Stepped Care Versus Group Cognitive Behaviour Therapy for Paediatric Anxiety in Primary Care - Trial NCT06212362

Timeline & Enrollment

Primary Outcome

Change in Pediatric Anxiety Rating Scale, PARS (clinician rated)

Summary

Objectives: Over the past decade in Sweden, a novel approach to primary healthcare units,
 known as first-line mental health (FLMH), has been introduced to enhance mental health
 services for children and adolescents. Through a structured and collaborative method
 involving experts, clinicians, and patients, a trans-diagnostic psychological intervention
 for anxiety was formulated based on cognitive behavioural therapy (CBT), designed to align
 with the FLMH care framework. This study seeks to assess the efficacy of the CBT intervention
 Step-by-Step in a randomised, single-blind, parallel-group, multisite non-inferiority
 trial. The objective is to investigate whether this treatment is not less effective than the
 evidence-based Cool Kids program.
 
 Rationale for the Study: Childhood anxiety is prevalent and linked to suffering and
 impairment across various life domains. While cognitive behavioural therapy (CBT) is a proven
 treatment for anxiety disorders in children, there is a pressing need to enhance access to
 such interventions. Introducing CBT for childhood anxiety within primary care settings offers
 an avenue for early and readily available treatment. However, a gap exists in the
 availability of CBT interventions specifically designed for and assessed within primary care
 contexts.

ICD-10 Classifications