got worse?
o Home/family?
o School?
o Friends?


Exit questions will ensure that the psychologist will not have missed important issues to discuss and to assist with making sure that the participant has had their say:

• Do you have anything else that they would like to tell me about your experiences, you’re your tics? Have I missed anything that you might want to tell me?

The psychologist will be mindful that the following questions below will not be encouraged to give the desired answer.

• So, do you agree that…?
• How bad was it that…?
• Your doctor did…, didn’t they?
• Would you say that…?
Intervention code [1] 324463 0
Treatment: Other
Intervention code [2] 324484 0
Behaviour
Comparator / control treatment
Stream 2
The second stream will include children and adolescents aged between 8-12 years who have a diagnosis of Tourette Syndrome (diagnosed by a GP, or Specialist such as a Pediatrician, Psychiatrist or Neurologist).

Participants will receive 10 x Cognitive Behavioral Intervention (CBIT) group sessions over a 10 week period. Each session will take approximately 90 minutes and will be conducted by a registered psychologist. Participants will be asked to complete online surveys on four different occasions. This will include completing a set of questionnaires before the completion of the program (4 questionnaires will be completed) and 8 questionnaires on 2 occasions after the child/adolescent completes the program (after the child’s first comprehensive assessment, and at 3 months post-assessment) (9 questionnaires will be completed).

There will be 88 participants in this group and each group session will have 8 adolescents enrolled in a group. A registered psychologist will conduct each session and sessions will be provided face to face. An attendance checklist will be taken prior to starting each session to monitor adherence to the program.

A group session guide has been developed to support the facilitation of group sessions with children/adolescents. The guide provides instructions on how the group sessions will be conducted and the types of open-ended questions asked to stimulate discussion in the sessions.

Parents/caregivers of these children will be invited to attend 4 x 90-minute group sessions run concurrently with the child's group sessions and these sessions will occur once a week over a four week period within the same time period as the child attending their group session . Adult participants will be invited to complete a set of questionnaires before the completion of the program (5 questionnaires will be completed) and on 2 occasions after their child completes the program (after their child’s first comprehensive assessment, at 3 months post-assessment) (a total of 15 questionnaires will be completed at the end of the study for this cohort).

There will be 88 participants in this group. Each session will have 8 parents/caregivers in each group. These sessions will be conducted via videoconferencing platform. A link to the videoconference meeting will be provided a week before each weekly session. An attendance checklist will be taken prior to starting each session to monitor adherence to the program.

A group session guide has been developed to support facilitation of group sessions with parents. The group sessions will be conducted by a registered psychologist, who will run the sessions each week. The guide provides instructions on how to run the group sessions and the types of open-ended questions that will be discussed to stimulate discussion in the sessions.

Format
The psychologist will introduce the session’s purpose and expected outcomes.

The final group session (session 10) will finish with ‘next steps’ as this will be important for participants to understand what happens with their comments and feedback after the final group session (session number 10), how their comments will be presented and to who, and when they will hear back about a plan of action.

Questioning
Age-appropriate, simple, and short questions will be the most important tool the psychologist will employ to engage with this young cohort to ascertain outcomes for the discussion. The psychologist will have a prepared list of open-ended questions, to encourage participant involvement. Examples of group questions for children/adolescents may include:

• Does anyone know what a group session is meant to do?
• Has anyone here ever been part of a group before?

Exploration questions will provide the psychologist with an opportunity to gather more specific information, introduce dedicated questions and explore answers more thoroughly:

• Would anyone in the group like to tell me a little bit about their Tic(s)?
• Can anyone tell me the number of times they may experience their tics during the day?
• What are some of the feelings you may experience when your tic(s) start?

Exit questions will ensure that the psychologist will not have missed important issues to discuss and to assist with making sure that all participants have had their say:

• Does anybody have anything else that they would like to tell me about their experiences, with their tics? Have I missed anything that you might want to tell me?

The psychologist will be mindful that the following questions below will not be encouraged to give the desired answer.

• So, do you agree that…?
• How bad was it that…?
• Your doctor did…, didn’t they?
• Would you say that…?

Content to be covered during the parent/caregiver sessions
The facilitator will have a prepared list of open-ended questions, starting generally to encourage involvement and then moving towards more specific questioning. Examples of group questions will include:

· Would anyone in the group like to tell me about their child’s tic(s)?

· Can anyone tell me the number of times that their children may experience their tics during the day?

· What are some of the feelings you or your child may experience when your child’s tic(s) start?

Exit questions will ensure that the facilitator will not have missed important issues to discuss and to assist with making sure that all participants have had their say:

· Does anybody have anything else that they would like to tell me about their experiences.
Control group
Active

Outcomes
Primary outcome [1] 332593 0
Proportion of participants completing individual sessions over 10 weeks consisting of 50 minutes (only required for children and adolescents 12-18 years). Session attendance will be checked using an attendance check list.
Timepoint [1] 332593 0
Time point 3 (6- weeks post intervention) and time point 4 (3-months after baseline)
Primary outcome [2] 332691 0
National Hospital Interview Schedule (NHIS) for the assessment of Tourette Syndrome (TS),
Timepoint [2] 332691 0
Time point 3 (6- weeks post intervention) and time point 4 (3-months after baseline)
Primary outcome [3] 332692 0
Functional Tics and related behaviours questionnaire
Timepoint [3] 332692 0
Time point 3 (6- weeks post intervention) and time point 4 (3-months after baseline)
Secondary outcome [1] 414003 0
Proportion of participants completing CBiT group sessions over 10 weeks consisting of 90 minutes (only required for children and adolescents 8-12 years) .Session attendance will be assessed using an attendance checklist.
Timepoint [1] 414003 0
Time point 3 (6-weeks post intervention) and time point 4 (3-months after baseline)
Secondary outcome [2] 414378 0
Proportion of parents/caregivers, of children aged 8-12 years, who attend 4 group sessions over 4 weeks consisting of approximately 60 minutes, and as determined by the Parent Tic Questionnaire and Tic Monitoring Sheet for Parents.
Timepoint [2] 414378 0
Time point 3 (6- weeks post intervention) and time point 4 (3-months after baseline)

Eligibility
Key inclusion criteria
Inclusion criteria for children and adolescents taking part in this study include:
1. Children and adolescents 8-18 years of age diagnosed with a Tic Disorder.
2. Referral from GP (a Mental Health Care Plan), Pediatrician, Psychiatrist or Neurologist
3. Tic Disorder as primary diagnosis/presenting problem
4. No further clinical investigations pending
5. Tics causing a significant impact on the functioning of a child or adolescent
6. Participants will be able to physically attend program sessions
7. Child and parent/carer consent to a referral to the program, assessment, and treatment
8. Commitment by referring specialist to stay involved in patient’s care after the study is completed

Inclusion criteria for parents/caregivers taking part in this study include:
1. Parent/caregiver has a child or adolescent between the ages of 8-18 years of age diagnosed with a Tic Disorder.
2. The parent/caregiver receives a referral from GP (a Mental Health Care Plan), Paediatricians, Psychiatrist or Neurologist for their child to participate in the program
3. The parent/caregiver has a child with a Tic Disorder as a primary diagnosis/presenting problem
4. The parent/caregiver has a child that requires no further clinical investigations pending
5. The parent/caregiver has a child with a Tic diagnosis that causes a significant impact on the functioning of their child
6. The parent/caregiver has a child that will be able to physically attend program sessions
7. The parent/carer provides consent to a referral to the program, assessment, and treatment
8. The parent/caregiver receives commitment by their child’s referring
Minimum age
8 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria for child/adolescent participants taking part in this study include:
1. Children and adolescents outside the age inclusion criteria as above
2. Significant cognitive impairment, learning or intellectual disability
3. Major mental illness leading to impairment in insight or judgment
4. Risk of harm to self or others as per consensus reached with the referrer

Exclusion criteria for parent/caregiver participants taking part in this study include:
1. The parent/caregiver has a child outside the age range for inclusion in the study as above
2. The parent/caregiver has a child with significant cognitive impairment, learning or intellectual disability
3. The parent/caregiver has a child with a major mental illness leading to impairment in insight or judgment
4. The parent/caregiver has a child which could cause be at risk of harm to self or others as per consensus reached with the referrer

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
We propose to evaluate the effectiveness of the Mindgardens Functional Neurological Symptom Disorders (FND) Tic program by examining the difference in the primary and the secondary outcomes before and after participants’ enrolment into the program (on entry into the Program versus post-assessment and 3 months after the initial assessment following the program) using appropriate statistical methods for different outcomes. We will use paired samples t-test to compare pre-versus post-intervention outcomes (e.g., Tic scores, quality of life scores) for each stream. Additionally, percent change at entry and completion of the program from baseline for efficacy variables will be analysed using analysis of covariance (ANCOVA) with respective baseline value as a covariate. Least-square means (LSM) and 95% confidence intervals will be evaluated from the ANCOVA. The data of percent changes will be assumed as normally distributed.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/10/2022
Actual
Date of last participant enrolment
Anticipated
31/03/2023
Actual
Date of last data collection
Anticipated
30/06/2023
Actual
Sample size
Target
176
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 312274 0
Charities/Societies/Foundations
Name [1] 312274 0
University of New South Wales Foundation (Philanthropic funds)
Country [1] 312274 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Research Ethics and Compliance Support (RECS)
University of New South Wales
High Street
Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 313818 0
None
Name [1] 313818 0
Address [1] 313818 0
Country [1] 313818 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311647 0
University of New South Wales Ethics Committee
Ethics committee address [1] 311647 0
Ethics committee country [1] 311647 0
Australia
Date submitted for ethics approval [1] 311647 0
06/06/2022
Approval date [1] 311647 0
05/08/2022
Ethics approval number [1] 311647 0
HC220362

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121842 0
Prof Professor Valsamma Eapen
Address 121842 0
University of New South Wales
Barker Street
Randwick NSW 2035
Country 121842 0
Australia
Phone 121842 0
+61 02 9616 4205
Fax 121842 0
+61 02 8738 6387
Email 121842 0
[email protected]
Contact person for public queries
Name 121843 0
Srilaxmi Balachandran
Address 121843 0
University of New South Wales
Barker Street
Randwick NSW 2035
Country 121843 0
Australia
Phone 121843 0
+61 02 9616 4205
Fax 121843 0
Email 121843 0
[email protected]
Contact person for scientific queries
Name 121844 0
Srilaxmi Balachandran
Address 121844 0
University of New South Wales
Barker Street
Randwick NSW 2035
Country 121844 0
Australia
Phone 121844 0
+61 02 9616 4205
Fax 121844 0
Email 121844 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17161Study protocol    384696-(Uploaded-20-09-2022-16-10-26)-Study-related document.docx
17163Informed consent form    384696-(Uploaded-20-09-2022-16-11-54)-Study-related document.docx
17164Informed consent form    384696-(Uploaded-20-09-2022-16-12-19)-Study-related document.docx
17165Ethical approval    384696-(Uploaded-20-09-2022-16-13-51)-Study-related document.pdf



Results publications and other study-related documents

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Documents added automatically
No additional documents have been identified.