Clinical trial NCT03506971: Early Childhood : Action Research in the Lunévillois Area (PERL)
Official title: Evaluate the Effects of a Preventive Care at Home on Young Child's Development
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Development, Infant
Perinatal Disorder
Keywords: Young child's development
Home visits
Early interactions
attachment
parenthood
Lead sponsor: Centre Psychothérapique de Nancy
Sponsor class: OTHER
Collaborators: name: Conseil Départemental, Protection Maternelle Infantile :PMI, France
name: Agence Regionale de Sante d'Ile de France
name: Family Allowance Fund, France
First posted: 2018-04-24
Enrollment: 128
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Brunet-Lézine-revised test : assessment of change between 3 and 24 months and between two groups of the study.
timeFrame: 3 and 24 months
measure: ADBB (Alarm Distress BaBy) : assessment of change between 3 and 24 months and between two groups of the study.
timeFrame: 3 and 24 months
measure: EPDS : Edinburgh Postnatal Depression Scale
timeFrame: 3 months
measure: 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.
timeFrame: 3 and 24 months
measure: ERTL 4 : Epreuve de repérage des Troubles du Langage = French questionnaire. No traduction for acronym
timeFrame: 4 YEARS
measure: Q-SORT attachment
timeFrame: 24 months
measure: Mini-MBQS (Maternal Behavior Q-Sort ) : assessment of change between 3 and 24 months and between two groups of the study.
timeFrame: 3 and 24 Months
measure: BDI : Beck Depression Inventory (13 items)
timeFrame: 24 Months
measure: SCL-90R (Symptom Checklist-90-R) : assessment of change between 3 and 24 months and between two groups of the study.
timeFrame: 3 and 24 Months
measure: BITSEA : Brief Infant Toddler Social and Emotional Assessment
timeFrame: 24 months
measure: HAQ : Helping Alliance Questionnaire
timeFrame: 3 months
measure: HAQ
timeFrame: 24 months
measure: Bobigny's early childhood interactions assessment
timeFrame: 3 months
measure: Bobigny's early childhood interactions assessment
timeFrame: 24 months
Secondary outcomes:
measure: FAS : Family Affluence Scale
timeFrame: 3 and 24 Months
Other outcomes:
Locations:
city: Laxou
country: France
facility: Centre Psychothérapique de Nancy
Study officials:
affiliation: Centre Psychothérapique de Nancy
name: Sophie BUCHHEIT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Buchheit S, Kabuth B, Colombo MC, Ligier F. Child Development and Early Interaction: PERL Research Protocol, a Preventive Home Visiting Program, Randomized Controlled Trial in France. Front Psychiatry. 2021 Jun 30;12:641468. doi: 10.3389/fpsyt.2021.641468. eCollection 2021.