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

NCT06212362 | Recruiting

• 1 other identifier: jaai02
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

anxiety; children; cognitive behavioural therapy

Outcome Measures

Primary Outcomes (1)

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

  The PARS is a semi-structured clinical interview aimed to assess the severity and functional impairment of anxiety in children aged 6-17 years. Questions are asked to both children and parents. The ratings of severity and impairment is made based on the overall picture of anxiety symptoms. PARS has been used as an outcome measure in several treatment studies.

  Three timepoints: Baseline assessment, 12 weeks after treatment initiation (post assessment), and 12 months after the post assessment

Secondary Outcomes (5)

• Change in Child Anxiety Severity Scale, CASS) (child- and parent-rated)

  Four timepoints: Baseline assessment, 5 weeks after treatment initiation (mid-treatment assessment), 12 weeks after treatment initiation (post assessment), and 12 months after the post assessment

• Change in The Revised Children's Anxiety and Depression Scale, RCADS (child- and parent-rated)

  Three timepoints: Baseline assessment, 12 weeks after treatment initiation (post assessment), and 12 months after the post assessment

• Change in The Family Accommodation Scale - Anxiety, FASA-A (child- and parent-rated)

  Four timepoints: Baseline assessment, 5 weeks after treatment initiation (mid-treatment assessment), 12 weeks after treatment initiation (post assessment), and 12 months after the post assessment

• Change in the Child Health Utility 9D, CHU9D (parent-rated)

  Three timepoints: Baseline assessment, 12 weeks after treatment initiation (post assessment), and 12 months after the post assessment

• Change in Brief Parental Self-Efficacy, BPSES (parent-rated)

  Four timepoints: Baseline assessment, 5 weeks after treatment initiation (mid-treatment assessment), 12 weeks after treatment initiation (post assessment), and 12 months after the post assessment

Other Outcomes (5)

• Unintended Treatment Effects

  12 weeks after treatment initiation (post assessment)

• Mental Health Care (register data)

  Three years following the completion of treatment

• Treatment Adherence (clinician-rated)

  12 weeks after treatment initiation (post assessment)

Study Arms (2)

Step-by-Step treatment

EXPERIMENTAL

Behavioral: Step-by-step

Cool Kids treatment

ACTIVE COMPARATOR

Behavioral: Cool Kids

Interventions

Step-by-step BEHAVIORAL

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)

Step-by-Step treatment

Cool Kids BEHAVIORAL

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)

Cool Kids treatment

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator
• Vastra Gotaland Region: collaborator

Study Sites (1)

Karolinska Institutet

Solna, 171 65, Sweden

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Johan Åhlén, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johan Åhlén, PhD

CONTACT

+46702814669; johan.ahlen@ki.se

Albin Isaksson, Msc

CONTACT

albin.isaksson@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors conducting 12 weeks-assessments will be blind to treatment allocation. The outcome measure (PARS) is identical for both groups, ensuring that the assessors remain blind. At the 12 week-assessment, participants will be reminded to not reveal their arm allocation. To measure blinding integrity, all assessors will record whether the participating families inadvertently reveal their group allocation, and subsequently guess each participant's treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Multi-site randomised non-inferiority trial. Half of the participants will be randomised to receive Step-by-step, and half of participants will be randomised to receive Cool Kids.

Study Record Dates

• First Submitted: December 26, 2023
• First Posted: January 18, 2024
• Study Start: January 8, 2024
• Primary Completion: July 31, 2025
• Study Completion (Estimated): July 31, 2028
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Available on request after the results are published in peer-reviewed journal.
• Access Criteria: Each request will be assessed individually

Locations

SE (1)