Parent-Child RelationsPANJONCT03007277
Evaluation of the French Maternal and Child Protection Services From 11 French Territories That Have Received Common Intervention Guidelines
A study testing PANJO in people with Parent-Child Relations and Maltreatment by Parent, run by L'Agence des Nouvelles Interventions Sociales et de Santé at 1 site in France.
Trial summary
The PANJO study aims to evaluate, within the French public health services, the impact of a home visitors training on parent-child attachment, families outcomes, use of services and child maltreatment indicators. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Parent-Child Relations, Maltreatment by Parent, Parents
- What is being tested?
- PANJO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 447 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2016to Feb 2019
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Nulliparous
- Pregnant <32 weeks of amenorrhea
- Answers yes to the following question: "do you feel alone facing the upcoming changes related to your child"
Who cannot join
- Intends to move outside the area in which she can receive the intervention
- Sees a psychologist or psychiatrist at least once per week
- Refuses to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation de l'Intervention Des Services de Protection Maternelle et Infantile de 11 départements français Ayant bénéficié d'un référentiel Commun d'Intervention à Domicile (Projet Panjo : Promotion de la Santé et de l'Attachement Des Nouveau-nés et de Leurs Jeunes Parents : un Outil de Renforcement Des Services de PMI)
The PANJO study aims to evaluate, within the French public health services, the impact of a home visitors training on parent-child attachment, families outcomes, use of services and child maltreatment indicators.
Read the detailed description
In translation
- Being tested
- PANJO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PANJOOther
PANJO consists on a 6 to 12 home visitation intervention aiming at supporting the parents, supporting their upcoming then relationship with their first newbord child and to help them reaching all services they may need.
| Study group | Role | What they receive |
|---|---|---|
| PANJO Intervention | Experimental | 201 nulliparous women will be recruited within the PMI public services. Nurses/Midwives will propose to enroll in the PANJO group, which consist in receiving 6 to 12 home visits by a home visitor trained by the PANJO team The visits will consist on 45 to 90-minutes interventions aiming at supporting the family in the everyday challenges they may encounter, and to support the development of qualitative parent-child relationships. Receives: Other: PANJO |
| Service as usual | Active comparator | 246 nulliparous women will be recruited within several maternity wards. They will recieve the services they may request from (a) the maternities, (b) the maternal and child protection services (PMI, usually 1 or 2 home visit without any standards) or any other service available. They will be provided with the address and telephone of the closest maternity ward. Receives: Other: PANJO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental self-efficacy
20-item questionnaire parental evaluating parental self efficacy and coercitive behaviors
Measured: Child 6th month
Parental Stress Inventory
Subscale "parent-child interactions"
Measured: Child 6th month
Service Use
Use of all social and health services by families
Measured: Child 6th month
Accidents
Nb of accidents and accidents leading to hospitalization in children
Measured: Child 6th month
Child Maltreatment
Number of services required within the child protection services
Measured: Child 6th month
Secondary outcomes (4)
Pacotis-Parental Impact
Subscale of parental impact self-reported
Measured: Child 6th and 12th month
Parental Stress Inventory - Parental Distress
Measure of Parental Distress
Measured: Child 6th and 12th month
Knowledge of Infant Development Inventory (KIDI questionnaire)
Measure of Knowledge of Infant Development
Measured: Child 6th and 12th month
Edinburgh Postnatal Depression Scale
Measure of depression in mothers
Measured: Child 6th and 12th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2017 (estimated)
- Study startOct 2016
- Primary completionFeb 2019
- Study completionFeb 2019
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 Parent-Child RelationsStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 447 participants (actual)
Sponsor and investigators
- Lead sponsor
- L'Agence des Nouvelles Interventions Sociales et de Santé
- Sponsor type
- University, hospital or other
- Collaborators
- Institut national de prevention et d'education pour la sante, Université du Québec a Montréal
- Responsible party
- Principal investigator, Thomas Saias, L'Agence des Nouvelles Interventions Sociales et de Santé
- Investigators
- Thomas Saïas, Ph.D., Principal investigator, L'Agence des Nouvelles Interventions Sociales et de Santé
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03007277
- Sponsor's protocol ID
- PANJO
- Acronym
- PANJO
- Status last verified
- Feb 2020
- First submitted
- 2 Dec 2016
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Saïas, T, Delawarde, C, Colson, S, Planche, M, Vallée, V, Du Roscoät, E, Bonnard, A, Bodard, J, Dugravier, R. De l'expérimentation scientifique à l'implantation dans les services publics : le projet Panjo. Revue Francophone Internationale de Recherche Infirmière, 2 : 232-241, 2016.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation de l'Intervention Des Services de Protection Maternelle et Infantile de 11 départements français Ayant bénéficié d'un référentiel Commun d'Intervention à Domicile (Projet Panjo : Promotion de la Santé et de l'Attachement Des Nouveau-nés et de Leurs Jeunes Parents : un Outil de Renforcement Des Services de PMI)
- ClinicalTrials.gov ID
- NCT03007277
- Acronym / sponsor ID
- PANJO / PANJO
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 447 participants (actual)
- Lead sponsor
- L'Agence des Nouvelles Interventions Sociales et de SantéUniversity, hospital or other
- Collaborators
- Institut national de prevention et d'education pour la sante, Université du Québec a Montréal
- Study start
- Oct 2016
- Primary completion
- Feb 2019 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 2 Jan 2017 (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.
The PANJO study aims to evaluate, within the French public health services, the impact of a home visitors training on parent-child attachment, families outcomes, use of services and child maltreatment indicators.
Detailed description
In translation
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PANJO Intervention | Experimental | Other: PANJO201 nulliparous women will be recruited within the PMI public services. Nurses/Midwives will propose to enroll in the PANJO group, which consist in receiving 6 to 12 home visits by a home visitor trained by the PANJO team The visits will consist on 45 to 90-minutes interventions aiming at supporting the family in the everyday challenges they may encounter, and to support the development of qualitative parent-child relationships. |
| Service as usual | Active comparator | Other: PANJO246 nulliparous women will be recruited within several maternity wards. They will recieve the services they may request from (a) the maternities, (b) the maternal and child protection services (PMI, usually 1 or 2 home visit without any standards) or any other service available. They will be provided with the address and telephone of the closest maternity ward. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Nulliparous
- Pregnant <32 weeks of amenorrhea
- Answers yes to the following question: "do you feel alone facing the upcoming changes related to your child"
Key exclusion criteria (3 listed)
- Intends to move outside the area in which she can receive the intervention
- Sees a psychologist or psychiatrist at least once per week
- Refuses to participate
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 |
|---|---|---|
| PANJOPANJO consists on a 6 to 12 home visitation intervention aiming at supporting the parents, supporting their upcoming then relationship with their first newbord child and to help them reaching all services they may need. | Other | PANJO Intervention, Service as usual |
Primary outcome
Parental self-efficacy
Time frame: Child 6th month
20-item questionnaire parental evaluating parental self efficacy and coercitive behaviors
Parental Stress Inventory
Time frame: Child 6th month
Subscale "parent-child interactions"
Service Use
Time frame: Child 6th month
Use of all social and health services by families
Accidents
Time frame: Child 6th month
Nb of accidents and accidents leading to hospitalization in children
Child Maltreatment
Time frame: Child 6th month
Number of services required within the child protection services
4 secondary outcomes
Pacotis-Parental Impact
Time frame: Child 6th and 12th month
Parental Stress Inventory - Parental Distress
Time frame: Child 6th and 12th month
Knowledge of Infant Development Inventory (KIDI questionnaire)
Time frame: Child 6th and 12th month
Edinburgh Postnatal Depression Scale
Time frame: Child 6th and 12th month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- BackgroundSaïas, T, Delawarde, C, Colson, S, Planche, M, Vallée, V, Du Roscoät, E, Bonnard, A, Bodard, J, Dugravier, R. De l'expérimentation scientifique à l'implantation dans les services publics : le projet Panjo. Revue Francophone Internationale de Recherche Infirmière, 2 : 232-241, 2016.
- 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.
Thomas Saïas, Ph.D. principal investigator
L'Agence des Nouvelles Interventions Sociales et de Santé
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PANJO in people with Parent-Child Relations and Maltreatment by Parent, run by L'Agence des Nouvelles Interventions Sociales et de Santé 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 3 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: finished, as of the sponsor's last update on 20 Feb 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Parental self-efficacy (time frame: Child 6th month). The study lists 5 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 NCT03007277, 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 20 Feb 2020.