Development, InfantPERLNCT03506971
Early Childhood : Action Research in the Lunévillois Area (PERL)
A study testing Psychologist's evaluation, Pediatric Nurse's interventions and Joint home visits in people with Development, Infant and Perinatal Disorder, run by Centre Psychothérapique de Nancy at 1 site in France.
Trial summary
The PERL project is a research in prevention in perinatality. The objective of this research is to offer preventive and regular care at familie's home in the Lunévillois area, while integrating it into the existing practices of the maternal and child protection, in the framework of a partnership between the PMI… Read more about this study
- Who is it for?
- Ages 1 minute to 15 daysHealthy volunteers can take part
- Conditions the study is for
- Development, Infant, Perinatal Disorder
- What is being tested?
- Psychologist's evaluation, Pediatric Nurse's interventions and Joint home visits
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteFrance
- Study dates
- 10 Sep 2018to 31 Jan 2024
- Phase
- Interventional
- 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 minute to 15 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parents living in the Lunevillois area
- Mother to be 8 months pregnant
- Baby who's born from january to december 2018
Who cannot join
- No exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluate the Effects of a Preventive Care at Home on Young Child's Development
The PERL project is a research in prevention in perinatality. The objective of this research is to offer preventive and regular care at familie's home in the Lunévillois area, while integrating it into the existing practices of the maternal and child protection, in the framework of a partnership between the PMI (Protection Maternal Infantile) and the child psychiatry.
An innovative prevention device to support the interactions and development of the child will be proposed to about sixty families, randomly recruited into the general population.
Read more
If the family agrees to participate, their will benefit from regular home visits by a pediatric nurse, accompanied on certain times by a psychologist, for a period of 4 years from the birth of the child.
This home-visits accompaniment, centered on listening and observation, focuses on three areas: baby's development, parenthood and parent-child's interactions.
A longitudinal and comparative evaluation will be carried out with a "control" group recruited according to the same conditions and at the same time as the "participants" group.
A parallel research on the processes and mechanism will be carried out in partnership with the School of Public Health in order to define and validate the intervention theory (what are the mobilized levers produced and how, what are the mechanisms linking the intervention to its results), to describe the implementation and the processes involved, and to analyze the effects of context, especially social, on processes and results.
- Conditions
- Development, Infant, Perinatal Disorder
- Being tested
- Psychologist's evaluation, Pediatric Nurse's interventions, Joint home visits
- Keywords
- Young child's development, Home visits, Early interactions, attachment, parenthood
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychologist's evaluationOther
The research coordinator psychologist will evaluate: the development of the baby, the early interactions between the baby and his mother, attachment, maternal psychiatric symptoms, the experience of parenting and maternal sensitivity.
Pediatric Nurse's interventionsOther
Pediatrics nurses perform preventive home visits that are based on : joint observation with the parents of the baby, play with the baby and his parents, interview with the parents on their parenthood
Rhythm of home visits:
- 1 every month from birth to 1 year
- 1 every 2 months from 1 year to 2 years
- 1 every 3 months from 2 years to 4 years
Joint home visitsOther
Coordinating psychologist and the referent pediatric nurse will perform home visits. During this time, the psychologist evaluate : the development of the baby, the early interactions between the baby and his mother, attachment, maternal psychiatric symptoms, the experience of parenting and maternal sensitivity.
Rhythm of joint home visits:
- 1 at 4 months
- 1 at 24 months
| Study group | Role | What they receive |
|---|---|---|
| Participants | Experimental | As part of this research, families will benefit from
* "pediatric nurse's interventions" : home visits by a pediatric nurse who will center around three times: a time of observation of the development and progress of the baby, a time for play with the baby and a time to listening the parents.
* "psychologist's evaluation" and "joint home visits" : home visits by the coordinating psychologist to evaluate three areas: child development, parenthood and parent-child interaction. Receives: Other: Pediatric Nurse's interventions; Other: Joint home visits |
| Control | Other | "psychologist's evaluation" : home visits by the coordinating psychologist to evaluate three areas: child development, parenthood and parent-child interaction. Receives: Other: Psychologist's evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brunet-Lézine-revised test : assessment of change between 3 and 24 months and between two groups of the study.
Assessment of children psychomotor development. This test can be used at any time from the age of 0 to 30 months
Measured: 3 and 24 months
ADBB (Alarm Distress BaBy) : assessment of change between 3 and 24 months and between two groups of the study.
Filmed evaluation of relational withdrawal of young children. This evaluation can be used at any time from the age of 2 to 24 months
Measured: 3 and 24 months
EPDS : Edinburgh Postnatal Depression Scale
The Edinburgh Postnatal Depression Scale (EPDS) is a set of 10 screening questions that can indicate whether a parent has symptoms that are common in women with depression and anxiety during pregnancy and in the year following the birth of a child.
To complete this set of questions, the parent should select the number next to the response that comes closest to how they have felt in the past seven days.
The total score is calculated by adding the numbers selected for each of the 10 items. If the parent's score is 10 points or above, they should speak to a health professional about those symptoms.
Measured: 3 months
ERP (Entretien sur les représentations Parentales, no traduction for acronym): assessment of change between 3 and 24 months and between two groups of the study.
Interview on Parent's Representations
Measured: 3 and 24 months
ERTL 4 : Epreuve de repérage des Troubles du Langage = French questionnaire. No traduction for acronym
Test of Spotting of language delays at 4 years, carried out in a systematic way by the teams of maternal and child protection
Measured: 4 YEARS
Q-SORT attachment
Q-SORT for evaluate the attachment
Measured: 24 months
Mini-MBQS (Maternal Behavior Q-Sort ) : assessment of change between 3 and 24 months and between two groups of the study.
25 items to obtain an assessment of global maternal sensitivity
Measured: 3 and 24 Months
BDI : Beck Depression Inventory (13 items)
This is a multiple-choice self-report inventory for measuring the severity of depression
Measured: 24 Months
SCL-90R (Symptom Checklist-90-R) : assessment of change between 3 and 24 months and between two groups of the study.
Symptom check-list, self-assessment questionnaire for psychiatric symptoms
Measured: 3 and 24 Months
BITSEA : Brief Infant Toddler Social and Emotional Assessment
Early screening of social and emotional difficulties or developmental delays for children. This assessment can be used at any time from the age of 12 to 36 months.
Measured: 24 months
HAQ : Helping Alliance Questionnaire
Evaluate the therapeutic alliance
Measured: 3 months
HAQ
Helping Alliance Questionnaire, to evaluate the therapeutic alliance
Measured: 24 months
Bobigny's early childhood interactions assessment
It's an assessment of early childhood interactions baby-mother
Measured: 3 months
Bobigny's early childhood interactions assessment
It's an assessment of early childhood interactions baby-mother
Measured: 24 months
Secondary outcomes (1)
FAS : Family Affluence Scale
Small questionnaire to describe family's affluence. 4 questions asked : How many computers do you have at home ? (none, 1, 2, more than 2) / Do you have a car at home? (no, 1, 2 or more) / Do you have your own bedroom at home? (yes, no) / For the last 12 months, how many times have you travelled with your family for holidays? (never, once, twice, more than twice) Assessment of change will be done between 3 and 24 months and between two groups of the study
Measured: 3 and 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2018
- Study start10 Sep 2018
- Primary completion14 Mar 2022
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Development, InfantStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Psychothérapique de Nancy
- Sponsor type
- University, hospital or other
- Collaborators
- Conseil Départemental, Protection Maternelle Infantile :PMI, France, Agence Regionale de Sante d'Ile de France, Family Allowance Fund, France
- Responsible party
- Sponsor
- Investigators
- Sophie BUCHHEIT, Principal investigator, Centre Psychothérapique de Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03506971
- Sponsor's protocol ID
- RIPH 2017-01
- Other IDs
- IDRCB 2017-A00896-47
- Acronym
- PERL
- Status last verified
- Sep 2023
- First submitted
- 16 Feb 2018
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Buchheit S, Kabuth B, Colombo MC, Ligier F. Child Development and Early Interaction: PERL Research Protocol, a Preventive Home Visiting Program, Randomized Controlled Trial in France. Front Psychiatry. 2021 Jun 30;12:641468. doi: 10.3389/fpsyt.2021.641468. eCollection 2021.
PubMed 34276432
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Effects of a Preventive Care at Home on Young Child's Development
- ClinicalTrials.gov ID
- NCT03506971
- Acronym / sponsor ID
- PERL / RIPH 2017-01
- Conditions
- Development, Infant, Perinatal Disorder
- Keywords
- Young child's development, Home visits, Early interactions, attachment, parenthood
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Centre Psychothérapique de NancyUniversity, hospital or other
- Collaborators
- Conseil Départemental, Protection Maternelle Infantile :PMI, France, Agence Regionale de Sante d'Ile de France, Family Allowance Fund, France
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- 14 Mar 2022 (actual)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 24 Apr 2018 (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 PERL project is a research in prevention in perinatality. The objective of this research is to offer preventive and regular care at familie's home in the Lunévillois area, while integrating it into the existing practices of the maternal and child protection, in the framework of a partnership between the PMI (Protection Maternal Infantile) and the child psychiatry.
An innovative prevention device to support the interactions and development of the child will be proposed to about sixty families, randomly recruited into the general population.
If the family agrees to participate, their will benefit from regular home visits by a pediatric nurse, accompanied on certain times by a psychologist, for a period of 4 years from the birth of the child.
This home-visits accompaniment, centered on listening and observation, focuses on three areas: baby's development, parenthood and parent-child's interactions.
A longitudinal and comparative evaluation will be carried out with a "control" group recruited according to the same conditions and at the same time as the "participants" group.
A parallel research on the processes and mechanism will be carried out in partnership with the School of Public Health in order to define and validate the intervention theory (what are the mobilized levers produced and how, what are the mechanisms linking the intervention to its results), to describe the implementation and the processes involved, and to analyze the effects of context, especially social, on processes and results.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants | Experimental | Other: Pediatric Nurse's interventions, Other: Joint home visitsAs part of this research, families will benefit from * "pediatric nurse's interventions" : home visits by a pediatric nurse who will center around three times: a time of observation of the development and progress of the baby, a time for play with the baby and a time to listening the parents. * "psychologist's evaluation" and "joint home visits" : home visits by the coordinating psychologist to evaluate three areas: child development, parenthood and parent-child interaction. |
| Control | Other | Other: Psychologist's evaluation"psychologist's evaluation" : home visits by the coordinating psychologist to evaluate three areas: child development, parenthood and parent-child interaction. |
Who may qualify
- Ages
- 1 minute to 15 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Parents living in the Lunevillois area
- Mother to be 8 months pregnant
- Baby who's born from january to december 2018
Key exclusion criteria (1 listed)
- No exclusion criteria
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 |
|---|---|---|
| Psychologist's evaluationThe research coordinator psychologist will evaluate: the development of the baby, the early interactions between the baby and his mother, attachment, maternal psychiatric symptoms, the experience of parenting and maternal sensitivity. | Other | Control |
| Pediatric Nurse's interventionsPediatrics nurses perform preventive home visits that are based on : joint observation with the parents of the baby, play with the baby and his parents, interview with the parents on their parenthood Rhythm of home visits: * 1 every month from birth to 1 year * 1 every 2 months from 1 year to 2 years * 1 every 3 months from 2 years to 4 years | Other | Participants |
| Joint home visitsCoordinating psychologist and the referent pediatric nurse will perform home visits. During this time, the psychologist evaluate : the development of the baby, the early interactions between the baby and his mother, attachment, maternal psychiatric symptoms, the experience of parenting and maternal sensitivity. Rhythm of joint home visits: * 1 at 4 months * 1 at 24 months | Other | Participants |
Primary outcome
Brunet-Lézine-revised test : assessment of change between 3 and 24 months and between two groups of the study.
Time frame: 3 and 24 months
Assessment of children psychomotor development. This test can be used at any time from the age of 0 to 30 months
ADBB (Alarm Distress BaBy) : assessment of change between 3 and 24 months and between two groups of the study.
Time frame: 3 and 24 months
Filmed evaluation of relational withdrawal of young children. This evaluation can be used at any time from the age of 2 to 24 months
EPDS : Edinburgh Postnatal Depression Scale
Time frame: 3 months
The Edinburgh Postnatal Depression Scale (EPDS) is a set of 10 screening questions that can indicate whether a parent has symptoms that are common in women with depression and anxiety during pregnancy and in the year following the birth of a child. To complete this set of questions, the parent should select the number next to the response that comes closest to how they have felt in the past seven days. The total score is calculated by adding the numbers selected for each of the 10 items. If the parent's score is 10 points or above, they should speak to a health professional about those symptoms.
ERP (Entretien sur les représentations Parentales, no traduction for acronym): assessment of change between 3 and 24 months and between two groups of the study.
Time frame: 3 and 24 months
Interview on Parent's Representations
ERTL 4 : Epreuve de repérage des Troubles du Langage = French questionnaire. No traduction for acronym
Time frame: 4 YEARS
Test of Spotting of language delays at 4 years, carried out in a systematic way by the teams of maternal and child protection
Q-SORT attachment
Time frame: 24 months
Q-SORT for evaluate the attachment
Mini-MBQS (Maternal Behavior Q-Sort ) : assessment of change between 3 and 24 months and between two groups of the study.
Time frame: 3 and 24 Months
25 items to obtain an assessment of global maternal sensitivity
BDI : Beck Depression Inventory (13 items)
Time frame: 24 Months
This is a multiple-choice self-report inventory for measuring the severity of depression
SCL-90R (Symptom Checklist-90-R) : assessment of change between 3 and 24 months and between two groups of the study.
Time frame: 3 and 24 Months
Symptom check-list, self-assessment questionnaire for psychiatric symptoms
BITSEA : Brief Infant Toddler Social and Emotional Assessment
Time frame: 24 months
Early screening of social and emotional difficulties or developmental delays for children. This assessment can be used at any time from the age of 12 to 36 months.
HAQ : Helping Alliance Questionnaire
Time frame: 3 months
Evaluate the therapeutic alliance
HAQ
Time frame: 24 months
Helping Alliance Questionnaire, to evaluate the therapeutic alliance
Bobigny's early childhood interactions assessment
Time frame: 3 months
It's an assessment of early childhood interactions baby-mother
Bobigny's early childhood interactions assessment
Time frame: 24 months
It's an assessment of early childhood interactions baby-mother
1 secondary outcome
FAS : Family Affluence Scale
Time frame: 3 and 24 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- Derived from this study: PubMed 34276432Buchheit S, Kabuth B, Colombo MC, Ligier F. Child Development and Early Interaction: PERL Research Protocol, a Preventive Home Visiting Program, Randomized Controlled Trial in France. Front Psychiatry. 2021 Jun 30;12:641468. doi: 10.3389/fpsyt.2021.641468. eCollection 2021.
- 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.
Sophie BUCHHEIT principal investigator
Centre Psychothérapique de Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychologist's evaluation, Pediatric Nurse's interventions and Joint home visits in people with Development, Infant and Perinatal Disorder, run by Centre Psychothérapique de Nancy 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 5 Sep 2023. 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. 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?
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?
Brunet-Lézine-revised test : assessment of change between 3 and 24 months and between two groups of the study. (time frame: 3 and 24 months). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03506971, which also lists 1 linked publication.
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 5 Sep 2023.