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Early Communication Intervention for Toddlers with Hearing Loss

Phase 2
Recruiting
Led By Megan Y Roberts, PhD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have one parent with normal hearing
Enrollment in the study between 12 and 18 months of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up monthly, up to 18 months, between post and follow-up when the child is 18 to 36 months (after intervention)
Awards & highlights

Study Summary

This trial is testing whether a parent-implemented early communication intervention can improve outcomes for children with hearing loss.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves educational and communication interventions rather than medical treatments, there are no direct physical side effects expected from participating in this study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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One of my parents has normal hearing.
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My child is between 12 and 18 months old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~monthly, up to 18 months, between post and follow-up when the child is 18 to 36 months (after intervention)
This trial's timeline: 3 weeks for screening, Varies for treatment, and monthly, up to 18 months, between post and follow-up when the child is 18 to 36 months (after intervention) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Total Scaled Score on the Communication and Symbolic Behavior Scales - Developmental Profile
Total number of pre-symbolic communicative acts from the Language Sample
Secondary outcome measures
Auditory Comprehension Standard Score on the Preschool Language Scale - 5th Edition
Caregiver Use of Communication Support Strategies
Child Spoken Words
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Parent-Implemented Communication Intervention (PICT)Experimental Treatment1 Intervention
Participants assigned to the PICT condition will receive weekly hour long intervention sessions in their home for 6 months. Parents will learn four sets of communication support strategies: (a) visual (e.g., modeling language within the child's line of sight), (b) interactive (e.g., following the child's attentional focus), (c) responsive (e.g., responding to all communicative attempts), and (d) linguistically stimulating (e.g., modeling language targets, expanding child communication).
Group II: No Intervention - Business-as-usual controlPlacebo Group1 Intervention
Participants assigned to the BAU control group will not receive the PICT intervention.

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,579 Previous Clinical Trials
916,689 Total Patients Enrolled
Ann & Robert H Lurie Children's Hospital of ChicagoOTHER
253 Previous Clinical Trials
5,187,632 Total Patients Enrolled
Megan Y Roberts, PhDPrincipal InvestigatorNorthwestern University
3 Previous Clinical Trials
236 Total Patients Enrolled

Media Library

Parent-Implemented Communication Intervention (PICT) Clinical Trial Eligibility Overview. Trial Name: NCT03803943 — Phase 2
Bilateral Hearing Loss Research Study Groups: Parent-Implemented Communication Intervention (PICT), No Intervention - Business-as-usual control
Bilateral Hearing Loss Clinical Trial 2023: Parent-Implemented Communication Intervention (PICT) Highlights & Side Effects. Trial Name: NCT03803943 — Phase 2
Parent-Implemented Communication Intervention (PICT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03803943 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people over the age of 45 encouraged to participate in this trial?

"Based on the age requirements set out by the researchers, the minimum age for participants is 1 year old while the maximum age is 18 months."

Answered by AI

What is the main goal of this experiment?

"The success of this medical intervention will be judged by the total scaled score on the communication and symbolic behavior scales - developmental profile over a 12 to 18 month period. Additionally, caregiver use of communication support strategies, expressive communication standard score on the preschool language scale - 5th edition, and auditory comprehension standard score on the preschool language scale - 5th edition will be analyzed as secondary outcomes."

Answered by AI

How many guinea pigs are being used in this test?

"That is correct. The clinical trial was originally posted on 6/15/2019 and was most recently updated on 1/4/2022, which suggests that they are presently searching for patients. They need 96 patients from 1 location."

Answered by AI

Do parents see any harmful effects from using PICT with their children?

"PICT has received a score of 2, meaning that while there is evidence backing its safety, the efficacy of this Parent-Implemented Communication Intervention remains unproven."

Answered by AI

Can new patients still enroll in this clinical trial?

"Presently, this study is looking for eligible candidates, as reflected on clinicaltrials.gov. This particular trial was originally posted on 6/15/2019 and updated most recently on 1/4/2022."

Answered by AI

Are there specific medical criteria for people who want to join this trial?

"Those with bilateral deafness that fall between the age of 12 months to 18 months may qualify for this clinical trial. Currently, there are 96 spots open for participants."

Answered by AI
~10 spots leftby Nov 2024