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Lexington, Kentucky 40502

  • Parenting

Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

1012142740-CTSAPilot-Bush


NCT ID:

NCT02423746


Secondary ID:


Study Acronym:


Brief Title:

Assessing and Addressing Behaviors in Children With Hearing Loss


Official Title:

Assessing and Addressing Behaviors in Children With Hearing Loss


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Kentucky


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

24


Enrollment Type:

Actual


Overall Contact Information

Official Name:Matthew L Bush, MD
Principal Investigator
University of Kentucky

Study Dates

Start Date:April 2015
Completion Date:September 2016
Completion Type:Actual
Primary Completion Date:September 2016
Primary Completion Type:Actual
Verification Date:February 2019
Last Changed Date:February 11, 2019
First Received Date:March 23, 2015

Study Outcomes

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

Study Interventions

Intervention Type:Behavioral
Name:Family Check Up Behavioral Parenting Training Prog
Description: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
Arm Name:Intervention Group
Intervention Type:Behavioral
Name:Behavioral Placebo
Description: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 accept
Arm Name:Control Group

Study Arms

Study Arm Type:Experimental
Arm Name:Intervention Group
Description: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 compl
Study Arm Type:Placebo Comparator
Arm Name:Control Group
Description: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 acceptab

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Kentucky

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: March 30, 2020

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