Assessing and Addressing Behaviors in Children With Hearing Loss

Hearing Loss Clinical Trial

Official title:

Assessing and Addressing Behaviors in Children With Hearing Loss

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02423746
• Other study ID #: 1012142740-CTSAPilot-Bush
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: September 2016

Study information

• Verified date: February 2019
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit and Disruptive Behavior Disorders
• Attention Deficit Disorder with Hyperactivity
• Deafness
• Hearing Loss
• Mental Disorders
• Parenting
• Problem Behavior

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.
• 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.

Locations

Country	Name	City	State
United States	Lexington Hearing and Speech Academy	Lexington	Kentucky
United States	University of Kentucky	Lexington	Kentucky
United States	Heuser Hearing Institute	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Kentucky

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of sessions attended by each enrolled parent		3 months
Secondary	Ability to recruit 12 parent-child dyas in the allotted time frame		10 months
Secondary	COACH fidelity rating form	Measuring interventionist adherence and competence	10 months months
Secondary	Time required per participant to complete all instruments		Up to 3 hours
Secondary	Proportion of missing data across all instruments and within each instrument		4 months
Secondary	Proportions of each full instrument and interview that are successfully completed		4 months