Parenting course for caregivers of children with fetal alcohol spectrum disorder (
FASD
) versus waitlist: a randomised controlled large‐scale feasibility study of the
SPECIF
Penny A. Cook, Alan D. Price, Katherine Perryman, Kate Bennett, Paul Earl, Anna Webster, Heather Gage, Peter Williams, Clare S. Allely, Jennifer Shields, Raja A. S. Mukherjee 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
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.