Randomised Controlled Trial of an Intervention (SPOCCL) to Enhance Parent-Infant Interactions and Improve Cognitive Outcomes of Children with Cleft lip.

ObjectivePrevious research has shown disruptions in parent-infant interactions and child cognition for families affected by cleft lip. This study assessed the impact of Video Feedback Treatment (VFT) vs. an active treatment control condition on these outcomes for children with cleft lip (CL) (with or without cleft palate) (CL ± P).DesignMulti-centre, parallel group, randomised controlled trial.SettingParticipants were recruited from 4 National Health Service (NHS) Cleft Centres in the UK.ParticipantsSixty-six parents of infants with CL ± P and without other serious medical conditions.InterventionThirty-two participants were allocated to the VFT group; thirty-four participants were allocated to an active control group - Support, Information and Advice (SIA). Parents in both groups received 6 home visits from a therapist from 1 week postpartum at approximately weekly intervals.Main Outcome MeasuresParental sensitivity (Global Rating Scale) in parent-infant interactions at 11 weeks, and infant cognitive performance (BSID-III) at 18 months.ResultsThere were no differences between VFT and SIA groups on the primary outcomes. Parent-infant interactions and infant cognitive outcomes in both VFT and SIA groups approached those for nonaffected populations and were better than those in previously reported, non-treated populations with CL ± P.ConclusionsThere were no differences between the 2 treatment groups for the main outcomes. The lack of a no-intervention control group precludes conclusions regarding treatment efficacy.