Tiny Heroes: Decrease and Prevent Anxiety Problems in Young Children (NCT06817304) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Tiny Heroes: Decrease and Prevent Anxiety Problems in Young Children
Sweden24 participantsStarted 2025-03-17
Plain-language 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).
Who can participate
Age range
18 Years – 64 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The clinical severity rating (CSR) of ADIS-P
Timeframe: From enrollment to follow up at 3 months after treatment completion.