Early Childhood : Action Research in the Lunévillois Area (PERL)
- Conditions
- Perinatal DisorderDevelopment, Infant
- Interventions
- Other: Pediatric Nurse's interventionsOther: Psychologist's evaluationOther: Joint home visits
- Registration Number
- NCT03506971
- Lead Sponsor
- Centre Psychothérapique de Nancy
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 128
- Parents living in the Lunevillois area
- Mother to be 8 months pregnant
- Baby who's born from january to december 2018
- No exclusion criteria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Participants Pediatric Nurse's interventions 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. Participants Joint home visits 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. Control Psychologist's evaluation "psychologist's evaluation" : home visits by the coordinating psychologist to evaluate three areas: child development, parenthood and parent-child interaction.
- Primary Outcome Measures
Name Time Method HAQ 24 months Helping Alliance Questionnaire, to evaluate the therapeutic alliance
SCL-90R (Symptom Checklist-90-R) : assessment of change between 3 and 24 months and between two groups of the study. 3 and 24 Months Symptom check-list, self-assessment questionnaire for psychiatric symptoms
Brunet-Lézine-revised test : assessment of change between 3 and 24 months and between two groups of the study. 3 and 24 months Assessment of children psychomotor development. This test can be used at any time from the age of 0 to 30 months
EPDS : Edinburgh Postnatal Depression Scale 3 months 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.Mini-MBQS (Maternal Behavior Q-Sort ) : assessment of change between 3 and 24 months and between two groups of the study. 3 and 24 Months 25 items to obtain an assessment of global maternal sensitivity
BDI : Beck Depression Inventory (13 items) 24 Months This is a multiple-choice self-report inventory for measuring the severity of depression
Bobigny's early childhood interactions assessment 24 months It's an assessment of early childhood interactions baby-mother
ADBB (Alarm Distress BaBy) : assessment of change between 3 and 24 months and between two groups of the study. 3 and 24 months Filmed evaluation of relational withdrawal of young children. This evaluation can be used at any time from the age of 2 to 24 months
ERTL 4 : Epreuve de repérage des Troubles du Langage = French questionnaire. No traduction for acronym 4 YEARS Test of Spotting of language delays at 4 years, carried out in a systematic way by the teams of maternal and child protection
Q-SORT attachment 24 months Q-SORT for evaluate the attachment
HAQ : Helping Alliance Questionnaire 3 months Evaluate the therapeutic alliance
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. 3 and 24 months Interview on Parent's Representations
BITSEA : Brief Infant Toddler Social and Emotional Assessment 24 months 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.
- Secondary Outcome Measures
Name Time Method FAS : Family Affluence Scale 3 and 24 Months 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
Trial Locations
- Locations (1)
Centre Psychothérapique de Nancy
🇫🇷Laxou, France