Family-based cognitive behavioural therapy versus family-based relaxation therapy for obsessive-compulsive disorder in children and adolescents: protocol for a randomised clinical trial (the TECTO trial)

Table 1 Participant timeline and outcome assessments in the 16-week TECTO trial and at the week-40 follow-up

	week
Activities/assessment	0	1	2	3	4	5	6	7	8	9–13	14	15	16	40
Intervention		x	x	x	x	x	x	x	x	x	x	x	x
Measures
Clinical state (CY-BOCS, KIDSCREEN, COIS, CGI-S, CGI-I*)	x				x				x				x	x
C-GAS	x												x
Self-rated obsessive-compulsive traits	x												x
Diagnostics (K-SADS-PL) including suicidality	x												x
Intelligence (WISC-V/WAIS-IV)	x
Social competences (SRS)	x
Negative effects of psychotherapy (NEQ)					x				x				x	x
Parental Stress (PSS), Family accommodation (FAS)	x				x				x				x	x
Family Environment (FES)*	x
Confidence in treatment		x
Motivation for treatment		x			x				x		x
Treatment compliance		x	x	x	x	x	x	x	x	x	x	x	x
Therapeutic alliance (TASC-R)		x			x				x				x

* Self-reported from age: 11 years. Parent-reported from age: 8–17 years, ** Not at assessed at week 0
CGAS The Children’s Global Assessment Scale; CGI-S/I The Clinical Global Impression Scale - severity/improvement; COIS Child Obsessive Compulsive Disorder Impact Scale; CY-BOCS Children’s Yale-Brown Obsessive-Compulsive Scale; FAS Family Accommodation Scale; FES Family Environment Scale; K-SADS-PL Kiddie-Schedule for Affective Disorders and Schizophrenia; NEQ Negative Effects Questionnaire; PSS Parental Stress Scale; SRS Social Responsiveness Scale; TASC-R Therapeutic Alliance Scale for Children; TOCS Toronto Obsessive-Compulsive Rating Scale; WAIS-IV The Wechsler Adult Intelligence Scale; WISC-V The Wechsler Intelligence Scale for Children. Note: assessments for sub-studies (MRI, neuroendocrine, neurocognitive, emotion regulation and qualitative interviews) are not stated here.

ISSN: 1471-244X