Early Childhood : Action Research in the Lunévillois Area (PERL)

Study Overview
=================
Brief Summary
-----------------
The PERL project is a research in prevention in perinatality. The objective of this research is to offer preventive and regular care at familie's home in the Lunévillois area, while integrating it into the existing practices of the maternal and child protection, in the framework of a partnership between the PMI (Protection Maternal Infantile) and the child psychiatry. An innovative prevention device to support the interactions and development of the child will be proposed to about sixty families, randomly recruited into the general population. If the family agrees to participate, their will benefit from regular home visits by a pediatric nurse, accompanied on certain times by a psychologist, for a period of 4 years from the birth of the child. This home-visits accompaniment, centered on listening and observation, focuses on three areas: baby's development, parenthood and parent-child's interactions. A longitudinal and comparative evaluation will be carried out with a control group recruited according to the same conditions and at the same time as the participants group. A parallel research on the processes and mechanism will be carried out in partnership with the School of Public Health in order to define and validate the intervention theory (what are the mobilized levers produced and how, what are the mechanisms linking the intervention to its results), to describe the implementation and the processes involved, and to analyze the effects of context, especially social, on processes and results.

Official Title
-----------------
Evaluate the Effects of a Preventive Care at Home on Young Child's Development

Conditions
-----------------
Development, Infant, Perinatal Disorder

Intervention / Treatment
-----------------
* Other: Psychologist's evaluation
* Other: Pediatric Nurse's interventions
* Other: Joint home visits


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parents living in the Lunevillois area Mother to be 8 months pregnant Baby who's born from january to december 2018 Exclusion Criteria: No exclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 1 Minute
Maximum Age: 15 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants<br>As part of this research, families will benefit from pediatric nurse's interventions : home visits by a pediatric nurse who will center around three times: a time of observation of the development and progress of the baby, a time for play with the baby and a time to listening the parents. psychologist's evaluation and joint home visits : home visits by the coordinating psychologist to evaluate three areas: child development, parenthood and parent-child interaction. | Other: Pediatric Nurse's interventions<br>* Pediatrics nurses perform preventive home visits that are based on : joint observation with the parents of the baby, play with the baby and his parents, interview with the parents on their parenthood Rhythm of home visits: 1 every month from birth to 1 year 1 every 2 months from 1 year to 2 years 1 every 3 months from 2 years to 4 years<br>Other: Joint home visits<br>* Coordinating psychologist and the referent pediatric nurse will perform home visits. During this time, the psychologist evaluate : the development of the baby, the early interactions between the baby and his mother, attachment, maternal psychiatric symptoms, the experience of parenting and maternal sensitivity. Rhythm of joint home visits: 1 at 4 months 1 at 24 months<br>|
| Other: Control<br>psychologist's evaluation : home visits by the coordinating psychologist to evaluate three areas: child development, parenthood and parent-child interaction. | Other: Psychologist's evaluation<br>* The research coordinator psychologist will evaluate: the development of the baby, the early interactions between the baby and his mother, attachment, maternal psychiatric symptoms, the experience of parenting and maternal sensitivity.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brunet-Lézine-revised test : assessment of change between 3 and 24 months and between two groups of the study. | Assessment of children psychomotor development. This test can be used at any time from the age of 0 to 30 months | 3 and 24 months | 
| ADBB (Alarm Distress BaBy) : assessment of change between 3 and 24 months and between two groups of the study. | Filmed evaluation of relational withdrawal of young children. This evaluation can be used at any time from the age of 2 to 24 months | 3 and 24 months | 
| EPDS : Edinburgh Postnatal Depression Scale | The Edinburgh Postnatal Depression Scale (EPDS) is a set of 10 screening questions that can indicate whether a parent has symptoms that are common in women with depression and anxiety during pregnancy and in the year following the birth of a child. To complete this set of questions, the parent should select the number next to the response that comes closest to how they have felt in the past seven days. The total score is calculated by adding the numbers selected for each of the 10 items. If the parent's score is 10 points or above, they should speak to a health professional about those symptoms. | 3 months | 
| ERP (Entretien sur les représentations Parentales, no traduction for acronym): assessment of change between 3 and 24 months and between two groups of the study. | Interview on Parent's Representations | 3 and 24 months | 
| ERTL 4 : Epreuve de repérage des Troubles du Langage = French questionnaire. No traduction for acronym | Test of Spotting of language delays at 4 years, carried out in a systematic way by the teams of maternal and child protection | 4 YEARS | 
| Q-SORT attachment | Q-SORT for evaluate the attachment | 24 months | 
| Mini-MBQS (Maternal Behavior Q-Sort ) : assessment of change between 3 and 24 months and between two groups of the study. | 25 items to obtain an assessment of global maternal sensitivity | 3 and 24 Months | 
| BDI : Beck Depression Inventory (13 items) | This is a multiple-choice self-report inventory for measuring the severity of depression | 24 Months | 
| SCL-90R (Symptom Checklist-90-R) : assessment of change between 3 and 24 months and between two groups of the study. | Symptom check-list, self-assessment questionnaire for psychiatric symptoms | 3 and 24 Months | 
| BITSEA : Brief Infant Toddler Social and Emotional Assessment | Early screening of social and emotional difficulties or developmental delays for children. This assessment can be used at any time from the age of 12 to 36 months. | 24 months | 
| HAQ : Helping Alliance Questionnaire | Evaluate the therapeutic alliance | 3 months | 
| HAQ | Helping Alliance Questionnaire, to evaluate the therapeutic alliance | 24 months | 
| Bobigny's early childhood interactions assessment | It's an assessment of early childhood interactions baby-mother | 3 months | 
| Bobigny's early childhood interactions assessment | It's an assessment of early childhood interactions baby-mother | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FAS : Family Affluence Scale | Small questionnaire to describe family's affluence. 4 questions asked : How many computers do you have at home ? (none, 1, 2, more than 2) / Do you have a car at home? (no, 1, 2 or more) / Do you have your own bedroom at home? (yes, no) / For the last 12 months, how many times have you travelled with your family for holidays? (never, once, twice, more than twice) Assessment of change will be done between 3 and 24 months and between two groups of the study | 3 and 24 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Young child's development, Home visits, Early interactions, attachment, parenthood