NCT06223152

Brief Summary

The purpose of this project is to evaluate the effectiveness of a parent guidance program on (1) the parent's communication skills, (2) the parent's sense of competence and (3) the child's language development. Concretely, 11 guidance sessions will be offered to parents by alternating two group sessions (in a common place) and one family session (at home). These sessions will be given every week and will last approximately 2 hours. The sessions will focus on working on and learning adult attitudes conducive to the development of communication and language in the child. These sessions will be interactive through questions (wooclap), exchanges, video illustrations, role playing, etc. A practical application will be proposed in daily life with the help of the video-feedback technique during the home sessions, individually with the parent. The effectiveness of this intervention will be evaluated via a pre- and post-test conducted in the families' homes. Episodes of parent-child interactions in a play situation will be filmed and coded in order to assess the parents' communication skills (receptivity, reactivity, language support strategies, etc.). The feeling of parental competence as well as the child's language will be estimated using parent questionnaires. The investigators hypothesize that parent guidance sessions will have an effect on the communication skills of parents of deaf children and will indirectly improve their sense of parenting competence as well as the child's language development. This study will therefore offer avenues for adapting the support of families of deaf children.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

January 25, 2024

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

May 15, 2025

Status Verified

May 1, 2025

Enrollment Period

1.2 years

First QC Date

June 20, 2022

Last Update Submit

May 12, 2025

Conditions

Keywords

deaf childrencommunicationlanguage parental support

Outcome Measures

Primary Outcomes (3)

  • Communication between parent and child

    An episode of parent-child interactions in a play situation will be filmed before and after the intervention (pre- and post-test) in order to assess parents' communicative skills (receptivity, responsiveness, language support strategies, etc.). Fifteen minutes of free face-to-face play with a common material (Fischer Price's farm) will be recorded to provide a sample of parent-child interaction in a natural situation. The filmed interactions will be coded qualitatively via coding of verbal, paraverbal, and non-verbal exchanges that will be done using an analysis/observation grid created based on a grouping of elements from different existing grids (Adams, Gaile, Freed \& Lockton, 2011; Ducerf, 2013; Prutting \& Kirchner, 1987, Sylvestre, A. et al, 2019).

    troughout the entire study, an average of 40 months

  • Child's language development

    Questionnaire estimating the child's language development French Inventory of Communication Development (Kern, Langue, Zesigner, \& Bovet, 2010)

    troughout the entire study, an average of 40 months

  • Questionnaires assessing the feeling of parental competence

    Global Scale of Sense of Parental Competence (GSSPC) (Meunier \& Roskam, 2009) Adaptation of the SPISE-R, Scale of Parental Involvement and Self-Efficacy, revised (DesJardin, 2020)

    troughout the entire study, an average of 40 months

Study Arms (1)

deaf children and parents

EXPERIMENTAL
Other: parental support

Interventions

parental support

deaf children and parents

Eligibility Criteria

Age18 Months - 4 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • deaf children and parents
  • months - 4 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bragard

Louvain-la-Neuve, Belgium

Location

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2022

First Posted

January 25, 2024

Study Start

October 1, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2025

Last Updated

May 15, 2025

Record last verified: 2025-05

Locations