Parenting course for caregivers of children with fetal alcohol spectrum disorder (FASD) versus waitlist: a randomised controlled large-scale feasibility study of the SPECIFiC (Salford parents and carers' education course for improvements in FASD outcomes in children) programme.

BACKGROUND: Children with fetal alcohol spectrum disorder (FASD) have difficulties with functioning in daily life, emotions and behaviour. Evidence for FASD-specific parenting interventions is scarce, with few randomised trials of FASD-specific parenting interventions published to date. The Salford Parents' and Carers' Education Course for Improvements in FASD outcomes in Children (SPECIFiC) is a co-designed, seven-session psychoeducation programme co-delivered online. The aim was to evaluate feasibility outcomes of recruitment, retention and acceptability, as well as candidate efficacy outcomes to establish primary outcomes for a definitive trial. METHODS: A two-arm randomised feasibility trial compared SPECIFiC with treatment as usual (TAU). Parents or carers (n = 119) of children (4-16 y) with a confirmed or probable FASD diagnosis were randomised 1:1 to intervention or TAU. Outcomes included parenting stress (Parenting Stress Index-Short Form, PSI-4-SF), parenting self-efficacy (Tool to Measure Parenting Self-Efficacy, TOPSE), child behavioural difficulties (Strengths and Difficulties Questionnaire, SDQ) and parent mental health (Depression Anxiety Stress Scale, DASS-21; Clinical Outcomes in Routine Evaluation, CORE-OM). Health economic analysis used the Client Service Receipt Inventory (CSRI) and quality of life using EuroQol (EQ-5D-5L). Analyses followed an intention-to-treat principle. The trial is registered at www.isrctn.com (ISRCTN14483801). RESULTS: Recruitment (41%) and retention (85%) met prespecified feasibility thresholds, and satisfaction was high. Parenting stress did not differ significantly between groups (adjusted mean difference - 3.89, 95% CI -11.1 to 3.32). No clear between-group differences were observed for child behaviour, parental mental health or quality of life outcomes. Parenting self-efficacy improved in the intervention group relative to treatment as usual (adjusted mean difference 24.9, 95% CI 5.43-44.4; Cohen's d = .80). The cost per participant ranged from £227-£302. Fidelity checks confirmed consistent delivery. CONCLUSIONS: SPECIFiC demonstrated feasibility and acceptability and showed a promising signal for improving parental self-efficacy. A definitive trial is warranted to determine clinical and cost-effectiveness.