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Parent Training for Childhood Hearing Loss (CHAMPS-DHH Trial)
N/A
Waitlist Available
Led By Christina Studts, PhD
Research Sponsored by Christina Studts
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Child is deaf or hard of hearing
Parent is age 18 or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months after parent baseline
Awards & highlights
No Placebo-Only Group
Summary
This trial will test an adapted version of an evidence-based parent training intervention to help parents of young deaf and hard of hearing children, in order to prevent costly long-term behavioral problems.
Who is the study for?
This trial is for parents aged 18 or older who are the custodial guardians of a deaf or hard of hearing child aged between 3 and 6 years. The parent must speak/understand English or use American Sign Language, live in a state with support services for DHH children, and have no active child protective services cases.
What is being tested?
The study is testing an adapted behavioral parent training intervention designed specifically for families with young deaf and hard of hearing children to see if it helps prevent behavior problems. It will be implemented in real-world clinical settings.
What are the potential side effects?
Since this is a behavioral intervention rather than a medical treatment, traditional side effects like those seen with medications are not expected. However, there may be indirect effects on family dynamics as parenting strategies change.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child is deaf or has difficulty hearing.
Select...
I am a parent and I am 18 years old or older.
Select...
I can communicate in English or use American Sign Language.
Select...
My child is between 3 and 6 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months after parent baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months after parent baseline
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Parenting Young Children (PARYC) Scale
Secondary study objectives
Beck Depression Inventory-II (BDI-II)
Change in Parenting Young Children scale (PARYC) scores over time
Child Behavior Checklist (CBCL)
+5 moreOther study objectives
Beginner's Intelligibility Test (BIT)
Clinical Evaluation of Language Fundamentals - Preschool
Data-logging of hearing aid/cochlear implant use by child
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Behavioral Parent TrainingExperimental Treatment1 Intervention
Group II: ControlActive Control1 Intervention
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Who is running the clinical trial?
Christina StudtsLead Sponsor
2 Previous Clinical Trials
75 Total Patients Enrolled
1 Trials studying Parenting
24 Patients Enrolled for Parenting
National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
353 Previous Clinical Trials
181,227 Total Patients Enrolled
Christina Studts, PhDPrincipal Investigator - University of Kentucky
University of Kentucky
1 Previous Clinical Trials
6 Total Patients Enrolled
1 Trials studying Parenting
6 Patients Enrolled for Parenting
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My child is deaf or has difficulty hearing.The child has already received help for their behavior from a professional.The child has been using hearing aids, cochlear implants, or bone conduction devices for more than 6 months.I am a parent and I am 18 years old or older.I can communicate in English or use American Sign Language.My child is between 3 and 6 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Behavioral Parent Training
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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