Comparing two therapies for children's anxiety in primary care
Stepped Care Versus Group Cognitive Behaviour Therapy for Paediatric Anxiety in Primary Care: a Multisite Randomised Controlled Non-inferiority Trial
This study is testing a new therapy called 'Step-by-Step' for children with anxiety to see if it works as well as the existing 'Cool Kids' program.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 7 Years to 12 Years |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 1 site (Solna) |
| Trial ID | NCT06212362 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 7-12 who are experiencing mild to moderate anxiety.
Not a fit: Patients with other psychiatric or developmental disorders, or those requiring different interventions for social issues, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more accessible and effective treatment option for children with anxiety in primary care settings.
How similar studies have performed: Previous studies have shown success with cognitive behavioural therapy for anxiety in children, but this specific approach within primary care settings is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Solna
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.