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Assessment and Remediation of Oral Disorders (ERTO)

Primary Purpose

Oral Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Psychological care
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Oral Disorder focused on measuring parental stress, ENT pathology

Eligibility Criteria

18 Months - 3 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Child (boy or girl) with oral feeding disorder(s) diagnosed by a speech therapist as part of a speech therapy assessment Patients under ENT care at Robert Debré Hospital Children aged 18 months to 3 years French-speaking parents Living at home in France Affiliation with a social security scheme or entitled beneficiary Informed consent signed by both parents Exclusion Criteria: Pathologies predominantly associated with ENT pathology Neurological disorders Deafness

Sites / Locations

  • Robert Debre Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Child with oral feeding disorder(s)

Arm Description

Child (boy or girl) with oral feeding disorder(s) diagnosed by a speech therapist as part of a speech therapy assessment.

Outcomes

Primary Outcome Measures

Parental stress and child representation
Montreal children's Hospital scale. Parental stress and child representation will be assessed by three times t1 (before psychological management), t2 (after 5 months of psychological management) and t3 (after one year of discussion group).

Secondary Outcome Measures

Full Information

First Posted
September 12, 2023
Last Updated
September 19, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT06046768
Brief Title
Assessment and Remediation of Oral Disorders
Acronym
ERTO
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Disorder
Keywords
parental stress, ENT pathology

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
To evaluate the impact of psychological treatment on the improvement of oral disorders perceived by parents in their child.
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Child with oral feeding disorder(s)
Arm Type
Experimental
Arm Description
Child (boy or girl) with oral feeding disorder(s) diagnosed by a speech therapist as part of a speech therapy assessment.
Intervention Type
Other
Intervention Name(s)
Psychological care
Intervention Description
Psychological consultations (interviews, scales), participation in a discussion group for parents in Visio via Zoom, a speech therapy assessment and possible complementary multidisciplinary consultations)
Primary Outcome Measure Information:
Title
Parental stress and child representation
Description
Montreal children's Hospital scale. Parental stress and child representation will be assessed by three times t1 (before psychological management), t2 (after 5 months of psychological management) and t3 (after one year of discussion group).
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Child (boy or girl) with oral feeding disorder(s) diagnosed by a speech therapist as part of a speech therapy assessment Patients under ENT care at Robert Debré Hospital Children aged 18 months to 3 years French-speaking parents Living at home in France Affiliation with a social security scheme or entitled beneficiary Informed consent signed by both parents Exclusion Criteria: Pathologies predominantly associated with ENT pathology Neurological disorders Deafness
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Natacha TEISSIER, MD PhD
Phone
+33.1.40.03.53.67
Email
natacha.teissier@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Elise CHAUVIN, Doctorant
Phone
+331.86.46.82.21.67
Email
elise.chauvin@aphp.fr
Facility Information:
Facility Name
Robert Debre Hospital
City
Paris
ZIP/Postal Code
75019
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natacha TEISSIER, MD PhD
Phone
+33.1.40.03.53.67
Email
natacha.teissier@aphp.fr
First Name & Middle Initial & Last Name & Degree
Elise CHAUVIN, Doctorant
Phone
+33.1.86.46.82.21
Email
elise.chauvin@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Assessment and Remediation of Oral Disorders

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