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DeafnessCHAMPS-DHHNCT03916146

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

A study testing Parent Training Intervention in people with Deafness and Hearing Loss, run by Christina Studts at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 3 to 99 years
Conditions the study is for
Deafness, Hearing Loss, Parenting
What is being tested?
Parent Training Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
295 participants
Where
1 siteUnited States
Study dates
17 Jun 2021to 31 May 2027
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 99 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Kentucky

    Lexington, Kentucky, 40506

Other trials in United States

About this study

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.

Read the detailed description

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.

Being tested
Parent Training Intervention
Medical subject headings
Deafness, Hearing Loss, Child Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Parent Training InterventionBehavioural

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

Study groups in NCT03916146
Study groupRoleWhat they receive
Behavioral Parent TrainingExperimentalParents are offered a evidence-based behavioral parent training intervention systematically adapted for parents of young deaf and hard of hearing children. The intervention is offered annually and includes up to 6 sessions each year.
Receives: Behavioral: Parent Training Intervention
ControlNo interventionParents are not offered the intervention but are not precluded from accessing other services for their young deaf and hard of hearing chidren.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Parenting Young Children (PARYC) Scale Total Score

    On the Parenting Young Children (PARYC) scale, parents self-report use of positive parenting strategies by rating 21 specific parenting behaviors from 1 (not at all) to 7 (most of the time) based on how often in the past month they engaged in each parenting behavior. The PARYC Total Score is the sum of three subscale scores (Supporting Positive Behaviors, Setting Limits, Proactive Parenting) and can range from 21-147 with higher scores indicating more positive parenting practices.

    Measured: 6 months after parent baseline

Secondary outcomes (26)
  1. Change in Parenting Young Children Scale (PARYC) Total Scores Over Time

    While the primary study outcome is PARYC Total scores 6 months after baseline, a secondary outcome is PARYC Total scores over time within and between study arms for up to 3 years. On the PARYC, parents self-report use of positive parenting strategies by rating 21 specific parenting behaviors from 1 (not at all) to 7 (most of the time) based on how often in the past month they engaged in each parenting behavior. The PARYC Total Score is the sum of three subscale scores (Supporting Positive Behaviors, Setting Limits, Proactive Parenting) and can range from 21-147 with higher scores indicating more positive parenting practices.

    Measured: Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment

  2. Change in Parenting Young Children Scale (PARYC) Supporting Positive Behavior Subscale Scores Over Time

    On the PARYC, parents self-report use of positive parenting strategies by rating 21 specific parenting behaviors from 1 (not at all) to 7 (most of the time) based on how often in the past month they engaged in each parenting behavior. The PARYC Supporting Positive Behavior subscale sums scores from 7 items describing this positive parenting strategy. The subscale score can range from 7-49 with higher scores indicating more use of strategies to support their child's positive behavior.

    Measured: Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment

  3. Change in Parenting Young Children Scale (PARYC) Setting Limits Subscale Scores Over Time

    On the PARYC, parents self-report use of positive parenting strategies by rating 21 specific parenting behaviors from 1 (not at all) to 7 (most of the time) based on how often in the past month they engaged in each parenting behavior. The PARYC Setting Limits subscale sums scores from 7 items describing this positive parenting strategy. The subscale score can range from 7-49 with higher scores indicating more use of strategies to set limits.

    Measured: Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment

  4. Change in Parenting Young Children Scale (PARYC) Proactive Parenting Subscale Scores Over Time

    On the PARYC, parents self-report use of positive parenting strategies by rating 21 specific parenting behaviors from 1 (not at all) to 7 (most of the time) based on how often in the past month they engaged in each parenting behavior. The PARYC Proactive Parenting subscale sums scores from 7 items describing this positive parenting strategy. The subscale score can range from 7-49 with higher scores indicating more use of proactive parenting strategies.

    Measured: Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment

  5. Child Behavior Checklist (CBCL) Total Problems T-Score

    Child Behavior Checklist (CBCL) Total Problems T-scores, including responses to all items. Parents of children ages 3-5 completed the CBCL/1-5 and parents of children ages 6 and up completed the CBCL/6-18. T-scores have a population mean of 50 with a standard deviation of 10. Higher T-scores indicate higher levels of behavioral problems. On the CBCL/1-5 and CBCL/6-18, T-scores less than 60 are in the normal range. For children ages 3-5 years, T-scores from 60-63 are in the at-risk/borderline range and T-scores 64 and above are in the clinical range. For children ages 6 years and up, T-scores from 60-64 are in the at-risk/borderline range and T-scores 65 and above are in the clinical range.

    Measured: Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment

  6. Child Behavior Checklist (CBCL) Internalizing Problems T-Score

    Child Behavior Checklist (CBCL) Internalizing Problems subscale T-scores. Parents of children ages 3-5 completed the CBCL/1-5 (99 items) and parents of children ages 6 and up completed the CBCL/6-18 (113 items). T-scores have a population mean of 50 with a standard deviation of 10. Higher T-scores indicate higher levels of internalizing behavior problems. T-scores less than 60 are in the normal range. For children ages 3-5 years, T-scores from 60-63 are in the at-risk/borderline range and T-scores 64 and above are in the clinical range. For children ages 6 years and up, T-scores from 60-64 are in the at-risk/borderline range and T-scores 65 and above are in the clinical range.

    Measured: Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment

  7. Child Behavior Checklist (CBCL) Externalizing Problems T-Score

    Child Behavior Checklist (CBCL) Externalizing Problems subscale T-scores. Parents of children ages 3-5 completed the CBCL/1-5 (99 items) and parents of children ages 6 and up completed the CBCL/6-18 (113 items). T-scores have a population mean of 50 with a standard deviation of 10. Higher T-scores indicate higher levels of externalizing behavioral problems. T-scores less than 60 are in the normal range. For children ages 3-5 years, T-scores from 60-63 are in the at-risk/borderline range and T-scores 64 and above are in the clinical range. For children ages 6 years and up, T-scores from 60-64 are in the at-risk/borderline range and T-scores 65 and above are in the clinical range.

    Measured: Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment

  8. Parent Sense of Competence Scale (PSCS) Total Score

    Parent Sense of Competence Scale (PSCS) Total Score combines the scores for the self-efficacy and satisfaction subscales, yielding a total score for parent sense of competence. Possible scores range from 16-96 with higher scores indicating higher levels of parent sense of competence.

    Measured: Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment.

  9. Parent Sense of Competence Scale (PSCS) Self-efficacy Score

    The Parent Sense of Competence Scale Self-efficacy subscale score measures parents' self-efficacy in the parenting role. Possible scores range from 7-42 with higher scores indicating higher levels of parent self-efficacy.

    Measured: Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment

  10. Parent Sense of Competence Scale (PSCS) Satisfaction Score

    The Parent Sense of Competence Scale (PSCS) Satisfaction subscale measures parent satisfaction with the parenting role. Possible scores range from 9-54 with higher scores indicating higher levels of parent satisfaction.

    Measured: Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment

  11. Beck Depression Inventory-II (BDI-II)

    The Beck Depression Inventory-II is a self-report measure of depressive symptoms. For each of 21 items, respondents select the response option (scored 0, 1, 2, or 3) closest to their own experience over the past week. Scores can range from 0-63 with higher scores indicating more/more severe depressive symptoms.

    Measured: Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment

  12. Parent Child Interaction System (PARCHISY) - Parent Positive Control

    The Parent Child Interaction System (PARCHISY) is an observational measure of parent-child interaction quality. Scores are given by trained observers reviewing video recordings of parents and children interacting in assigned tasks. The Parent Positive Control score reflects parents' use of positive behaviors (e.g., use of explanation, open-ended prompting, praise) in interacting with their child. Scores range from 1 (no evidence) to 7 (consistent occurrence), with higher scores indicating more use of positive behaviors by parents.

    Measured: Every 6 months from baseline to up to 18 months after baseline

  13. Parent Child Interaction System (PARCHISY) - Parent Negative Control

    The Parent Child Interaction System (PARCHISY) is an observational measure of parent-child interaction quality. Scores are given by trained observers reviewing video recordings of parents and children interacting in assigned tasks. The Parent Negative Control score reflects parents' use of negative behaviors (e.g., use of physical control, criticism) in interacting with their child. Scores range from 1 (no evidence) to 7 (consistent occurrence), with higher scores indicating more use of negative behaviors by parents.

    Measured: Every 6 months from baseline to up to 18 months after baseline

  14. Parent Child Interaction System (PARCHISY) - Parent Positive Affect

    The Parent Child Interaction System (PARCHISY) is an observational measure of parent-child interaction quality. Scores are given by trained observers reviewing video recordings of parents and children interacting in assigned tasks. The Parent Positive Affect score reflects parents' positive affect (e.g., warmth, smiling, laughing) in interacting with their child. Scores range from 1 (no evidence) to 7 (consistent occurrence), with higher scores indicating higher levels of positive affect observed in parents.

    Measured: Every 6 months from baseline to up to 18 months after baseline

  15. Parent Child Interaction System (PARCHISY) - Parent Negative Affect

    The Parent Child Interaction System (PARCHISY) is an observational measure of parent-child interaction quality. Scores are given by trained observers reviewing video recordings of parents and children interacting in assigned tasks. The Parent Negative Affect score reflects parents' negative affect (e.g., rejection, frowning, cold/harsh voice) in interacting with their child. Scores range from 1 (no evidence) to 7 (consistent occurrence), with higher scores indicating higher levels of negative affect observed in parents.

    Measured: Every 6 months from baseline to up to 18 months after baseline

  16. Parent Child Interaction System (PARCHISY) - Child Positive Affect

    The Parent Child Interaction System (PARCHISY) is an observational measure of parent-child interaction quality. Scores are given by trained observers reviewing video recordings of parents and children interacting in assigned tasks. The Child Positive Affect score reflects children's positive affect (e.g., warmth, smiling, laughing) in interacting with their parent. Scores range from 1 (no evidence) to 7 (consistent occurrence), with higher scores indicating higher levels of positive affect observed in children.

    Measured: Every 6 months from baseline to up to 18 months after baseline

  17. Parent Child Interaction System (PARCHISY) - Child Negative Affect

    The Parent Child Interaction System (PARCHISY) is an observational measure of parent-child interaction quality. Scores are given by trained observers reviewing video recordings of parents and children interacting in assigned tasks. The Child Negative Affect score reflects children's negative affect (e.g., rejection, cold/harsh voice tones) in interacting with their parent. Scores range from 1 (no evidence) to 7 (consistent occurrence), with higher scores indicating higher levels of negative affect observed in children.

    Measured: Every 6 months from baseline to up to 18 months after baseline

  18. Parent Child Interaction System (PARCHISY) - Child On-Task

    The Parent Child Interaction System (PARCHISY) is an observational measure of parent-child interaction quality. Scores are given by trained observers reviewing video recordings of parents and children interacting in assigned tasks. The Child On-Task score reflects parents' children's initiative and persistence in engaged with the assigned task while interacting with their parent. Scores range from 1 (no evidence) to 7 (consistent occurrence), with higher scores indicating higher levels of children's observed on-task behavior.

    Measured: Every 6 months from baseline to up to 18 months after baseline

  19. Parent Child Interaction System (PARCHISY) - Child Noncompliance

    The Parent Child Interaction System (PARCHISY) is an observational measure of parent-child interaction quality. Scores are given by trained observers reviewing video recordings of parents and children interacting in assigned tasks. The Child Noncompliance score reflects children's level of compliance while interacting with their parent. Scores range from 1 (no evidence) to 7 (consistent occurrence), with higher scores indicating higher levels of child noncompliance.

    Measured: Every 6 months from baseline to up to 18 months after baseline

  20. Parent Child Interaction System (PARCHISY) - Conflict

    The Parent Child Interaction System (PARCHISY) is an observational measure of parent-child interaction quality. Scores are given by trained observers reviewing video recordings of parents and children interacting in assigned tasks. The Conflict score reflects parent-child dyads' level of minor or major disagreement (e.g., shared negative affect, arguing, tussling over toy, etc.) in interacting with each other. Scores range from 1 (no evidence) to 7 (consistent occurrence), with higher scores indicating higher levels of conflict.

    Measured: Every 6 months from baseline to up to 18 months after baseline

  21. Parent Motivation Inventory (PMI) Total Score

    The Parent Motivation Inventory (PMI) is a self-report measure of parents' motivation to change parenting behaviors. The Total Score is the sum of the 3 subscales (Desire for Change, Readiness to Change, Perceived Ability to Change). Total scores can range from 25 to 125 with higher scores indicated higher motivation to change.

    Measured: Annually from 12 months after baseline up to 36 months after baseline

  22. Parent Motivation Inventory (PMI) Desire for Change Subscale

    The Parent Motivation Inventory (PMI) is a self-report measure of parents' motivation to change parenting behaviors. The Desire for Change subscale includes 7 items measuring parents' desire for their child's behaviors to change. Subscale scores can range from 7 to 35 with higher scores indicated higher desire.

    Measured: Annually from 12 months after baseline up to 36 months after baseline

  23. Parent Motivation Inventory (PMI) Readiness to Change Subscale

    The Parent Motivation Inventory (PMI) is a self-report measure of parents' motivation to change parenting behaviors. The Readiness to Change subscale includes 14 items measuring parents' readiness to change their parenting behaviors. Subscale scores can range from 14 to 70 with higher scores indicated higher readiness to change.

    Measured: Annually from 12 months after baseline up to 36 months after baseline

  24. Parent Motivation Inventory (PMI) Perceived Ability to Change Subscale

    The Parent Motivation Inventory (PMI) is a self-report measure of parents' motivation to change parenting behaviors. The Perceived Ability to Change subscale includes 4 items measuring parents' perceived ability to change their parenting behaviors. Subscale scores can range from 4 to 20 with higher scores indicated higher perceived ability to change.

    Measured: Annually from 12 months after baseline up to 36 months after baseline

  25. Hearing Aid Adherence Questionnaire

    The Hearing Aid Adherence Questionnaire is a parent-report measure assessing their child's use of their hearing aids. This measure includes a list of 9 situations (e.g., riding in a car, being at someone else's house) for which parents rate the frequency of their child's hearing aid use on a Likert-type scale from 1 (never) to 5 (always). The scale score is the mean of the parent's responses to each item. Scores can range from 1-5 and higher scores indicate more hearing aid use in more situations.

    Measured: Every 12 months from completion of baseline assessment up to 36 months after baseline assessment

  26. Therapy Attitude Inventory (TAI)

    The Therapy Attitude Inventory is a parent-report measure evaluating parent satisfaction with therapy (developed for use with Parent-Child Interaction Therapy; in this study used to assess satisfaction with the adapted Behavioral Parent Training intervention). Parents rate their agreement with 10 items using a Likert-type scale (1-5) for each item. Scores can range from 10 to 50 with higher scores indicating more satisfaction.

    Measured: Annually from 6 months after baseline up to 30 months after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2019
  2. Study start17 Jun 2021
  3. Primary completion14 Oct 2024
  4. Study completion31 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
295 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03916146
Sponsor's protocol ID
45213
Other IDs
R01DC016957
Acronym
CHAMPS-DHH
Status last verified
Jul 2026
First submitted
11 Apr 2019
Last updated
3 Aug 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Parent Training Intervention in people with Deafness and Hearing Loss, run by Christina Studts at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Parenting Young Children (PARYC) Scale Total Score (time frame: 6 months after parent baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.

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