Behavioral Parent Training for Families With Deaf and Hard of Hearing Preschoolers (CHAMPS-DHH)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Parenting; Hearing Loss; Deafness; Child Behavior
• Intervention / Treatment: Behavioral: Parent Training Intervention

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 Type: Interventional
• Enrollment (Actual): 295
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40506
      • University of Kentucky

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 99 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Behavioral Parent Training; 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.	Behavioral: Parent Training Intervention; Adapted version of the Family Check-Up/Everyday Parenting intervention
No Intervention: Control; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months after parent baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Annually from 6 months after baseline up to 30 months after baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
MacArthur Bates Communicative Development Inventories - Words & Sentences - Words Produced (Raw Score)	The MacArthur Bates Communicative Development Inventories - Words & Sentences - Words Produced section assesses the number of words currently spontaneously used by a child via parent-report. Raw scores can range from 0-680 with higher scores indicating more words produced by a child.	Annually from baseline through up to 36 months.
MacArthur Bates Communicative Development Inventories - Words & Sentences - Sentence Complexity Score	The MacArthur Bates Communicative Development Inventories - Words & Sentences - Sentence Complexity Score assesses grammatical development by having parents review 37 pairs of sentences. For each pair, the parent selects the sentence that sounds more like their child's speech. One point is added for each selection of the more complex sentence in a pair. Sentence Complexity Scores can range from 0-37 with higher scores indicating higher levels of grammatical development.	Annually from baseline through up to 36 months.
Peabody Picture Vocabulary Test (PPVT) Standard Score	The Peabody Picture Vocabulary Test (PPVT) Standard Score is a measure of a child's receptive language. The PPVT assesses receptive vocabulary by requiring children to identify one of four pictures corresponding to a spoken word. Administration follows standardized basal and ceiling procedures. Standard scores are derived with the standard score metric (M = 100, SD = 15) and higher scores indicate higher levels of receptive vocabulary.	Annually from baseline assessment through up to 36 months after baseline
Clinical Evaluation of Language Fundamentals (CELF) - Core Language Score (Standard Scores)	The Clinical Evaluation of Language Fundamentals - Core Language Score (CELF-CLS) assesses language ability. The CELF is an individually administered standardized language assessment that assesses performance across multiple expressive and receptive language subtests. Age-appropriate versions of the CELF were administered (i.e., the CELF-Preschool-3 for children ages 3 and 4 years; the CELF-5 for children ages 5 years and up). On both versions of the CELF, the CLS is a composite score derived from subsets of language subtests appropriate for the child's age, estimating overall language ability by combining receptive and expressive language skills. The CLS standard score has a mean of 100 and standard deviation of 15. Interpretation of CLS standard scores: 130 or higher = very superior; 120-129 = superior; 110-119 = high average; 90-109 = average; 80-89 = low average; 70-79 = moderately low; less than 70 = very low. Higher scores indicate higher levels of language ability.	Annually from baseline through up to 36 months after baseline
Beginner's Intelligibility Test (BIT)	The Beginner's Intelligibility Test (BIT) assesses the intelligibility of 10 sentences repeated by a child in response to the test administrator speaking the sentence and showing a picture illustrating the sentence. The child's spoken sentences are audiorecorded and played for 3 naive listeners who write down what they heard. The BIT score is calculated as the mean percentage of opportunity words (the original words spoken by the test administrator) identified across the 3 listeners. Scores can range from 0 to 100.	Every 6 months beginning with baseline through up to 36 months
Meaningful Auditory Integration Scale (MAIS) - Bonding/Attachment to Hearing Device Domain	The Meaningful Auditory Integration Scale - Bonding/Attachment to Hearing Device domain of the MAIS assesses to what degree a child seeks out or depends on their hearing device. Two interview questions are asked of the parent (one about child wearing the device, one about child's response when the device is non-functional) and parent responses are coded from 0 (Never) to 4 (Always). The sum of the coded responses is the score, which can range from 0-8, with higher scores indicating better bonding/attachment to the hearing device.	Annually from baseline through up to 36 months
Clinical Evaluation of Language Fundamentals (CELF) - Expressive Language Index (Standard Scores)	The Clinical Evaluation of Language Fundamentals - Expressive Language Index (CELF-ELI) assesses expressive language. The CELF is an individually administered standardized language assessment that assesses performance across multiple expressive and receptive language subtests. Age-appropriate versions of the CELF were administered (i.e., the CELF-Preschool-3 for children ages 3 and 4 years; the CELF-5 for children ages 5 years and up). On both versions of the CELF, the ELI is a composite score derived from subsets of expressive language subtests appropriate for the child's age. The ELI standard score has a mean of 100 and standard deviation of 15. Interpretation of ELI standard scores: 130 or higher = very superior; 120-129 = superior; 110-119 = high average; 90-109 = average; 80-89 = low average; 70-79 = moderately low; less than 70 = very low. Higher scores indicate higher levels of expressive language ability.	Annually from baseline through up to 36 months after baseline
Parent Child Interaction System (PARCHISY) - Parent Responsiveness	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 Responsiveness score reflects parents' responsiveness (verbal or behavioral) to their child's questions, comments, and behaviors in interacting with their child. Scores range from 1 (no evidence) to 7 (consistent occurrence), with higher scores indicating higher levels of parent responsiveness.	Every 6 months from baseline to up to 18 months after baseline
Parent Child Interaction System (PARCHISY) - Parent 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 Parent On-Task score reflects parents' initiative and persistence in engaging with the assigned task while interacting with their child. Scores range from 1 (no evidence) to 7 (consistent occurrence), with higher scores indicating higher levels of parents' observed on-task behavior.	Every 6 months from baseline to up to 18 months after baseline
Parent Child Interaction System (PARCHISY) - Parent Verbalizations	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 Verbalizations score reflects parents' amount of verbalizations in interacting with their child. Scores range from 1 (no evidence) to 7 (consistent occurrence), with higher scores indicating higher levels of parent verbalizations.	Every 6 months from baseline to up to 18 months after baseline
Parent Child Interaction System (PARCHISY) - Child Responsiveness	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 Responsiveness score reflects children's responsiveness (verbal or behavioral) to their parent's questions, comments, and behaviors in interacting with their parent. Scores range from 1 (no evidence) to 7 (consistent occurrence), with higher scores indicating higher levels of child responsiveness.	Every 6 months from baseline to up to 18 months after baseline
Parent Child Interaction System (PARCHISY) - Child Autonomy	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 Autonomy score reflects children's autonomy/independence (e.g., leads and controls task - but does not include off-task behaviors) in interacting with their parent. Scores range from 1 (no evidence) to 7 (consistent occurrence), with higher scores indicating higher levels of child autonomy.	Every 6 months from baseline to up to 18 months after baseline
Parent Child Interaction System (PARCHISY) - Child Activity	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 Activity score reflects children's level of physical movements (e.g., moving arms, jumping up and down) in interacting with their parent. Scores range from 1 (no evidence) to 7 (consistent occurrence), with higher scores indicating higher levels of child activity.	Every 6 months from baseline to up to 18 months after baseline
Parent Child Interaction System (PARCHISY) - Child Verbalizations	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 Verbalizations score reflects children's amount of verbalizations in interacting with their parent. Scores range from 1 (no evidence) to 7 (consistent occurrence), with higher scores indicating higher levels of child verbalizations.	Every 6 months from baseline to up to 18 months after baseline
Parent Child Interaction System (PARCHISY) - Reciprocity	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 Reciprocity score reflects parent-child dyads' level of reciprocity (e.g., shared positive affect, eye contact, turn-taking quality) in interacting with each other. Scores range from 1 (no evidence) to 7 (consistent occurrence), with higher scores indicating higher levels of reciprocity.	Every 6 months from baseline to up to 18 months after baseline
Parent Child Interaction System (PARCHISY) - Cooperation	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 Cooperation score reflects parent-child dyads' level of explicit agreement/discussion of how to complete the task together (e.g., "Shall we do this next?" "Yes") in interacting with each other. Scores range from 1 (no evidence) to 7 (consistent occurrence), with higher scores indicating higher levels of cooperation.	Every 6 months from baseline to up to 18 months after baseline

Collaborators and Investigators

• Sponsor: Christina Studts
• Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
• Investigators: Principal Investigator: Christina Studts, PhD, MSPH, MSW, University of Colorado, Denver; Principal Investigator: Julie Lowman, PhD, University of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2021
• Primary Completion (Actual): October 14, 2024
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: April 11, 2019
• First Submitted That Met QC Criteria: April 12, 2019
• First Posted (Actual): April 16, 2019

Study Record Updates

• Last Update Posted (Actual): August 3, 2026
• Last Update Submitted That Met QC Criteria: July 9, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Hearing Loss; Deafness; Child Behavior
• Other Study ID Numbers: 45213; R01DC016957 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No