Assessment and Remediation of Oral Disorders

Oral Disorder Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06046768
• Other study ID #: APHP230152
• Secondary ID: IDRCB: 2023-A002
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: January 31, 2025

Study information

• Verified date: September 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Natacha TEISSIER, MD PhD
• Phone: +33.1.40.03.53.67
• Email: natacha.teissier[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16
• Est. completion date: January 31, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months to 3 Years

Eligibility

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

Related Conditions & MeSH terms

• Mouth Diseases
• Oral Disorder

Intervention

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)

Locations

Country	Name	City	State
France	Robert Debre Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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