Comparing two therapies for children's anxiety in primary care

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of a new cognitive behavioural therapy (CBT) intervention called 'Step-by-Step' against the established 'Cool Kids' program for treating mild to moderate anxiety in children aged 7-12. Conducted in primary care settings in Sweden, the trial employs a randomized, single-blind, parallel-group design to assess whether 'Step-by-Step' is as effective as 'Cool Kids'. The research aims to enhance access to evidence-based psychological treatments for children experiencing anxiety, addressing a significant gap in mental health services. The study also explores the suitability of the new intervention for different patient subgroups based on their baseline characteristics.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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).

Where it's running

• Karolinska Institutet
  Solna, Sweden Recruiting

Study contacts

• Principal investigator: Johan Åhlén, PhD — Karolinska Institutet
• Study coordinator: Johan Åhlén, PhD
• Email: johan.ahlen@ki.se
• Phone: +46702814669

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.