Clinical trial NCT03916146: Behavioral Parent Training for Families with Deaf and Hard of Hearing Preschoolers
Official title: Behavioral Parent Training for Families with Deaf and Hard of Hearing Preschoolers
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Deafness
Hearing Loss
Parenting
Child Behavior
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2019-04-16
Enrollment: 250
Sex: ALL
Minimum age (years): 3
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Parenting Young Children (PARYC) Scale
timeFrame: 6 months after parent baseline
Secondary outcomes:
measure: Child Behavior Checklist (CBCL)
timeFrame: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after parent baseline
measure: Parent Sense of Competence Scale (PSCS)
timeFrame: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after parent baseline
measure: Parent Child Interaction System (PARCHISY)
timeFrame: 12 months, 24 months, 36 months after parent baseline
measure: Beck Depression Inventory-II (BDI-II)
timeFrame: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after parent baseline
measure: Parent Motivation Inventory (PMI)
timeFrame: 12 months, 24 months, 36 months after parent baseline
measure: Therapy Attitude Inventory (TAI)
timeFrame: 6 months, 18 months, 30 months after parent baseline
measure: Hearing Aid Adherence Questionnaire
timeFrame: 12 months, 24 months, 36 months after parent baseline
measure: Change in Parenting Young Children scale (PARYC) scores over time
timeFrame: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after parent baseline
Other outcomes:
measure: Data-logging of hearing aid/cochlear implant use by child
timeFrame: 12 months, 24 months, 36 months after parent baseline
measure: MacArthur Bates Communicative Development Inventories
timeFrame: 12 months, 24 months, 36 months after parent baseline
measure: Peabody Picture Vocabulary Test (PPVT)
timeFrame: 12 months, 24 months, 36 months after parent baseline
measure: Clinical Evaluation of Language Fundamentals - Preschool
timeFrame: 12 months, 24 months, 36 months after parent baseline
measure: Beginner's Intelligibility Test (BIT)
timeFrame: 12 months, 24 months, 36 months (children ages 3 years +) after parent baseline
measure: Meaningful Auditory Integration Scale (MAIS)
timeFrame: 12 months, 24 months, 36 months after parent baseline
Locations:
city: Lexington
country: United States
facility: University of kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Christina Studts, PhD
role: PRINCIPAL_INVESTIGATOR
References: