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

Centre Psychothérapique de Nancy

Status: Active, not recruiting

Conditions: Perinatal Disorder; Development, Infant

Treatments: Other: Joint home visits; Other: Psychologist's evaluation; Other: Pediatric Nurse's interventions

Study type: Interventional

Funder types: Other

Identifiers

NCT03506971

IDRCB 2017-A00896-47 (Other Identifier)

RIPH 2017-01

Details and patient eligibility

About

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.

Enrollment: 128 estimated patients

Sex: All

Ages: 1 minute to 15 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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128 participants in 2 patient groups

Participants

Experimental group

Description:

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.

Treatment:

Other: Pediatric Nurse's interventions

Other: Joint home visits

Control

Other group

Description:

"psychologist's evaluation" : home visits by the coordinating psychologist to evaluate three areas: child development, parenthood and parent-child interaction.

Treatment:

Other: Psychologist's evaluation