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Parent Training for Childhood Hearing Loss (CHAMPS-DHH Trial)

N/A

Recruiting

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, 12 months, 18 months, 24 months, 30 months, 36 months after parent baseline

Awards & highlights

CHAMPS-DHH Trial 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.Check my eligibility

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.See study design

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.

CHAMPS-DHH Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My child is deaf or has difficulty hearing.

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I am a parent and I am 18 years old or older.

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I can communicate in English or use American Sign Language.

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My child is between 3 and 6 years old.

CHAMPS-DHH Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after parent baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months, 12 months, 18 months, 24 months, 30 months, 36 months after parent baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after parent baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Parenting Young Children (PARYC) Scale

Secondary outcome measures

Beck Depression Inventory-II (BDI-II)

Change in Parenting Young Children scale (PARYC) scores over time

Child Behavior Checklist (CBCL)

+5 more

Other outcome measures

Beginner's Intelligibility Test (BIT)

Clinical Evaluation of Language Fundamentals

Data-logging of hearing aid/cochlear implant use by child

+5 more

CHAMPS-DHH Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Behavioral Parent TrainingExperimental Treatment1 Intervention

Group II: ControlActive Control1 Intervention

0 / 4Eligibility criteria met

Find a Location

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

330 Previous Clinical Trials

178,221 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

Media Library

Parent Training Intervention Clinical Trial Eligibility Overview. Trial Name: NCT03916146 — N/A

Parenting Research Study Groups: Control, Behavioral Parent Training

Parent Training Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT03916146 — N/A

Parenting Clinical Trial 2023: Parent Training Intervention Highlights & Side Effects. Trial Name: NCT03916146 — N/A

Frequently Asked Questions

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

Is enrollment for this study limited to those aged 65 or younger?

"To be included in the trial, the patient must meet a certain age range criterion; 3 to 99 years old. Additionally, there are 136 studies for minors and 199 for elders."

Answered by AI

Is this research experiment open for recruitment to participants?

"Currently, this medical trial is enlisting volunteers. The initial posting was on January 31st 2020 and the latest update occurred on March 21st 2022."

Answered by AI

What is the size of this study's population?

"Affirmative, the information provided on clinicaltrials.gov alludes to this research program's ongoing recruitment efforts. It was originally published on January 31st 2020 and received its last update March 21st 2022; with a target of 250 participants from one site."

Answered by AI

Who is eligible to participate in this clinical research?

"250 individuals with auditory impairments are being accepted into this study. The necessary prerequisites for qualification include: living in a parent/guardian's home, parental custodianship of the child, fluency in English or American Sign Language, residence in Kentucky over three years' duration, between 3 and 6 years of age at baseline assessment, deafness or hearing loss experienced for more than half-a-year; and usage of hearing aids(s), cochlear implant(s) and/or bone conduction device(s)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Behavioral Parent Training for Families With Deaf and Hard of Hearing Preschoolers

Christina Studts 2020. "Behavioral Parent Training for Families With Deaf and Hard of Hearing Preschoolers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03916146.

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