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New online tool aims to tame toddler anxiety

NCT ID NCT06817304

Symptom relief Sponsor: Karolinska Institutet Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 12, 2026 · Updated 2 times

Summary

This study tests a new online program called Tiny Heroes, designed to help parents of anxious children aged 3 to 6. The program teaches parents cognitive behavioral therapy techniques through four online modules. Researchers want to see if it is practical and effective in reducing children's worry and fear. Only 24 families are taking part, and results will help decide if a larger study is needed.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Online cognitive behavioral therapy (iCBT) for parents
What this could lead to
If it works, this could provide a simple, online tool for parents to help reduce anxiety in young children, potentially preventing more serious problems later.
What could go wrong
This is a very small feasibility study with only 24 families, no control group, and no long-term follow-up. It is too early to know if the program truly works.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

24 people

The number who actually took part.

Started

Mar 2025

Finished

Oct 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 64 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

anxiety anxiety disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anxiety, mild to moderate Inhibited temperament

Contacts and locations

Locations

  • Karolinska Institutet

    Stockholm, Karolinska Institutet, 17177, Sweden

  • Karolinska Institutet

    Stockholm, 17177, Sweden

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