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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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.
- Conditions
- Deafness, Hearing Loss, Parenting, Child Behavior
- 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 group | Role | What they receive |
|---|---|---|
| Behavioral Parent Training | Experimental | Parents 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 |
| Control | No intervention | Parents 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.
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)
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
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
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
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
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
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
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
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.
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted16 Apr 2019
- Study start17 Jun 2021
- Primary completion14 Oct 2024
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DeafnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Christina Studts
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor-investigator, Christina Studts, University of Kentucky
- Investigators
- Christina Studts, PhD, MSPH, MSW, Principal investigator, University of Colorado, DenverJulie Lowman, PhD, Principal investigator, University of Kentucky
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Parent Training for Families With Deaf and Hard of Hearing Preschoolers
- ClinicalTrials.gov ID
- NCT03916146
- Acronym / sponsor ID
- CHAMPS-DHH / 45213
- Conditions
- Deafness, Hearing Loss, Parenting, Child Behavior
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 295 participants (actual)
- Lead sponsor
- Christina StudtsUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 17 Jun 2021 (actual)
- Primary completion
- 14 Oct 2024 (actual)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 16 Apr 2019 (actual)
- Results
- Posted 27 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral Parent Training | Experimental | Behavioral: Parent Training InterventionParents 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. |
| Control | No intervention | –Parents are not offered the intervention but are not precluded from accessing other services for their young deaf and hard of hearing chidren. |
Who may qualify
- Ages
- 3 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parent Training InterventionAdapted version of the Family Check-Up/Everyday Parenting intervention | Behavioural | Behavioral Parent Training |
Primary outcome
Parenting Young Children (PARYC) Scale Total Score
Time frame: 6 months after parent baseline
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.
26 secondary outcomes
Change in Parenting Young Children Scale (PARYC) Total Scores Over Time
Time frame: Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment
Change in Parenting Young Children Scale (PARYC) Supporting Positive Behavior Subscale Scores Over Time
Time frame: Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment
Change in Parenting Young Children Scale (PARYC) Setting Limits Subscale Scores Over Time
Time frame: Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment
Change in Parenting Young Children Scale (PARYC) Proactive Parenting Subscale Scores Over Time
Time frame: Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment
Child Behavior Checklist (CBCL) Total Problems T-Score
Time frame: Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment
Child Behavior Checklist (CBCL) Internalizing Problems T-Score
Time frame: Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment
Child Behavior Checklist (CBCL) Externalizing Problems T-Score
Time frame: Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment
Parent Sense of Competence Scale (PSCS) Total Score
Time frame: Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment.
Parent Sense of Competence Scale (PSCS) Self-efficacy Score
Time frame: Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment
Parent Sense of Competence Scale (PSCS) Satisfaction Score
Time frame: Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment
Beck Depression Inventory-II (BDI-II)
Time frame: Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment
Parent Child Interaction System (PARCHISY) - Parent Positive Control
Time frame: Every 6 months from baseline to up to 18 months after baseline
Parent Child Interaction System (PARCHISY) - Parent Negative Control
Time frame: Every 6 months from baseline to up to 18 months after baseline
Parent Child Interaction System (PARCHISY) - Parent Positive Affect
Time frame: Every 6 months from baseline to up to 18 months after baseline
Parent Child Interaction System (PARCHISY) - Parent Negative Affect
Time frame: Every 6 months from baseline to up to 18 months after baseline
Parent Child Interaction System (PARCHISY) - Child Positive Affect
Time frame: Every 6 months from baseline to up to 18 months after baseline
Parent Child Interaction System (PARCHISY) - Child Negative Affect
Time frame: Every 6 months from baseline to up to 18 months after baseline
Parent Child Interaction System (PARCHISY) - Child On-Task
Time frame: Every 6 months from baseline to up to 18 months after baseline
Parent Child Interaction System (PARCHISY) - Child Noncompliance
Time frame: Every 6 months from baseline to up to 18 months after baseline
Parent Child Interaction System (PARCHISY) - Conflict
Time frame: Every 6 months from baseline to up to 18 months after baseline
Parent Motivation Inventory (PMI) Total Score
Time frame: Annually from 12 months after baseline up to 36 months after baseline
Parent Motivation Inventory (PMI) Desire for Change Subscale
Time frame: Annually from 12 months after baseline up to 36 months after baseline
Parent Motivation Inventory (PMI) Readiness to Change Subscale
Time frame: Annually from 12 months after baseline up to 36 months after baseline
Parent Motivation Inventory (PMI) Perceived Ability to Change Subscale
Time frame: Annually from 12 months after baseline up to 36 months after baseline
Hearing Aid Adherence Questionnaire
Time frame: Every 12 months from completion of baseline assessment up to 36 months after baseline assessment
Therapy Attitude Inventory (TAI)
Time frame: Annually from 6 months after baseline up to 30 months after baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina Studts, PhD, MSPH, MSW principal investigator
University of Colorado, Denver
Julie Lowman, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
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.