Clinical trial NCT02423746: Assessing and Addressing Behaviors in Children With Hearing Loss
Official title: Assessing and Addressing Behaviors in Children With Hearing Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Attention Deficit and Disruptive Behavior Disorders
Parenting
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2015-04-22
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Number of sessions attended by each enrolled parent
timeFrame: 3 months
Secondary outcomes:
measure: Ability to recruit 12 parent-child dyas in the allotted time frame
timeFrame: 10 months
measure: COACH fidelity rating form
timeFrame: 10 months months
measure: Time required per participant to complete all instruments
timeFrame: Up to 3 hours
measure: Proportion of missing data across all instruments and within each instrument
timeFrame: 4 months
measure: Proportions of each full instrument and interview that are successfully completed
timeFrame: 4 months
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Lexington Hearing and Speech Academy
state: Kentucky
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Louisville
country: United States
facility: Heuser Hearing Institute
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Matthew L Bush, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Kentucky
name: Christina R Studts, PhD
role: PRINCIPAL_INVESTIGATOR
References: