Table 4.
Screen | Visit 1 | Visit 2 6-month |
Visit 3 12-month |
Visit 4 18-month |
Visit 5 24-month |
|
---|---|---|---|---|---|---|
Visit Visit schedule |
Week -4-0 | Baseline Week 0 | Weeks 22–30 | Weeks 48–56 | Weeks 74–82 | Weeks 100–108 |
Informed consent/assent | ✓ or | ✓ | ||||
Inclusion/exclusion criteria | ✓ or | ✓ | ||||
Demographics | ✓ | |||||
Family medical and psychiatric history | ✓ | |||||
Child medical and psychiatric history | ✓ | |||||
Developmental history | ✓ | |||||
Medication history and current medications | ✓ | |||||
Psychiatric medication (s) Prescribed or continued at visit (including drug and dose and concordance) | ✓ | ✓ | ✓ | ✓ | ✓ | |
Other medication since last visit | ✓ | ✓ | ✓ | ✓ | ||
Learning difficulties | ✓ | |||||
Cardiac examination | ✓ | |||||
Vital signs | ✓ | ✓ | ✓ | ✓ | ✓ | |
Height | ✓ | ✓ | ✓ | ✓ | ✓ | |
Weight | ✓ | ✓ | ✓ | ✓ | ✓ | |
BMI | ✓ | ✓ | ✓ | ✓ | ✓ | |
Parental height | ✓ | |||||
Target height | ✓ | |||||
Calculation of predictive definitive height value (Tanner-Whitehouse method) | ✓ | |||||
Pubertal maturation | ✓ | ✓ | ✓ | ✓ | ✓ | |
SNAP-IV | ✓ | ✓ | ✓ | ✓ | ||
CGI-S | ✓ | ✓ | ✓ | ✓ | ||
CGI-I | ✓ | ✓ | ✓ | |||
CGAS | ✓ | ✓ | ✓ | ✓ | ||
DCDQ'07 | ✓ | ✓ | ||||
SCQ | ✓ | ✓ | ||||
SDQ | ✓ | ✓ | ✓ | ✓ | ||
AIMS | ✓ | ✓ | ✓ | ✓ | ||
CSHQ | ✓ | ✓ | ✓ | ✓ | ||
MFQ-P (parent version) | ✓ | ✓ | ✓ | ✓ | ||
MFQ-C (self-report version) ages≥8 years | ✓ | ✓ | ✓ | ✓ | ||
PLikS | ✓ | ✓ | ✓ | ✓ | ||
DAWBA Tics | ✓ | ✓ | ✓ | ✓ | ||
YGTSS | ✓ | ✓ | ✓ | ✓ | ||
DAWBA rapidly changing mood (parent version) | ✓ | ✓ | ✓ | ✓ | ||
DAWBA rapidly changing mood (child version) | ✓ | ✓ | ✓ | ✓ | ||
DAWBA awkward and troublesome behaviour | ✓ | ✓ | ✓ | ✓ | ||
C-SSRS (baseline) | ✓ | |||||
C-SSRS (since last seen) | ✓ | ✓ | ✓ | |||
Substance use questionnaire | ✓ | ✓ | ✓ | ✓ |
AIMS, Abnormal Involuntary Movement Scale; BMI, body mass index; CGAS, Children's Global Assessment; CGI, Clinical Global Impressions; CSHQ, Child's Sleep Habits Questionnaire; C-SSRS, Columbia-Suicide Severity Rating Scale; DAWBA, Development and Wellbeing Assessment; DCDQ'07, Developmental Coordination Disorder Questionnaire '07; MFQ, Mood and Feelings Questionnaire; PLikS, Psychosis Like Symptoms; SCQ, Social Communication Questionnaire; SDQ, Strength and Difficulties Questionnaire; SNAP-IV, Swanson Nolan and Pelham IV rating scale; YGTSS, Yale Global Tic Severity Scale.