Child Behavior, Deafness, Hearing Loss, Parenting
Conditions
Brief 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. 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.
Interventions
BEHAVIORALParent Training Intervention
Adapted version of the Family Check-Up/Everyday Parenting intervention
Sponsors
Christina Studts
National Institute on Deafness and Other Communication Disorders (NIDCD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Parenting Young Children (PARYC) Scale Total Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Parenting Young Children Scale (PARYC) Total Scores Over Time | Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment | 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. |
| Change in Parenting Young Children Scale (PARYC) Supporting Positive Behavior Subscale Scores Over Time | Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment | 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. |
| Change in Parenting Young Children Scale (PARYC) Setting Limits Subscale Scores Over Time | Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment | 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. |
| Change in Parenting Young Children Scale (PARYC) Proactive Parenting Subscale Scores Over Time | Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment | 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-Score | Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment | 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 T-Score | Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment | 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 T-Score | Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment | 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 | Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment. | 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. |
| Parent Sense of Competence Scale (PSCS) Self-efficacy Score | Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment | 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. |
| Parent Sense of Competence Scale (PSCS) Satisfaction Score | Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment | 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. |
| Beck Depression Inventory-II (BDI-II) | Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment | 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. |
| Parent Child Interaction System (PARCHISY) - Parent Positive Control | Every 6 months from baseline to up to 18 months after baseline | 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. |
| Parent Child Interaction System (PARCHISY) - Parent Negative Control | Every 6 months from baseline to up to 18 months after baseline | 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. |
| Parent Child Interaction System (PARCHISY) - Parent Positive Affect | Every 6 months from baseline to up to 18 months after baseline | 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. |
| Parent Child Interaction System (PARCHISY) - Parent Negative Affect | Every 6 months from baseline to up to 18 months after baseline | 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. |
| Parent Child Interaction System (PARCHISY) - Child Positive Affect | Every 6 months from baseline to up to 18 months after baseline | 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. |
| Parent Child Interaction System (PARCHISY) - Child Negative Affect | Every 6 months from baseline to up to 18 months after baseline | 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. |
| Parent Child Interaction System (PARCHISY) - Child On-Task | Every 6 months from baseline to up to 18 months after baseline | 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. |
| Parent Child Interaction System (PARCHISY) - Child Noncompliance | Every 6 months from baseline to up to 18 months after baseline | 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. |
| Parent Child Interaction System (PARCHISY) - Conflict | Every 6 months from baseline to up to 18 months after baseline | 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. |
| Parent Motivation Inventory (PMI) Total Score | Annually from 12 months after baseline up to 36 months after baseline | 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. |
| Parent Motivation Inventory (PMI) Desire for Change Subscale | Annually from 12 months after baseline up to 36 months after baseline | 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. |
| Parent Motivation Inventory (PMI) Readiness to Change Subscale | Annually from 12 months after baseline up to 36 months after baseline | 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. |
| Parent Motivation Inventory (PMI) Perceived Ability to Change Subscale | Annually from 12 months after baseline up to 36 months after baseline | 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. |
| Hearing Aid Adherence Questionnaire | Every 12 months from completion of baseline assessment up to 36 months after baseline assessment | 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. |
| Therapy Attitude Inventory (TAI) | Annually from 6 months after baseline up to 30 months after baseline | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORChristina Studts, PhD, MSPH, MSW
University of Colorado, Denver
PRINCIPAL_INVESTIGATORJulie Lowman, PhD
University of Kentucky
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous Children | 4.99 years STANDARD_DEVIATION 1.24 |
| Age, Continuous Interventionists | 43.20 years STANDARD_DEVIATION 12.02 |
| Age, Continuous Parents | 35.33 years STANDARD_DEVIATION 5.63 |
| Ethnicity (NIH/OMB) Children Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Children Not Hispanic or Latino | 65 Participants |
| Ethnicity (NIH/OMB) Children Unknown or Not Reported | 1 Participants |
| Ethnicity (NIH/OMB) Interventionists Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Interventionists Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Interventionists Unknown or Not Reported | 0 Participants |
| Ethnicity (NIH/OMB) Parents Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Parents Not Hispanic or Latino | 138 Participants |
| Ethnicity (NIH/OMB) Parents Unknown or Not Reported | 0 Participants |
| Ethnicity (NIH/OMB) Stakeholders Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Stakeholders Not Hispanic or Latino | 15 Participants |
| Ethnicity (NIH/OMB) Stakeholders Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Children American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Children Asian | 0 Participants |
| Race (NIH/OMB) Children Black or African American | 3 Participants |
| Race (NIH/OMB) Children More than one race | 14 Participants |
| Race (NIH/OMB) Children Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Children Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) Children White | 56 Participants |
| Race (NIH/OMB) Interventionists American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Interventionists Asian | 0 Participants |
| Race (NIH/OMB) Interventionists Black or African American | 0 Participants |
| Race (NIH/OMB) Interventionists More than one race | 0 Participants |
| Race (NIH/OMB) Interventionists Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Interventionists Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Interventionists White | 10 Participants |
| Race (NIH/OMB) Parents American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Parents Asian | 2 Participants |
| Race (NIH/OMB) Parents Black or African American | 2 Participants |
| Race (NIH/OMB) Parents More than one race | 7 Participants |
| Race (NIH/OMB) Parents Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Parents Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Parents White | 17 Participants |
| Race (NIH/OMB) Stakeholders American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Stakeholders Asian | 0 Participants |
| Race (NIH/OMB) Stakeholders Black or African American | 0 Participants |
| Race (NIH/OMB) Stakeholders More than one race | 0 Participants |
| Race (NIH/OMB) Stakeholders Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Stakeholders Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Stakeholders White | 15 Participants |
| Region of Enrollment United States | 295 participants |
| Sex: Female, Male Children Female | 65 Participants |
| Sex: Female, Male Children Male | 60 Participants |
| Sex: Female, Male Interventionists Female | 10 Participants |
| Sex: Female, Male Interventionists Male | 0 Participants |
| Sex: Female, Male Parents Female | 141 Participants |
| Sex: Female, Male Parents Male | 1 Participants |
| Sex: Female, Male Stakeholders Female | 15 Participants |
| Sex: Female, Male Stakeholders Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 71 | 0 / 54 |
| other Total, other adverse events | 5 / 71 | 3 / 54 |
| serious Total, serious adverse events | 0 / 71 | 0 / 54 |
Outcome results
None listed