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Clinical Trials/NCT03300713
NCT03300713
Recruiting
Not Applicable

MOther-Child Interaction Assessment TRAINING for Pediatricians

University Hospital, Lille1 site in 1 country3,504 target enrollmentDecember 2, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Child Behavior Disorders
Sponsor
University Hospital, Lille
Enrollment
3504
Locations
1
Primary Endpoint
Frequency of pathological Alarm Distress BaBy (ADBB) scores
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2, 2017
End Date
December 2026
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Lille
Responsible Party
Sponsor

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).

Outcomes

Primary Outcomes

Frequency of pathological Alarm Distress BaBy (ADBB) scores

Time Frame: in 12-month-aged children.

Secondary Outcomes

  • Frequency of dyads referred for psychiatric or perinatal psychiatric consultations(in 4, 9, 12 and 24 month-aged children)
  • Frequency of digestive disorders(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)(at 12 and 24 months postpartum)
  • Frequency of maternal psychotropic medication(in 4, 9, 12 and 24 month-aged children)
  • Frequency of pathological Alarm Distress BaBy (ADBB) scores(in 4, 9 and 24 month-aged children)

Study Sites (1)

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