NCT03007277

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
447

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 2, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

2.3 years

First QC Date

December 2, 2016

Last Update Submit

February 18, 2020

Conditions

Parent-Child RelationsMaltreatment by ParentParentsMental Health Wellness 1

Outcome Measures

Primary Outcomes (5)

  • Parental self-efficacy

    20-item questionnaire parental evaluating parental self efficacy and coercitive behaviors

    Child 6th month

  • Parental Stress Inventory

    Subscale "parent-child interactions"

    Child 6th month

  • Service Use

    Use of all social and health services by families

    Child 6th month

  • Accidents

    Nb of accidents and accidents leading to hospitalization in children

    Child 6th month

  • Child Maltreatment

    Number of services required within the child protection services

    Child 6th month

Secondary Outcomes (4)

  • Pacotis-Parental Impact

    Child 6th and 12th month

  • Parental Stress Inventory - Parental Distress

    Child 6th and 12th month

  • Knowledge of Infant Development Inventory (KIDI questionnaire)

    Child 6th and 12th month

  • Edinburgh Postnatal Depression Scale

    Child 6th and 12th month

Study Arms (2)

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.

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.

Other: PANJO

Interventions

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.

PANJO InterventionService as usual

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Nulliparous
  • Pregnant \<32 weeks of amenorrhea
  • Answers yes to the following question: "do you feel alone facing the upcoming changes related to your child"

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Agence Nationale de Santé Publique

Saint-Denis, 93203, France

Location

Related Publications (1)

  • 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.

    BACKGROUND

Study Officials

  • Thomas Saïas, Ph.D.

    L'Agence des Nouvelles Interventions Sociales et de Santé

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professeur

Study Record Dates

First Submitted

December 2, 2016

First Posted

January 2, 2017

Study Start

October 1, 2016

Primary Completion

February 1, 2019

Study Completion

February 1, 2019

Last Updated

February 20, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)