Communication Treatment for Hearing Loss

Overseen By Emily (Shimeng) Xu, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Disqualifiers: Severe motor/cognitive disability, Bacterial meningitis, Cochlear nerve deficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 48 months

700 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to enhance language development in children with bilateral sensorineural hearing loss (a type of hearing impairment affecting both ears) after they receive cochlear implants. Researchers are developing brain imaging models to predict language outcomes and assess whether personalized, parent-led communication treatments, known as Parent-Implemented Communication Treatment (PICT), can benefit children at risk of poorer language skills. The trial consists of two parts: one focuses on building predictive models, while the other tests whether a specific communication treatment improves language for English-speaking children. Eligible children have sensorineural hearing loss in both ears, use English or Spanish as their primary language, and have not yet developed strong spoken language skills. As an unphased trial, this study provides a unique opportunity for families to contribute to pioneering research that could enhance language development strategies for children with hearing loss.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this communication treatment is safe for children with hearing loss?

Research shows that the Parent-Implemented Communication Treatment (PICT) is generally safe for children. Previous studies have examined how this method helps young children with hearing loss improve their communication skills. For example, one study with infants found that parents could use this method to boost their children's early communication abilities. Importantly, these studies reported no major negative effects.

Another study with toddlers who have hearing loss also tested this treatment. The results showed it improved communication without serious side effects. Parents successfully used the techniques, leading to better communication skills in their children.

While these findings suggest that PICT is safe, each child's unique situation should be considered. Those considering joining a trial should consult a healthcare provider to ensure it suits their child's needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for hearing loss, which often involve hearing aids or cochlear implants, the Parent-Implemented Communication Treatment is unique because it empowers parents to actively participate in their child's communication development. This approach focuses on enhancing everyday interactions between parents and children to improve language skills. Researchers are excited about this method because it leverages the natural parent-child bond to promote language acquisition, potentially leading to more personalized and effective outcomes without the need for technological devices.

What evidence suggests that Parent-Implemented Communication Treatment might be an effective treatment for hearing loss?

Research shows that Parent-Implemented Communication Treatment (PICT), which participants in this trial may receive, can help children with hearing loss improve their communication skills. Studies have found that parents can successfully use these methods to support their children's communication development. In one study, PICT helped toddlers who are deaf or hard of hearing communicate better. Another study suggested that PICT may have positive short-term effects on children's communication. While more research is needed to understand the long-term benefits, these findings indicate that PICT could be helpful for children with hearing loss. ^{1 3 4 6 7}

Who Is on the Research Team?

Nancy Young, MD

Principal Investigator

Ann & Robert H Lurie Children's Hospital of Chicago

Are You a Good Fit for This Trial?

This trial is for children under 5 with bilateral sensorineural hearing loss who are candidates for cochlear implantation, and speak English or Spanish. It's also open to kids under 7 at the Lurie site with unilateral hearing loss meeting implant criteria. Participants must be exposed to spoken language at home.

Inclusion Criteria

My child is exposed to spoken language at home by at least one parent.

My child is under 7 years old and qualifies for a cochlear implant due to hearing loss in one ear.

I was 36 months old or younger when my treatment started.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-surgical Evaluation

Pre-surgical MRI and audiology evaluations as part of routine pre-operative evaluation

1-2 weeks

1 visit (in-person)

Treatment

Children receive cochlear implantation and follow-up audiology evaluations at 6, 12, 18, 24, 36, and/or 48 months

48 months

Multiple visits (in-person) at specified intervals

Communication Treatment

Parent Implemented Communication Treatment (PICT) with weekly virtual sessions for six months

6 months

Weekly sessions (virtual)

Follow-up

Participants are monitored for language and communication development through surveys and evaluations

4 years

Annual evaluations (in-person) and surveys (online)

What Are the Treatments Tested in This Trial?

Interventions

• Parent-Implemented Communication Treatment

Trial Overview The study aims to develop neural predictive models based on brain imaging to forecast language development post-cochlear implantation. It will test if a custom therapy called Parent-Implemented Communication Treatment (PICT) can improve language in those predicted to have lower outcomes.

How Is the Trial Designed?

Group I: Communication Treatment Experimental Treatment 1 Intervention

Group II: Non-treatment Model Building Active Control 1 Intervention

Who Is Running the Clinical Trial?

Ann & Robert H Lurie Children's Hospital of Chicago

Lead Sponsor

Trials

275

Recruited

5,182,000+

The University of Texas at Dallas

Collaborator

Trials

71

Recruited

108,000+

Chinese University of Hong Kong

Collaborator

Trials

1,387

Recruited

1,372,000+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

University of Southern California

Collaborator

Trials

956

Recruited

1,609,000+

University of Miami

Collaborator

Trials

976

Recruited

423,000+

Published Research Related to This Trial

The study developed and validated two scales, the Parental Teaching Skill (PTS) and Parental Behavioural Skill (PBS) scales, to assess the teaching and behavioral skills of 344 parents involved in rehabilitation programs for children with hearing loss.

Both scales demonstrated good reliability and validity, indicating they can effectively guide early intervention professionals in evaluating parental skills, with maternal educational level being a significant factor in performance ratings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing new scales for assessing parents' aural and oral rehabilitation skills to interact with children with hearing loss. Chen, PH., Lim, TZ., Chang, ST., et al.[2021]

Clinicians trained using the Cascading Model (CM) were more likely to complete their training and reported higher satisfaction and better learning experiences compared to those in other training models.

Supervisors in the Learning Collaborative (LC) condition reported greater knowledge and satisfaction, while Distance Education (DE) produced comparable results in terms of treatment implementation and clinician satisfaction, suggesting that different training methods can be effective in various contexts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Statewide Randomized Controlled Trial to Compare Three Models for Implementing Parent Child Interaction Therapy. Herschell, AD., Kolko, DJ., Scudder, AT., et al.[2023]

The study involved 16 hearing parents of prelingual deaf and hard-of-hearing children, and after participating in a video feedback intervention, there was a significant increase in the children's communicative autonomy, indicating improved communication skills.

The intervention also led to a decrease in children's no-responses during interactions, suggesting that enhancing parental emotional availability can positively impact the quality of communication between parents and their deaf or hard-of-hearing children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Communication Skills and Communicative Autonomy of Prelinguistic Deaf and Hard-of-Hearing Children: Application of a Video Feedback Intervention. Wadnerkar Kamble, M., Lam-Cassettari, C., James, DM.[2022]

Palin Parent-Child Interaction therapy significantly reduces stuttering frequency and improves children's attitudes towards communication, with these benefits lasting for at least one year after treatment, based on assessments from a large cohort of children.

Parents also reported increased confidence in managing their child's stuttering and reduced worry about its impact, indicating that the therapy not only helps the child but also supports the family dynamic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Palin Parent-Child Interaction Therapy: The Bigger Picture. Millard, SK., Zebrowski, P., Kelman, E.[2019]

The training package 'Connect, Communicate and Collaborate' (3Cs) significantly improved the confidence and knowledge of six service providers in delivering family-responsive services for children with hearing loss, as evidenced by pre- and post-training assessments showing significant improvements (p < 0.002).

Participants reported enhanced self-evaluation skills and a more considerate approach to family engagement in therapy, although they still faced challenges in guiding families through decision-making processes related to habilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new training package (3Cs: Connect, Communicate and Collaborate) for improving family responsive service delivery in early intervention for children with hearing loss: A proof of concept study. Alduhaim, A., Purcell, A., Cumming, S., et al.[2021]

Over a 12-month period, five hearing parents of hearing-impaired children showed significant improvements in their communication skills, including spoken and signed input, after receiving targeted feedback and intervention sessions.

All parents made progress in at least one area of communication, enabling them to deliver clear and understandable messages to their children, which is crucial for effective interaction and support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing parents' use of SEE-2. Progress and retention. Luetke-Stahlman, B., Moeller, MP.[2019]

Parent-child interaction (PCI) is crucial for the language development of deaf infants, as many are born to hearing parents who may struggle with effective communication techniques, impacting the child's attention and communication skills.

There is a need for specific assessment tools to evaluate PCI in families with deaf children, as existing methods do not adequately address the unique challenges these families face, despite evidence that targeted interventions can improve parental communication skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing parent-child interaction in infant deafness. Curtin, M., Herman, R., Cruice, M., et al.[2023]

In a pilot trial with 19 children aged 6 to 24 months who have moderate to profound hearing loss, a parent-implemented communication treatment led to a 17% increase in parents' use of communication strategies and significant improvements in children's prelinguistic speech skills.

The treatment group showed notable gains in speech prelinguistic skills (effect size d = 1.09), suggesting that parent involvement can positively influence communication development in young children with hearing loss, although larger studies are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent-Implemented Communication Treatment for Infants and Toddlers With Hearing Loss: A Randomized Pilot Trial. Roberts, MY.[2020]

Parent Training (PT) and coaching programs show promise in improving parents' sensitivity and responsiveness, which can help promote language development in deaf and hard of hearing (DHH) children after hearing aid fitting or cochlear implant activation, based on a review of five studies.

However, the evidence is not strong enough to draw definitive conclusions due to variability in study designs and outcomes, indicating a need for more rigorous research to assess the effectiveness and cost-effectiveness of these programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of Parent Training in the Rehabilitation of Deaf or Hard of Hearing Children of Hearing Parents: A Systematic Review. Giallini, I., Nicastri, M., Mariani, L., et al.[2021]

Direct-to-consumer advertisements for Parent-Child Interaction Therapy (PCIT) can effectively influence Spanish-speaking parents' intentions to seek help, especially when the messenger is a therapist rather than a parent.

The study highlights the importance of tailored advertising strategies to improve access to mental health services for racial and ethnic minority families, as Spanish-speaking participants showed varying help-seeking intentions based on the messenger used in the advertisements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Direct-to-Consumer Marketing for Parent-Child Interaction Therapy: Impact of Language and Messenger. Barnett, ML., Bernal, NA., Luis Sanchez, BE.[2022]

Parent-Child Interaction Therapy (PCIT) significantly improved parent skills and child behavior in a treatment group of 18 children with hearing loss, indicating its effectiveness as a behavioral intervention.

A matched experimental subset of 6 children showed a significant increase in utterances and a trend toward improved receptive vocabulary compared to a matched control group, suggesting that PCIT can enhance language development in children with hearing loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent-Child Interaction Therapy as a Behavior and Spoken Language Intervention for Young Children With Hearing Loss. Costa, EA., Day, L., Caverly, C., et al.[2019]

Parent-Child Interaction Therapy (PCIT) is an effective intervention for childhood conduct problems, but its adoption by clinicians in routine care settings is still low despite its proven effectiveness.

This systematic review identified only three studies focused on training clinicians in PCIT, highlighting a need for more research on how to support clinicians in adopting and sustaining the use of PCIT after training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinician adoption of Parent-Child Interaction Therapy: A systematic review of implementation interventions. Woodfield, MJ., Merry, S., Hetrick, SE.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6437700/

Parent-Implemented Communication Treatment for Infants ... This study provides modest preliminary support for the short-term effects of a parent-implemented communication treatment for children with ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07205484

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 ...

3. reporter.nih.gov reporter.nih.gov/project-details/11227031

Early communication intervention for deaf/hard of hearing toddlers ... Results suggest that PICT is an efficacious approach to supporting DHH toddlers' communication development. Parents learned to effectively implement ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03803943

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 ...

5. publications.aap.org publications.aap.org/pediatrics/article/155/6/e2024066847/201954/Early-Communication-Intervention-for-Deaf-Hard-of

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.

6. pubmed.ncbi.nlm.nih.gov pubmed.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 ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT03803943/early-communication-intervention-for-toddlers-with-hearing-loss

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 ...