Developmental Care Program in Neonatal Intensive Care Unit

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Developmental Family Centred Care Program in Neonatal Intensive Care Unit

Conditions
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Premature Birth

Intervention / Treatment
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* Behavioral: Family Education and Active Listening
* Behavioral: Family Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parents of preterm <34 weeks without brain lesion Exclusion Criteria: Parents of infants with brain Lesions Parents of clinically unstable infants, based on standard medical evaluation of preterm infants (eg: children with mechanical ventilation or under sedation) Parents of infants with genetic-malformative conditions Parents with severe psychiatric disorders

Ages Eligible for Study
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Minimum Age: 1 Week
Maximum Age: 10 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two intervention groups, Randomised Controlled Trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Family Education Only<br>Family Education Only. Parents will be asked to participate in an evidence based program s that includes 6-8 visits with a a trained healthcare provider. This program of early intervention based on the promotion of the parent-child relationship through the recognition of behavioral states, methods of interaction, facilitation strategies in the relationship. Active listening Visits includes a cycle of 5-6 consecutive meetings lasting about an hour. The meetings will take place in a defined and dedicated space (private room) or if possible (if no other parents are present) at the baby's cradle. The meeting will take place between a single parent and a trained direct operator. This is not a psychotherapeutic intervention but a support that is provided to the parent. The support is mainly based on active listening, on the problems posed by the parent and on the subject's empowerment. | Behavioral: Family Education and Active Listening<br>* 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.<br>* Other names: Intervention A;|
| Active Comparator: Family Education and Active Listening<br>Family Education and Active Listening. Parents of infants will be asked to participate in an evidence based program for parents of NICU infants that includes 6-8 visits with a a trained healthcare provider operator. This evidence-based program of early intervention based on the promotion of the parent-child relationship through the recognition of behavioral states, methods of interaction, facilitation strategies in the relationship. The program takes its conceptual basis from the Mother Infant Transaction Program (MITP). It involves about 6 meetings (1-2 a week) of 30-45 minutes that are carried out during the hospitalisation in the NICU directly at the child's bed between the operator and one or both parents. | Behavioral: Family Education<br>* Bedside intervention directly with infant with trained healthcare providers and parents. Includes family education meetings completed with individual infant parent/s and trained operator.<br>* Other names: Intervention B;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parent Infant interaction behaviours coding | Video footage of key vocal, facial, and motor parental and infant interactive behaviours are analysed using micro coding system. | 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. | 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. | 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. | 12 months corrected age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Family well-being questionnaires | The Infant Toddler Quality of Life QuestionnaireTM (ITQOL) | 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) | Before discharge from the Neonatal Unit (on average at 5 weeks post term age), 3, 6, 12 months corrected age | 
| Family well-being questionnaire | Depression Anxiety Stress Scale (DASS-21) | 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) | Before discharge from the Neonatal Unit (on average at 5 weeks post term age), 3, 6, 12 months corrected age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neonatology, Family-Centered Care, Early intervention, Counseling