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

Hearing Loss Clinical Trial

— CHAMPS-DHH  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03916146
• Other study ID #: 45213
• Secondary ID: R01DC016957
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 31, 2020
• Est. completion date: May 2025

Study information

• Verified date: May 2024
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: May 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Child Behavior
• Deafness
• Hearing Loss
• Parenting

Intervention

Behavioral:
• Parent Training Intervention
Adapted version of the Family Check-Up/Everyday Parenting intervention

Locations

Country	Name	City	State
United States	University of kentucky	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Christina Studts	National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	MacArthur Bates Communicative Development Inventories	parent-report of children's developing abilities in early language	12 months, 24 months, 36 months after parent baseline
Other	Peabody Picture Vocabulary Test (PPVT)	measure of child's receptive language	12 months, 24 months, 36 months after parent baseline
Other	Clinical Evaluation of Language Fundamentals - Preschool	assessment of language pragmatics for children	12 months, 24 months, 36 months after parent baseline
Other	Beginner's Intelligibility Test (BIT)	assessment of child's intelligibility	12 months, 24 months, 36 months (children ages 3 years +) after parent baseline
Other	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
Primary	Parenting Young Children (PARYC) Scale	parent self-report of use of positive parenting strategies	6 months after parent baseline
Secondary	Child Behavior Checklist (CBCL)	subscale and total scores	6 months, 12 months, 18 months, 24 months, 30 months, 36 months after parent baseline
Secondary	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
Secondary	Parent Child Interaction System (PARCHISY)	observational measure of parent-child interaction quality	12 months, 24 months, 36 months after parent baseline
Secondary	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
Secondary	Parent Motivation Inventory (PMI)	parent-report motivation to change parenting behaviors	12 months, 24 months, 36 months after parent baseline
Secondary	Therapy Attitude Inventory (TAI)	parent-report satisfaction with intervention	6 months, 18 months, 30 months after parent baseline
Secondary	Hearing Aid Adherence Questionnaire	parent-report use of hearing aids by child	12 months, 24 months, 36 months after parent baseline
Secondary	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