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Completed
NCT06817304
Tiny Heroes: Decrease and Prevent Anxiety Problems in Young Children
Conditions: Anxiety, Mild to Moderate, Inhibited Temperament
Sex: All
Ages: 18 Years – 64 Years
Healthy volunteers: No
Phase: NA
Enrollment: 24
Sponsor: Karolinska Institutet
Location: Karolinska Institutet Stockholm Karolinska Institutet
Summary
In Sweden, there is a lack of evidence-based methods to reduce and prevent young children's emotional problems, such as worry and anxiety. In the project, the intervention Tiny Heroes will be evaluated in an open feasibility trial.
Tiny Heroes is an online cognitive behavioral therapy (iCBT) directed at parents, adapted to the Swedish clinical setting in workshops with clinicians and health care developers in Region Stockholm. Feedback from parents will be included in the feasibility study and inform the intervention.
Research questions
* Is Tiny Heroes preliminary effective in reducing children's anxiety symptoms?
* What support is needed from clinicians during Tiny Heroes?
* How many modules are completed by parents?
* How is Tiny Heroes perceived by parents?
If Tiny Heroes is feasible and preliminary effective, a randomized controlled trial will be planned for (not included in this project plan).
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
* Parent or caretaker has 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 (NCT06817304). StuddyBuddy aggregates publicly available trial information.