Tiny Heroes: Decrease and Prevent Anxiety Problems in Young Children

NCT06817304 | Active Not Recruiting

• 1 other identifier: 2024-07258-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Anxiety, Mild to Moderate; Inhibited Temperament

Keywords

preschool anxiety

Outcome Measures

Primary Outcomes (1)

• The clinical severity rating (CSR) of ADIS-P

  Clinical diagnostic status will be determined with Anxiety Disorders Interview Schedule for DSM-V: Parent version (ADIS-P), pre treatment, post treatment and 3 months post treatment

  From enrollment to follow up at 3 months after treatment completion.

Secondary Outcomes (4)

• Preschool Anxiety Scale

  From enrollment to follow up at 3 months after treatment completion.

• Brief Parental Self-Efficacy Scale (BPSES).

  From enrollment to follow up at 3 months after treatment completion.

• Family Accommodation Scale Anxiety (FASA)

  From enrollment to follow up at 3 months after treatment completion.

• Child Anxiety Life Interference Scale - Preschool version (CALIS-PV).

  From enrollment to follow up at 3 months after treatment completion.

Other Outcomes (3)

• Client satisfaction questionnaire (CSQ-8)

  Assessed only once at follow-up six weeks after the baseline assessment.

• Adverse Events scale (AE)

  Assessed only once at follow-up six weeks after the baseline assessment.

• Written feedback from parents

  From enrollment to end of treatment (4-6 weeks depending on speed of treatment progression)

Study Arms (1)

Parent-directed online cognitive behavioral therapy

EXPERIMENTAL

Behavioral: Tiny Heroes

Interventions

Tiny Heroes BEHAVIORAL

This is a four modules online intervention based on cognitive behavioral therapy directed at parets of anxious children 3-6 years

Parent-directed online cognitive behavioral therapy

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (2)

Karolinska Institutet

Stockholm, Karolinska Institutet, 17177, Sweden

Location

Karolinska Institutet

Stockholm, 17177, Sweden

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: This is a behavioral intervention, therefore study phase is not applicable

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: February 10, 2025
• Study Start: March 17, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)