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Tiny Heroes Compared to Treatment as Usual to Decrease and Prevent Anxiety Problems in Young Children - a Randomized Controlled Study
Sponsor: Karolinska Institutet
Summary
The aim of this randomized controlled trial is to evaluate the effectiveness and cost-effectiveness of Tiny Heroes, a parent-directed internet-delivered cognitive behavioral therapy (iCBT) program for anxiety problems in children aged 3 to 6 years within first-line mental health care in Region Stockholm, Sweden. The study will compare Tiny Heroes with treatment as usual at MALINA clinics and investigate whether the intervention leads to greater reductions in child anxiety symptoms. Secondary objectives include assessing effects on parental self-efficacy, family accommodation, life interference, treatment satisfaction, adverse events, and healthcare-related costs.
Key Details
Gender
All
Age Range
3 Years - 6 Years
Study Type
INTERVENTIONAL
Enrollment
350
Start Date
2026-10-15
Completion Date
2029-06-01
Last Updated
2026-10-13
Healthy Volunteers
No
Interventions
Parent-directed online cognitive behavioral therapy
This is a five-module online intervention based on cognitive behavioral therapy directed at parents of anxious children aged 3-6 years. Parents recieve support from a psychologist through the online platform during the intervention.
Treatment as Usual (TAU)
Regular care at the MALINA clinic