Extract

Background and study aims Cleft lip affects around 1 in 700 infants and is the most common congenital (present at birth) disorder. Affected children are at increased risk for a range of psychological problems in infancy and the school years. Previous research has found that, compared to interactions between mothers and unaffected infants, interactions between mothers and infants with cleft lips are more likely to be disrupted, particularly in the first few months of life, before surgical lip repair is conducted. These interactions have been found to be significant for the cognitive (recognising and understanding things) development of the child, both in children with a cleft lip and within normal populations. We propose to test whether a treatment aimed at enhancing the quality of the mother-infant interactions, in those first few months of life before surgery is conducted, improves mothers' sensitivity to their babies and leads to a better cognitive development of the baby at 18 months. Who can participate? Mothers must be 18 or over. The mothers themselves are healthy, but their babies must be diagnosed with a cleft lip. What does the study involve? We propose to randomly assign half of the participants to 'Watch & Discover' treatment, and the other half to 'Support, Information and Advice'. 'Watch & Discover' is the test treatment, whereby we would make short films of mother and baby together and then watch them back with the mother highlighting positive interactions and their baby's cues. In this way we would hope to enhance the quality of the mother-child interaction. The control treatment group would receive support, information and advice, giving mothers the opportunity to discuss issues around having a baby with cleft lip. We would visit the mother and baby at home over six sessions, starting when the baby is between 1-2 weeks old, and ending before the baby has lip surgery at 12 weeks. We would perform assessments on the baby and mother-child interactions at 11 weeks (after the treatment has finished), 9 months and 18 months, with the final assessment of cognitive outcome at 18 months. What are the possible benefits and risks of participating? The information we get from this study may benefit future treatments. We believe that there are minimal risks for mothers participating in the study, and indeed hope it will be a positive experience for them. However the study may involve discussion of potentially emotionally sensitive areas; the study therapist has extensive experience of working with mothers in this field and this support will be addition to their routine clinical care. Where is the study run from? University of Oxford (lead centre), University of Reading, Spires Cleft Centre, West Midlands Regional Cleft Centre, South Thames Cleft Service. When is the study starting and how long is it expected to run for? The study started in Jan 2012 and will run until May 2016. The study will be recruiting participants for 35 months. Who is funding the study? This study is funded by the Barclay Foundation. Who is the main contact? Professor Alan Stein [email protected]

Inclusion criteria

• cleft lip and palate

Links

• ictrp
• isrctn