Optimising outcomes for families with children with a Fetal Alcohol Spectrum Disorder diagnosis or 'At Risk' designation: A mixed-methods randomised trial of Parents under Pressure and the Alert® Program

INTERVENTION: Parents Under Pressure The Parents under Pressure (PuP) Program is a home‐based intervention based on a systemic and strengths‐based framework, drawing on theoretical influences that include attachment, behavioural parenting, and emotional regulation. The PuP program is individually tailored to each family using a case formulation process. The delivery of the PuP program is guided by a Practitioner Manual and practitioners and families collaborate to develop a therapeutic family support plan with identified goals. A Parent Workbook is also available as additional support to complement sessions. It contains twelve modules addressing different domains of family functioning that may or may not be targeted in a treatment plan. There is a significant focus on enhancing the caregiving relationship and emotional regulation in both parents and children. For example, the module How to Manage Emotions When Under Pressure: Increasing Mindful Awareness integrates mindfulness exercises to enhance parent emotion regulation. The ‘Supporting Your Child to Develop Self‐Regulation’ and ‘Connecting With Your Child To Help Them Feel Loved And Safe’ modules provide parents with developmentally appropriate and non‐punitive strategies to enhance child self‐regulation, including ‘mindful play’, skills for understanding their children’s cognitive and emotional states, and mindfulness techniques to promote sensitive caregiving in stressful parenting contexts. This trial extends the PuP program to address the needs of families of children with a diagnosis of Fetal Alcohol Spectrum Disorder (FASD) or an 'At Risk' designation (as per the Australian Guidelines). Adaptations to the existing program have been informed by consultation with experienced clinicians in the diagnosis and treatme CONDITION: Fetal Alcohol Spectrum Disorder;Prenatal Alcohol Exposure; ; Fetal Alcohol Spectrum Disorder ; Prenatal Alcohol Exposure Mental Health ‐ Other mental health disorders Neurological ‐ Other neurological disorders SECONDARY OUTCOME: Caregiver emotion regulation, as measured by the Difficulties in Emotional Regulation Scale (DERS; Gratz & Roemer, 2004). The DERS is a 36‐item self‐report measure of difficulties with emotion regulation. Items are rated on a five‐point Likert‐type scale which reflect the proportion of time an individual experiences a particular aspect of emotion regulation. The DERS provides a score for total difficulties with emotion regulation and si Xsubscales (Non‐Acceptance of Emotional Responses, Difficulty Engaging in Goal Directed Behaviour, Impulse Control Difficulties, Lack of Emotional Awareness, Limited Access to Emotion Regulation Strategies, and Lack of Emotional Clarity), with higher scores indicative of greater difficulties with emotion regulation.[Baseline, post‐intervention (within 2 weeks of intervention completion), 6‐months post‐intervention (primary timepoint), 12‐months post‐intervention] Caregiver heart‐rate variability, as a physiological measure of emotional regulation. The data collection process involves placing two recording electrodes that have a slightly sticky adhesive to the skin (less adhesive than a typical band‐aid). These can be placed by the caregiver or researcher just below their neckline. Recording will commence with a baseline period where the caregiver and participating child watch a neutral video (Spot the Dog). The caregiver and child then undertake a task where they engage in a brief period of play (jigsaw or etcher sketch depending on child's age).[Baseline, post‐intervention (within 2 weeks of intervention completion), 6‐months post‐intervention (primary timepoint), 12‐months post‐intervention] Caregiver psychological wellbeing, as measured by the Depression Anxiety Stress Scales (DASS) (Lovibond & Lovibond, 1995). The DASS‐21 is a 21‐item assessment tool that consists of three, 14‐item scales measuring depression, anxiety, and stress.[Baseline, post‐intervention (within 2 weeks of intervention completion), 6‐months post‐intervention (primary timepoint), 12‐months post‐intervention] Child heart‐rate variability, as a physiological measure of emotional regulation. The data collection process involves placing two recording electrodes that have a slightly sticky adhesive to the skin (less adhesive than a typical band‐aid). These can be placed by the caregiver or researcher or the child themselves just below their neckline. Recording will commence with a baseline period where the participating caregiver and child watch a neutral video (Spot the Dog). The caregiver and child then undertake a task where they engage in a brief period of play (jigsaw or etcher sketch depending on child's age).[Baseline, post‐intervention (within 2 weeks of intervention completion), 6‐months post‐intervention (primary timepoint), 12‐months post‐intervention] Child inhibitory attention and attention (direct measure of executive function) using the Flanker task within the NIH Toolbo Xsuite of assessments, administered on an iPad. Children are required to focus on a target stimulus (i.e., a fish) while inhibiting attention to stimuli flanking it (“flankers”). Some trials present the target stimulus pointing in the same direction as the flankers (congruent), with other trials in the opposite direction (incongruent). [Baseline, post‐intervention (within 2 weeks of intervention completion), 6‐months post‐intervention (primary timepoint), 12‐months post‐intervention] Quality of parent/carer‐child caregiving as measured by the Emotional Availability Scales (EA Scales) (Biringen, 2008). Emotional availability is a multidimensional construct for understanding emotional relationships within a dyadic structure. The EA Scales allow for assessment in varied settings and cultures by the coding of a 10 to 20‐minute filmed interaction between the parent and child. The scales assess si Xdimensions of emotional availability (EA) in the relationship: four for the adult (sensitivity, structuring, non‐intrusiveness and non‐hostility) and two for the child (responsiveness to adult and involvement with adult).[Baseline, post‐intervention (within 2 weeks of intervention completion), 6‐months post‐intervention (primary timepoint), 12‐months post‐intervention] Set shifting (direct measure of executive function) using the Dimensional Change Card Sort task, within the NIH Toolbo Xsuite of assessments, administered on an iPad. A visual target stimulus is presented, and the child must match this to one of two choice stimuli. On each trial, the child is instructed whether to match stimuli based on shape or colour both through a word presented on the screen, as well as orally through a voice recording.[Baseline, post‐intervention (within 2 weeks of intervention completion), 6‐months post‐intervention (primary timepoint), 12‐months post‐intervention] Utility of the intervention models as measured by comprehensive implementation data collected for both intervention arms throughout implementation. The data collected aims to facilitate a cost‐benefit analysis, following the approach taken by Barlow et al., 2019 (e.g., resources required to implement each intervention including staffing, time, and materials). [Throughout implementation and evaluation period] Utility of the intervention models as measured by short semi‐structured qualitative interviews with the practitioners implementing the interventions and a random sample of families from the study. These interviews will focus on ascertaining barriers and facilitators to implementation and gaining an understanding of what was helpful and/or not helpful for each intervention model. These interviews will be voice‐recorded and transcribed for analysis.[Within one‐month of intervention completion] PRIMARY OUTCOME: Child behavioural and emotional functioning using the Behaviour System for Children, 3rd Edition (BASC‐3; Reynolds & Kamphaus, 2015). The BASC‐3 is standardised and normed parent‐ and teacher‐report measure of behavioural and emotional functioning in children aged 2 – 21 years and 11 months. The measure will be administered via a secure online platform. The parent‐report version contains (a) composite scales (Adaptive Skills, Behavioural Symptoms Index, Externalising Problems, Internalising Problems); (b) clinical symptom scales (Aggression, Anxiety, Attention Problems, Atypicality, Conduct Problems, Depression, Hyperactivity, Learning Problems, Somatisation, and Withdrawal); (c) content scales (Anger Control, Bullying, Developmental Social Disorders, Emotional Self‐Control, Executive Functioning, Negative Emotionality, and Resiliency); (d) adaptive scales (Activities of Daily Living, Adaptability, Functional Communication, Leadership, Social Skills, and Study Skills); and (e) probability, impairment and executive function indices (Clinical Probability Index, Emotional Behavioural Disorder Probability Index, Autism Probability Index, Attention‐Deficit/Hyperactivity Disorder Probability Index, Functional Impairment Index, Executive Functioning Indexes (Problem‐ Solving, Attentional Control, Behavioural Control, Emotional Control, and Overall)). The teacher‐report BASC‐3 contains the above, in addition to a School Problems composite scale.[Baseline, post‐intervention (within 2 weeks of intervention completion), 6‐months post‐intervention (primary timepoint), 12‐months post‐intervention] Child global executive function (indirect) using the Behaviour Rating Inventory of Executive Functioning – 2 (BRIEF‐2) and Behaviour Rating Inventory of Executive Functioning – Preschool (BRIEF‐P) (Gioia et al., 2003) which are standardised and normed caregiver‐ and teacher‐report measures of behaviours associated with specific aspects of executive functioning in children aged 5 to 18 years and 2 to 5 years 11 months, respectively. This measure will be administered by a secure online platform. The BRIEF‐2 has 10 subscales (Inhibit, Self‐Monitor, Shift, Emotional Control, Initiate, Working Memory, Plan/Organize, Task Monitor, Organization of Materials), which reduce to Behaviour Regulation, Emotion Regulation and Cognitive Regulation. The BRIEF‐P has four subscales (Inhibit, Shift, Emotional Control, Working Memory) that form three broad index scores (Inhibitory Self‐Control, Flexibility, and Emergent Metacognition). [Baseline, post‐intervention (within 2 weeks of intervention completion), 6‐months post‐intervention (primary timepoint), 12‐months post‐intervention] INCLUSION CRITERIA: Children who have been assessed and received either a diagnosis of FASD with or without 3 sentinel facial features or an 'At Risk' designation within 18‐months prior to referral will be eligible for the trial. This will be based on the Australian Guide to FASD. Children must be enrolled in preparatory to Grade 2 at school and must reach age 5 years by June 30 of enrolling year through to maximum age 8.5 years. Children may be residing with a biological parent, kinship carer, or foster carer. Families must reside either in the Gold City Council Area, Brisbane City Council Area, Sunshine Coast or Moreton Bay Regional Council area to be eligible for recruitment. No other inclusion or exclusion criteria will be imposed, including English proficiency or characteristics of caregivers. If literacy is an issue, measures and forms can be read to potential participants. At least one caregiver per child is required to participate. Caregiver must be aged 18 ye