Mental health problems and their long term effects.

Diagnosed mental health disorders, such as disruptive behaviour, anxiety and mood problems, affect one in seven Australian children [1]. However, mental health problems, which can still impact the child but may not reach diagnostic criteria for a mental health disorder. These more common behavioural and emotional problems likely affect around one in four children [1]. These common problems impact children’s short and long term outcomes including difficulty with relationships [2], reduced educational achievement [2], increased risk of criminality [3, 4], alcohol and drug problems [5] and lower earning potential [3].

Half of all adult mental health disorders start in childhood [6]. Evidence-based treatments including parenting interventions have been shown to improve child behavioural and emotional problems, including face to face therapy, group parenting programs (e.g., Tuning in to Kids) and online parenting interventions (e.g., computer assisted cognitive behaviour therapy, such as BRAVE online) [7, 8]. Often, interventions target the parents given that parenting is a key modifiable factor in child mental health [9, 10].

Despite the availability of a range of evidence-based interventions for mental health problems, most children with a mental health disorder do not receive professional help [11–14]. Reasons for this are multifactorial and include accessibility barriers, stigma, and poor parental (and professional) mental health literacy [11]. Mental health literacy is the “knowledge and beliefs about mental disorders which aid their recognition, management or prevention” [15]^[p182]. This can include knowing where a child can go to get mental health help, or strategies parents can implement to help alleviate their child’s problem.

Qualitative studies have shown that parents often face difficulty navigating the maze of services for mental health [16, 17]. Parents can find it hard to know where to go or who can help. Many will end up seeing a paediatrician to help their child [18].

In Australia, the paediatrician is the largest provider of longitudinal care of children with a mental health disorder [11]. Paediatricians are often an ‘early port of call’ for children with mental health disorders and play a crucial role in diagnosis, exclusion of medical causes of child mental health problems and prescription of medication. Paediatricians generally do not deliver behaviour management therapy nor are they trained in cognitive behavioural therapy. They generally refer to other providers for these interventions.

With few publicly funded paediatric services available, anecdotal reports suggest wait times in excess of six to twelve months to access a paediatrician in Australia. Pre-COVID (2019), mean wait time to access a paediatrician in the states of Victoria and South Australia was 44 days with four out of 10 providers closing their books to new patients mid-year [19]. This problem of accessibility has worsened due to the COVID-19 pandemic, especially for families who cannot afford private care.

Parents want support and information while they wait to see a mental health specialist.

Parents want information while they wait to access mental health care [20]. This includes a better understanding of how the mental health system works and how to access other forms of treatment to help their child while they wait, such as group therapy, online interventions or telephone support [20].

There is little qualitative data on parent’s information preferences while waiting to see a specialist mental health professional. From first author’s qualitative interviews with 16 parents waiting to get help from a paediatrician (unpublished data), inductive content analysis revealed that parents want to understand whether their child’s problem is normal or not, what they could try while they waited to see the paediatrician, which services could help their child’s problem, and a list of available professional help in their community.

Why a digital health intervention might help.

Digital health interventions (DHIs) may be able to address these information gaps identified by parents. DHIs are desirable for the following reasons: they facilitate the rapid exchange of tailored information to consumers, are scalable, are liked by parents, can have vast reach, are accessible on demand, and generally thought to be cost-effective [21].

Our recent systematic review identified only five studies examining the effects of a DHI on parents’ mental health literacy or help-seeking for their child’s mental health problem [22]. There is some evidence that DHIs, such as websites and emailed PowerPoint presentations, may help improve mental health literacy [23–25]. However, the review included only one randomised controlled trial [26]. A Finnish study measured help-seeking behaviours of parents of four year old children with a recognised behaviour problem at a routine four year old check with a universal service. The randomised controlled trial found an information website, coupled with a telephone coach decreased uptake of services. However, this decrease in uptake of services was associated with improved child behaviour using a validated measure. This study showed a DHI, with a telephone coach, can affect help-seeking [26]. However, no quantitative studies have shown DHIs can improve uptake of services for children with a mental health problem.

A new co-designed website to improve help-seeking and child mental health outcomes.

To design a new website to improve parents’ knowledge of treatments and reduce barriers to accessing evidence-based therapies for their child, we followed a framework proposed by Gemert-Pijen et al. [27]. This is a user-centred, iterative approach that refines the DHI to match the needs of the user, during every phase of the development cycle [27]. The website was developed in collaboration with parents and clinicians. As part of this process, we undertook a contextual enquiry with parents, three co-design workshops and six one-on-one usability studies. Through this process, we designed and developed a website with the content detailed in the intervention section below.

Evaluating the feasibility and acceptability of the DHI.

The World Health Organisation recommends evaluating the feasibility of a new DHI, after usability testing and prior to efficacy and effectiveness evaluation [28]. The measurement of feasibility is complicated by the absence of a singular definition of feasibility testing, and the synonymous use of feasibility studies and pilot studies [29, 30]. Feasibility trials typically involve 20–100 participants, and evaluate the suitability of outcome measures, participant acceptance of the intervention (recruitment and retention rates) and DHI usage (e.g. adherence) [28–32].

From our systematic review of five included studies, we found single cohort trials limited the strength of evidence of effectiveness as this methodology is inherently prone to confounding bias [33]. None of the included studies in the systematic review identified or adjusted for the presence of confounding. To address this, we plan to conduct a randomised controlled pilot study with a “routine care” control group. This also allows us to describe differences in efficacy of secondary outcomes between the two groups, accounting for confounding and natural history of child mental health problems over time.

Hypothesis.

We hypothesise that FindWays is an acceptable and feasible DHI with the potential to help parents find ways to improve their child’s mental health problems while they wait to see a paediatrician.

Inclusion criteria.

Each participant must meet all the following criteria to be enrolled in this trial:

• is a parent or carer of a child between two and 12 years old at the time of randomisation;
• has been referred for a first appointment with a paediatrician to manage a child’s behavioural or emotional problem;
• child has a behavioural or emotional problem as listed for review on the referral letter from the child’s general practitioner; and
• provides verbal consent that is signed and dated by the researcher (DP).

Exclusion criteria.

Participants meeting any of the following criteria will be excluded from the trial:

• child has a parent-reported diagnosis of an Intellectual Disability or Autism Spectrum Disorder;
• child is in out of home care; or
• paediatrician decides the child needs an early review (such as for a severe mental health problem or to exclude a medical problem).

Purpose.

The intervention consists of a new, co-designed website. This website, FindWays, offers parents relevant and specific information on behavioural and emotional problems. This information focuses on ways parents can manage a behavioural or emotional problem.

Theory.

Human-centred and participatory design methods were used to inform the website’s design, as was persuasive technology [35]. These methods align with those suggested by existing theoretical framework for DHIs [27]. In order to encourage behaviour change, the UK Behavioural Insights Team EAST behavioural insights were applied to the design and content of website [36]. The behavioural insights team recommend four principles to encourage a behaviour: make is easy, attractive, social and timely [36].

Contextual enquiry.

The content of the website was informed by inductive content analysis of 16 qualitative interviews completed in early 2020 by DP with parents recently referred to a paediatrician to manage their child’s behavioural or emotional problem.

Prototyping.

We conducted a further three co-design sessions in 2022 with five parents to inform the functional requirements and look and feel of the website. We designed the intervention using an iterative process, sketching wireframes and mock-ups of the website using free sketch on pen and paper, PowerPoint, Adobe XD and finally in Figma, and asking parents for feedback on content and usability. The development of the prototype in Figma and the website in Webflow was assisted by digital technology design company Curve Tomorrow [37]. The prototype was built in Webflow utilising the Content Management System. Usability testing was completed with a further six parents. These usability tests were completed as one-on-one interviews, either face-to-face in a paediatric clinic or over Zoom.

Technical.

This static website contains 60 pages of content, 47 videos and a list of 63 local and online services for child mental health, hosted on Webflow. The parent can select specific ages (preschool or primary school aged) and problems (15 in total) to find tailored information relevant to their child.

Content.

The website contains the following elements: i) strategies for parents to try at home based on a program logic that identifies evidence-based strategies associated with positive child mental health outcomes, ii) descriptions of the roles of professionals and programs that can help a child’s mental health problem, and iii) lists of local professionals and available programs. The website content includes videos, written content, and links to relevant external content and services, including local psychologists, occupational therapists and evidence-based programs. The content is tailored to the child’s age and specific sub-problem (e.g., separation anxiety, tantrums), as identified by the parent. The parent can choose what help they want for their child, but the website guides parents, who self-identify through the website that they want more help, to a local professional or program that can help their child’s specific sub-problem.

The parenting strategies provided by the website reference existing information sources such as the Raising Children Network, Beyond Blue and the Diagnostic Standard Manual-V (DSM-V) [38]. The Raising Children Network and Beyond Blue are both Australian websites providing mental health content for consumers, funded in part by the Australian Government. DSM-V is a diagnostic tool, published by the American Psychiatric Association (APA) and used by clinicians as a standardised guide to classify mental health disorders [38].

All content on FindWays was written by first author DP, a general paediatrician. The content underwent a quality review process including review by another paediatrician (HH). Video scripts were reviewed and approved by the paediatricians in Geelong. The content was also reviewed by NH (a psychologist and Director, Raising Children Network) to ensure the tone is appropriate for families.

Prompts.

Throughout the intervention, parents will receive scheduled prompts to use the website. These prompts, delivered by SMS and email, will contain static information drawn from the website, and a link to the website. These will be delivered at regular, pre-scheduled intervals and are not tailored. Parents will be able to request the prompts stop at any time, either by email or text message.

Control group.

The control group will receive routine care. This care is provided by usual providers (e.g., GP, existing online resources, teachers at school). The control group will not be provided access to the FindWays website. The FindWays website is not listed on search engines, and the URL is not publicly available.

Primary outcomes measures.

Despite the lack of a singular definition of feasibility, they typically involve measures of recruitment rates, attrition rates, evidence of harm, user satisfaction and DHI usage [28, 29] and will be assessed in the following ways:

• feasibility will be measured by recruitment rates including the proportion of potentially eligible parents who consent to participate in the study and complete outcome measures;
• adherence will be measured by the number of consenting participants in the intervention group who access the website as measured by Google Analytics;
• At 4-months post randomisation:
  1. ○ acceptability measured by likelihood of recommending the intervention measured by Likert scale Net Promoter Score
  2. ○ acceptability measured by usability and safety feedback measured by semi-structured phone interview
  3. ○ retention measured by number of consented parents who complete all baseline measures and final measures
  4. ○ adherence measured by tasks completed on the website (e.g., strategies found, suitable providers found) measured by parent survey.

Secondary outcome measures.

Secondary outcomes measured by parent-reported surveys at baseline and 4-months post randomisation include:

• Child behaviour and emotions measured by the Strengths and Difficulties Questionnaire (SDQ)—a 25-item, validated measure of psychological attributes for 2–17 year olds, as reported by the parents [39].
• Family impact, degree of burden and impairment from the child’s behaviour and emotions as measured by parent-reported SDQ Impact Supplement [40].
• Parent mental health and distress as measured by the Depression, Anxiety and Stress Scale (DASS-21), a 21-item, validated measure of adult emotions [41, 42].
• Health services use for the child’s emotional or behavioural problems, and out of pocket costs in Australian dollars, as reported by parents. Health service use is measured at 4-months post randomisation only.

Demographic characteristics of the user will be recorded by parent survey at baseline.

The feasibility of these secondary outcomes will also be assessed by reviewing how many parents complete the secondary outcome measures. This will be used to inform the design of a later trial powered to assess the effectiveness of the FindWays website.

Phone parents direct.

For those parents who wish to hear more about the study, the administration staff will take and record verbal consent from the parent to pass on their contact details (parent name, email address, phone number and postcode) to DP. At this time, the clinic will also post the parents a copy of the participant information statement. DP will then contact the parents to tell them more about the study, check they received the participant information statement and answer any questions.

Sequence generation.

A statistician, not involved in the analysis of the trial results, will prepare the randomisation schedule. The randomisation schedule will be created using computer-generated random numbers before the first participant has been recruited, in a one-to-one ratio. The participant cohort will be stratified by child age (two-six year olds and seven-twelve year olds) and clinic (clinic one, clinic two and clinic three). Within each stratum, permuted block randomisation will be used to ensure balance between the intervention and control group. A randomly generated sequence of block sizes containing two, four, or six participants will be used. This will help prevent any predictability when randomising participants to intervention or control [43].

Allocation concealment.

The schedule will be held by the independent statistician, and allocation will not be revealed prematurely to DP. Because of these procedures, the research team will be unable to predict which group participants will be allocated to.

Implementation.

When a participant has consented to participate, and completed their baseline measures, DP will contact the independent statistician so they can reveal the participant’s randomisation status. Both DP and the participant will become aware of which trial group they were allocated to after randomisation.

Blinding.

The participant and researcher will not be blind to their intervention status because it is impossible to blind a novel website intervention to participants. The administration staff and paediatricians will not be notified by the researchers of the intervention status of the participants.