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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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ClinicalTrials.gov Identifier: NCT03483428
Recruitment Status : Completed
First Posted : March 30, 2018
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Christina Studts, University of Kentucky

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.

Condition or disease Intervention/treatment Phase
Hearing Loss Behavior Disorders Parenting Behavioral: Interventionist training and supervision Behavioral: Behavioral parent training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Adaptation and Pilot Implementation of the Family Check-Up for Deaf and Hard of Hearing Children
Actual Study Start Date : April 11, 2018
Actual Primary Completion Date : December 13, 2018
Actual Study Completion Date : December 13, 2018

Resource links provided by the National Library of Medicine


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.
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.

Experimental: Parent-Child Dyads
Parents and children will receive the adapted "Family Check-Up" behavioral parent training (BPT) intervention delivered by parent coaches.
Behavioral: Behavioral parent training
Up to 6 sessions of the "Family Check-Up" program, involving discussions, assessments, feedback, and skills training with a parent coach.




Primary Outcome Measures :
  1. Feasibility: Enrollment [ Time Frame: 2 weeks after final parent-child dyad completes the study ]
    Proportion of parents agreeing to enroll in the intervention out of all parents approached


Secondary Outcome Measures :
  1. 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

  2. Interventionist fidelity [ Time Frame: 2 weeks after final parent-child dyad completes the study ]
    Fidelity ratings of two recorded sessions per interventionist

  3. Feasibility: usability of battery of measures [ Time Frame: 2 weeks after final parent-child dyad completes the study ]
    Proportion of missing data across and within instruments for parent, child, and interventionist outcome measures

  4. Acceptability: parent satisfaction [ Time Frame: 10 weeks after parent baseline ]
    European Parent Satisfaction Scale about Early Intervention (EPASSEI) - adapted; range: 20 (high satisfaction) to 100 (low satisfaction)

  5. Acceptability: interventionist satisfaction [ Time Frame: 2 weeks after final parent-child dyad completes the study ]
    Therapist Satisfaction Index (TSI)



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03483428


Locations
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United States, Kentucky
University of Kentuckyi
Lexington, Kentucky, United States, 40506
Sponsors and Collaborators
University of Kentucky
Investigators
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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

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Responsible Party: Christina Studts, Assistant Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT03483428     History of Changes
Other Study ID Numbers: 17-0460-F6A
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hearing Loss
Mental Disorders
Deafness
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms