NCT02423746

Assessing and Addressing Behaviors in Children With Hearing Loss

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University of Kentucky · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hearing Loss
• Attention Deficit and Disruptive Behavior Disorders
• Parenting

Interventions

Type	Name	Description
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	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.

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2015-04-22
• Last updated: 2019-02-12

Locations

3 sites across 1 country: United States