Parent Training for Childhood Hearing Loss

(CHAMPS-DHH Trial)

Overseen By Julie Jacobs, MPH

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Christina Studts

Disqualifiers: Active child protective case, others

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

Compensation: Varies

Number of Visits: 6

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a parent training program designed to help manage behavior problems in young children who are deaf or hard of hearing (DHH). The program aims to be more relevant and acceptable for parents, ensuring effective use in real-world hearing healthcare settings. The study includes two groups: one receives the parent training, and the other does not, to compare results. Parents of DHH children aged 3 to 6 who have used hearing devices for over six months might be a good fit for this trial. As an unphased trial, this study offers a unique opportunity for parents to contribute to research that could enhance support for DHH children.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on parent training for children with hearing loss, so it's best to consult with the trial coordinators for specific guidance.

What prior data suggests that this parent training intervention is safe for children with hearing loss?

Research shows that the Parent Training Intervention is generally safe and well-received. Studies have adapted this training for families with young children who are deaf or hard of hearing, aiming to improve communication and reduce behavior issues in children.

No specific reports have indicated problems directly caused by this intervention. The focus remains on helping parents better manage and support their children. Unlike drug trials, this support typically doesn't involve significant safety risks. Instead, it teaches parents effective ways to communicate and manage behavior.

Overall, the intervention is designed to be helpful and supportive, with no major safety concerns reported in the research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on improving outcomes for children with hearing loss by training their parents. Unlike traditional treatments that often focus directly on the child, such as hearing aids or cochlear implants, this approach empowers parents with strategies to support their child's language and communication skills at home. This method acknowledges the crucial role of the family environment in a child's development and aims to enhance communication in everyday situations. By equipping parents with these skills, researchers hope to see more holistic improvements in the child's social and emotional well-being, beyond what typical medical treatments offer.

What evidence suggests that this parent training intervention might be effective for childhood hearing loss?

Research shows that training programs for parents can benefit families with children who are deaf or hard of hearing (DHH). These programs improve communication skills and reduce behavior issues in young children. In this trial, some participants will receive the Behavioral Parent Training intervention. One study found that when parents participated in training, their children developed better language and social skills. Another study showed that parents who received training felt more confident in supporting their child's needs. These findings suggest that parent training can significantly support the development of young DHH children. ^{2 3 4 6 7}

Who Is on the Research Team?

Christina Studts, PhD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My child is deaf or has difficulty hearing.

The child has been using hearing aids, cochlear implants, or bone conduction devices for more than 6 months.

Parent is custodial guardian of child

Exclusion Criteria

The child has already received help for their behavior from a professional.

Active child protective services case is open

Parent participated in formative research for this study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Parents participate in a behavioral parent training intervention adapted for families with deaf and hard of hearing preschoolers

6 months

Regular visits as per intervention schedule

Follow-up

Participants are monitored for effectiveness and implementation of the intervention in real-world settings

36 months

Assessments at 6, 12, 18, 24, 30, and 36 months

What Are the Treatments Tested in This Trial?

Interventions

• Parent Training Intervention

Trial Overview 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.

How Is the Trial Designed?

Group I: Behavioral Parent Training Experimental Treatment 1 Intervention

Group II: Control Active Control 1 Intervention

Who Is Running the Clinical Trial?

Christina Studts

Lead Sponsor

Trials

3

Recruited

330+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8698273/

Benefits of Parent Training in the Rehabilitation of Deaf or ... The present study is a systematic review on the effectiveness of Parent Training (PT) and coaching in deaf and hard of hearing (DHH) ...

2. pubs.asha.org pubs.asha.org/doi/10.1044/2022_JSLHR-22-00055

Behavioral Parent Training for Families With Young Deaf or ... The purpose of this article is to describe a program of stakeholder-engaged research adapting and assessing behavioral parent training with caregivers of young ...

3. 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.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9567338/

Study Protocol: Type 1 Hybrid Effectiveness ... This protocol describes a study aiming to test the effectiveness of an evidence-based behavioral parent training intervention adapted for parents of young ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03803943

Early Communication Intervention for Toddlers With ... Improving spoken language outcomes for children with hearing loss has important public health implications. This is a randomized clinical trial of 96 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12422838/

Perspective of Parents of Infants and Children with Hearing ... Early intervention with hearing aids or cochlear implants is linked to improved speech and language outcomes as well as improved long-term ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165587624000181

The effect of having a child with hearing impairment on ... This study aimed to compare the care burden, self-efficacy, and psychological resilience levels of parents of children with NH and hearing impeirment.