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

NCT03506971 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2023-09-05

No results posted yet for this study

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.

Conditions

  • Development, Infant
  • Perinatal Disorder

Interventions

OTHER

Psychologist's evaluation

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.

OTHER

Pediatric Nurse's interventions

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

OTHER

Joint home visits

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

Sponsors & Collaborators

  • Conseil Départemental, Protection Maternelle Infantile :PMI, France

    collaborator UNKNOWN
  • Agence Regionale de Sante d'Ile de France

    collaborator OTHER_GOV
  • Family Allowance Fund, France

    collaborator OTHER
  • Centre Psychothérapique de Nancy

    lead OTHER

Principal Investigators

  • Sophie BUCHHEIT · Centre Psychothérapique de Nancy

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Minute
Max Age
15 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-10
Primary Completion
2022-03-14
Completion
2024-01-31

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03506971 on ClinicalTrials.gov