Emotional NeglectRESOPSYBBNCT02774863
How to Collect the Expression of Psychological Suffering of Children Under Two Years?
An observational study of Emotional Neglect, run by Nantes University Hospital at 6 sites in France.
Trial summary
Emotional Neglect (NE) is a form of abuse to the child whose prevalence is high (WHO Europe). Experiencing NE, psycho-emotional development and brain child may be impacted generating psychic suffering signs may progress to severe developmental disorders. Read more about this study
- Who is it for?
- Ages 1 year to 24 months
- Conditions the study is for
- Emotional Neglect
- What is being tested?
- Home passages
- How many people
- 6 participants
- Where
- 6 sitesFrance
- Study dates
- 23 Nov 2016to 5 Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 1 year to 24 months
- All sexes
- No healthy volunteers
- Child
Study population: Fifty children and their families (parents / guardians) will be included in the research in the department of Loire-Atlantique, coming visit to the Mother and Child Protection within the first two years of their child.
Who may be able to join
- Families say vulnerable falling M.Heaman selection criteria associated with two significant items of Q-Sort, agreeing to participate in the research project.
- Patient 24 months or less at the time of the first consultation PMI.
- Parents / legal representatives agreeing to participate in the research project.
- Non inclusion Criteria:
- Serious genetic and somatic pathologies resulting deficiency, physical pain,
- Non-French speaking families.
- Families whose baby is monitored as part of the network grow together because of their prematurity.
- Minor or major Parents Trust
Who cannot join
None listed.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Medical-social Center Dalby Millet
Nantes, 44000
Medical-Social center Bellevue
Nantes, 44100
Medical-social center Pilotière
Nantes, 44300
Medical-Social center Port Boyer
Nantes, 44300
Medical-social St-Etienne de Montluc
Saint-Étienne-de-Montluc, 44360
Medical-social Saint-Servan
Saint-Herblain, 44800
About this study
Official title: Regional Prospective Multicenter Pilot Study: How to Collect the Expression of Psychological Suffering of Children Under Two Years ?
Emotional Neglect (NE) is a form of abuse to the child whose prevalence is high (WHO Europe). Experiencing NE, psycho-emotional development and brain child may be impacted generating psychic suffering signs may progress to severe developmental disorders. The recognition of suffering can prevent and treat these disorders.
This research promotes a multi-professional device, centered on observation, collection of expression of the baby's psychic pain (≤ 2 years) living in vulnerable families. The investigators assume that this collection requires the crossing of looks of a child psychiatrist and a repeated observation at home by a trained nurse.
The two devices described in these two groups are devices set up as part of the routine management of these patients. Usually, depending on the means of structures (human and financial), one of these devices may be preferred over another.
- Conditions
- Emotional Neglect
- Being tested
- Home passages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home passagesOther
Three home passages between the 2nd and 3rd months of follow up.
| Study group | Role | What they receive |
|---|---|---|
| Group "Maternal and Child Protection" | Followed by the doctor and pediatric nurse of the Maternal and Child Protection . A child psychiatric consultation (usual care) can take place during the monitoring of this patient. | |
| Group "Home passages" | A child psychiatric consultation is scheduled in the month following the inclusion and three home passages between the 2nd and 3rd months of follow up. Receives: Other: Home passages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the sensitivity of the Global Printing-scale gravity relative to the Development Quotient (reference) between the 2 supported (Group A versus Group B).
Development Quotient level will be measured by Brunet Lezine R. This questionnaire provides an objective measure of the impact of mental suffering. It will be measured by psychomotor between the 3rd and 4th month follow up.
A child with a score of QD lower or equal 85 is considered a child with developmental impairment.
- Clinical Global Impression Severity Scale suitable for measuring the assessment of mental suffering of children less than two years is considered an indicator of the intensity of suffering. This will be assessed by a nurse between the 3rd and 4th months of follow up.
A child with a CGI-severity score between 1 and 4 inclusive shall be considered a child with developmental impairment.
Measured: up to three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study start23 Nov 2016
- Primary completion5 Jul 2017
- Study completion5 Jul 2017
Why it stopped: Not enough inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional NeglectStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02774863
- Sponsor's protocol ID
- RC15_0445
- Acronym
- RESOPSYBB
- Status last verified
- Aug 2017
- First submitted
- 11 May 2016
- Last updated
- 9 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional Prospective Multicenter Pilot Study: How to Collect the Expression of Psychological Suffering of Children Under Two Years ?
- ClinicalTrials.gov ID
- NCT02774863
- Acronym / sponsor ID
- RESOPSYBB / RC15_0445
- Conditions
- Emotional Neglect
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Not enough inclusion
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 23 Nov 2016 (actual)
- Primary completion
- 5 Jul 2017 (actual)
- Study completion
- 5 Jul 2017 (actual)
- First posted
- 17 May 2016 (estimated)
- 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.
Emotional Neglect (NE) is a form of abuse to the child whose prevalence is high (WHO Europe). Experiencing NE, psycho-emotional development and brain child may be impacted generating psychic suffering signs may progress to severe developmental disorders. The recognition of suffering can prevent and treat these disorders.
This research promotes a multi-professional device, centered on observation, collection of expression of the baby's psychic pain (≤ 2 years) living in vulnerable families. The investigators assume that this collection requires the crossing of looks of a child psychiatrist and a repeated observation at home by a trained nurse.
The two devices described in these two groups are devices set up as part of the routine management of these patients. Usually, depending on the means of structures (human and financial), one of these devices may be preferred over another.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group "Maternal and Child Protection" | – | –Followed by the doctor and pediatric nurse of the Maternal and Child Protection . A child psychiatric consultation (usual care) can take place during the monitoring of this patient. |
| Group "Home passages" | – | Other: Home passagesA child psychiatric consultation is scheduled in the month following the inclusion and three home passages between the 2nd and 3rd months of follow up. |
Who may qualify
- Ages
- 1 year to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Fifty children and their families (parents / guardians) will be included in the research in the department of Loire-Atlantique, coming visit to the Mother and Child Protection within the first two years of their child.
Key inclusion criteria (8 listed)
- Families say vulnerable falling M.Heaman selection criteria associated with two significant items of Q-Sort, agreeing to participate in the research project.
- Patient 24 months or less at the time of the first consultation PMI.
- Parents / legal representatives agreeing to participate in the research project.
- Serious genetic and somatic pathologies resulting deficiency, physical pain,
- Non-French speaking families.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Home passagesThree home passages between the 2nd and 3rd months of follow up. | Other | Group "Home passages" |
Primary outcome
Comparison of the sensitivity of the Global Printing-scale gravity relative to the Development Quotient (reference) between the 2 supported (Group A versus Group B).
Time frame: up to three months
Development Quotient level will be measured by Brunet Lezine R. This questionnaire provides an objective measure of the impact of mental suffering. It will be measured by psychomotor between the 3rd and 4th month follow up. A child with a score of QD lower or equal 85 is considered a child with developmental impairment. - Clinical Global Impression Severity Scale suitable for measuring the assessment of mental suffering of children less than two years is considered an indicator of the intensity of suffering. This will be assessed by a nurse between the 3rd and 4th months of follow up. A child with a CGI-severity score between 1 and 4 inclusive shall be considered a child with developmental impairment.
Results and safety
The study was stopped early (reason given: Not enough inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2017.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emotional Neglect, run by Nantes University Hospital at 6 sites 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 8 inclusion and 0 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: stopped early, as of the sponsor's last update on 9 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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. 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?
The study was stopped early (reason given: Not enough inclusion). Results are not available in the source record.
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?
Comparison of the sensitivity of the Global Printing-scale gravity relative to the Development Quotient (reference) between the 2 supported (Group A versus Group B). (time frame: up to three months). 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 9 Aug 2017.