Assessment and Remediation of Oral Disorders

NCT ID: NCT06046768

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2025-01-31

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.

Conditions

Oral Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Psychological care

Intervention Type: OTHER

Psychological consultations (interviews, scales), participation in a discussion group for parents in Visio via Zoom, a speech therapy assessment and possible complementary multidisciplinary consultations)

Interventions

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)

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Months
• Maximum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Robert Debre Hospital

Paris, , France

Countries

France

Central Contacts

Natacha TEISSIER, MD PhD

Role: CONTACT

natacha.teissier@aphp.fr

+33.1.40.03.53.67

Elise CHAUVIN, Doctorant

Role: CONTACT

elise.chauvin@aphp.fr

+331.86.46.82.21.67

Facility Contacts

Natacha TEISSIER, MD PhD

Role: primary

natacha.teissier@aphp.fr

+33.1.40.03.53.67

Elise CHAUVIN, Doctorant

Role: backup

elise.chauvin@aphp.fr

+33.1.86.46.82.21

Other Identifiers

IDRCB: 2023-A00202-43

Identifier Type: REGISTRY

Identifier Source: secondary_id

APHP230152

Identifier Type: -

Identifier Source: org_study_id