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Behavioral Parent Training for Families With Deaf and Hard of Hearing Preschoolers (CHAMPS-DHH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03916146
Recruitment Status : Suspended (Research activity paused for COVID-19)
First Posted : April 16, 2019
Last Update Posted : June 9, 2020
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Christina Studts, University of Kentucky

Brief Summary:
Children who are deaf and hard of hearing (DHH) rarely receive behavioral interventions to prevent the long-term costly outcomes of behavior problems. This project will systematically adapt an evidence-based parent training intervention to increase its acceptability and relevance for parents of young DHH children. Effectiveness of the adapted intervention and its implementation in "real world" hearing healthcare clinics will be assessed.

Condition or disease Intervention/treatment Phase
Deafness Hearing Loss Parenting Child Behavior Behavioral: Parent Training Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Behavioral Parent Training for Families With Deaf and Hard of Hearing Preschoolers
Actual Study Start Date : January 31, 2020
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Behavioral Parent Training Behavioral: Parent Training Intervention
Adapted version of the Family Check-Up/Everyday Parenting intervention

No Intervention: Control



Primary Outcome Measures :
  1. Parenting Young Children (PARYC) Scale [ Time Frame: 6 months after parent baseline ]
    parent self-report of use of positive parenting strategies


Secondary Outcome Measures :
  1. Child Behavior Checklist (CBCL) [ Time Frame: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after parent baseline ]
    subscale and total scores

  2. Parent Sense of Competence Scale (PSCS) [ Time Frame: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after parent baseline ]
    parent-report self-efficacy and satisfaction with the parenting role

  3. Dyadic Parent-Child Interaction Coding System (DPICS) [ Time Frame: 12 months, 24 months, 36 months after parent baseline ]
    observational measure of parent-child interaction quality

  4. Beck Depression Inventory-II (BDI-II) [ Time Frame: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after parent baseline ]
    parent-report depressive symptoms

  5. Parent Motivation Inventory (PMI) [ Time Frame: 12 months, 24 months, 36 months after parent baseline ]
    parent-report motivation to change parenting behaviors

  6. Therapy Attitude Inventory (TAI) [ Time Frame: 6 months, 18 months, 30 months after parent baseline ]
    parent-report satisfaction with intervention

  7. Hearing Aid Adherence Questionnaire [ Time Frame: 12 months, 24 months, 36 months after parent baseline ]
    parent-report use of hearing aids by child

  8. Change in Parenting Young Children scale (PARYC) scores over time [ Time Frame: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after parent baseline ]
    While the primary study outcomes is PARYC scores 6 months after baseline, we will also assess differences in changes over 3 years in PARYC scores within and between study arms


Other Outcome Measures:
  1. Data-logging of hearing aid/cochlear implant use by child [ Time Frame: 12 months, 24 months, 36 months after baseline ]
    as available from audiological medical records

  2. Vineland Adaptive Behavior Scales [ Time Frame: 12 months, 24 months, 36 months after parent baseline (children ages 3+ years) ]
    parent-report adaptive behavior of child

  3. MacArthur Bates Communicative Development Inventories [ Time Frame: 12 months, 24 months, 36 months after parent baseline (children ages 2 through 4 years) ]
    parent-report of children's developing abilities in early language

  4. Peabody Picture Vocabulary Test (PPVT) [ Time Frame: 12 months, 24 months, 36 months after child baseline (children ages 2.5 years +) ]
    measure of child's receptive language

  5. Preschool Language Scales (PLS) [ Time Frame: 12 months, 24 months, 36 months after child baseline ]
    comprehensive developmental language assessment of children (children ages 2-8 years)

  6. Clinical Evaluation of Language Fundamentals [ Time Frame: 12 months, 24 months, 36 months after child baseline (replacing PLS) ]
    assessment of language pragmatics for children (children age 8 years +)

  7. Goldman-Fristoe Test of Articulation (GFTA) [ Time Frame: 12 months, 24 months, 36 months after child baseline ]
    assessment of child's articulation

  8. Beginner's Intelligibility Test (BIT) [ Time Frame: 12 months, 24 months, 36 months after child baseline (children ages 3 years +) ]
    assessment of child's in

  9. Meaningful Auditory Integration Scale (MAIS) [ Time Frame: 12 months, 24 months, 36 months after parent baseline ]
    parent report of child's language skills in real-world situations



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Years to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Parent is age 18 or older
  • Parent is custodial guardian of child
  • Parent can either speak/understand English or use American Sign Language
  • At baseline, child is between the ages of 2 and 5 years
  • At baseline, child lives majority of time in the parent/guardian's home
  • Child is deaf or hard of hearing
  • Child has used hearing aid(s) and/or cochlear implant(s) for greater than 6 months

Exclusion Criteria:

  • Active child protective services case is open
  • Parent has already accessed behavioral health services for the child
  • Parent participated in formative research for this study

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): NCT03916146


Locations
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United States, Kentucky
University of kentucky
Lexington, Kentucky, United States, 40506
Sponsors and Collaborators
Christina Studts
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
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Principal Investigator: Christina Studts, PhD University of Kentucky
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Responsible Party: Christina Studts, Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT03916146    
Other Study ID Numbers: 45213
R01DC016957 ( U.S. NIH Grant/Contract )
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data will be made publicly available (by request to the PI) immediately following the acceptance for publication of the main findings from the final dataset.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Analytic Code
Time Frame: De-identified data will be made publicly available (by request to the PI) immediately following the acceptance for publication of the main findings from the final dataset.
Access Criteria: De-identified data will be made publicly available (by request to the PI) immediately following the acceptance for publication of the main findings from the final dataset.

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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
Deafness
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases