- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03483428
Adaptation and Pilot Testing of a Behavioral Parent Training Program for Parents of Deaf and Hard of Hearing Children
April 15, 2019 updated by: Christina Studts, University of Kentucky
Adaptation and Pilot Implementation of the Family Check-Up for Deaf and Hard of Hearing Children
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kentucky
-
Lexington, Kentucky, United States, 40506
- University of Kentuckyi
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Parent Coaches
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.
|
Online and in-person training and weekly supervision with licensed clinical social worker while delivering the "Family Check-Up" to 5 families.
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EXPERIMENTAL: Parent-Child Dyads
Parents and children will receive the adapted "Family Check-Up" behavioral parent training (BPT) intervention delivered by parent coaches.
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Up to 6 sessions of the "Family Check-Up" program, involving discussions, assessments, feedback, and skills training with a parent coach.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility: Enrollment
Time Frame: 2 weeks after final parent-child dyad completes the study
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Proportion of parents agreeing to enroll in the intervention out of all parents approached
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2 weeks after final parent-child dyad completes the study
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility: Number of sessions completed
Time Frame: 2 weeks after final parent-child dyad completes the study
|
Number of sessions completed by each enrolled parent
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2 weeks after final parent-child dyad completes the study
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Interventionist fidelity
Time Frame: 2 weeks after final parent-child dyad completes the study
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Fidelity ratings of two recorded sessions per interventionist
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2 weeks after final parent-child dyad completes the study
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Feasibility: usability of battery of measures
Time Frame: 2 weeks after final parent-child dyad completes the study
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Proportion of missing data across and within instruments for parent, child, and interventionist outcome measures
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2 weeks after final parent-child dyad completes the study
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Acceptability: parent satisfaction
Time Frame: 10 weeks after parent baseline
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European Parent Satisfaction Scale about Early Intervention (EPASSEI) - adapted; range: 20 (high satisfaction) to 100 (low satisfaction)
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10 weeks after parent baseline
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Acceptability: interventionist satisfaction
Time Frame: 2 weeks after final parent-child dyad completes the study
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Therapist Satisfaction Index (TSI)
|
2 weeks after final parent-child dyad completes the study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christina Studts, PhD, University of Kentucky, Dept of Health, Behavior & Society
- Principal Investigator: Matthew Bush, MD, PhD, University of Kentucky, Dept of Otolaryngology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 11, 2018
Primary Completion (ACTUAL)
December 13, 2018
Study Completion (ACTUAL)
December 13, 2018
Study Registration Dates
First Submitted
March 23, 2018
First Submitted That Met QC Criteria
March 23, 2018
First Posted (ACTUAL)
March 30, 2018
Study Record Updates
Last Update Posted (ACTUAL)
April 17, 2019
Last Update Submitted That Met QC Criteria
April 15, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17-0460-F6A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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