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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

Tracking Information
First Submitted Date  ICMJE April 11, 2019
First Posted Date  ICMJE April 16, 2019
Last Update Posted Date June 9, 2020
Actual Study Start Date  ICMJE January 31, 2020
Estimated Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2020)
Parenting Young Children (PARYC) Scale [ Time Frame: 6 months after parent baseline ]
parent self-report of use of positive parenting strategies
Original Primary Outcome Measures  ICMJE
 (submitted: April 12, 2019)
Parenting Young Children (PARYC) Scale [ Time Frame: 6 months after parent baseline ]
post-intervention parent self-report of use of positive parenting strategies
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2020)
  • 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
  • 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
  • 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
  • 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
  • Parent Motivation Inventory (PMI) [ Time Frame: 12 months, 24 months, 36 months after parent baseline ]
    parent-report motivation to change parenting behaviors
  • Therapy Attitude Inventory (TAI) [ Time Frame: 6 months, 18 months, 30 months after parent baseline ]
    parent-report satisfaction with intervention
  • Hearing Aid Adherence Questionnaire [ Time Frame: 12 months, 24 months, 36 months after parent baseline ]
    parent-report use of hearing aids by child
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2019)
  • 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
  • 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
  • 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
  • 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
  • Parent Motivation Inventory (PMI) [ Time Frame: 12 months, 24 months, 36 months after parent baseline ]
    parent-report motivation to change parenting behaviors
  • European Parent Satisfaction Scale about Early Intervention (EPASSEI) [ Time Frame: 12 months, 24 months, 36 months after parent baseline ]
    parent-report satisfaction with intervention
  • Hearing Aid Adherence Questionnaire [ Time Frame: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after parent baseline ]
    parent-report use of hearing aids by child
  • 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
Current Other Pre-specified Outcome Measures
 (submitted: February 20, 2020)
  • 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
  • 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
  • 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
  • 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
  • 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)
  • 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 +)
  • Goldman-Fristoe Test of Articulation (GFTA) [ Time Frame: 12 months, 24 months, 36 months after child baseline ]
    assessment of child's articulation
  • 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
  • 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
Original Other Pre-specified Outcome Measures
 (submitted: April 12, 2019)
Data-logging of hearing aid/cochlear implant use by child [ Time Frame: 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after parent baseline ]
as available from audiological medical records
 
Descriptive Information
Brief Title  ICMJE Behavioral Parent Training for Families With Deaf and Hard of Hearing Preschoolers
Official Title  ICMJE Behavioral Parent Training for Families With Deaf and Hard of Hearing Preschoolers
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Deafness
  • Hearing Loss
  • Parenting
  • Child Behavior
Intervention  ICMJE Behavioral: Parent Training Intervention
Adapted version of the Family Check-Up/Everyday Parenting intervention
Study Arms  ICMJE
  • Experimental: Behavioral Parent Training
    Intervention: Behavioral: Parent Training Intervention
  • No Intervention: Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: April 12, 2019)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2023
Estimated Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 99 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03916146
Other Study ID Numbers  ICMJE 45213
R01DC016957 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: 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.
Responsible Party Christina Studts, University of Kentucky
Study Sponsor  ICMJE Christina Studts
Collaborators  ICMJE National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators  ICMJE
Principal Investigator: Christina Studts, PhD University of Kentucky
PRS Account University of Kentucky
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP