The aim of this randomized controlled trial is to evaluate the effectiveness and cost-effectiveness of Tiny Heroes, a parent-directed internet-delivered cognitive behavioral therapy (iCBT) program for anxiety problems in children aged 3 to 6 years within first-line mental health care in Region Stockholm, Sweden. The study will compare Tiny Heroes with treatment as usual at MALINA clinics and investigate whether the intervention leads to greater reductions in child anxiety symptoms. Secondary objectives include assessing effects on parental self-efficacy, family accommodation, life interference, treatment satisfaction, adverse events, and healthcare-related costs.
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
access to computer, tablet or mobile phone with internet connection.
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).
Parallel
Parent-directed online cognitive behavioral therapy
Other interventionThis is a five-module online intervention based on cognitive behavioral therapy directed at parents of anxious children aged 3-6 years. Parents recieve support from a psychologist through the online platform during the intervention.
Treatment as Usual (TAU)
BehavioralRegular care at the MALINA clinic
Preschool Anxiety Scale
Child anxiety will be assessed with the Preschool Anxiety Scale. The PAS is a 34-item measure assessed by parents, pre treatment, post treatment and 1 month post treatment. Subscales align with the DSM-V anxiety diagnoses. The PAS has shown moderate to good psychometric properties with good internal consistency.
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 and post treatment. Only subscales social anxiety, specific phobia, seperation anxiety and generalized anxiety disorder will be administrated. The maximal and total clinical severity rating for ADIS-P will be assessed.
Brief Parental Self-Efficacy Scale (BPSES).
Parental self-efficacy will assessed with the Brief Parental Self-Efficacy Scale (BPSES). BPSES is a five item scale that has shown a satisfactory level of internal consistency (Cronbach's alpha 0.75) . It was originally developed for the use in parents with children who displayed disruptive behavior. The research group has translated the scale to Swedish and adapted it to fit parents whose children suffer from anxiety. Parents included in the study will fill out the scale pre, post and 3 months post treatment.
Child Anxiety Life Interference Scale - Preschool version (CALIS-PV).
Life interference will be assessed with the Child Anxiety Life Interference Scale - Preschool version (CALIS-PV). CALIS-PV is an 18-item parent-assessed scale assessing interference of child's anxiety on the child's life and the life of the parent. It has shown good validity and internal consistency. Parents will fill out the questionnaire pre, post and 3 months post treatment.
Family Accommodation Scale Anxiety (FASA)
Family accommodation to the child's anxiety is assessed with Family Accommodation Scale Anxiety (FASA). The scale consists of 13 items about how the family accommodates to the child's anxiety. It has shown good internal consistency and also convergent and divergent validity. Parents will fill out the questionnaire. Pre, post and 3 months post treatment
Adverse Events scale (AE)
Negative effects of the intervention will be assessed with the Adverse Events scale (AE).
Client Satisfaction Questionnaire (CSQ)
Parental satisfaction will be assessed with the 8 item scale CSQ
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Karolinska Institutet
Lead sponsor
Region Stockholm
Collaborator
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