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Adaptation and Pilot Testing of a Behavioral Parent Training Program for Parents of Deaf and Hard of Hearing Children

Primary Purpose

Hearing Loss, Behavior Disorders, Parenting

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Interventionist training and supervision
Behavioral parent training
Sponsored by
University of Kentucky
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hearing Loss

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Parent/Caregivers and Children:

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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:

Inclusion Criteria:

  • Age 18 years or older
  • Parent of a DHH child
  • Able to speak, understand, and read English

Exclusion Criteria:

- None

Sites / Locations

  • University of Kentuckyi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Parent Coaches

Parent-Child Dyads

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Feasibility: Number of sessions completed
Number of sessions completed by each enrolled parent
Interventionist fidelity
Fidelity ratings of two recorded sessions per interventionist
Feasibility: usability of battery of measures
Proportion of missing data across and within instruments for parent, child, and interventionist outcome measures
Acceptability: parent satisfaction
European Parent Satisfaction Scale about Early Intervention (EPASSEI) - adapted; range: 20 (high satisfaction) to 100 (low satisfaction)
Acceptability: interventionist satisfaction
Therapist Satisfaction Index (TSI)

Full Information

First Posted
March 23, 2018
Last Updated
April 15, 2019
Sponsor
University of Kentucky
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1. Study Identification

Unique Protocol Identification Number
NCT03483428
Brief Title
Adaptation and Pilot Testing of a Behavioral Parent Training Program for Parents of Deaf and Hard of Hearing Children
Official Title
Adaptation and Pilot Implementation of the Family Check-Up for Deaf and Hard of Hearing Children
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
April 11, 2018 (Actual)
Primary Completion Date
December 13, 2018 (Actual)
Study Completion Date
December 13, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kentucky

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Behavior Disorders, Parenting

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Parent Coaches
Arm Type
Experimental
Arm Description
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.
Arm Title
Parent-Child Dyads
Arm Type
Experimental
Arm Description
Parents and children will receive the adapted "Family Check-Up" behavioral parent training (BPT) intervention delivered by parent coaches.
Intervention Type
Behavioral
Intervention Name(s)
Interventionist training and supervision
Intervention Description
Online and in-person training and weekly supervision with licensed clinical social worker while delivering the "Family Check-Up" to 5 families.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral parent training
Intervention Description
Up to 6 sessions of the "Family Check-Up" program, involving discussions, assessments, feedback, and skills training with a parent coach.
Primary Outcome Measure Information:
Title
Feasibility: Enrollment
Description
Proportion of parents agreeing to enroll in the intervention out of all parents approached
Time Frame
2 weeks after final parent-child dyad completes the study
Secondary Outcome Measure Information:
Title
Feasibility: Number of sessions completed
Description
Number of sessions completed by each enrolled parent
Time Frame
2 weeks after final parent-child dyad completes the study
Title
Interventionist fidelity
Description
Fidelity ratings of two recorded sessions per interventionist
Time Frame
2 weeks after final parent-child dyad completes the study
Title
Feasibility: usability of battery of measures
Description
Proportion of missing data across and within instruments for parent, child, and interventionist outcome measures
Time Frame
2 weeks after final parent-child dyad completes the study
Title
Acceptability: parent satisfaction
Description
European Parent Satisfaction Scale about Early Intervention (EPASSEI) - adapted; range: 20 (high satisfaction) to 100 (low satisfaction)
Time Frame
10 weeks after parent baseline
Title
Acceptability: interventionist satisfaction
Description
Therapist Satisfaction Index (TSI)
Time Frame
2 weeks after final parent-child dyad completes the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Parent/Caregivers and Children: Inclusion Criteria: 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 Exclusion Criteria: 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: Inclusion Criteria: Age 18 years or older Parent of a DHH child Able to speak, understand, and read English Exclusion Criteria: - None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina Studts, PhD
Organizational Affiliation
University of Kentucky, Dept of Health, Behavior & Society
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Matthew Bush, MD, PhD
Organizational Affiliation
University of Kentucky, Dept of Otolaryngology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentuckyi
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40506
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Adaptation and Pilot Testing of a Behavioral Parent Training Program for Parents of Deaf and Hard of Hearing Children

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