- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03506971
Early Childhood : Action Research in the Lunévillois Area (PERL) (PERL)
Evaluate the Effects of a Preventive Care at Home on Young Child's Development
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Laxou, France, 54200
- Centre Psychothérapique de Nancy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Participants
As part of this research, families will benefit from
|
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:
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:
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Other: Control
"psychologist's evaluation" : home visits by the coordinating psychologist to evaluate three areas: child development, parenthood and parent-child interaction.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brunet-Lézine-revised test : assessment of change between 3 and 24 months and between two groups of the study.
Time Frame: 3 and 24 months
|
Assessment of children psychomotor development.
This test can be used at any time from the age of 0 to 30 months
|
3 and 24 months
|
ADBB (Alarm Distress BaBy) : assessment of change between 3 and 24 months and between two groups of the study.
Time Frame: 3 and 24 months
|
Filmed evaluation of relational withdrawal of young children.
This evaluation can be used at any time from the age of 2 to 24 months
|
3 and 24 months
|
EPDS : Edinburgh Postnatal Depression Scale
Time Frame: 3 months
|
The 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. |
3 months
|
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.
Time Frame: 3 and 24 months
|
Interview on Parent's Representations
|
3 and 24 months
|
ERTL 4 : Epreuve de repérage des Troubles du Langage = French questionnaire. No traduction for acronym
Time Frame: 4 YEARS
|
Test of Spotting of language delays at 4 years, carried out in a systematic way by the teams of maternal and child protection
|
4 YEARS
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Q-SORT attachment
Time Frame: 24 months
|
Q-SORT for evaluate the attachment
|
24 months
|
Mini-MBQS (Maternal Behavior Q-Sort ) : assessment of change between 3 and 24 months and between two groups of the study.
Time Frame: 3 and 24 Months
|
25 items to obtain an assessment of global maternal sensitivity
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3 and 24 Months
|
BDI : Beck Depression Inventory (13 items)
Time Frame: 24 Months
|
This is a multiple-choice self-report inventory for measuring the severity of depression
|
24 Months
|
SCL-90R (Symptom Checklist-90-R) : assessment of change between 3 and 24 months and between two groups of the study.
Time Frame: 3 and 24 Months
|
Symptom check-list, self-assessment questionnaire for psychiatric symptoms
|
3 and 24 Months
|
BITSEA : Brief Infant Toddler Social and Emotional Assessment
Time Frame: 24 months
|
Early 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.
|
24 months
|
HAQ : Helping Alliance Questionnaire
Time Frame: 3 months
|
Evaluate the therapeutic alliance
|
3 months
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HAQ
Time Frame: 24 months
|
Helping Alliance Questionnaire, to evaluate the therapeutic alliance
|
24 months
|
Bobigny's early childhood interactions assessment
Time Frame: 3 months
|
It's an assessment of early childhood interactions baby-mother
|
3 months
|
Bobigny's early childhood interactions assessment
Time Frame: 24 months
|
It's an assessment of early childhood interactions baby-mother
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
FAS : Family Affluence Scale
Time Frame: 3 and 24 Months
|
Small 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
|
3 and 24 Months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sophie BUCHHEIT, Centre Psychothérapique de Nancy
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RIPH 2017-01
- IDRCB 2017-A00896-47 (Other Identifier: ANSM (French competent authority))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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