Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Assessing and Addressing Behaviors in Children With Hearing Loss

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02423746
Recruitment Status : Completed
First Posted : April 22, 2015
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Matthew Bush, MD, University of Kentucky

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.


Condition or disease Intervention/treatment Phase
Hearing Loss Attention Deficit and Disruptive Behavior Disorders Parenting Behavioral: Family Check Up Behavioral Parenting Training Program (BPT) Behavioral: Behavioral Placebo Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Assessing and Addressing Behaviors in Children With Hearing Loss
Study Start Date : April 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Control Group

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.

Behavioral: Behavioral Placebo

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.


Experimental: Intervention Group

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.

Behavioral: Family Check Up Behavioral Parenting Training Program (BPT)

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.





Primary Outcome Measures :
  1. Number of sessions attended by each enrolled parent [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Ability to recruit 12 parent-child dyas in the allotted time frame [ Time Frame: 10 months ]
  2. COACH fidelity rating form [ Time Frame: 10 months months ]
    Measuring interventionist adherence and competence

  3. Time required per participant to complete all instruments [ Time Frame: Up to 3 hours ]
  4. Proportion of missing data across all instruments and within each instrument [ Time Frame: 4 months ]
  5. Proportions of each full instrument and interview that are successfully completed [ Time Frame: 4 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02423746


Locations
Layout table for location information
United States, Kentucky
Lexington Hearing and Speech Academy
Lexington, Kentucky, United States, 40502
University of Kentucky
Lexington, Kentucky, United States, 40536
Heuser Hearing Institute
Louisville, Kentucky, United States, 40203
Sponsors and Collaborators
University of Kentucky
Investigators
Layout table for investigator information
Principal Investigator: Matthew L Bush, MD University of Kentucky
Principal Investigator: Christina R Studts, PhD University of Kentucky

Layout table for additonal information
Responsible Party: Matthew Bush, MD, Matthew Bush, MD, Assistant Professor, University of Kentucky, University of Kentucky
ClinicalTrials.gov Identifier: NCT02423746     History of Changes
Other Study ID Numbers: 1012142740-CTSAPilot-Bush
First Posted: April 22, 2015    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019

Additional relevant MeSH terms:
Layout table for MeSH terms
Hearing Loss
Deafness
Hearing Disorders
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Problem Behavior
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Behavioral Symptoms