MOther-Child Interaction Assessment TRAINING for Pediatricians

Depression, Postpartum Clinical Trial

— MOCITRAINING  

Official title:

MOther-Child Interaction Assessment TRAINING for Pediatricians

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03300713
• Other study ID #: 2015_04
• Secondary ID: 2016-A00540-51
• Status: Recruiting
• Phase: N/A
• Start date: December 2, 2017
• Est. completion date: December 2026

Study information

• Verified date: September 2022
• Source: University Hospital, Lille
• Contact: Renaud Jardri, MD,PhD
• Phone: (0) 320 446 747
• Email: renaud.jardri[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3504
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 23 Days to 37 Days

Eligibility

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).

Related Conditions & MeSH terms

• Child Behavior Disorders
• Depression, Postpartum
• Mental Disorders
• Mother-child Relations

Intervention

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.
• usual follow-up
usual follow-up

Locations

Country	Name	City	State
France	CHU	Lille

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

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