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| ID | Type | Description | Link |
|---|---|---|---|
| R01DC016957 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Deafness and Other Communication Disorders (NIDCD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavioral Parent Training | Experimental |
| |
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parent Training Intervention | Behavioral | Adapted version of the Family Check-Up/Everyday Parenting intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Parenting Young Children (PARYC) Scale | parent self-report use of positive parenting strategies; score on a scale from 1 to 7, with higher scores indicating more positive parenting practices | 6 months after parent baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Child Behavior Checklist (CBCL) | subscale and total scores | 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after parent baseline |
| Parent Sense of Competence Scale (PSCS) | parent-report self-efficacy and satisfaction with the parenting role |
| Measure | Description | Time Frame |
|---|---|---|
| Data-logging of Hearing Aid/Cochlear Implant Use by Child | as available from audiological medical records | 12 months, 24 months, 36 months after parent baseline |
| MacArthur Bates Communicative Development Inventories |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christina Studts, PhD, MSPH, MSW | University of Colorado, Denver | Principal Investigator |
| Julie Lowman, PhD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40506 | United States |
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.
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.
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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Aim 4 was the clinical trial in this study. Parents of 3 to 6 year-old deaf or hard of hearing children enrolled themselves and their children in the study. After parents and children completed baseline data collection, they were randomized to either the intervention group (71 families=142 parents & children) or the control group (54 families=108 parents & children). 18 parents that completed Aim 4 were later enrolled in Aim 5 (not double counted) which makes the total enrollment 295.
Aim 2 participants were recruited for parent interviews and stakeholder focus groups. Participant recruitment for the Aim 4 clinical trial began in June 2021 and ended in April 2024. Recruitment for Aim 5 is still active.
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| ID | Title | Description |
|---|---|---|
| FG000 | Aim 2 Interviews and Focus Groups for Intervention Adaptation | Qualitative data were collected from parents and stakeholders to inform adaptation of the intervention. |
| FG001 | Aim 4 Behavioral Parent Training | Parent Training Intervention: Adapted version of the Family Check-Up/Everyday Parenting intervention |
| FG002 | Aim 4 Control | No intervention |
| FG003 | Aim 5 Implementation Data | Process data and qualitative data from parents, interventionists, and stakeholders described implementation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adaptation Phase |
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| Effectiveness Phase |
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| Implementation Phase |
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Aim 2 participants were not enrolled in Aim 4 or Aim 5; there is no overlap in participants across Aim 2 and Aim 4 and across Aim 2 and Aim 5. Aim 5 demographics are reported for (n=10) interventionists. Aim 5 demographics do not include: 1) stakeholders (n = 10) because they haven't been enrolled yet and 2) parents (n = 18) because they were also enrolled in Aim 4 and those demographics are reported under Aim 4.
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| ID | Title | Description |
|---|---|---|
| BG000 | Aim 2 Interviews and Focus Groups for Intervention Adaptation | Qualitative data were collected from parents and stakeholders to inform adaptation of the intervention. |
| BG001 | Aim 4 Behavioral Parent Training |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately. Age is not collected for the stakeholder group. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Parenting Young Children (PARYC) Scale | parent self-report use of positive parenting strategies; score on a scale from 1 to 7, with higher scores indicating more positive parenting practices | Parents completed the primary outcome measure (PARYC). 4 parents from the intervention arm withdrew or were lost-to-follow-up by the 6-month follow-up appointment (primary endpoint). | Posted | Mean | Standard Deviation | score on a scale | 6 months after parent baseline |
|
36 months
One data instrument, the Beck Depression Inventory II, including a question about suicidal thoughts or wishes. Parent participants completed this questionnaire, and safety protocols were created to immediately alert the research team if a parent endorsed suicidal ideation. Adverse Event data were not collected for Child participants, Aim 2 or Aim 5 participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Behavioral Parent Training | Parent Training Intervention: Adapted version of the Family Check-Up/Everyday Parenting intervention |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal Ideation | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christina Studts | University of Colorado - Anschutz Medical Campus | 303-724-2495 | christina.studts@cuanschutz.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Sep 19, 2025 | Oct 14, 2025 | Prot_SAP_ICF_001.pdf |
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| ID | Term |
|---|---|
| D003638 | Deafness |
| D034381 | Hearing Loss |
| D002652 | Child Behavior |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after parent baseline |
| Parent Child Interaction System (PARCHISY) | observational measure of parent-child interaction quality | 12 months, 24 months, 36 months after parent baseline |
| Beck Depression Inventory-II (BDI-II) | parent-report depressive symptoms | 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after parent baseline |
| Parent Motivation Inventory (PMI) | parent-report motivation to change parenting behaviors | 12 months, 24 months, 36 months after parent baseline |
| Therapy Attitude Inventory (TAI) | parent-report satisfaction with intervention | 6 months, 18 months, 30 months after parent baseline |
| Hearing Aid Adherence Questionnaire | parent-report use of hearing aids by child | 12 months, 24 months, 36 months after parent baseline |
| Change in Parenting Young Children Scale (PARYC) Scores Over Time | 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 | 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after parent baseline |
parent-report of children's developing abilities in early language
| 12 months, 24 months, 36 months after parent baseline |
| Peabody Picture Vocabulary Test (PPVT) | measure of child's receptive language | 12 months, 24 months, 36 months after parent baseline |
| Clinical Evaluation of Language Fundamentals - Preschool | assessment of language pragmatics for children | 12 months, 24 months, 36 months after parent baseline |
| Beginner's Intelligibility Test (BIT) | assessment of child's intelligibility | 12 months, 24 months, 36 months (children ages 3 years +) after parent baseline |
| Meaningful Auditory Integration Scale (MAIS) | parent report of child's language skills in real-world situations | 12 months, 24 months, 36 months after parent baseline |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
|
|
Parent Training Intervention: Adapted version of the Family Check-Up/Everyday Parenting intervention
| BG002 | Aim 4 Control | No intervention |
| BG003 | Aim 5 Implementation Data | Process data and qualitative data from parents, interventionists, and stakeholders described implementation. |
| BG004 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately. | Count of Participants | Participants |
|
| Race (NIH/OMB) | 125 families enrolled, but within each family both a parent and a child were enrolled as participants; baseline characteristics are described for parents, children, interventionists, and stakeholders separately. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Child Behavior Checklist (CBCL) | subscale and total scores | Not Posted | 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after parent baseline | Participants |
| Secondary | Parent Sense of Competence Scale (PSCS) | parent-report self-efficacy and satisfaction with the parenting role | Not Posted | 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after parent baseline | Participants |
| Secondary | Parent Child Interaction System (PARCHISY) | observational measure of parent-child interaction quality | Not Posted | 12 months, 24 months, 36 months after parent baseline | Participants |
| Secondary | Beck Depression Inventory-II (BDI-II) | parent-report depressive symptoms | Not Posted | 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after parent baseline | Participants |
| Secondary | Parent Motivation Inventory (PMI) | parent-report motivation to change parenting behaviors | Not Posted | 12 months, 24 months, 36 months after parent baseline | Participants |
| Secondary | Therapy Attitude Inventory (TAI) | parent-report satisfaction with intervention | Not Posted | 6 months, 18 months, 30 months after parent baseline | Participants |
| Secondary | Hearing Aid Adherence Questionnaire | parent-report use of hearing aids by child | Not Posted | 12 months, 24 months, 36 months after parent baseline | Participants |
| Secondary | Change in Parenting Young Children Scale (PARYC) Scores Over Time | 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 | Not Posted | 6 months, 12 months, 18 months, 24 months, 30 months, 36 months after parent baseline | Participants |
| Other Pre-specified | Data-logging of Hearing Aid/Cochlear Implant Use by Child | as available from audiological medical records | Not Posted | 12 months, 24 months, 36 months after parent baseline | Participants |
| Other Pre-specified | MacArthur Bates Communicative Development Inventories | parent-report of children's developing abilities in early language | Not Posted | 12 months, 24 months, 36 months after parent baseline | Participants |
| Other Pre-specified | Peabody Picture Vocabulary Test (PPVT) | measure of child's receptive language | Not Posted | 12 months, 24 months, 36 months after parent baseline | Participants |
| Other Pre-specified | Clinical Evaluation of Language Fundamentals - Preschool | assessment of language pragmatics for children | Not Posted | 12 months, 24 months, 36 months after parent baseline | Participants |
| Other Pre-specified | Beginner's Intelligibility Test (BIT) | assessment of child's intelligibility | Not Posted | 12 months, 24 months, 36 months (children ages 3 years +) after parent baseline | Participants |
| Other Pre-specified | Meaningful Auditory Integration Scale (MAIS) | parent report of child's language skills in real-world situations | Not Posted | 12 months, 24 months, 36 months after parent baseline | Participants |
| 0 |
| 71 |
| 0 |
| 71 |
| 5 |
| 71 |
| EG001 | Control | No intervention | 0 | 54 | 0 | 54 | 3 | 54 |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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