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

Hearing Loss Clinical Trial

Official title:

Adaptation and Pilot Implementation of the Family Check-Up for Deaf and Hard of Hearing Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03483428
• Other study ID #: 17-0460-F6A
• Status: Completed
• Phase: N/A
• Start date: April 11, 2018
• Est. completion date: December 13, 2018

Study information

• Verified date: April 2019
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: December 13, 2018
• Est. primary completion date: December 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Behavior Disorders
• Deafness
• Hearing Loss
• Mental Disorders
• Parenting

Intervention

Behavioral:
• Interventionist training and supervision
Online and in-person training and weekly supervision with licensed clinical social worker while delivering the "Family Check-Up" to 5 families.
• Behavioral parent training
Up to 6 sessions of the "Family Check-Up" program, involving discussions, assessments, feedback, and skills training with a parent coach.

Locations

Country	Name	City	State
United States	University of Kentuckyi	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Kentucky

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Feasibility: Number of sessions completed	Number of sessions completed by each enrolled parent	2 weeks after final parent-child dyad completes the study
Secondary	Interventionist fidelity	Fidelity ratings of two recorded sessions per interventionist	2 weeks after final parent-child dyad completes the study
Secondary	Feasibility: usability of battery of measures	Proportion of missing data across and within instruments for parent, child, and interventionist outcome measures	2 weeks after final parent-child dyad completes the study
Secondary	Acceptability: parent satisfaction	European Parent Satisfaction Scale about Early Intervention (EPASSEI) - adapted; range: 20 (high satisfaction) to 100 (low satisfaction)	10 weeks after parent baseline
Secondary	Acceptability: interventionist satisfaction	Therapist Satisfaction Index (TSI)	2 weeks after final parent-child dyad completes the study