Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
To assess the process evaluation of the interventions qualitative interviews will be conducted |
A sub-sample of participants will be as asked to participate in qualitative interviews as part of a process evaluation. |
3months |
|
Primary |
Assessing change in tics in participants using the Yale Global Tic Severity Scale - Total Tic score |
Investigator administered semi structured symptom checklist of 46 tic disorder symptoms. The Total Tic Score is derived by adding the Total Motor Tic Score and the Total Phonic Tic Score |
Baseline, 3, 6, 12 and 18 months |
|
Secondary |
Assessing change in tics in participants using the Parent Tic Questionnaire |
Self administered questionnaire to collect the number, frequency and intensity of 14 common motor and 14 common vocal tics |
Baseline, 5wks, 3mths, 6mths, 12mths & 18 months |
|
Secondary |
Assessing change in symptom severity/improvement in participants using the Clinical Global Impressions Scale. |
Clinician determined measure that summarises the patient's history, symptoms, behaviours and psychosocial circumstances |
3, 6, 12 & 18 months |
|
Secondary |
Assessing change in tic impairment in participants using the Yale Global Tic Severity Scale Impairment Scale (assessing change) |
This forms part of the YGTSS but focuses on distress and impairment experienced in the individuals life |
Baseline, 3, 6, 12 & 18 months |
|
Secondary |
Assessing change in global functioning in participants using the Children's Global Assessment Scale |
A measure of psychiatric disturbance integrating psychological, social and academic functioning |
Baseline, 3, 6, 12 & 18 months |
|
Secondary |
Assessing change in general functioning in participants using the Strengths and Difficulties Questionnaire |
Self-report, parent completed questionnaire measuring behavioural and emotional difficulties in children. The baseline SDQ is completed as part of a screening tool "DAWBA". |
Baseline, 3, 6, 12 & 18 months |
|
Secondary |
Assessing change in mood in participants using the Mood and Feelings Questionnaire |
Child completed, self-report questionnaire collecting information on depressive symptoms |
Baseline, 1, 3, 6, 12 & 18 months |
|
Secondary |
Assessing change in anxiety in participants using the Spence Child Anxiety Scale |
Self-report child completed questionnaire evaluating symptoms of separation anxiety, social phobia, obsessive-compulsive disorder, pain, agoraphobia, generalised anxiety and fear of physical injury |
Baseline, 3, 6, 12 & 18 months |
|
Secondary |
Assessing change in quality of life in participants using the Child Health Utility 9D |
Self-report parent and child completed quality of life measure |
Baseline, 3, 6,12,18 months |
|
Secondary |
Assessing change in tic-related quality of life in participants using the Child and Adolescent Gilles de la Tourette Syndrome |
A disease specific measure of health related quality of life for children and adolescents with Tourette Syndrome. There are two version, one for children aged 6-12 years and a second for young people aged 3-8 years |
Baseline, 3, 6, 12 & 18 months |
|
Secondary |
Assessing participants change in use of services using the Modified Client Service Receipt Inventory |
A questionnaire to collect information on services received, service related issues, school attendance and family income |
Baseline, 3, 6, 12 & 18 months |
|
Secondary |
Assessing change in side effects in participants using the Adverse events/side effects |
A 17 item scale of common side effects |
Baseline, 1, 3, 6, 12 & 18 months |
|
Secondary |
Assessing participants perception of treatment credibility using a specifically created 'treatment credibility' questionnaire |
A two item questionnaire to assess how well the treatment suits children, according to the perception of the 1) parent/carer and 2) child/young person |
3 weeks |
|
Secondary |
Assessing participants perception of treatment satisfaction using a specifically created 'treatment satisfaction' questionnaire |
A 7 item scale questionnaire developed for the study to assess treatment satisfaction from the perception of the 1) parent/carer and 2) child/young person |
3 months |
|
Secondary |
Assessing participants perception of their need for further treatment using a specifically created 'Need for further treatment' questionnaire |
A single item questionnaire asking if the child or young person requires more treatment for their tics from the perception of the 1) parent/carer and 2) child/young |
3 months |
|
Secondary |
Assessing participants change of use of other medication/interventions using a specifically created 'Concomitant interventions' questionnaire |
Assessment of any other treatment or interventions the child or young person is accessing during the study |
Baseline, 3, 6, 12 & 18 months |
|
Secondary |
Describing sample characteristics using Development and Wellbeing Assessment (DAWBA) at screening/baseline |
The DAWBA is a package of interviews and questionnaires completed by parents and teachers and designed to generate ICD-10 and DSM-IV / DSM-5 psychiatric diagnoses for children and young people. |
Screening/Baseline |
|
Secondary |
Determining presence of an intellectual disability at screening/baseline using the Child and Adolescent Intellectual Disability Screening Questionnaire (CAIDS-Q) |
A 7-item questionnaire to determine the presence of intellectual disability at screening/baseline, completed by the parent/ |
Screening/Baseline |
|
Secondary |
Understanding the characteristics of the sample a specifically created demographics questionnaire at screening/baseline |
Parent completed questionnaire asking about the child's age, gender, ethnicity, parental education/ occupation, list of the child's current diagnoses and interventions (including medications) and GP and school details. |
Screening/Baseline |
|
Secondary |
Determining the for presence of Autism Spectrum Disorder using the Social Communication Questionnaire (SCQ) at screening/baseline |
A 40 item, parent-report questionnaire asking about characteristic autistic behaviour at the age of 4 to 5 years and currently. |
Screening/Baseline |
|
Secondary |
Assessing Premonitory urges for tics using the Premonitory Urge for Tics Scale (PUTS) at screening/baseline |
A self-report instrument specifically designed to measure the current frequency of different types of premonitory urges in patients with tic disorders |
Screening/Baseline |
|
Secondary |
Assessing ADHD symptoms using the Swanson, Nolan, and Pelham Rating Scale (SNAP-IV) at screening/baseline |
A parent completed 26-item behavioural rating scale that employs the core symptoms of ADHD and oppositional defiance disorder (ODD) as defined by the Diagnostic and Statistical Manual of Mental Disorders. |
Screening/Baseline |
|