Tiny Heroes Compared to Treatment as Usual to Decrease and Prevent Anxiety Problems in Young Children - a Randomized Controlled Study

Aim 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 a randomized controlled trial.

Tiny Heroes is a parent-directed online cognitive behavioral therapy (iCBT), adapted to the Swedish clinical setting in workshops with clinicians and health care developers in Region Stockholm. Tiny Heroes has been tested in a feasibility study which demonstrated strong acceptance among both clinicians and families and preliminary effectiveness in reducing anxiety symptoms in children aged 3-6 years. The present study will investigate whether Tiny Heroes is superior to treatment as usual in reducing anxiety symptoms in children 3-6 years with anxiety problems.

Research questions

Is Tiny Heroes superior to treatment as usual in reducing anxiety symptoms within first line of mental health care for young children (Malina) in region Stockholm?

Is Tiny Heroes cost effective?

Background

Anxiety

Anxiety is the most prevalent mental disorder in children (1) and the most 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) (2).

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 (3). Due to this over-time comorbidity, there has been a shift 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, i.e., behaviors aimed at maintaining proximity to attachment figures, distress when managing novel situations, and socially withdrawn behaviors (3) . A parenting style that has been associated with childhood anxiety is overprotective parenting (4) . Parents are the most important and influential people for young children. If parents receive appropriate support, they can positively influence how their child learns to deal with difficult emotions and situations. According to the transactional model, anxiety in childhood develops from the interplay between child temperament and parenting (4). A child who is high in behavioral inhibition will elicit overprotective parenting, which in turn will reinforce inhibited and withdrawn behaviours. In CBT for anxiety in young children, this vicious circle is targeted by trying to decrease both overprotective parenting and the child's behavioral avoidance.

CBT

CBT is the first-line treatment for anxiety in children, but very few young children receive CBT (5). A recent Cochrane analysis recommends further research on how to make CBT more accessible and how to reach neglected populations (6). Internet platforms, such as the national treatment platform Stöd och behandling, enable the scaling up of CBT and thus extend its availability to more families (7). 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 (8). As online treatments are less resource-intensive than in-person care, resources can be redirected to families with greater needs. Families can participate in online interventions without taking time off work and engage with the material at times that fit their schedules. Moreover, the content is structured and thereby quality assured. Furthermore, it can easily be translated into different languages, enabling parents who don't comprehend Swedish to take part in the treatment.

MALINA - First-line mental healthcare for children 0-5 years

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 is individualized based on the clinician's evaluation of the child and the family's needs. It typically varies from one to five sessions and can include elements of psychoeducation, exposure and/or play directed therapy.

Evidence based treatment in first-line mental healthcare

Most mental health interventions are developed for use in mental health care settings, and very few protocols have been fitted to first-line mental healthcare clinics. Interventions in first-line mental healthcare are generally shorter, and clinicians often make ad-hoc adjustments in which they shorten interventions. Thus, interventions are often provided in a way that differs distinctively from how they were evaluated (9). The present project will fill important gaps in clinical practice and research by co-developing and fitting cognitive behavioral therapy (Tiny Heroes) for young children with mild to moderate anxiety problems to first-line mental healthcare at MALINA.

Parental support

The purpose of targeting parents of young children is twofold: First, it allows children to receive support through the most influential people in their lives - their parents. Second, parents can provide ongoing support over many years, which may help prevent the development of future anxiety. Even though parental support is recommended for young children with anxiety, such programs are lacking in Swedish healthcare today, which is why Tiny Heroes will fill important gaps in clinical practice and research.

Methods

The project is a collaboration between Center for Epidemiology and Community Medicine (CES) in Region Stockholm, MALINA (all six MALINA units in Region Stockholm will be involved), Karolinska Institutet (KI), and the Child Health Care unit in Region Stockholm (which supports MALINA via healthcare developers). The families will receive Tiny Heroes as part of their health care at MALINA. However, the data collection, i.e., online questionnaires and clinical assessments, will be conducted by KI.

Participants

In the present study, caretakers/parents of 350 children will be recruited at MALINA. If there are two (or more) caretakers/parents, only one will be asked to participate in the assessments. However, all caretakers/parents are expected to be involved in the Tiny Heroes intervention or the control group intervention.

Psychologists at MALINA will assess the inclusion and exclusion criteria. Inclusion criteria: a) parent or caretaker of child 3-6 years with primary problem of worries, fear, or anxiety, assessed by a licensed psychologist at MALINA, b) parent or caretaker can read Swedish, c) access to computer, tablet or mobile phone with internet connection. Exclusion criteria: d) child having major developmental disorder (e.g., intellectual disability or severe autism spectrum disorder), and e) parent having significant intellectual impairment or mental health problems (likely to interfere with participation in the treatment), f) 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).

Psychologists at MALINA will inform participants about the scope of the study and that they will be randomized to either receive CBT in an online format or treatment as usual with a MALINA psychologist.

Eligible parents interested in participating in the study will use a link provided by MALINA to the secure platform REDCap where informed consent will be collected, and questionnaires will be assessed. A shortened version of the Anxiety Disorders Interview Schedule for DSM-V: Parent version (ADIS-P) (10) will also be assessed by research staff with the caretaker/parent. This will be done using a closed meeting on the KI Zoom platform. The interview will be recorded, and the audio file will be saved on a secure, encrypted server space at KI. The audio files will be stored until the manuscript from the study has been published to allow for quality checks, after which they will be deleted.

Randomization

The families will then be randomized in a 1:1 ratio to either Tiny Heroes or regular care. The randomization will be conducted by an independent researcher not otherwise involved in the study to ensure the integrity of the randomization. A list randomizer at www.random.org will be used to produce the randomization sequence. 400 allocations, 200 for each group, will be used to ensure allocation concealment. The result will be placed in the randomized order in 400 opaque and closed envelopes in a locked cupboard. When a family is included, the project leader will take the envelope on top of the pile, and the family will be allocated to the group revealed in the envelope. The allocation will be documented in RedCap and communicated via a weekly scheduled telephone call to the Malina clinic where the child is a patient.

Control group

Participants randomized to the control group are offered standard clinical contact at the Malina clinics once the research assessment has been completed. The contact consists of 1-4 psychologist sessions over a period of 1-8 weeks, conducted either in person or via video. The child may attend one or several sessions, depending on the psychologist's clinical judgement and the family's needs.

The content follows the Malina clinics' usual approach for mild to moderate anxiety, with the important exception that no treatment content is provided before randomization.

For each session, clinicians will document location (in-person/video), who was present, and main focus of the session. The total number of sessions will also be documented. Clinicians will report this information in REDCap.

Difference between standard care and the study's control condition

In routine care at the MALINA clinics, assessment and treatment occur in parallel. Psychologists typically provide psychoeducation, guidance, and initial therapeutic input already during the first contact, while the assessment is still ongoing.

In the study, this workflow needs to be temporarily modified. To ensure a valid research assessment and correct randomization, psychologists will first conduct a full assessment without any treatment components, and only after randomization, provide standard clinical care within the framework of the control condition. This means that the control group resembles treatment as usual but is not identical to it. The key difference is that, in the study, assessment and treatment are separated in time, whereas in routine care they occur simultaneously.

Methods for data collection

All questionnaires will be self-assessed by the parents within the web application Research Electronic Data Capture (REDCap), provided by KI. Questionnaires will be collected at baseline, at follow-up one month after intervention completion, and at follow-up 12 months after the end of the intervention. The clinical interview ADIS-P will only be assessed at baseline and at follow-up one month after intervention completion.

Measures

Clinical interview

Clinical diagnostic status will be determined with ADIS-P (10). Only sections covering separation anxiety, social anxiety, specific phobia, and generalized anxiety will be conducted. The clinical severity rating (CSR) of ADIS-P ranges from 0 (symptoms are absent) to 8 (very severe and interfering symptoms). The clinical cut-off for an anxiety diagnosis is 4. However, at MALINA, some children have sub-clinical anxiety problems and therefore there will be no cut-off used for inclusion in the present study.

Questionnaires

Child anxiety will be assessed with the Preschool Anxiety Scale (10) The PAS is a 34-item measure assessed by parents. Subscales align with the DSM-V anxiety diagnoses. The PAS has shown moderate to good psychometric properties with good internal consistency.

Parental self-efficacy will 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) (11). 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.

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 the child's anxiety. It has shown good internal consistency, as well as convergent and divergent validity (12).

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 demonstrated good validity and internal consistency (13).

Selective mutism will be assessed with the Selective Mutism Questionnaire (14).

Costs related to the children's anxiety will be estimated using an adapted version of the Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P) (15).

Treatment satisfaction will be assessed using the 8-item Client Satisfaction Questionnaire (CSQ-8), completed by the parents (16).

Negative effects of the intervention will be assessed with the Adverse Events scale (AE) (17).

Compensation

Participating families will be compensated with a gift card worth 150 SEK upon completion of questionnaires and diagnostic interview at 1 month post intervention and after completion of questionnaires at 1 year follow-up.

Methods for analysis of data

General Analytical Approach

All analyses will be conducted according to the intention-to-treat (ITT) principle, including all randomized participants regardless of treatment adherence. Statistical significance will be evaluated at a two-sided alpha level of 0.05. Descriptive statistics will be used to summarize baseline characteristics. Continuous variables will be reported as means and standard deviations, and categorical variables as frequencies and percentages.

Primary Outcome Analysis

The primary outcome is child anxiety symptoms, measured by the Preschool Anxiety Scale (PAS). A linear mixed-effects model (LMM) will be used to evaluate differences between the intervention group (Tiny Heroes) and the control group (treatment as usual). This model accounts for repeated measurements over time and handles missing data under the missing-at-random assumption.

Relevance of the project

The present study aims to fill important gaps in both clinic and research due to the lack of evidence-based interventions for young children with mild to moderate anxiety problems within first-line mental healthcare. Today, many children with anxiety problems don't receive adequate help. Even though CBT with significant parental involvement is recommended for the treatment of anxiety in young children (5) there is a lack of such methods. Digital interventions directed at parents have been highlighted as a way to increase the number of children treated for anxiety problems without compromising treatment outcomes ( 8) . An intervention similar to Tiny Heroes was recently found effective and credible by parents and therapists (8). Another feature that strengthens the study's quality is the use of co-development in creating Tiny Heroes.

Most evidence-based methods are not developed within the same setting as they are used. Here, clinicians from MALINA have been involved from the start. Discussions about the length, type of treatment, delivery format, treatment components, and adjustments to fit the intervention into regular care informed the development of Tiny Heroes. During 2023, the research group preliminarily tested the treatment Cool Little Kids, also targeting parents of anxious children aged 3-6 years. Group discussions with the parents included in this testing informed the decision to develop the online program Tiny Heroes instead. Among other things, the parents expressed a need to make the treatment more accessible and possible to take part in outside office hours, hence the online format.

Tiny Heroes may fill an important treatment gap by offering a structured early intervention for very young children with anxiety problems. The parent-based intervention will be offered at a time in the children's lives when parents are very influential. In Tiny Heroes, parents encourage their children to increase brave behaviors and to decrease avoidant behaviors in a step-by-step manner. This will likely help children engage in more activities in their daily lives. It may shift children's future trajectories from anxious and avoidant paths to more active and healthy ones.

The internet format of Tiny Heroes offers a unique opportunity to ensure that families get exactly the treatment evaluated in research. If proven effective, access to Tiny Heroes can easily be scaled up and translated to commonly used languages in Sweden. Thus, it has the capacity to increase access to evidence-based interventions in the community and decrease inequalities in health.

The gender perspective

In Sweden, there are many parent support methods for children's externalizing problems, while there is a lack of parental support methods for internalizing problems, such as anxiety. This is, although CBT with significant parental involvement is recommended for the treatment of anxiety problems in young children (18). Because externalizing problems are more common in boys and internalizing problems are more common in girls, this is an obvious example of gender inequality. The gender difference, with more girls and women than boys and men being affected by anxiety problems, increases with age. The aim of targeting young children with a parental intervention is twofold: First, the intervention has the potential to help children here and now through the influence of their most influential persons - their parents. Second, because the parents will likely remain important for the children over many years, this intervention may also prevent future anxiety. If Tiny Heroes is proven effective in decreasing anxiety problems, it could help decrease the gender inequality gap in mental health.

Ethical considerations

A randomized controlled trial is the golden standard in evaluating a method's effectiveness, and it can be argued that this study's design, enabling good evidence, is ethically advantageous. This is particularly true for the patients who gain access to an evidence-based intervention after its evaluation. However, randomized controlled trials are not without ethical implications, particularly when young children are involved. Informed consent cannot be obtained from the children whose parents participate in the study, as the children are too young to take a position. The researchers and clinicians have important roles in explaining the study procedures (verbally and in written information consent forms) so that the parents have the chance to decide whether it is suitable for them and their children to participate in the study. Adverse events will be systematically gathered at follow-up assessments.

Being randomized to one intervention may disappoint participants who had preferred the other. Tiny Heroes is an online intervention, and some parents may prefer face-to-face support. Others may prefer the flexibility of the online format, which allows participants to engage in the treatment at a time of their own choice. However, we believe that the knowledge gained from this project will be invaluable and justifies the efforts and potential risks for the participants involved.

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