This project is a Randomised Clinical Trial that includes a family centred education intervention and/or non-directive active listening counselling intervention with families of preterm infants at risk for sensori-motor disorders.
Preterm babies, specifically with gestational age \< 33+6 weeks, will be recruited and assigned (randomized) into an a Family Education + Active Listening Group (intervention A) or a Family Education Only Group (intervention B). When the clinical condition of the child is stable the parents are approached for consent and randomised. All families (in intervention A and intervention B) will receive the evidence-based program of Family Education which is based on the promotion of the parent-child relationship through the recognition of behavioral states, methods of interaction, facilitation strategies in the relationship. It takes its conceptual basis from the Mother Infant Transaction Program (MITP). It is a specific and re-adapted version for the preterm infant hospitalized in NICU The family education sessions involve about 6 meetings (1-2 a week) of 30-45 minutes that are carried out during the hospitalization in the NICU directly at the child's bed between the operator and one or both parents. Each meeting involves the discussion of one of the following topics. The Families in intervention group A will also receive 4-6 weekly meetings with a psychologist for an active listening counselling session.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
70
Bedside intervention directly with infant with trained healthcare providers and parents. Includes family education meetings completed with individual infant parent/s and trained operator. In addition, weekly meetings of parent/s with a psychologist in a private location for an active listening counselling session.
Bedside intervention directly with infant with trained healthcare providers and parents. Includes family education meetings completed with individual infant parent/s and trained operator.
IRCCS Fondazione Stella Maris
Pisa, PI, Italy
Parent Infant interaction behaviours coding
Video footage of key vocal, facial, and motor parental and infant interactive behaviours are analysed using micro coding system.
Time frame: 1 months corrected age
Parent Infant interaction behaviours coding
Video footage of key vocal, facial, and motor parental and infant interactive behaviours are analysed using micro coding system.
Time frame: 3 months corrected age
Parent Infant interaction behaviours coding
Video footage of key vocal, facial, and motor parental and infant interactive behaviours are analysed using micro coding system.
Time frame: 6 months corrected age
Developmental outcome assessment
Bayley Scales of Infant Development Third Edition will be conducted including the Cognitive, Language (Receptive \& Expressive), Motor (Gross \& Fine), Social-Emotional and Adaptive sub scales. Each sub scale score will be calculated based on the age (months of age) of the infant at the time assessment. Higher scores mean a better outcome.
Time frame: 12 months corrected age
Family well-being questionnaires
The Infant Toddler Quality of Life QuestionnaireTM (ITQOL)
Time frame: Before discharge from the Neonatal Unit (on average at 5 weeks post term age), 3, 6, 12 months corrected age
Family well-being questionnaire
Edinburg Postnatal Depression Scale (EPDS)
Time frame: Before discharge from the Neonatal Unit (on average at 5 weeks post term age), 3, 6, 12 months corrected age
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Family well-being questionnaire
Depression Anxiety Stress Scale (DASS-21)
Time frame: Frame: Before discharge from the Neonatal Unit (on average at 5 weeks post term age), 3, 6, 12 months corrected age
Family well-being questionnaire
Coping Orientation to Problems Experienced (COPE - NVI)
Time frame: Before discharge from the Neonatal Unit (on average at 5 weeks post term age), 3, 6, 12 months corrected age