NCT03483428

Brief Summary

Despite being more likely than typical hearing children to experience disruptive behavior problems, children who are deaf and hard of hearing (DHH) rarely receive behavioral interventions to prevent the long-term costly outcomes of behavior problems. This pilot project will systematically adapt an evidence-based behavioral parent training (BPT) intervention to increase its acceptability and relevance for parents of young DHH children. Two parents of DHH children will be trained in the adapted BPT for DHH children. They will each deliver the intervention to five families with DHH preschool-aged children.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 30, 2018

Completed
12 days until next milestone

Study Start

First participant enrolled

April 11, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2018

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

8 months

First QC Date

March 23, 2018

Last Update Submit

April 15, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Feasibility: Enrollment

    Proportion of parents agreeing to enroll in the intervention out of all parents approached

    2 weeks after final parent-child dyad completes the study

Secondary Outcomes (5)

  • Feasibility: Number of sessions completed

    2 weeks after final parent-child dyad completes the study

  • Interventionist fidelity

    2 weeks after final parent-child dyad completes the study

  • Feasibility: usability of battery of measures

    2 weeks after final parent-child dyad completes the study

  • Acceptability: parent satisfaction

    10 weeks after parent baseline

  • Acceptability: interventionist satisfaction

    2 weeks after final parent-child dyad completes the study

Study Arms (2)

Parent Coaches

EXPERIMENTAL

Parent coaches will complete interventionist training and supervision in the "Family Check-Up," an evidence-based behavioral parent training (BPT) program, including in the adaptations for families with DHH children. Each parent coach will deliver the intervention to 5 parent-child dyads.

Behavioral: Interventionist training and supervision

Parent-Child Dyads

EXPERIMENTAL

Parents and children will receive the adapted "Family Check-Up" behavioral parent training (BPT) intervention delivered by parent coaches.

Behavioral: Behavioral parent training

Interventions

Online and in-person training and weekly supervision with licensed clinical social worker while delivering the "Family Check-Up" to 5 families.

Parent Coaches

Up to 6 sessions of the "Family Check-Up" program, involving discussions, assessments, feedback, and skills training with a parent coach.

Parent-Child Dyads

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Parent/caregiver is age 18 years or older
  • Parent/caregiver is the custodial guardian of a deaf or hard of hearing (DHH) child
  • DHH child is 2-5 years old
  • DHH child has used hearing aid(s) and/or cochlear implant(s) for \> 6 months
  • Parent/caregiver is able to read English and either speak/understand English or use American Sign Language

You may not qualify if:

  • Active child protective services case
  • DHH child of interest has been diagnosed with a severe developmental delay, severe autism, debilitating neurological condition, etc.
  • Parent/caregiver has already accessed behavioral health services for the DHH child
  • Parent Coaches/Interventionists:
  • Age 18 years or older
  • Parent of a DHH child
  • Able to speak, understand, and read English
  • \- None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentuckyi

Lexington, Kentucky, 40506, United States

Location

MeSH Terms

Conditions

Hearing LossMental Disorders

Interventions

Organization and Administration

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Services Administration

Study Officials

  • Christina Studts, PhD

    University of Kentucky, Dept of Health, Behavior & Society

    PRINCIPAL INVESTIGATOR
  • Matthew Bush, MD, PhD

    University of Kentucky, Dept of Otolaryngology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 23, 2018

First Posted

March 30, 2018

Study Start

April 11, 2018

Primary Completion

December 13, 2018

Study Completion

December 13, 2018

Last Updated

April 17, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations