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

NCT05686512 | Active Not Recruiting

• 1 other identifier: jaai01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (5)

• Recruitment pace

  Number of included patients per month will be registered for each first line mental health unit, to explore the feasibility of conducting a full scale randomized controlled trial.

  Post intervention (defined as 12 weeks after the start of the intervention)

• Time between first assessment and treatment initiation

  The investigators will explore number of days between first assessment and treatment initiation to explore if patients do access treatment within a reasonable period of time?

  Post intervention (defined as 12 weeks after the start of the intervention)

• Treatment hours

  Based on patients' attendance in treatment, therapist time for each patient will be calculated. (For group sessions, hours will be multiplied by number of therapists, and divided by number of patients)

  Post intervention (defined as 12 weeks after the start of the intervention)

• Therapists' views of the intervention

  A eight item questionnaire will be rated by therapists regarding different aspects of the acceptability, appropriateness, and the feasibility of the intervention content and format.

  Post intervention (defined as 12 weeks after the start of the intervention)

• Patient completion rate

  Based on patients' attendance in treatment, the investigators will calculate how many patients that attend more than 70% of the sessions.

  Post intervention (defined as 12 weeks after the start of the intervention)

Secondary Outcomes (6)

• Treatment credibility inventory (parent- and child-rated)

  Two weeks after the start of the treatment

• Client Satisfaction Questionnaire, CSQ (parent-rated)

  Post intervention (defined as 12 weeks after the start of the intervention)

• Working Alliance Inventory, WAI (parent rated)

  Post intervention (defined as 12 weeks after the start of the intervention)

• The Pediatric Anxiety Rating Scale, PARS (clinician rated)

  Post intervention (defined as 12 weeks after the start of the intervention)]

• The Pediatric Anxiety Rating Scale - self-rated, PARS-SR (parent- and child-rated)

  Post intervention (defined as 12 weeks after the start of the intervention)

Study Arms (2)

Step-by-Step treatment

EXPERIMENTAL

Stepped care cognitive behavioral therapy

Behavioral: Step-by-Step

Cool Kids treatment

EXPERIMENTAL

Cognitive behavioral therapy

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. 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)

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). (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 caregiver and subsequently by the 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 caregiver.

Sponsors & Collaborators

• Region Stockholm: lead
• Karolinska Institutet: collaborator

Study Sites (1)

Center for epidemiology and community medicine (CES), Stockholm Region

Stockholm, 10435, Sweden

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Johan Åhlén, PhD

  Center for epidemiology and community medicine (CES), Stockholm Region

  PRINCIPAL INVESTIGATOR

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 GOV
• Responsible Party: SPONSOR

Model Details: Single-blind parallel-group pilot randomised controlled feasibility trial

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: January 17, 2023
• Study Start: February 13, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2025
• Last Updated: September 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: Study protocol, ICF will be publicly available at osf.io in February-2023, and Analytic code will be available in (anticipated) November 2023.
• Access Criteria: Underlying data is made available upon request after ensuring compliance with relevant legislation and Region Stockholm guidelines

Locations

SE (1)