Deaf Nonspeaking, Not Elsewhere ClassifiedIrsa-TriangleNCT06223152
Evaluation of the Effectiveness of a Guidance Program for Parents of Deaf Children
A study testing parental support in people with Deaf Nonspeaking, Not Elsewhere Classified, run by Université Catholique de Louvain at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 months to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Deaf Nonspeaking, Not Elsewhere Classified
- What is being tested?
- parental support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Oct 2021to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- deaf children and parents
- 18 months - 4 years
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- parental support
- Keywords
- deaf children, communication, language parental support
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
parental supportOther
parental support
| Study group | Role | What they receive |
|---|---|---|
| deaf children and parents | Experimental | Not described Receives: Other: parental support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: 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)
Measured: troughout the entire study, an average of 40 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start1 Oct 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2025 (estimated)
Why it stopped: My collaborator on this study (valérie deville) is away for an extended period.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deaf Nonspeaking, Not Elsewhere ClassifiedStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06223152
- Sponsor's protocol ID
- IRSA-Triangle Wallonie
- Acronym
- Irsa-Triangle
- Status last verified
- May 2025
- First submitted
- 20 Jun 2022
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of a Guidance Program for Parents of Deaf Children
- ClinicalTrials.gov ID
- NCT06223152
- Acronym / sponsor ID
- Irsa-Triangle / IRSA-Triangle Wallonie
- Keywords
- deaf children, communication, language parental support
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: My collaborator on this study (valérie deville) is away for an extended period.
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 25 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| deaf children and parents | Experimental | Other: parental support |
Who may qualify
- Ages
- 18 months to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- deaf children and parents
- 18 months - 4 years
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| parental supportparental support | Other | deaf children and parents |
Primary outcome
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).
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing parental support in people with Deaf Nonspeaking, Not Elsewhere Classified, run by Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Communication between parent and child (time frame: troughout the entire study, an average of 40 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.