Table 1 Outcomes in the TECTO trial
Outcomes | Type of data |
|---|---|
Primary outcome | |
 OCD symptoms Children’s Yale–Brown Obsessive Compulsive Scale (CY-BOCS) [14] | Continuous Assessed at weeks 0, 4, 8, and 16 |
Secondary outcomes | |
 Health-related quality of lifea KIDSCREEN-10 [17] | Continuous Assessed at weeks 0, 4, 8, and 16 |
 Adverse events Negative Effects Questionnaire (NEQ) with 32 items [18] | Continuous Assessed at weeks 4, 8, and 16 |
Exploratory outcomes | |
 Serious adverse events | Dichotomousc Assessed for weeks 0 to 16 |
 Assessment of childhood OCDb Child Obsessive-Compulsive Impact Scale-Revised (COIS-R) [20] | Continuous Assessed at weeks 0, 4, 8, and 16 |
 Severity of psychopathology Clinical Global Impressions Severity (CGI-S) [21] | Continuous Assessed at weeks 0, 4, 8, and 16 |
 Change of psychopathology after initiation of treatment Clinical Global Impressions Improvement (CGI-I) [21] | Continuous Assessed at weeks 4, 8, and 16 |
 Severity of psychiatric disturbance and social disability Children’s Global Assessment Scale (CGAS) [22] | Continuous Assessed at weeks 0 and 16 |
 Response rate Defined as a CY-BOCS score reduction of at least 30% from baseline | Dichotomous Assessed at weeks 0 and 16 |
 Remission rate Defined as no longer meeting the diagnostic criteria for OCD, ICD-10 F42 assessed with K-SADS-PL [13] | Dichotomous Assessed at week 16 |
 Suicidality Suicidality items sum-score assessed with K-SADS-PL [13] | Continuous Assessed at week 16 |
 Obsessive-compulsive traitsb Toronto Obsessive-Compulsive Scale (TOCS) [23] | Continuous Assessed at weeks 0 and 16 |
 Parental accommodation to children’s obsessions and compulsions Family Accommodation Scale – Parent Report (FAS-PR) [24] | Continuous Assessed at weeks 0, 4, 8, and 16 |
 Parental stress Parental Stress Scale (PSS) | Continuous Assessed at weeks 0, 4, 8, and 16 |