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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03007277
Other study ID # PANJO
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2016
Est. completion date February 2019

Study information

Verified date February 2020
Source L'Agence des Nouvelles Interventions Sociales et de Santé
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Description:

In translation


Recruitment information / eligibility

Status Completed
Enrollment 447
Est. completion date February 2019
Est. primary completion date February 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Nulliparous

- Pregnant <32 weeks of amenorrhea

- Answers yes to the following question: "do you feel alone facing the upcoming changes related to your child"

Exclusion Criteria:

- 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

Study Design


Intervention

Other:
PANJO
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.

Locations

Country Name City State
France Agence Nationale de Santé Publique Saint Denis

Sponsors (3)

Lead Sponsor Collaborator
L'Agence des Nouvelles Interventions Sociales et de Santé Institut national de prevention et d'education pour la sante, Université du Québec a Montréal

Country where clinical trial is conducted

France, 

References & 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.

Outcome

Type Measure Description Time frame Safety issue
Primary Parental self-efficacy 20-item questionnaire parental evaluating parental self efficacy and coercitive behaviors Child 6th month
Primary Parental Stress Inventory Subscale "parent-child interactions" Child 6th month
Primary Service Use Use of all social and health services by families Child 6th month
Primary Accidents Nb of accidents and accidents leading to hospitalization in children Child 6th month
Primary Child Maltreatment Number of services required within the child protection services Child 6th month
Secondary Pacotis-Parental Impact Subscale of parental impact self-reported Child 6th and 12th month
Secondary Parental Stress Inventory - Parental Distress Measure of Parental Distress Child 6th and 12th month
Secondary Knowledge of Infant Development Inventory (KIDI questionnaire) Measure of Knowledge of Infant Development Child 6th and 12th month
Secondary Edinburgh Postnatal Depression Scale Measure of depression in mothers Child 6th and 12th month
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