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Trial record 11 of 1528 for:    child psychiatry

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

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ClinicalTrials.gov Identifier: NCT03506971
Recruitment Status : Recruiting
First Posted : April 24, 2018
Last Update Posted : July 16, 2019
Sponsor:
Collaborators:
Conseil Départemental, Protection Maternelle Infantile :PMI, France
Agence Regionale de Sante d'Ile de France
Family Allowance Fund, France
Information provided by (Responsible Party):
Centre Psychothérapique de Nancy

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.


Condition or disease Intervention/treatment Phase
Development, Infant Perinatal Disorder Other: Psychologist's evaluation Other: Pediatric Nurse's interventions Other: Joint home visits Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluate the Effects of a Preventive Care at Home on Young Child's Development
Actual Study Start Date : September 10, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Participants

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.
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

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




Primary Outcome Measures :
  1. 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

  2. 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. 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.


  4. 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

  5. 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

  6. Q-SORT attachment [ Time Frame: 24 months ]
    Q-SORT for evaluate the attachment

  7. 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

  8. BDI : Beck Depression Inventory (13 items) [ Time Frame: 24 Months ]
    This is a multiple-choice self-report inventory for measuring the severity of depression

  9. 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

  10. 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.

  11. HAQ : Helping Alliance Questionnaire [ Time Frame: 3 months ]
    Evaluate the therapeutic alliance

  12. HAQ [ Time Frame: 24 months ]
    Helping Alliance Questionnaire, to evaluate the therapeutic alliance

  13. Bobigny's early childhood interactions assessment [ Time Frame: 3 months ]
    It's an assessment of early childhood interactions baby-mother

  14. Bobigny's early childhood interactions assessment [ Time Frame: 24 months ]
    It's an assessment of early childhood interactions baby-mother


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 15 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03506971


Contacts
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Contact: Tatiana DABROWSKI +33383925349 unic@cpn-laxou.com

Locations
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France
Centre Psychothérapique de Nancy Recruiting
Laxou, France, 54200
Contact: Sophie BUCHHEIT       sophie.buchheit@cpn-laxou.com   
Contact: Tatiana DABROWSKI       tatiana.dabrowski@cpn-laxou.com   
Sponsors and Collaborators
Centre Psychothérapique de Nancy
Conseil Départemental, Protection Maternelle Infantile :PMI, France
Agence Regionale de Sante d'Ile de France
Family Allowance Fund, France
Investigators
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Principal Investigator: Sophie BUCHHEIT Centre Psychothérapique de Nancy

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Responsible Party: Centre Psychothérapique de Nancy
ClinicalTrials.gov Identifier: NCT03506971     History of Changes
Other Study ID Numbers: RIPH 2017-01
First Posted: April 24, 2018    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Psychothérapique de Nancy:
Young child's development
Home visits
Early interactions
attachment
parenthood