Long-Term Outcomes of Early Communication Intervention for Deaf/Hard of Hearing Toddlers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Parent-Mediated Intervention (PMI).
- Who it may be relevant to
- Registry conditions: Hearing Loss, Bilateral. Basic parameters: 5 years — 8 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Early Communication Intervention for Deaf/Hard of Hearing Toddlers: Long-Term Language and Literacy Outcomes
Overview
The overall goal of this randomized clinical trial is to learn about the effects of a parent-mediated intervention (PMI) designed to support communication outcomes for deaf and hard-of-hearing (DHH) children. Previously, the investigators enrolled 96 DHH children between 12 and 18 months of age and their parents. Families were randomly assigned to receive either the PMI or a business-as-usual control group. The PMI was a 6-month intervention that included weekly, hour-long Zoom sessions. During the intervention sessions, parents were taught communication support strategies to support their child's language development throughout daily routines and play. This current period of the trial follows the same children into early elementary school to determine whether the effects of the PMI are long-lasting. The main questions it aims to answer are: * Does the PMI improve language, reading, and social communication outcomes in the early school years? * Does parent involvement during early intervention support continued engagement in their child's education? The investigators will compare parents and children who received the PMI to those in the business-as-usual control group to determine whether the intervention has lasting effects on these outcomes. Participants will complete standardized assessments, parent-report surveys, and video-recorded naturalistic interactions. All assessments will be completed remotely.
Detailed description
Hearing loss is one of the most prevalent congenital conditions. Recent advances in early detection and technology have contributed to significant improvements in long-term outcomes for deaf/hard-of-hearing (DHH) children. Despite this progress, language and literacy outcomes for school-age DHH children are inconsistent, and many DHH children do not "catch up" to their hearing peers. Closing this gap requires the implementation of effective early communication interventions. Yet, until recently, there was a significant paucity of research on early communication interventions for DHH children. Parent-mediated interventions (PMIs), which involve teaching parents strategies to enhance their child's language learning experiences, are a promising form of early intervention for DHH toddlers. During the previous project period (NCT03803943), 96 DHH children, between 12 and 18 months of age and their parents, were enrolled. Parent-child dyads were randomly assigned to receive either the PMI or business-as-usual control group. The investigators examined the effects of the intervention on (a) parent strategy use and (b) child communication outcomes during and after the 6-month intervention period. The follow-up period of the clinical trial is outlined here.
This trial will be the first large-scale evaluation of the long-term effects of an early communication intervention on school-age language and literacy outcomes for DHH children. The study enrolled 96 parent-child dyads, 88 of whom remain involved and consented to contact for the follow-up period. The investigators will complete follow-up assessments during early elementary school. The investigators plan to examine the long-term effects of the intervention on school-age outcomes and characterize the intermediary mechanisms of these effects. The investigators consider not only how early communication interventions affect subsequent child outcomes, but also how involving parents early in their child's development may lay the foundation for sustained parent engagement as children transition to school-based services. Taken together, the investigators plan to integrate child and parent outcomes to fully characterize how early language learning experiences shape long-term language and literacy outcomes. Understanding the pathways through which early interventions affect the developmental trajectory of DHH children will have widespread implications for research and clinical practice.
Interventions
- Behavioral Parent-Mediated Intervention (PMI)
The PMI consisted of weekly, 1-hour intervention sessions via Zoom for 6 months. In total, the intervention consisted of 26 intervention sessions.
Primary outcome measures
- Clinical Evaluation of Language Fundamentals, Fifth Edition (CELF-5) [Time frame: 7 - 8 years old]
- Peer-Peer Interaction, Pragmatic Observational Measure (POM) [Time frame: 7 - 8 years old]
- Woodcock Reading Mastery Tests, Third Edition (WRMT-III) [Time frame: 7 - 8 years old]
Secondary outcome measures (5)
- Parent-Child Interaction, Keys to Interactive Parenting Scale (KIPS) [Time frame: 5 - 6 years old]
- Parent Empowerment and Efficacy Measure (PEEM) [Time frame: 5 - 6 years old]
- Parental Involvement Survey in Their Child's Elementary Studies (PISCES) [Time frame: 5 - 6 years old]
- The Parent Advocacy Skills and Comfort Survey [Time frame: 5 - 6 years old]
- Clinical Evaluation of Language Fundamentals, Fifth Edition (CELF-5) [Time frame: 5 - 6 years old]
Eligibility criteria
Eligibility for the follow-up period of the clinical trial is dependent on enrollment in the initial period of the clinical trial.
Child inclusion criteria were:
- between 12-18 months
- diagnosed with bilateral hearing loss
- no additional diagnoses (e.g., Down syndrome, cerebral palsy, seizure disorder, blindness, etc.)
- one parent with typical hearing
- exposed to some degree of spoken language by their parents.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Northwestern University — Evanston
Identifiers
NCT: NCT07205484 · 2R01DC016877-06A1