Assessment and Remediation of Oral Disorders (ERTO)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Oral Disorder
• Intervention / Treatment: Other: Psychological care

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.

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Natacha TEISSIER, MD PhD; Phone Number: +33.1.40.03.53.67; Email: natacha.teissier@aphp.fr
• Study Contact Backup: Name: Elise CHAUVIN, Doctorant; Phone Number: +331.86.46.82.21.67; Email: elise.chauvin@aphp.fr

Study Locations

• France
  • Paris, France, 75019
    • Robert Debré Hospital
    • Contact: Natacha TEISSIER, MD PhD; Phone Number: +33.1.40.03.53.67; Email: natacha.teissier@aphp.fr
    • Contact: Elise CHAUVIN, Doctorant; Phone Number: +33.1.86.46.82.21; Email: elise.chauvin@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Child with oral feeding disorder(s); Child (boy or girl) with oral feeding disorder(s) diagnosed by a speech therapist as part of a speech therapy assessment.	Other: Psychological care; Psychological consultations (interviews, scales), participation in a discussion group for parents in Visio via Zoom, a speech therapy assessment and possible complementary multidisciplinary consultations)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	12 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: September 12, 2023
• First Submitted That Met QC Criteria: September 19, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 19, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: parental stress; ENT pathology
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases
• Other Study ID Numbers: APHP230152; IDRCB: 2023-A00202-43 (Registry Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No