Mental health problems account for a substantial burden of disease globally, with the World Health Organisation predicting that by 2030, mental health problems will be the highest ranking disease in terms of burden in affluent countries [
1]. Similar to Australian adults (where up to one in five have a mental health problem) [
2], one in seven Australian children (aged 4–17) has a mental health problem, yet in a national survey only a quarter of children accessed treatment [
3]. The relative lack of child and adolescent mental health services poses a pressing problem as prevalence persists [
1]. To curb and manage this problem, effective prevention is essential.
During childhood, mental health problems most commonly manifest as externalising (behavioural) and internalising (emotional) problems [
4‐
8]. Externalising problems include conduct disorders, oppositional defiance and aggression, while internalising problems include anxiety, social withdrawal and depression. These problems bear considerable ongoing costs for individuals, families and society [
9] including difficulties with peer interaction, learning, family stress and the need for clinical services [
10]. Associated problems can also be enduring; mental health problems in early childhood are the single strongest longitudinal predictor of mental health throughout childhood and into early adolescence [
4]. If left untreated, up to 50% of these problems can persist throughout childhood and then adolescence [
6], resulting in an increased risk of school dropout, substance abuse, family violence, unemployment, involvement with criminal justice services, and suicide [
9,
11].
Externalising and internalising problems share early risk factors, many of which are identifiable in the pre-school years [
7,
12]. Risk factors include family stressors such as parental mental health problems, single parenthood, substance abuse, relationship conflict, social isolation, low income and maternal perception of difficult child temperament [
7,
12]. The single strongest modifiable risk factor, however, is negative parenting practices [
13,
14]. Negative parenting practices characterised by harsh discipline and low warmth are predictive of externalising problems, and over-involved protective parenting and low warmth are predictive of internalising problems [
12,
15]. Thus, a focus on parenting practices is an essential component of prevention programs for mental health problems in childhood.
Universal and targeted approaches to prevention of child mental health problems
Two broad types of prevention programs exist: universal (i.e. provided to all) and selective or targeted (i.e. provided to ‘at risk’ populations), but in reality the boundaries between these two approaches are often blurred [
16]. Our systematic review of randomised controlled trials of early intervention and prevention programs for child mental health revealed a number of targeted programs that reduced externalising problems in randomised controlled trials [
17]. These include the Olds Home Visiting Program (an intensive program promoting maternal health and a good parent-infant relationship in the first two years of life) that has shown lasting reductions in anti-social adolescent behaviour [
18], yet lacks demonstrated comparable efficacy when translated to the Australian population [
19,
20]. Similarly,
The Incredible Years program has shown reductions in externalising behaviours [
17] and more recently has shown promise for reducing co-occurring internalising problems in children aged 4–7 years with existing oppositional defiant disorder [
21]. However, both of these programs are limited by their resource intensity with a minimum of 40 contact hours per family [
17,
21]. The most promising targeted program, in terms its brevity and effectiveness, is the
Family Check-Up program (detailed below in Methods). The
Family Check-Up provides a relatively small number of one-on-one sessions (an average of 3.3 sessions per family) to ‘at-risk’ families i.e. those experiencing child behaviour problems and/or economic and family hardship. It has proven effective in preventing both externalising and internalising problems [
22]. However, it has only been trialed in disadvantaged American families. Yet child mental health problems occur across all socioeconomic groups and numerically the bulk of problems occurs in middle and high socioeconomic groups in many countries, because these groups comprise the bulk of society [
17,
23]. There is a need, therefore, to test the efficacy of the
Family Check-Up in countries other than the US, across a range of socioeconomic groups.
Although often effective, targeted programs can be stigmatising for families and lead to poor uptake rates, as low as 20% in some studies [
23]. An alternative approach to improve the reach of targeted programs may be to offer a universal prevention program first. Universal programs include
Triple P (i.e. Positive Parenting Program) which has been trialed in both Australia [
24] and Germany [
25]. In these two trials,
Triple P involved four weekly 2-hour parenting groups plus optional 15-minute phone contacts for parents of children aged 3–6 years. Improvements in parenting, child behaviour and family stress have been reported [
24,
25]. Neither trial however, delivered
Triple P in a truly universal manner [
24,
25]. The recruitment rate for the German trial was 31% of the population and a high proportion of these children (32%) had pre-existing behaviour problems [
25]. The Australian trial was restricted to families from low socioeconomic areas, was not randomised and nearly half of the children had pre-existing behaviour problems. Population recruitment rates need to be higher in universal prevention trials for generalisability, interpretation of effect sizes and understanding the logistics of program dissemination [
24].
The
Toddlers Without Tears program is one of the few truly universal mental health prevention programs [
15,
26,
27]. Developed in Australia to address negative parenting styles that can contribute to child mental health problems, it consists of a nurse delivered one-on-one session at child aged 8 months followed by two parent group sessions delivered at child age 12 and 15 months by maternal and child health nurses and a co-facilitator with expertise in parenting. In a large (N = 733) randomised controlled trial with high recruitment (69% of the population), the program led to some modest improvements in parenting practices but did not prevent behavioural and emotional problems in preschoolers [
26,
27]. This suggests that this program alone is insufficient to prevent child mental health problems. Whether this program combined with a targeted program could lead to greater population reach, uptake and effectiveness remains to be determined. Given that no trial to date has evaluated the effects of a combined universal-targeted approach versus a targeted approach alone, this trial’s findings are likely to be of international significance.
The Families in Mind trial therefore aims to compare the effectiveness, cost-effectiveness and population reach and uptake of a targeted approach alone (the Family Check-Up program) with a combined universal (the Toddlers Without Tears group parenting sessions) and targeted approach in the Australian population. Both programs will be delivered through existing child health workforces in the state of Victoria, and will be compared to the provision of usual care alone (‘control’ group).
We hypothesise that families offered this targeted program, either alone or in combination with this universal program, will have better outcomes than families who are not offered these programs. Outcomes include mean scores at child age three, four and five years for:
a)
child externalising and internalising behaviour problem s (primary outcome)
b)
harsh discipline and nuturing parenting practices (primary outcome), and
c)
parental mental health (secondary outcome)
Additionally, we hypothesise that uptake of the targeted program by ‘at risk’ families will be greater with the combined approach where the universal parenting program precedes the targeted program (to reduce stigma), than with the targeted program alone.