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: Recruiting
• Conditions: Parenting; Hearing Loss; Deafness; Child Behavior
• Intervention / Treatment: Behavioral: Parent Training Intervention

• Study Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julie Jacobs, MPH; Phone Number: 859-218-2018; Email: julie.jacobs@uky.edu

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40506
      • Recruiting
      • University of Kentucky
      • Contact: Julie Jacobs

Participation Criteria

Eligibility Criteria

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

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 of use of positive parenting strategies	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
Dyadic Parent-Child Interaction Coding System (DPICS)	observational measure of parent-child interaction quality	12 months, 24 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
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
Data-logging of hearing aid/cochlear implant use by child	as available from audiological medical records	12 months, 24 months, 36 months after baseline
MacArthur Bates Communicative Development Inventories	parent-report of children's developing abilities in early language	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 (children ages 3 years +)
Preschool Language Scales (PLS)	comprehensive developmental language assessment of children (children ages 3-8 years)	12 months, 24 months, 36 months
Clinical Evaluation of Language Fundamentals	assessment of language pragmatics for children (children age 8 years +)	12 months, 24 months, 36 months (replacing PLS)
Goldman-Fristoe Test of Articulation (GFTA)	assessment of child's articulation	12 months, 24 months, 36 months
Beginner's Intelligibility Test (BIT)	assessment of child's in	12 months, 24 months, 36 months (children ages 3 years +)
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

Collaborators and Investigators

• Sponsor: Christina Studts
• Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
• Investigators: Principal Investigator: Christina Studts, PhD, University of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2020
• Primary Completion (Anticipated): May 1, 2025
• Study Completion (Anticipated): May 1, 2025

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): April 7, 2023
• Last Update Submitted That Met QC Criteria: April 5, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness
• 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