Attention Deficit Hyperactivity Disorder (ADHD) and tics Mental and Behavioural Disorders
Conditions
Interventions
Participants will be randomised to either the intervention arm in which they will be prescribed a stimulant medication (Modified-Release Methylphenidate) to be taken orally, once daily or the comparat
Sponsors
University of Nottingham
Eligibility
Sex/Gender
All
Age
6 Years to 17 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria for the young person: 1. Aged =6 years up to 5 on the Yale Global Tic Severity Scale (YGTSS) Total Tic Severity Score (TTSS) 4. Any ICD-10 Tic Disorder F95 (F95.0-F95.9) 5. Referred to CAMHS or community paediatrics taking part in the trial 6. Parent/carer and CYP seeking medication for ADHD (either ADHD medication naïve or seeking medication change) 7. Willing to adhere to the trial procedures= 8. If currently or recently on a different medication for ADHD or tics willing to go through or complete the appropriate wash-out period (as per standard care) to be able to receive the allocated trial IMP 9. Able to give valid, informed assent (aged <16 years) or consent (aged 16 years) 10. Able to understand and complete assessments in English 11. Eligible parent/carer willing and able to participate alongside the CYP Inclusion criteria for the parent/carer: 1. Individual with parental responsibility 2. Individual with sufficient knowledge of CYP’s medical history to be able to complete the relevant assessment tools 3. Access to reliable internet connection and email 4. Able to give valid, informed consent 5. Able to speak, understand and complete assessments in English
Exclusion criteria
Exclusion criteria: Exclusion criteria for the young person: 1. Current pharmacotherapy for tics 2. Current pharmacotherapy for ADHD 3. Abnormal cardiovascular examination (e.g., BP >95th percentile, tachycardia) 4. Diagnoses of alcohol/substance dependence, psychosis or mania (as per clinician judgement) 5. Intellectual disability (clinical estimate of IQ <70) (confirmed by Child and Adolescent Intellectual Disability Screening Questionnaire; CAIDS-Q) 6. Contraindications to MR-MPH and guanfacine 7. Immediate risk to self or others 8. Individual who is pregnant or plans to get pregnant while in the trial 9. Individual who is breastfeeding Exclusion criteria for the parent/carer: 1. Local authority representative
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. ADHD symptoms measured using Swanson, Nolan, and Pelham Rating Scale (SNAP-IV) at 12 weeks post-randomisation 2. Tics severity measured by Yale Global Tic Severity Scale (YGTSS) Total Tic Severity Score (TTSS) at 12 weeks post-randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical: 1.1 ADHD symptoms measured using SNAP-IV at 24 and 52 weeks 1.2 Tics severity measured by YGTSS (TTSS) at 24 and 52 weeks 1.3 Global measure of clinical functioning: Clinical Global Impressions (CGI-I) at 1–12, 24 and 52 weeks 2. Safety: 2.1 Medication adverse events at 1–12, 24 and 52 weeks. Adverse events will be recorded throughout the 52-week follow-up period on a modified version of the side effects scale developed by Hill and Taylor. Serious adverse events will be recorded and reported in a timely fashion (within 24 hours of awareness of the event) following the procedure outlined in the protocol submitted with this application. Cardiovascular examination (blood pressure and pulse) will be conducted as part of routine safety monitoring as required. Physical measures and monitoring will be adjusted depending on treatment route; a decision based on individual risk factors and the baseline examination. 3. Health Economics: 3.1 Child health-related quality of life: Child Health Utility – Nine Dimensions (CHU-9D), EQ-5DY at Baseline, 12, 24 and 52 weeks 3.2 Parent health-related quality of life: EQ5D-5I at Baseline, 12, 24 and 52 weeks | — |
Countries
England, United Kingdom
Contacts
Public ContactEmily McGann
Outcome results
None listed