Early Intervention for Cleft Palate

VR
Overseen ByVictoria Reynolds, LLB BSc PhD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Old Dominion University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether teaching speech skills to infants with cleft palates before surgery aids in developing better speech and language abilities. Researchers aim to determine if techniques, typically used for late-talking children, can help these infants produce more sounds and learn new words more quickly. Families with infants aged 6 to 10 months who have an unrepaired cleft palate (a gap in the roof of the mouth) and not just a cleft lip are eligible to participate. As an unphased trial, this study offers families the chance to contribute to research that could improve early speech development strategies for infants with cleft palates.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these early intervention techniques are safe for infants with cleft palates?

Research has shown that early speech treatments for children with a cleft palate are generally safe. Specifically, surgery to repair the cleft before 18 months of age is linked to better speech and social skills, regardless of the cleft's severity. Although this study focused on surgery, the positive results suggest that starting treatment early can be beneficial and is usually well-tolerated.

Another study found that certain speech techniques, such as the Principles of Motor Learning (PML), successfully improved speech in children with a cleft palate. While this study was in the early stages, it did not identify any major safety issues.

Overall, these treatments appear safe and could help improve speech skills in children with a cleft palate.12345

Why are researchers excited about this trial?

Researchers are excited about this early intervention for cleft palate because it focuses on enhancing language, articulation, and palatal function skills right from the start. Unlike traditional treatments that often begin after the child has developed speech difficulties, this approach targets the issue proactively, potentially preventing problems before they arise. The method emphasizes early and consistent intervention, which could lead to better long-term outcomes for speech and communication skills in affected children. By addressing these skills early, the intervention aims to significantly improve quality of life and reduce the need for more extensive therapies later on.

What evidence suggests that early intervention techniques are effective for infants with cleft palates?

Research has shown that starting treatment early can greatly improve speech and language skills in babies with cleft palates. In this trial, all participants will receive early intervention focused on language, articulation, and palatal function skills. Studies have found that customized speech therapy can lead to better communication and fewer speech problems later on. For instance, early treatment helps babies learn more words and make important sounds like "b" and "p". A review of research found that personalized speech therapy effectively prevents long-term issues with talking, reading, and social skills in children with cleft conditions. Overall, early treatment appears to be a promising way to help children with cleft palates develop better speech and language skills.678910

Who Is on the Research Team?

VR

Victoria Reynolds, LLB BSc PhD

Principal Investigator

Old Dominion University

Are You a Good Fit for This Trial?

This trial is for infants with unrepaired cleft palates. It's designed to see if early speech skills teaching helps language development before palate repair surgery. Infants will be evaluated and attend clinic visits twice a week for six weeks in a group setting.

Inclusion Criteria

My infant has an unrepaired cleft palate, with or without a cleft lip.
I am between 6 and 10 months old.

Exclusion Criteria

Medically fragile status that would preclude participation in this community-based study
Infants with cleft lip only
I have had surgery to repair my palate.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person or via Telehealth)

Baseline Evaluation

Participants undergo a baseline evaluation of speech and language skills

1 week
1 visit (in-person or via Telehealth)

Treatment

Participants attend twice-weekly sessions for six weeks to learn techniques to help infants develop speech and language skills

6 weeks
12 visits (in-person)

Final Evaluation

Participants undergo a final evaluation of speech and language skills

1 week
1 visit (in-person or via Telehealth)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Early Intervention for Language, Articulation, and Palatal Function Skills
Trial Overview The study tests whether standard techniques used to encourage talking in late talkers can also benefit infants with cleft palates, focusing on sound use, making stop sounds like 'b' and 'p', and learning new words with gestures.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Intervention groupExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Old Dominion University

Lead Sponsor

Trials
25
Recruited
15,500+

Childrens Hospital of the King's Daughters

Collaborator

Citations

Parent-implemented early intervention design for improving ...Additionally, 8–16 month-old Mandarin-speaking infants with cleft lip and palate experience an 85% delay in expressive vocabulary skills (7). By ...
The Impact of Early Intervention on Speech and Lexical ...The purpose of the present investigation was to examine the impact of early intervention on speech and lexical measures for toddlers with cleft palate.
What works for whom? A systematic review on ...The aim of this systematic review is to summarize the evidence of the effects of personalized speech intervention in children with a CP ± L, aged 3–18 years.
In children with cleft palate speech disorder, is ...Therapy early on can prevent long-term problems with communication, reading, learning and social skills.
An evaluation of speech therapy care in the surrounding ...In 50% of children with cleft palate, speech therapy is required to train newly built or underdeveloped anatomical structures. Non-cleft ...
Caregiver-reported outcomes of speech and social function ...Early palatoplasty before 18 months is associated with improved caregiver-reported speech and social outcomes, irrespective of cleft severity.
Parent-implemented early intervention design for ...Studies indicate that 36–47 month-old toddlers with cleft lip and palate experience a staggering 69.5% delay in vocabulary skills (6).
Speech Intervention for Children With Cleft Palate Using ...Conclusion: This Phase I study has shown that articulatory kinematic speech intervention that applies the PML is effective in improving the speech outcomes for ...
9.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/34767284/
A systematic review of early speech interventions for ...Background: Children with cleft palate with or without cleft lip (CP±L) are at high risk of problems with early speech sound production, ...
Linguistic development in cleft palate patients with and ...Cleft palate patients present with CAD, demonstrated a significantly higher frequency of delay in language development as compared with cleft palate patients ...
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