Ignite Creation Date:
2024-05-06 @ 3:59 AM
Last Modification Date:
2024-10-26 @ 11:41 AM
Study NCT ID:
NCT02423746
Status:
COMPLETED
Last Update Posted:
2019-02-12
First Post:
2015-03-23
Brief Title:
Assessing and Addressing Behaviors in Children With Hearing Loss
Sponsor:
University of Kentucky
Organization:
University of Kentucky
Study Overview
Official Title:
Assessing and Addressing Behaviors in Children With Hearing Loss
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 n12 and 6 parents and their preschool-aged child with a hearing aid HA n12 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 Checklist15-5 CBCL15-5
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None