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Clinical Trials/NCT06817304
NCT06817304CompletedNot Applicable

Tiny Heroes: Decrease and Prevent Anxiety Problems in Young Children - a Feasibility Study

Karolinska Institutet1 site in 1 country24 target enrollmentStarted: March 17, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
24
Locations
1
Primary Endpoint
The clinical severity rating (CSR) of ADIS-P

Study Overview

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).

Detailed Description

Anxiety is the most prevalent mental disorder in children and the most commonly reported reason for children having contact with first-line mental healthcare. In pre-school children, the most prevalent anxiety disorders are specific phobia (i.e., exaggerated fear in specific situations or of certain objects), social anxiety (i.e., fear in social situations), and separation anxiety (i.e., fear of being separated from parents or other significant persons). Childhood anxiety may impact many areas of the child's functioning, including the family, preschool, and peer relations. It is predictive of anxiety, depression and substance abuse in later childhood and adulthood. Due to this over-time comorbidity, there has been a move towards developing interventions for very young children.

Behavioral inhibition is a temperamental trait associated with anxiety in children. Behavioral inhibition is characterised by avoidance behaviors, behaviours aiming to maintain proximity to safety figures, distress when dealing with novelty, and socially withdrawn behaviors. A parenting style that has been associated with childhood anxiety is overprotective parenting. Parents are the most important and influential persons for young children. If parents receive appropriate support, they can positively influence how their child learn to deal with difficult emotions and situations. According to the transactional model, anxiety in childhood develops from the interplay between child temperament and parenting. A child who is high in behavioral inhibition will elicit overprotective parenting, which in turn will reinforce inhibited and withdrawn behaviours. In CBT, this vicious circle is targeted by trying to decrease both overprotective parenting and the child's behavioral avoidance.

CBT is the first-line treatment for anxiety in children, but very few young children receive CBT. A recent Cochrane analysis recommends research about how to make CBT more accessible and how to reach neglected populations. Internet platforms, such as the national platform Stöd och behandling, offer a possibility to scale up CBT and thereby making it available to more families. Online CBT directed at parents has recently been found to be non-inferior to treatment as usual in a large randomized controlled trial for anxiety in young children. Because less resources are needed when administering online treatments compared to face-to-face treatments, resources can then be unlocked for families with pressing needs. Families can engage in online interventions without taking time off from work and engage in the intervention at a time that fit their lives. The content is structured and thereby quality assured, and it can easily be translated to different languages, enabling parents who don't comprehend Swedish to take part of the treatment.

In Sweden, first-line mental healthcare units are commissioned to help children with mild to moderate anxiety. For the youngest children (0-5 years) in Region Stockholm, six MALINA clinics offer these services. The clinicians at MALINA are psychologists and the level of care lies between child health services (BVC) and child and adolescent mental health services (BUP). The standard treatment for children with anxiety problems at MALINA today is information to parents about anxiety and how they can support their anxious children.

Most mental health interventions are developed for the use in a mental health care setting and very few protocols have been fitted to first-line mental healthcare clinics. Interventions in first-line mental healthcare are generally shorter and oftentimes clinicians make ad-hoc adjustments in which they shorten interventions. Thus, interventions are often provided in a way that differ distinctively from how they were evaluated.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 64 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Arms & Interventions

Parent-directed online cognitive behavioral therapy

Experimental

Intervention: Tiny Heroes (Behavioral)

Outcomes

Primary Outcomes

The clinical severity rating (CSR) of ADIS-P

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

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

Secondary Outcomes

  • Preschool Anxiety Scale(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.)
  • Brief Parental Self-Efficacy Scale (BPSES).(From enrollment to follow up at 3 months after treatment completion.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Maria Lalouni

Associate professor

Karolinska Institutet

Study Sites (1)

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