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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
First received
Last updated
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
Health authority
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).

Study Design


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
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