MOther-Child Interaction Assessment TRAINING for Pediatricians (MOCITRAINING)

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.

Study Overview

• Status: Recruiting
• Conditions: Depression, Postpartum; Mother-child Relations; Child Behavior Disorders
• Intervention / Treatment: Other: MOCITRAINING program; Other: usual follow-up

• Study Type: Interventional
• Enrollment (Anticipated): 3504
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Renaud Jardri, MD,PhD; Phone Number: +33 (0) 320 446 747; Email: renaud.jardri@chru-lille.fr

Study Locations

• France
  • Lille, France
    • Recruiting
    • CHU
    • Principal Investigator: Renaud Jardri, MD,PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 weeks to 1 month (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: F+ group (Mocitraining program); 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.	Other: MOCITRAINING program; 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.
Sham Comparator: F- group (usual follow-up); grouping 8 pediatricians' clusters. They will not receive the initial training on early interactional disorders and PND screening	Other: usual follow-up; usual follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Frequency of pathological Alarm Distress BaBy (ADBB) scores	in 12-month-aged children.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of pathological Alarm Distress BaBy (ADBB) scores		in 4, 9 and 24 month-aged children
Frequency of digestive disorders	presence/absence of infantile regurgitations and colics	in 4, 9, 12 and 24 month-aged children
Number of daytime sleep hours		in 4, 9, 12 and 24 month-aged children
Number of nighttime awakenings		in 4, 9, 12 and 24 month-aged children
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)	at 12 and 24 months postpartum
Frequency of dyads referred for psychiatric or perinatal psychiatric consultations		in 4, 9, 12 and 24 month-aged children
Frequency of maternal psychotropic medication		in 4, 9, 12 and 24 month-aged children

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Collaborators: Ministry of Health, France
• Investigators: Principal Investigator: Renaud Jardri, MD, PhD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2017
• Primary Completion (Anticipated): December 1, 2026
• Study Completion (Anticipated): December 1, 2026

Study Registration Dates

• First Submitted: September 28, 2017
• First Submitted That Met QC Criteria: September 28, 2017
• First Posted (Actual): October 3, 2017

Study Record Updates

• Last Update Posted (Actual): October 3, 2022
• Last Update Submitted That Met QC Criteria: September 30, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Mass screening; Pediatrician training
• Additional Relevant MeSH Terms: Mood Disorders; Pregnancy Complications; Puerperal Disorders; Neurodevelopmental Disorders; Depressive Disorder; Mental Disorders; Depression, Postpartum; Child Behavior Disorders
• Other Study ID Numbers: 2015_04; 2016-A00540-51 (Other Identifier: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No