ERTO: Assessment and Remediation of Oral Disorders

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06046768

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Oral Disorder	Other: Psychological care	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

16 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

To evaluate the impact of psychological treatment on the improvement of oral disorders perceived by parents in their child.To evaluate the impact of psychological treatment on the improvement of oral disorders perceived by parents in their child.

Masking:

None (Open Label)

Primary Purpose:

Other

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Jan 31, 2025

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

Parental stress and child representation [12 months]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Months to 3 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Robert Debre Hospital	Paris		France	75019

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier:

NCT06046768

Other Study ID Numbers:

APHP230152
IDRCB: 2023-A00202-43

First Posted:

Sep 21, 2023

Last Update Posted:

Sep 21, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Assistance Publique - Hôpitaux de Paris

parental stress

ENT pathology

Additional relevant MeSH terms:

Mouth Diseases

Study Results

No Results Posted as of Sep 21, 2023