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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03506971
Acronym
PERL
Enrollment
128
Registered
2018-04-24
Start date
2018-09-10
Completion date
2024-01-31
Last updated
2023-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Development, Infant, Perinatal Disorder

Keywords

Young child's development, Home visits, Early interactions, attachment, parenthood

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.

Interventions

OTHERPsychologist'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.

OTHERPediatric 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

OTHERJoint 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

Conseil Départemental, Protection Maternelle Infantile :PMI, France
CollaboratorUNKNOWN
Agence Regionale de Sante d'Ile de France
CollaboratorOTHER_GOV
Family Allowance Fund, France
CollaboratorOTHER
Centre Psychothérapique de Nancy
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Minutes to 15 Days
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Bobigny's early childhood interactions assessment3 monthsIt's an assessment of early childhood interactions baby-mother
Brunet-Lézine-revised test : assessment of change between 3 and 24 months and between two groups of the study.3 and 24 monthsAssessment of children psychomotor development. This test can be used at any time from the age of 0 to 30 months
ADBB (Alarm Distress BaBy) : assessment of change between 3 and 24 months and between two groups of the study.3 and 24 monthsFilmed evaluation of relational withdrawal of young children. This evaluation can be used at any time from the age of 2 to 24 months
EPDS : Edinburgh Postnatal Depression Scale3 monthsThe 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.
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 monthsInterview on Parent's Representations
ERTL 4 : Epreuve de repérage des Troubles du Langage = French questionnaire. No traduction for acronym4 YEARSTest of Spotting of language delays at 4 years, carried out in a systematic way by the teams of maternal and child protection
Q-SORT attachment24 monthsQ-SORT for evaluate the attachment
Mini-MBQS (Maternal Behavior Q-Sort ) : assessment of change between 3 and 24 months and between two groups of the study.3 and 24 Months25 items to obtain an assessment of global maternal sensitivity
BDI : Beck Depression Inventory (13 items)24 MonthsThis is a multiple-choice self-report inventory for measuring the severity of depression
SCL-90R (Symptom Checklist-90-R) : assessment of change between 3 and 24 months and between two groups of the study.3 and 24 MonthsSymptom check-list, self-assessment questionnaire for psychiatric symptoms
BITSEA : Brief Infant Toddler Social and Emotional Assessment24 monthsEarly 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.
HAQ : Helping Alliance Questionnaire3 monthsEvaluate the therapeutic alliance
HAQ24 monthsHelping Alliance Questionnaire, to evaluate the therapeutic alliance

Secondary

MeasureTime frameDescription
FAS : Family Affluence Scale3 and 24 MonthsSmall 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026