Initial Evaluation of a Stepped Care Model for Treating Mild to Moderate Childhood Anxiety in Primary Care

Summary

Objectives: In the past ten years in Sweden, a new form of primary care units called first line mental health (FLMH) has been implemented to improve mental health services for children and adolescents. Using a structured and collaborative approach including experts, clinicians, and patients, the investigators have developed a transdiagnostic psychological intervention for anxiety based on cognitive behavioural therapy (CBT) that aims to fit the FLMH care context. The current study aims to test the CBT intervention "Step-by-Step" in a randomized pilot study (N=36) to explore the feasibility of the study design.

Rationale for study: Childhood anxiety is common and associated with suffering and impairment in several life areas. CBT is an evidence-based treatment for anxiety disorders in children, but there is a need of increasing access to treatment. Offering CBT for childhood anxiety in primary care is a way to offer early and accessible treatment. However, there is a lack of CBT interventions developed for and evaluated in primary care.

Prior to a properly powered randomized controlled study, evaluating efficacy of the Step-by-Step, the investigators need to conduct a pilot study to, primarily, establish the feasibility of the study design and trial procedures and secondarily, provide preliminary data on acceptability and clinical efficacy.

Conditions

• Anxiety Disorder

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. See Figure 1 for a schematic representation of the stepped care approach, and Table 2 for an overview of session content. 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). (120 minutes)

Sponsors & Collaborators

• Karolinska Institutet

  collaborator OTHER

• Region Stockholm

  lead OTHER_GOV

Principal Investigators

• Johan Åhlén, PhD · Center for epidemiology and community medicine (CES), Stockholm Region

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

2023-02-13

Primary Completion

2023-12-31

Completion

2025-12-31

Countries

• Sweden

Study Locations