RecruitingNot ApplicableNCT06212362

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

Stepped Care Versus Group Cognitive Behaviour Therapy for Paediatric Anxiety in Primary Care: a Multisite Randomised Controlled Non-inferiority Trial

Sponsor

Karolinska Institutet

Enrollment

150 participants

Start Date

Jan 8, 2024

Study Type

INTERVENTIONAL

Conditions

Anxiety

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.

Eligibility

Min Age: 7 YearsMax Age: 12 Years

Inclusion Criteria2

The child is 7-12 years old (Confirmed by the parent/guardian and from medical records)
The child suffers from mild to moderate anxiety. The term "mild to moderate anxiety" has not been explicitly defined but is a term aimed to specify a demarcation between the FLMH and the psychiatric specialist services. Adequate level of care for the patient is decided based on an overall clinical assessment. The Children Global Assessment Scale (CGAS) is often used to guide the decision on level of care, where a CGAS value above 60 clearly indicates primary care services, a value below 50 clearly indicates specialist services. For values between 50 and 60 the overall clinical evaluation of symptom severity and impaired function guide the decision on level of care. (Confirmed by the assessor at the FLMH-unit).

Exclusion Criteria2

Other psychiatric or developmental disorders than anxiety, or social issues that primarily require other interventions, i.e., where an intervention targeting mild to moderate anxiety is not adequate. (Confirmed by assessor at the FLMH-unit).
The child has another ongoing psychological intervention. An ongoing psychological treatment for any other psychiatric disorder. (Confirmed by the parent/guardian).

Interventions

BEHAVIORALStep-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)

BEHAVIORALCool 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)