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

Primary Purpose

Deafness, Hearing Loss, Parenting

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Parent Training Intervention
Sponsored by
Christina Studts
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Deafness

Eligibility Criteria

3 Years - 99 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 expects to live in Kentucky for the next 3 years
  • 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

Sites / Locations

  • University of kentuckyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Behavioral Parent Training

Control

Arm Description

Outcomes

Primary Outcome Measures

Parenting Young Children (PARYC) Scale
parent self-report of use of positive parenting strategies

Secondary Outcome Measures

Child Behavior Checklist (CBCL)
subscale and total scores
Parent Sense of Competence Scale (PSCS)
parent-report self-efficacy and satisfaction with the parenting role
Dyadic Parent-Child Interaction Coding System (DPICS)
observational measure of parent-child interaction quality
Beck Depression Inventory-II (BDI-II)
parent-report depressive symptoms
Parent Motivation Inventory (PMI)
parent-report motivation to change parenting behaviors
Therapy Attitude Inventory (TAI)
parent-report satisfaction with intervention
Hearing Aid Adherence Questionnaire
parent-report use of hearing aids by child
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

Full Information

First Posted
April 11, 2019
Last Updated
April 5, 2023
Sponsor
Christina Studts
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
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1. Study Identification

Unique Protocol Identification Number
NCT03916146
Brief Title
Behavioral Parent Training for Families With Deaf and Hard of Hearing Preschoolers
Acronym
CHAMPS-DHH
Official Title
Behavioral Parent Training for Families With Deaf and Hard of Hearing Preschoolers
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 31, 2020 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Christina Studts
Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deafness, Hearing Loss, Parenting, Child Behavior

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Behavioral Parent Training
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Parent Training Intervention
Intervention Description
Adapted version of the Family Check-Up/Everyday Parenting intervention
Primary Outcome Measure Information:
Title
Parenting Young Children (PARYC) Scale
Description
parent self-report of use of positive parenting strategies
Time Frame
6 months after parent baseline
Secondary Outcome Measure Information:
Title
Child Behavior Checklist (CBCL)
Description
subscale and total scores
Time Frame
6 months, 12 months, 18 months, 24 months, 30 months, 36 months after parent baseline
Title
Parent Sense of Competence Scale (PSCS)
Description
parent-report self-efficacy and satisfaction with the parenting role
Time Frame
6 months, 12 months, 18 months, 24 months, 30 months, 36 months after parent baseline
Title
Dyadic Parent-Child Interaction Coding System (DPICS)
Description
observational measure of parent-child interaction quality
Time Frame
12 months, 24 months, 36 months after parent baseline
Title
Beck Depression Inventory-II (BDI-II)
Description
parent-report depressive symptoms
Time Frame
6 months, 12 months, 18 months, 24 months, 30 months, 36 months after parent baseline
Title
Parent Motivation Inventory (PMI)
Description
parent-report motivation to change parenting behaviors
Time Frame
12 months, 24 months, 36 months after parent baseline
Title
Therapy Attitude Inventory (TAI)
Description
parent-report satisfaction with intervention
Time Frame
6 months, 18 months, 30 months after parent baseline
Title
Hearing Aid Adherence Questionnaire
Description
parent-report use of hearing aids by child
Time Frame
12 months, 24 months, 36 months after parent baseline
Title
Change in Parenting Young Children scale (PARYC) scores over time
Description
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
Time Frame
6 months, 12 months, 18 months, 24 months, 30 months, 36 months after parent baseline
Other Pre-specified Outcome Measures:
Title
Data-logging of hearing aid/cochlear implant use by child
Description
as available from audiological medical records
Time Frame
12 months, 24 months, 36 months after baseline
Title
MacArthur Bates Communicative Development Inventories
Description
parent-report of children's developing abilities in early language
Time Frame
12 months, 24 months, 36 months after parent baseline
Title
Peabody Picture Vocabulary Test (PPVT)
Description
measure of child's receptive language
Time Frame
12 months, 24 months, 36 months (children ages 3 years +)
Title
Preschool Language Scales (PLS)
Description
comprehensive developmental language assessment of children (children ages 3-8 years)
Time Frame
12 months, 24 months, 36 months
Title
Clinical Evaluation of Language Fundamentals
Description
assessment of language pragmatics for children (children age 8 years +)
Time Frame
12 months, 24 months, 36 months (replacing PLS)
Title
Goldman-Fristoe Test of Articulation (GFTA)
Description
assessment of child's articulation
Time Frame
12 months, 24 months, 36 months
Title
Beginner's Intelligibility Test (BIT)
Description
assessment of child's in
Time Frame
12 months, 24 months, 36 months (children ages 3 years +)
Title
Meaningful Auditory Integration Scale (MAIS)
Description
parent report of child's language skills in real-world situations
Time Frame
12 months, 24 months, 36 months after parent baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julie Jacobs, MPH
Phone
859-218-2018
Email
julie.jacobs@uky.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina Studts, PhD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Jacobs

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

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

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