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NCT07870213
Tiny Heroes Compared to Treatment as Usual to Decrease and Prevent Anxiety Problems in Young Children - a Randomized Controlled Study
Conditions: Anxiety Mild to Moderate, Inhibition (Psychology)
Sex: All
Ages: 3 Years – 6 Years
Healthy volunteers: No
Phase: NA
Enrollment: 350
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.
Eligibility Criteria
Inclusion Criteria:
* parent or caretaker of child 3-6 years with primary problem of worries, fear, or anxiety, assessed by a licensed psychologist at MALINA
* parent or caretaker can read Swedish
* access to computer, tablet or mobile phone with internet connection.
Exclusion Criteria:
* child having major developmental disorder (e.g., intellectual disability or severe autism spectrum disorder)
* parent having significant intellectual impairment or mental health problems (likely to interfere with participation in the treatment)
* social problems which the psychologist at MALINA appraise will hinder participation in Tiny Heroes (e.g., ongoing separation between parents, serious problems with the child's pre-school).
Source: ClinicalTrials.gov (NCT07870213). StuddyBuddy aggregates publicly available trial information.