MOther-Child Interaction Assessment TRAINING for Pediatricians

NCT ID: NCT03300713

Last Updated: 2022-10-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 3504 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-02
• Study Completion Date: 2026-12-31

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.

Conditions

Child Behavior Disorders; Mother-child Relations; Depression, Postpartum

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

MOCITRAINING program

Intervention Type: OTHER

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.

F- group (usual follow-up)

grouping 8 pediatricians' clusters. They will not receive the initial training on early interactional disorders and PND screening

Group Type: SHAM_COMPARATOR

usual follow-up

Intervention Type: OTHER

usual follow-up

Interventions

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.

Intervention Type: OTHER

usual follow-up

usual follow-up

Intervention Type: OTHER

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).

• Minimum Eligible Age: 23 Days
• Maximum Eligible Age: 37 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, France

OTHER_GOV

Sponsor Role: collaborator

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Renaud Jardri, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

CHU

Lille, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Renaud Jardri, MD,PhD

Role: CONTACT

renaud.jardri@chru-lille.fr

(0) 320 446 747 ext. +33

Other Identifiers

2016-A00540-51

Identifier Type: OTHER

Identifier Source: secondary_id

2015_04

Identifier Type: -

Identifier Source: org_study_id