Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2026-01-01 @ 10:52 AM
Study NCT ID:
NCT06046768
Status:
UNKNOWN
Last Update Posted:
2023-09-21
First Post:
2023-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment and Remediation of Oral Disorders
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
The Consequences of Child Verbal and Eating Disorders on Family Dynamics in the Context of Ear Nose and Throat (ENT) Pathologies - Integration of Non-verbal Communication and Parental Support
Status:
UNKNOWN
Status Verified Date:
2023-09
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ERTO
Brief Summary:
As part of the Reference Center for Rare Diseases of the Robert Debré Hospital, many children have eating and verbal oral disorders. In this doctoral research, we question the psychological impact of oral disorders on the dynamics of family functioning.Our research entitled: Evaluation and Remediation of Orality Disorders (ERTO) aims to evaluate the impact of psychological care of the child and a support program for parents.
We hypothesized that this comprehensive management could contribute to improving disorders and consequently modify parental representations of the child and his disorders.
In addition, care focused on intra-family relations and communication would allow a decentralization and a repositioning of the problem of disorders within the family dynamic.
The results of this research will have concrete applications for the management of children suffering from oral disorders.
We hypothesized that this comprehensive management could contribute to improving disorders and consequently modify parental representations of the child and his disorders.
In addition, care focused on intra-family relations and communication would allow a decentralization and a repositioning of the problem of disorders within the family dynamic.
The results of this research will have concrete applications for the management of children suffering from oral disorders.
Detailed Description:
The ERTO search follows the first PREORA search. As soon as the results of the PREORA questionnaires are obtained, we would constitute a cohort of 16 children - a maximum of 32 parents and siblings. It will be extracted from participants in the PREORA study by random draw after screening eligibility according to the inclusion criteria and their desire to participate in this study.
We will study a population of children aged 18 months to 3 years, with ENT pathology, requiring surgery and invasive care.
The research consists of three stages:
T0: An inclusion interview: standardized psychological interview (recorded Stern R interview and PSI Parental Stress Scale). ""R interview"" is a questionnaire published and validated in 1989 by Stern, Robert-Tissot, Besson, et al.
It allows the evaluation of maternal representations. The Parental Stress Index (PSI), translated in Quebec by Bigras and Lafrenière, is used to detect difficulties in parent-child dyads.
T1-T5: Then a follow-up will be proposed (five psychological consultations (interviews, scales), participation in a discussion group for parents in Visio via Zoom, a speech therapy assessment and possible complementary multidisciplinary consultations) T6: Again an assessment with the T0 retest (Stern R Interview, PSI Parental Stress Scale, MCH scale). This study is a non-randomized exploratory research with two controlled groups, before/after.
Parental stress and child representation will be assessed according to the two subgroups of belonging, group A (antenatal diagnosis), group B (postnatal diagnosis), t1 (before psychological management), t2 (after 5 months of psychological management) and t3 (after one year of discussion group). Qualitative and quantitative analyses will be provided, based on variables.
We will study a population of children aged 18 months to 3 years, with ENT pathology, requiring surgery and invasive care.
The research consists of three stages:
T0: An inclusion interview: standardized psychological interview (recorded Stern R interview and PSI Parental Stress Scale). ""R interview"" is a questionnaire published and validated in 1989 by Stern, Robert-Tissot, Besson, et al.
It allows the evaluation of maternal representations. The Parental Stress Index (PSI), translated in Quebec by Bigras and Lafrenière, is used to detect difficulties in parent-child dyads.
T1-T5: Then a follow-up will be proposed (five psychological consultations (interviews, scales), participation in a discussion group for parents in Visio via Zoom, a speech therapy assessment and possible complementary multidisciplinary consultations) T6: Again an assessment with the T0 retest (Stern R Interview, PSI Parental Stress Scale, MCH scale). This study is a non-randomized exploratory research with two controlled groups, before/after.
Parental stress and child representation will be assessed according to the two subgroups of belonging, group A (antenatal diagnosis), group B (postnatal diagnosis), t1 (before psychological management), t2 (after 5 months of psychological management) and t3 (after one year of discussion group). Qualitative and quantitative analyses will be provided, based on variables.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| IDRCB: 2023-A00202-43 | REGISTRY | ANSM | View |