NCT06046768

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

1 year

First QC Date

September 12, 2023

Last Update Submit

September 19, 2023

Conditions

Keywords

parental stressENT pathology

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Child with oral feeding disorder(s)

EXPERIMENTAL

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

Other: Psychological care

Interventions

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

Child with oral feeding disorder(s)

Eligibility Criteria

Age18 Months - 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Pathologies predominantly associated with ENT pathology
  • Neurological disorders
  • Deafness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Robert Debre Hospital

Paris, 75019, France

Location

MeSH Terms

Conditions

Mouth Diseases

Condition Hierarchy (Ancestors)

Stomatognathic Diseases

Central Study Contacts

Natacha TEISSIER, MD PhD

CONTACT

Elise CHAUVIN, Doctorant

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: To evaluate the impact of psychological treatment on the improvement of oral disorders perceived by parents in their child.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2023

First Posted

September 21, 2023

Study Start

October 1, 2023

Primary Completion

October 1, 2024

Study Completion

January 31, 2025

Last Updated

September 21, 2023

Record last verified: 2023-09

Locations