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

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.

Conditions

• Anxiety

Interventions

BEHAVIORAL

Step-by-step

The Step-by-Step follows a stepped care approach, were all children (and caregivers) complete the first step (a brief group intervention followed by an individual session). Those with more needs are offered to continue to step 2 where individual CBT is given. Step 1 Session 1-4: Group sessions including psychoeducation, parenting skills and mapping stress and vulnerability factors, exposure and coping skills (90 minutes) Session 5: Individual session - If ending after step 1 a maintenance plan is completed. If continuing to step 2 continued exposure and selection of optional focus areas such as emotion regulation, social skills, stress- and vulnerability factors, child worry or parental worry. (45 minutes) Step 2 Session 6-8: Individual sessions - Exposure and selected focus areas. (45 minutes)

BEHAVIORAL

Cool Kids

The Cool Kids Program is an Australian manualized group CBT treatment of child anxiety, which has been broadly implemented in Sweden. Several studies have found evidence of its efficacy. Session 1-10: Group sessions including psychoeducation, cognitive restructuring (gather evidence to reevaluate anxiety related thoughts), parent skills, exposure, social skills, coping skills (cognitive and behavioral strategies to handle anxiety reactions, learning problem-solving skills). (90-120 minutes)

Sponsors & Collaborators

• Region Stockholm

  collaborator OTHER_GOV

• Vastra Gotaland Region

  collaborator OTHER_GOV

• Karolinska Institutet

  lead OTHER

Principal Investigators

• Johan Åhlén, PhD · Karolinska Institutet

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

7 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-08

Primary Completion

2025-07-31

Completion

2028-07-31

Countries

• Sweden

Study Locations