Early Communication Intervention for Toddlers with Hearing Loss

MY
LJ
Overseen ByLaura J Sudec, MSW
Age: < 18
Sex: Any
Trial Phase: Phase 2
Sponsor: Northwestern University
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a parent-led communication program designed to help toddlers with hearing loss improve their language skills. It teaches parents strategies to support their child's communication development through weekly home sessions over six months. The trial includes children with hearing loss who are 12 to 18 months old, have no additional disabilities, and live in homes where English is the primary language. Parents of eligible children will learn techniques to enhance their child's language abilities, such as modeling language and responding to communication attempts. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering a unique opportunity to contribute to developing effective communication strategies for toddlers with hearing loss.

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.

What prior data suggests that the Parent-Implemented Communication Intervention (PICT) is safe for toddlers with hearing loss?

Research has shown that teaching parents communication support strategies can positively impact how children with hearing loss communicate. In previous studies, parents who learned these strategies helped their children improve communication skills without any safety issues. The Parent-Implemented Communication Intervention (PICT) employs techniques that are visual, interactive, responsive, and encourage language development. These are not medical treatments, so they carry very low risk. Since this intervention is now in a Phase 2 trial, it has already passed initial safety checks in earlier research, indicating it is generally well-tolerated.12345

Why are researchers excited about this trial?

The Parent-Implemented Communication Intervention (PICT) is unique because it empowers parents to play an active role in their toddler's communication development right at home. Unlike traditional therapies that often require clinical settings and professional intervention, PICT involves parents learning specific strategies to support their child's language development in everyday interactions. Researchers are excited about PICT because it focuses on visual, interactive, responsive, and linguistically stimulating techniques, which could lead to more natural and consistent language learning opportunities for toddlers with hearing loss. This approach not only personalizes the intervention but also has the potential to create a more engaging and supportive learning environment for the child.

What evidence suggests that the Parent-Implemented Communication Intervention (PICT) might be effective for improving language outcomes in toddlers with hearing loss?

Research has shown that the Parent-Implemented Communication Intervention (PICT), which participants in this trial may receive, can greatly improve communication skills in children with hearing loss. In earlier studies, parents who used the PICT method helped their children develop early language skills. The program teaches parents strategies such as speaking where their child can see them and responding to all their child's communication attempts. These techniques have enhanced the child's ability to communicate and understand language. Overall, early findings suggest that PICT could lead to better language development for children with hearing loss.12367

Who Is on the Research Team?

Megan Y. Roberts, PhD, CCC-SLP | The ...

Megan Y Roberts, PhD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for toddlers aged 12-18 months with bilateral, congenital hearing loss. They should have no other disabilities like Down syndrome or cerebral palsy, and English must be the primary language spoken at home. One parent must have normal hearing, and the child should already be exposed to some spoken language.

Inclusion Criteria

You are able to hear and understand spoken language from your parents.
Have English as the primary language spoken at home
One of my parents has normal hearing.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly, 1-hour intervention sessions for 6 months focusing on communication support strategies

24 weeks
Weekly virtual visits

Follow-up

Participants are monitored for language development outcomes after the intervention

18 months
Monthly assessments

What Are the Treatments Tested in This Trial?

Interventions

  • No Intervention - Business-as-usual control
  • Parent-Implemented Communication Intervention (PICT)
Trial Overview The study tests a Parent-Implemented Communication Intervention (PICT) against a control group with no intervention. It aims to improve prelinguistic and spoken language in children with hearing loss through sessions via video call, providing technology for virtual visits.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Parent-Implemented Communication Intervention (PICT)Experimental Treatment1 Intervention
Group II: No Intervention - Business-as-usual controlPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials
1,674
Recruited
989,000+

Ann & Robert H Lurie Children's Hospital of Chicago

Collaborator

Trials
275
Recruited
5,182,000+

Citations

Parent-Implemented Communication Treatment for Infants ...The proposed research is a pilot study of a parent-implemented communication treatment (PICT) for children with hearing loss. The intervention ( ...
Early Communication Intervention for Toddlers With ...This is a randomized clinical trial of 96 children with hearing loss that examines the effects of a parent-implemented early communication intervention on ...
Early Communication Intervention for Deaf/Hard of Hearing ...The current study is the first large-scale randomized clinical trial of a communication intervention for deaf and hard-of-hearing toddlers.
4.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/30535174/
Parent-Implemented Communication Treatment for Infants ...This randomized pilot trial tested the effects of a parent-implemented communication treatment targeting prelinguistic communication skills in infants and ...
Long-Term Outcomes of Early Communication Intervention ...This trial will be the first large-scale evaluation of the long-term effects of an early communication intervention on school-age language and ...
Communication Outcomes of Children with Hearing LossThe study found that children in the LSL-SA group had statistically significant better communication outcomes, with 63% achieving age-appropriate speech ...
Communication Outcomes of Children with Hearing LossContribution: This study provides contextually relevant evidence for implementing an LSL-SA intervention approach for children with hearing loss ...
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