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

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 treatment of FASD, along with the extant treatment literature. There are three ways in which the current study extends the PuP program to comprehensively address the needs of families of children with FASD or an 'At Risk' designation. First, psychoeducation will be provided concerning the child's individual profile of neurodevelopmental strengths and needs, and how this impacts their daily functioning and behaviour. This will be informed by the child’s neurodevelopmental assessment that informed their diagnosis. The caregiver's role in supporting the child’s developing self-regulation will be emphasised, and environmental modifications tailored to the child's profile will be discussed (e.g., anticipating/preparing for challenging situations, using executive instructions and reminders, picture routines or schedules). Second, age-appropriate strategies for enhancing young children's self-regulatory capacities will be introduced to the child and caregiver. PuP practitioners will use play-based approaches to teach child breathing techniques (e.g., using a flickering candle or bubble blowing exercise), mindfulness strategies (e.g., using a storybook, child-friendly tablet apps), emotion identification (e.g., use of visual aids and cartoons), developing coping self-talk or ‘mantras’ with children and caregivers to help the child manage frustration and impulsive behaviour. Third, liaison with the child's teacher will enable any recommended strategies to be generalised to this environment, ensuring consistency of approach and improving child engagement with education. Allied and mental health practitioners who have undergone the PuP accreditation process will implement the trial (e.g., psychologists, social workers, family support workers). All implementing practitioners will receive regular supervision by a senior PuP trainer and clinical psychologist to ensure fidelity to the program model. In addition, practitioners will be required to complete a short progress note at the end of each session aiming to capture the components of the intervention captured in the session (e.g., Module from the Parent Workbook, the proportion of the intervention focused on emotion regulation). The PuP arm of the trial will run continuously for the duration of the project, with 2 – 3 PuP practitioners holding a maximum caseload of 5 families at any time. The intervention will be delivered face-to-face individually with each family, predominantly in the home. Some sessions may occur in other settings, as determined by the family’s needs (e.g., child’s school, appointments with other allied health professionals, community agencies). Sessions will be conducted over 12 – 16 weeks for approximately 1 – 2 hours. Families may also be in contact with their PuP practitioner between sessions as needed to problem-solve issues as they arise (e.g., short phone calls or emails). The amount of engagement with the Parent Workbook each week will be at the discretion of the family and/or their PuP practitioner.