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Active, Not Recruiting

NCT Number: NCT03916146

Behavioral Parent Training for Families With Deaf and Hard of Hearing Preschoolers

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 with parents of young DHH children followed in "real world" hearing healthcare clinics will be assessed.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Deafness Behavior Child Behavior Ear Diseases Hearing Disorders Hearing Loss Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Parenting Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

3 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky

Lexington, Kentucky, 40506, United States

About this study

Aim 1: This part of the study convened a Community Advisory Board for input on the study. CAB members were considered collaborators rather than research subjects. They provided no personal data for use in publications or other research dissemination efforts. No adverse event data related to the CAB were collected.

Aim 2: This part of the study involved qualitative interviews with parents and focus groups with stakeholders (speech-language pathologists, audiologists, and teachers of the Deaf) to guide the adaptation of the intervention. There was no intervention in this aim and it was not a clinical trial. No adverse event data related to the qualitative interviews were collected.

Aim 3: Please see Record NCT03483428 for details and results of Aim 3.

Aim 4: This part of the study was a randomized controlled trial of the adapted parent training intervention. Parents of DHH children were randomized to either receive the intervention or to a control condition.

Aim 5: This part of the study is collecting process data about how the intervention was delivered in Aim 4, as well as qualitative data regarding perspectives about the intervention from key stakeholders, including a subset of parents from Aim 4, the interventionists who delivered the intervention, and other stakeholders. There is no intervention in this aim and it is not a clinical trial. No adverse event data will be collected.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Parent lives in a state with an established referral network for parents of DHH children if additional services are needed
  • At baseline, child is between the ages of 3 and 6 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), cochlear implant(s) and/or bone conduction device(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

Treatment and study plan

Parent Training Intervention

Behavioral

Adapted version of the Family Check-Up/Everyday Parenting intervention

Primary outcomes

  1. Parenting Young Children (PARYC) Scale

    Time frame: 6 months after parent baseline

    parent self-report use of positive parenting strategies; score on a scale from 1 to 7, with higher scores indicating more positive parenting practices

Secondary outcomes

  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. Parent Child Interaction System (PARCHISY)

    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 outcomes

  1. Data-logging of Hearing Aid/Cochlear Implant Use by Child

    Time frame: 12 months, 24 months, 36 months after parent baseline

    as available from audiological medical records

  2. MacArthur Bates Communicative Development Inventories

    Time frame: 12 months, 24 months, 36 months after parent baseline

    parent-report of children's developing abilities in early language

  3. Peabody Picture Vocabulary Test (PPVT)

    Time frame: 12 months, 24 months, 36 months after parent baseline

    measure of child's receptive language

  4. Clinical Evaluation of Language Fundamentals - Preschool

    Time frame: 12 months, 24 months, 36 months after parent baseline

    assessment of language pragmatics for children

  5. Beginner's Intelligibility Test (BIT)

    Time frame: 12 months, 24 months, 36 months (children ages 3 years +) after parent baseline

    assessment of child's intelligibility

  6. 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

Sponsors and collaborators

Lead sponsor

Christina Studts

Other

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

Registry information

Acronym: CHAMPS-DHH

Important dates

Study start
2021
Primary completion
2024
Study completion
2026
First posted
Apr 16, 2019
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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