Back to resultsMOther-Child Interaction Assessment TRAINING for Pediatricians (MOCITRAINING)
Primary Purpose
Child Behavior Disorders, Mother-child Relations, Depression, Postpartum
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MOCITRAINING program
usual follow-up
Sponsored by
About this trial
This is an interventional supportive care trial for Child Behavior Disorders focused on measuring Mass screening, Pediatrician training
Eligibility Criteria
Inclusion Criteria:
- Each child will be included WITH his biological mother at the first-month visit after birth.
- Age: 1 month + / - 15 days (child), accompanied by his biological mother
- Mother able to read French;
- Signed consent letter after complete information of parents about the MOCITRAINING study, its principle, advantages and disadvantages.
Exclusion Criteria:
- Preterm babies.
- Children from a twin or multiple pregnancy.
- Children with somatic diagnosis explaining the presence of digestive, sleeping or interactional disorders.
- Refusal to participate after clear information about the study;
- Refusal to sign the consent letter;
- Refusal to be informed of a diagnostic hypothesis;
- Participants not covered by the Social Security system;
- Participants incapable of consenting or under legal protection (guardianship or curatorship).
Sites / Locations
- CHURecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
F+ group (Mocitraining program)
F- group (usual follow-up)
Arm Description
including 8 pediatricians' clusters. F+ pediatricians will attend a specific training focused on mother-child interactions, maternal psychiatric disorders, particularly PND screening and early interventions for non-psychiatric physician.
grouping 8 pediatricians' clusters. They will not receive the initial training on early interactional disorders and PND screening
Outcomes
Primary Outcome Measures
Frequency of pathological Alarm Distress BaBy (ADBB) scores
Secondary Outcome Measures
Frequency of pathological Alarm Distress BaBy (ADBB) scores
Frequency of digestive disorders
presence/absence of infantile regurgitations and colics
Number of daytime sleep hours
Number of nighttime awakenings
Scores on maternal self-evaluation scales (Likert scales)
Scores on maternal self-evaluation scales (Likert scales) about parent-child relations (Items concerning comfort and pleasure during interactions)
Frequency of dyads referred for psychiatric or perinatal psychiatric consultations
Frequency of maternal psychotropic medication
Full Information
NCT ID
NCT03300713
First Posted
September 28, 2017
Last Updated
September 30, 2022
Sponsor
University Hospital, Lille
Collaborators
Ministry of Health, France
1. Study Identification
Unique Protocol Identification Number
NCT03300713
Brief Title
MOther-Child Interaction Assessment TRAINING for Pediatricians
Acronym
MOCITRAINING
Official Title
MOther-Child Interaction Assessment TRAINING for Pediatricians
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 2, 2017 (Actual)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
Ministry of Health, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The originality of the MOCITRAINING study lies in the integration of infant and maternal care during the pediatric consultation and the assessment of the impact of this type of care in the short and medium term on The MOCITRAINING program could contribute to improving the quality of parent-child interactions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Behavior Disorders, Mother-child Relations, Depression, Postpartum
Keywords
Mass screening, Pediatrician training
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3504 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
F+ group (Mocitraining program)
Arm Type
Experimental
Arm Description
including 8 pediatricians' clusters. F+ pediatricians will attend a specific training focused on mother-child interactions, maternal psychiatric disorders, particularly PND screening and early interventions for non-psychiatric physician.
Arm Title
F- group (usual follow-up)
Arm Type
Sham Comparator
Arm Description
grouping 8 pediatricians' clusters. They will not receive the initial training on early interactional disorders and PND screening
Intervention Type
Other
Intervention Name(s)
MOCITRAINING program
Intervention Description
The program is clinical and psychometric tools for screening for interactions and postpartum psychiatric disorders. The program will expose the existing care arrangements and the different possible orientations of the families according to the identified problem.
Intervention Type
Other
Intervention Name(s)
usual follow-up
Intervention Description
usual follow-up
Primary Outcome Measure Information:
Title
Frequency of pathological Alarm Distress BaBy (ADBB) scores
Time Frame
in 12-month-aged children.
Secondary Outcome Measure Information:
Title
Frequency of pathological Alarm Distress BaBy (ADBB) scores
Time Frame
in 4, 9 and 24 month-aged children
Title
Frequency of digestive disorders
Description
presence/absence of infantile regurgitations and colics
Time Frame
in 4, 9, 12 and 24 month-aged children
Title
Number of daytime sleep hours
Time Frame
in 4, 9, 12 and 24 month-aged children
Title
Number of nighttime awakenings
Time Frame
in 4, 9, 12 and 24 month-aged children
Title
Scores on maternal self-evaluation scales (Likert scales)
Description
Scores on maternal self-evaluation scales (Likert scales) about parent-child relations (Items concerning comfort and pleasure during interactions)
Time Frame
at 12 and 24 months postpartum
Title
Frequency of dyads referred for psychiatric or perinatal psychiatric consultations
Time Frame
in 4, 9, 12 and 24 month-aged children
Title
Frequency of maternal psychotropic medication
Time Frame
in 4, 9, 12 and 24 month-aged children
10. Eligibility
Sex
All
Minimum Age & Unit of Time
23 Days
Maximum Age & Unit of Time
37 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Each child will be included WITH his biological mother at the first-month visit after birth.
Age: 1 month + / - 15 days (child), accompanied by his biological mother
Mother able to read French;
Signed consent letter after complete information of parents about the MOCITRAINING study, its principle, advantages and disadvantages.
Exclusion Criteria:
Preterm babies.
Children from a twin or multiple pregnancy.
Children with somatic diagnosis explaining the presence of digestive, sleeping or interactional disorders.
Refusal to participate after clear information about the study;
Refusal to sign the consent letter;
Refusal to be informed of a diagnostic hypothesis;
Participants not covered by the Social Security system;
Participants incapable of consenting or under legal protection (guardianship or curatorship).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Renaud Jardri, MD,PhD
Phone
(0) 320 446 747
Ext
+33
Email
renaud.jardri@chru-lille.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renaud Jardri, MD, PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renaud Jardri, MD,PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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MOther-Child Interaction Assessment TRAINING for Pediatricians
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