Assessing and Addressing Behaviors in Children With Hearing Loss

NCT02423746 | Completed

• 1 other identifier: 1012142740-CTSAPilot-Bush
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

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.

Conditions

Hearing Loss; Attention Deficit and Disruptive Behavior Disorders; Parenting

Outcome Measures

Primary Outcomes (1)

• Number of sessions attended by each enrolled parent

  3 months

Secondary Outcomes (5)

• Ability to recruit 12 parent-child dyas in the allotted time frame

  10 months

• COACH fidelity rating form

  10 months months

• Time required per participant to complete all instruments

  Up to 3 hours

• Proportion of missing data across all instruments and within each instrument

  4 months

• Proportions of each full instrument and interview that are successfully completed

  4 months

Study Arms (2)

Control Group

PLACEBO COMPARATOR

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 acceptability ratings of intervention.

Behavioral: Behavioral Placebo

Intervention Group

EXPERIMENTAL

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 complete post-test measures repeating baseline measures, plus acceptability ratings of intervention.

Behavioral: Family Check Up Behavioral Parenting Training Program (BPT)

Interventions

Family Check Up Behavioral Parenting Training Program (BPT) BEHAVIORAL

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.

Intervention Group

Behavioral Placebo BEHAVIORAL

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.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kentucky: lead

Study Sites (3)

Lexington Hearing and Speech Academy

Lexington, Kentucky, 40502, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Heuser Hearing Institute

Louisville, Kentucky, 40203, United States

Location

MeSH Terms

Conditions

Hearing Loss; Attention Deficit and Disruptive Behavior Disorders

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Matthew L Bush, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

• Christina R Studts, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Matthew Bush, MD, Assistant Professor, University of Kentucky

Study Record Dates

• First Submitted: March 23, 2015
• First Posted: April 22, 2015
• Study Start: April 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: February 12, 2019

Record last verified: 2019-02

Locations

US (3)