Clinical Trial: Assessing and Addressing Behaviors in Children With Hearing Loss

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: Assessing and Addressing Behaviors in Children With Hearing Loss

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 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.


Sponsor: University of Kentucky

Current Primary Outcome: Number of sessions attended by each enrolled parent [ Time Frame: 3 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Ability to recruit 12 parent-child dyas in the allotted time frame [ Time Frame: 10 months ]
  • COACH fidelity rating form [ Time Frame: 10 months months ]
    Measuring interventionist adherence and competence
  • Time required per participant to complete all instruments [ Time Frame: Up to 3 hours ]
  • Proportion of missing data across all instruments and within each instrument [ Time Frame: 4 months ]
  • Proportions of each full instrument and interview that are successfully completed [ Time Frame: 4 months ]


Original Secondary Outcome: Same as current

Information By: University of Kentucky

Dates:
Date Received: March 23, 2015
Date Started: April 2015
Date Completion: November 2017
Last Updated: January 20, 2017
Last Verified: January 2017