Trials / Unknown
UnknownNCT03506971
Early Childhood : Action Research in the Lunévillois Area (PERL)
Evaluate the Effects of a Preventive Care at Home on Young Child's Development
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 128 (estimated)
- Sponsor
- Centre Psychothérapique de Nancy · Academic / Other
- Sex
- All
- Age
- 1 Minute – 15 Days
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2018-09-10
- Primary completion
- 2022-03-14
- Completion
- 2024-01-31
- First posted
- 2018-04-24
- Last updated
- 2023-09-05
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT03506971. Inclusion in this directory is not an endorsement.