Cleft lip and palate Neonatal Diseases Cleft palate with cleft lip
Conditions
Interventions
There are two therapies which constitute the study interventions:
1. The index group will receive a treatment aimed specifically to improve mother-infant interaction (Watch & Discover)
2. The control
Sponsors
University of Oxford (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Mother is willing and able to give informed consent for participation in the study 2. Mother, aged 18 years or above 3. Infant diagnosed with cleft lip with/without cleft palate 4. Able (in the Investigators' opinion) and willing to comply with all study requirements 5. Infant born at > 35 weeks gestation 6. Infant birth weight of > 2000 grams 7. Mother willing to allow her and her infant?s General Practitioner and cleft Consultant to be notified of participation in the study
Exclusion criteria
Exclusion criteria: 1. Life-threatening or other serious physical illness in the mother 2. Serious illness or medical complication in the infant 3. Infant in Child Protection Plan (child protection register) 4. Mother unable to converse in English 5. Mother not primary caregiver to infant 6. Mother has severe psychiatric diagnosis 7. Mother and infant live outwith 90 minutes travel of research centre
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Maternal sensitivity in face to face interaction with the infant immediately following treatment (when infant aged 11 weeks and prior to lip cleft repair), measured using the Global Rating Scale dimension of sensitivity. 2. Infant cognitive development at 18 months (assessed by Bayley Scales of Infant and Toddler Development, 3rd edition) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Maternal gaze, measured by eye tracking at 11 weeks 2. Maternal imitation at 11 weeks 3. Infant attention (assessed by the Focused Attention Task) at 9 & 18 months 4. Infant emotion regulation (assessed by the LAB-TAB) at 9 & 18 months 5. Maternal appraisal, mood and trauma symptoms immediately after treatment and at 9 & 18 months, assessed by means of self-report questionnaires [Hospital Anxiety & Depression Scale (HADS), Parental Appraisal of Cleft Questionnaire (PAC-Q) and Post-traumatic Stress Diagnostic Scale (PDS)] | — |
Countries
England, United Kingdom
Outcome results
None listed