Child Behavior DisordersMOCITRAININGNCT03300713
MOther-Child Interaction Assessment TRAINING for Pediatricians
A study testing MOCITRAINING program and usual follow-up in people with Child Behavior Disorders and Mother-child Relations, run by University Hospital, Lille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 23 to 37 days
- Conditions the study is for
- Child Behavior Disorders, Mother-child Relations, Depression, Postpartum
- What is being tested?
- MOCITRAINING program and usual follow-up
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,504 participants
- Where
- 1 siteFrance
- Study dates
- 2 Dec 2017to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 37 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- MOCITRAINING program, usual follow-up
- Keywords
- Mass screening, Pediatrician training
- Medical subject headings
- Child Behavior Disorders, Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOCITRAINING programOther
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-upOther
usual follow-up
| Study group | Role | What they receive |
|---|---|---|
| F+ group (Mocitraining program) | Experimental | 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. Receives: Other: MOCITRAINING program |
| F- group (usual follow-up) | Sham comparator | grouping 8 pediatricians' clusters. They will not receive the initial training on early interactional disorders and PND screening Receives: Other: usual follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of pathological Alarm Distress BaBy (ADBB) scores
Measured: in 12-month-aged children.
Secondary outcomes (7)
Frequency of pathological Alarm Distress BaBy (ADBB) scores
Measured: in 4, 9 and 24 month-aged children
Frequency of digestive disorders
presence/absence of infantile regurgitations and colics
Measured: in 4, 9, 12 and 24 month-aged children
Number of daytime sleep hours
Measured: in 4, 9, 12 and 24 month-aged children
Number of nighttime awakenings
Measured: 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)
Measured: at 12 and 24 months postpartum
Frequency of dyads referred for psychiatric or perinatal psychiatric consultations
Measured: in 4, 9, 12 and 24 month-aged children
Frequency of maternal psychotropic medication
Measured: in 4, 9, 12 and 24 month-aged children
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start2 Dec 2017
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child Behavior DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,504 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Renaud Jardri, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03300713
- Sponsor's protocol ID
- 2015_04
- Other IDs
- 2016-A00540-51
- Acronym
- MOCITRAINING
- Status last verified
- May 2026
- First submitted
- 28 Sep 2017
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MOther-Child Interaction Assessment TRAINING for Pediatricians
- ClinicalTrials.gov ID
- NCT03300713
- Acronym / sponsor ID
- MOCITRAINING / 2015_04
- Keywords
- Mass screening, Pediatrician training
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,504 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 2 Dec 2017 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 3 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| F+ group (Mocitraining program) | Experimental | Other: MOCITRAINING programincluding 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. |
| F- group (usual follow-up) | Sham comparator | Other: usual follow-upgrouping 8 pediatricians' clusters. They will not receive the initial training on early interactional disorders and PND screening |
Who may qualify
- Ages
- 23 to 37 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MOCITRAINING programThe 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. | Other | F+ group (Mocitraining program) |
| usual follow-upusual follow-up | Other | F- group (usual follow-up) |
Primary outcome
Frequency of pathological Alarm Distress BaBy (ADBB) scores
Time frame: in 12-month-aged children.
7 secondary outcomes
Frequency of pathological Alarm Distress BaBy (ADBB) scores
Time frame: in 4, 9 and 24 month-aged children
Frequency of digestive disorders
Time frame: in 4, 9, 12 and 24 month-aged children
Number of daytime sleep hours
Time frame: in 4, 9, 12 and 24 month-aged children
Number of nighttime awakenings
Time frame: in 4, 9, 12 and 24 month-aged children
Scores on maternal self-evaluation scales (Likert scales)
Time frame: at 12 and 24 months postpartum
Frequency of dyads referred for psychiatric or perinatal psychiatric consultations
Time frame: in 4, 9, 12 and 24 month-aged children
Frequency of maternal psychotropic medication
Time frame: in 4, 9, 12 and 24 month-aged children
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renaud Jardri, MD, PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MOCITRAINING program and usual follow-up in people with Child Behavior Disorders and Mother-child Relations, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of pathological Alarm Distress BaBy (ADBB) scores (time frame: in 12-month-aged children.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.