- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06223152
Evaluation of the Effectiveness of a Guidance Program for Parents of Deaf Children (Irsa-Triangle)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Louvain-la-Neuve, Belgium
- Bragard
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- deaf children and parents
- 18 months - 4 years
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: deaf children and parents
|
parental support
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Communication between parent and child
Time Frame: troughout the entire study, an average of 40 months
|
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
Time Frame: troughout the entire study, an average of 40 months
|
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
Time Frame: troughout the entire study, an average of 40 months
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IRSA-Triangle Wallonie
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.