Behavioral Parent Training for Families With Deaf and Hard of Hearing Preschoolers (CHAMPS-DHH)

Children who are deaf and hard of hearing (DHH) rarely receive behavioral interventions to prevent the long-term costly outcomes of behavior problems. This project will systematically adapt an evidence-based parent training intervention to increase its acceptability and relevance for parents of young DHH children. Effectiveness of the adapted intervention and its implementation with parents of young DHH children followed in "real world" hearing healthcare clinics will be assessed.

Study Overview

• Status: Active, not recruiting
• Conditions: Parenting; Hearing Loss; Deafness; Child Behavior
• Intervention / Treatment: Behavioral: Parent Training Intervention

Detailed Description

Aim 1: This part of the study convened a Community Advisory Board for input on the study. CAB members were considered collaborators rather than research subjects. They provided no personal data for use in publications or other research dissemination efforts. No adverse event data related to the CAB were collected.

Aim 2: This part of the study involved qualitative interviews with parents and focus groups with stakeholders (speech-language pathologists, audiologists, and teachers of the Deaf) to guide the adaptation of the intervention. There was no intervention in this aim and it was not a clinical trial. No adverse event data related to the qualitative interviews were collected.

Aim 3: Please see Record NCT03483428 for details and results of Aim 3.

Aim 4: This part of the study was a randomized controlled trial of the adapted parent training intervention. Parents of DHH children were randomized to either receive the intervention or to a control condition.

Aim 5: This part of the study is collecting process data about how the intervention was delivered in Aim 4, as well as qualitative data regarding perspectives about the intervention from key stakeholders, including a subset of parents from Aim 4, the interventionists who delivered the intervention, and other stakeholders. There is no intervention in this aim and it is not a clinical trial. No adverse event data will be collected.

• Study Type: Interventional
• Enrollment (Actual): 295
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40506
      • University of Kentucky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 99 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Parent is age 18 or older
• Parent is custodial guardian of child
• Parent can either speak/understand English or use American Sign Language
• Parent lives in a state with an established referral network for parents of DHH children if additional services are needed
• At baseline, child is between the ages of 3 and 6 years
• At baseline, child lives majority of time in the parent/guardian's home
• Child is deaf or hard of hearing
• Child has used hearing aid(s), cochlear implant(s) and/or bone conduction device(s) for greater than 6 months

Exclusion Criteria:

• Active child protective services case is open
• Parent has already accessed behavioral health services for the child
• Parent participated in formative research for this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Behavioral Parent Training	Behavioral: Parent Training Intervention; Adapted version of the Family Check-Up/Everyday Parenting intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parenting Young Children (PARYC) Scale	parent self-report use of positive parenting strategies; score on a scale from 1 to 7, with higher scores indicating more positive parenting practices	6 months after parent baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child Behavior Checklist (CBCL)	subscale and total scores	6 months, 12 months, 18 months, 24 months, 30 months, 36 months after parent baseline
Parent Sense of Competence Scale (PSCS)	parent-report self-efficacy and satisfaction with the parenting role	6 months, 12 months, 18 months, 24 months, 30 months, 36 months after parent baseline
Beck Depression Inventory-II (BDI-II)	parent-report depressive symptoms	6 months, 12 months, 18 months, 24 months, 30 months, 36 months after parent baseline
Parent Motivation Inventory (PMI)	parent-report motivation to change parenting behaviors	12 months, 24 months, 36 months after parent baseline
Therapy Attitude Inventory (TAI)	parent-report satisfaction with intervention	6 months, 18 months, 30 months after parent baseline
Hearing Aid Adherence Questionnaire	parent-report use of hearing aids by child	12 months, 24 months, 36 months after parent baseline
Parent Child Interaction System (PARCHISY)	observational measure of parent-child interaction quality	12 months, 24 months, 36 months after parent baseline
Change in Parenting Young Children Scale (PARYC) Scores Over Time	While the primary study outcomes is PARYC scores 6 months after baseline, we will also assess differences in changes over 3 years in PARYC scores within and between study arms	6 months, 12 months, 18 months, 24 months, 30 months, 36 months after parent baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
MacArthur Bates Communicative Development Inventories	parent-report of children's developing abilities in early language	12 months, 24 months, 36 months after parent baseline
Meaningful Auditory Integration Scale (MAIS)	parent report of child's language skills in real-world situations	12 months, 24 months, 36 months after parent baseline
Peabody Picture Vocabulary Test (PPVT)	measure of child's receptive language	12 months, 24 months, 36 months after parent baseline
Clinical Evaluation of Language Fundamentals - Preschool	assessment of language pragmatics for children	12 months, 24 months, 36 months after parent baseline
Beginner's Intelligibility Test (BIT)	assessment of child's intelligibility	12 months, 24 months, 36 months (children ages 3 years +) after parent baseline
Data-logging of Hearing Aid/Cochlear Implant Use by Child	as available from audiological medical records	12 months, 24 months, 36 months after parent baseline

Collaborators and Investigators

• Sponsor: Christina Studts
• Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
• Investigators: Principal Investigator: Christina Studts, PhD, MSPH, MSW, University of Colorado, Denver; Principal Investigator: Julie Lowman, PhD, University of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2021
• Primary Completion (Actual): October 14, 2024
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: April 11, 2019
• First Submitted That Met QC Criteria: April 12, 2019
• First Posted (Actual): April 16, 2019

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Hearing Loss; Deafness; Child Behavior
• Other Study ID Numbers: 45213; R01DC016957 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data will be made publicly available (by request to the PI) immediately following the acceptance for publication of the main findings from the final dataset.
• IPD Sharing Time Frame: De-identified data will be made publicly available (by request to the PI) immediately following the acceptance for publication of the main findings from the final dataset.
• IPD Sharing Access Criteria: De-identified data will be made publicly available (by request to the PI) immediately following the acceptance for publication of the main findings from the final dataset.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No