Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02895126 |
| Other study ID # |
9237 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 4, 2014 |
| Est. completion date |
October 18, 2022 |
Study information
| Verified date |
September 2023 |
| Source |
University Hospital, Montpellier |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
In so-called at risk families, the child-parent attachment relationship is more difficult to
set up and this can be a barrier to social and emotional development of young children. To
help parents build and sustain this relationship, and to prevent child development disorders,
many parenting programs have been created, usually with frequent home visits by early
childhood professionals. In France, therapeutic interventions at home are little used and
they are not evaluated.
In Montpellier, an action of this type has been conducted since 2001 by the "Conseil
Départemental de l'Hérault" in collaboration with the University Hospital of Montpellier
including, in addition to home visits, supervision of professionals: the Appui Parental
Program.
Before extending this action to other areas of Herault, the "Conseil Départemental de
l'Hérault", the "Abri Languedocien" and the University Hospital of Montpellier are conducting
an assessment to know the effectiveness of the program for families under care.
This 3-year multicenter prospective study includes 88 children aged 1 to 20 months from
families meeting vulnerability criteria previously defined, 44 benefiting Appui Parental
program (experimental group) and 44 benefiting a regular support (control group).
A paediatric examination on the basis of the Denver scale, parental questionnaires,
questionnaires to professionals and an a video of infant-parent interactions are used. The
data, collected at baseline and 18 months later, will be compared.
Description:
Objective: the main objective of this study is to determine the efficiency of Appui Parental
program by evaluating its impact on the development of children aged from 0 to 3 years. The
secondary objectives are to study the effects of the intervention on: the mother-child
interactions, the degree of therapeutic alliance between parent and professionals, the
parenting skills feeling, perceived social support, anxiety and depression of parents,
frequency of legal interventions (placements, educational measures). An assessment of stress
among professionals involved in the study and evaluation of the therapeutic alliance with
families will also be conducted to assess the effectiveness of the supervision included in
the program.
Hypothesis: Scores on Symptom Check List after 18 months of follow up will be significantly
higher in subjects who benefited the Appui Parental program compared to subjects with
conventional parental support. Similarly, it is expected that other developmental assessments
of children have the best results in the Appui Parental Program group than in the control
group. Finally, it is assumed that the mother-child interactions, the parenting skills
feeling, and the therapeutic alliance between parent and professional are better in the Appui
Parental program than in the control group.
