Evaluation of feasibility and effectiveness of the Mindgardens Functional Neurological Symptom Disorders (FND) Tic program for children and adolescents.
- Conditions
- Chronic Tics DisordersTourette SyndromeMental Health - Other mental health disordersNeurological - Other neurological disorders
- Registration Number
- ACTRN12622001292763
- Lead Sponsor
- niversity of New South Wales
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 176
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
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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.[Time point 3 (6- weeks post intervention) and time point 4 (3-months after baseline)];National Hospital Interview Schedule (NHIS) for the assessment of Tourette Syndrome (TS), [Time point 3 (6- weeks post intervention) and time point 4 (3-months after baseline)];Functional Tics and related behaviours questionnaire[Time point 3 (6- weeks post intervention) and time point 4 (3-months after baseline)]
- Secondary Outcome Measures
Name Time Method 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.<br><br><br> [Time point 3 (6-weeks post intervention) and time point 4 (3-months after baseline)];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.[Time point 3 (6- weeks post intervention) and time point 4 (3-months after baseline)]