Trial Outcomes & Findings for Behavioral Parent Training for Families With Deaf and Hard of Hearing Preschoolers (NCT NCT03916146)

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

The Therapeutic Alliance Scale for Caregivers and Parents measures self-reported strength of perceived therapeutic alliance with their interventionist. Parents rate their level of agreement with 12 statements describing aspects of the therapeutic alliance using Likert-type scales from 1 (Not true) to 4 (Very true). The TASCP score is the mean of these responses with possible scores ranging from 1 to 4. Higher scores indicate stronger perceived therapeutic alliance with the interventionist. This measure was added to the study to capture an aspect of satisfaction not included in the Therapy Attitude Inventory.

Several aspects of satisfaction with the intervention and interventionist were not captured in originally planned measures. The investigators created 7 items for parents to rate their level of agreement with using Likert-type scales from 1 (Not true) to 4 (Very true). These items are not intended to be a scale but to provide information about specific aspects of satisfaction and experience. The score for each item can range from 1-4. Higher scores indicate higher levels of agreement with each individual statement. These items were added to the study to capture aspects of satisfaction not included in the Therapy Attitude Inventory.