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Assessing and Addressing Behaviors in Children With Hearing Loss

Primary Purpose

Hearing Loss, Attention Deficit and Disruptive Behavior Disorders, Parenting

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Family Check Up Behavioral Parenting Training Program (BPT)
Behavioral Placebo
Sponsored by
University of Kentucky
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hearing Loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Parent is age 18 years or older and the custodial guardian
  • The child is aged 3-5 years and lives full-time in the caregiver's home
  • The child has had a hearing aid or cochlear implant for at least 6 months and is currently being treated for hearing loss
  • The child scores above the 70th but below the 90th percentile on the externalizing subscale of the CBCL/1.5-575 (i.e., elevated level of disruptive behavior problems without clear need for specialized behavioral services)
  • Parent can speak, understand, and read English

Exclusion Criteria:

  • The child has been diagnosed with a severe developmental condition (e.g., extreme developmental delay, severe autism, or debilitating neurological conditions, for which this intervention may not be adequate or appropriate)
  • The parent already has accessed behavioral health services for the child

Sites / Locations

  • Lexington Hearing and Speech Academy
  • University of Kentucky
  • Heuser Hearing Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control Group

Intervention Group

Arm Description

The control group will include 3 hearing aid (HA) and 3 cochlear implant (CI) caregiver-child dyads. Parents in the control group will receive an initial assessment session followed by three behavioral placebo sessions followed by a post-placebo-intervention assessment. All sessions will be delivered in the patients' usual hearing clinics and will last between 60 and 90 minutes. One month post-intervention, participants will complete post-test measures repeating baseline measures, plus acceptability ratings of intervention.

The intervention group will include 3 hearing aid (HA) and 3 cochlear implant (CI) caregiver-child dyads. Intervention parents receive the initial assessment session followed by the 3-session Family Check Up Behavioral Parenting Training Program (BPT) within one month of baseline assessment followed by a post-intervention assessment. All sessions will be delivered in the patients' usual hearing clinics and will last between 60 and 90 minutes. One month post-intervention, participants will complete post-test measures repeating baseline measures, plus acceptability ratings of intervention.

Outcomes

Primary Outcome Measures

Number of sessions attended by each enrolled parent

Secondary Outcome Measures

Ability to recruit 12 parent-child dyas in the allotted time frame
COACH fidelity rating form
Measuring interventionist adherence and competence
Time required per participant to complete all instruments
Proportion of missing data across all instruments and within each instrument
Proportions of each full instrument and interview that are successfully completed

Full Information

First Posted
March 23, 2015
Last Updated
February 11, 2019
Sponsor
University of Kentucky
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1. Study Identification

Unique Protocol Identification Number
NCT02423746
Brief Title
Assessing and Addressing Behaviors in Children With Hearing Loss
Official Title
Assessing and Addressing Behaviors in Children With Hearing Loss
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kentucky

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Purpose: This study is a feasibility trial of an existing evidence-based behavioral parent training program with parents of preschool-aged children who were born deaf or hard of hearing (DHH). The hypotheses of this study are (a) that a randomized control trial of the Family Check Up with this population will be feasible, (b) parents will rate the intervention as acceptable, and (c) a signal of effect will be observable among intervention group parents compared to controls for the following outcome variables: child behaviors, parenting behaviors, and parenting sense of competence.
Detailed Description
24 participants, comprising 6 parents and their preschool-aged child with a cochlear implant (CI; n=12) and 6 parents and their preschool-aged child with a hearing aid (HA; n=12) will be identified and recruited at routine clinic visits through university-affiliated hearing clinics. A dyad will consist of the child and his or her primary caregiver. Eligible participants will include children with clinically elevated behavior problems, as determined by having scored between the 70th and 90th percentiles on the Child Behavioral Checklist/1.5-5 (CBCL/1.5-5). 3 HA and 3 CI dyads will be randomized to the intervention group, and 3 HA and 3 CI dyads will be randomized to the control group. The intervention will consist of 3 Family Check-Up sessions within one month of baseline assessment. The control condition will consist of 3 behavioral placebo session within the same time frame, in which general information about healthy lifestyles will be presented. All intervention and control sessions will be delivered in the patients' usual hearing clinics. Each session will last between 60 and 90 minutes. One month post-intervention, all parent participants will complete post-test measures repeating baseline measures, plus acceptability ratings of the intervention. Feasibility data will be collected via process measures of recruitment, retention, and session attendance. Acceptability will be measured with a parent-completed satisfaction survey. Measures of parenting behaviors, parent self-efficacy, parent-satisfaction, parent competence, child disruptive behaviors, parenting stress, and parental depression will also be piloted in preparation for a future study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Attention Deficit and Disruptive Behavior Disorders, Parenting

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
The control group will include 3 hearing aid (HA) and 3 cochlear implant (CI) caregiver-child dyads. Parents in the control group will receive an initial assessment session followed by three behavioral placebo sessions followed by a post-placebo-intervention assessment. All sessions will be delivered in the patients' usual hearing clinics and will last between 60 and 90 minutes. One month post-intervention, participants will complete post-test measures repeating baseline measures, plus acceptability ratings of intervention.
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
The intervention group will include 3 hearing aid (HA) and 3 cochlear implant (CI) caregiver-child dyads. Intervention parents receive the initial assessment session followed by the 3-session Family Check Up Behavioral Parenting Training Program (BPT) within one month of baseline assessment followed by a post-intervention assessment. All sessions will be delivered in the patients' usual hearing clinics and will last between 60 and 90 minutes. One month post-intervention, participants will complete post-test measures repeating baseline measures, plus acceptability ratings of intervention.
Intervention Type
Behavioral
Intervention Name(s)
Family Check Up Behavioral Parenting Training Program (BPT)
Intervention Description
The Family Check Up is an evidence-based Behavioral Parenting Training (BPT) program focused on harnessing parents' motivation to change and skills training. Intervention parents receive the initial assessment session followed by 3 Family Check-up Sessions within one month of baseline assessment followed by a post-intervention assessment. All sessions will be delivered in the patients' usual hearing clinics and will last between 60 and 90 minutes. One month post-intervention, participants will complete post-test measures repeating baseline measures, plus acceptability ratings of intervention.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Placebo
Intervention Description
The Behavioral Placebo sessions will consist of presentations of information about healthy lifestyles. Parents in the control group will receive an initial assessment session followed by three behavioral placebo sessions followed by a post-placebo-intervention assessment. All sessions will be delivered in the patients' usual hearing clinics and will last between 60 and 90 minutes. One month post-intervention, participants will complete post-test measures repeating baseline measures, plus acceptability ratings of intervention.
Primary Outcome Measure Information:
Title
Number of sessions attended by each enrolled parent
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Ability to recruit 12 parent-child dyas in the allotted time frame
Time Frame
10 months
Title
COACH fidelity rating form
Description
Measuring interventionist adherence and competence
Time Frame
10 months months
Title
Time required per participant to complete all instruments
Time Frame
Up to 3 hours
Title
Proportion of missing data across all instruments and within each instrument
Time Frame
4 months
Title
Proportions of each full instrument and interview that are successfully completed
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Parent is age 18 years or older and the custodial guardian The child is aged 3-5 years and lives full-time in the caregiver's home The child has had a hearing aid or cochlear implant for at least 6 months and is currently being treated for hearing loss The child scores above the 70th but below the 90th percentile on the externalizing subscale of the CBCL/1.5-575 (i.e., elevated level of disruptive behavior problems without clear need for specialized behavioral services) Parent can speak, understand, and read English Exclusion Criteria: The child has been diagnosed with a severe developmental condition (e.g., extreme developmental delay, severe autism, or debilitating neurological conditions, for which this intervention may not be adequate or appropriate) The parent already has accessed behavioral health services for the child
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew L Bush, MD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christina R Studts, PhD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lexington Hearing and Speech Academy
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40502
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Heuser Hearing Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40203
Country
United States

12. IPD Sharing Statement

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