Adfærdsforældretræning for familier med døve og hørehæmmede førskolebørn (CHAMPS-DHH)
9. juli 2026 opdateret af: Christina Studts
Børn, der er døve og hørehæmmede (DHH) modtager sjældent adfærdsmæssige interventioner for at forhindre de langsigtede omkostningsfulde konsekvenser af adfærdsproblemer.
Dette projekt vil systematisk tilpasse en evidensbaseret forældretræningsintervention for at øge dens accept og relevans for forældre til små DHH-børn.
Effektiviteten af den tilpassede intervention og dens implementering med forældre til unge DHH-børn fulgt i "den virkelige verden" høreklinikker vil blive vurderet.
Studieoversigt
Status
Aktiv, ikke rekrutterende
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Formål 1: Denne del af studiet samlede et Community Advisory Board for input til studiet. CAB-medlemmer blev betragtet som samarbejdspartnere snarere end forskningsemner. De leverede ingen personlige data til brug i publikationer eller andre forskningsformidlingsindsatser. Der blev ikke indsamlet data om bivirkninger relateret til CAB.
Formål 2: Denne del af studiet omfattede kvalitative interviews med forældre og fokusgrupper med interessenter (tale-sprogpatologer, audiologer og lærere for døve) for at guide tilpasningen af interventionen. Der var ingen intervention i dette formål, og det var ikke en klinisk undersøgelse. Der blev ikke indsamlet data om bivirkninger relateret til de kvalitative interviews.
Formål 3: Se venligst Record NCT03483428 for detaljer og resultater af Formål 3.
Formål 4: Denne del af studiet var en randomiseret kontrolleret undersøgelse af den tilpassede forældretræningsintervention. Forældre til DHH-børn blev randomiseret til enten at modtage interventionen eller til en kontroltilstand.
Formål 5: Denne del af studiet indsamler procesdata om, hvordan interventionen blev leveret i Formål 4, samt kvalitative data vedrørende perspektiver på interventionen fra centrale interessenter, herunder en delmængde af forældre fra Formål 4, de interventionister, der leverede interventionen, og andre interessenter. Der er ingen intervention i dette formål, og det er ikke en klinisk undersøgelse. Der vil ikke blive indsamlet data om bivirkninger.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
295
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Kentucky
-
Lexington, Kentucky, Forenede Stater, 40506
- University of Kentucky
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
3 år til 99 år (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
- Forælder er 18 år eller ældre
- Forælder er værge for barnet
- Forældre kan enten tale/forstå engelsk eller bruge amerikansk tegnsprog
- Forælder bor i en stat med et etableret henvisningsnetværk for forældre til DHH-børn, hvis der er behov for yderligere ydelser
- Ved baseline er barnet mellem 3 og 6 år
- Ved baseline bor barnet det meste af tiden i forældres/værges hjem
- Barnet er døvt eller hørehæmmet
- Barnet har brugt høreapparat(er), cochleaimplantat(er) og/eller knogleledningsanordning(er) i mere end 6 måneder
Ekskluderingskriterier:
- Sagen om aktiv børnebeskyttelse er åben
- Forældre har allerede adgang til adfærdsmæssige sundhedstjenester til barnet
- Forældre deltog i formativ forskning til denne undersøgelse
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
Tilpasset version af Familietjek/Hverdagsforældreintervention
|
|
Ingen indgriben: Control
Parents are not offered the intervention but are not precluded from accessing other services for their young deaf and hard of hearing chidren.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Parenting Young Children (PARYC) Scale Total Score
Tidsramme: 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.
|
6 months after parent baseline
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Parenting Young Children Scale (PARYC) Total Scores Over Time
Tidsramme: 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.
|
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
Tidsramme: 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.
|
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
Tidsramme: 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.
|
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
Tidsramme: 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.
|
Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment
|
|
Child Behavior Checklist (CBCL) Total Problems T-Score
Tidsramme: 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.
|
Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment
|
|
Child Behavior Checklist (CBCL) Internalizing Problems T-Score
Tidsramme: 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.
|
Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment
|
|
Child Behavior Checklist (CBCL) Externalizing Problems T-Score
Tidsramme: 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.
|
Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment
|
|
Parent Sense of Competence Scale (PSCS) Total Score
Tidsramme: 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.
|
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
Tidsramme: 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.
|
Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment
|
|
Parent Sense of Competence Scale (PSCS) Satisfaction Score
Tidsramme: 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.
|
Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment
|
|
Beck Depression Inventory-II (BDI-II)
Tidsramme: 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.
|
Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment
|
|
Parent Child Interaction System (PARCHISY) - Parent Positive Control
Tidsramme: 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.
|
Every 6 months from baseline to up to 18 months after baseline
|
|
Parent Child Interaction System (PARCHISY) - Parent Negative Control
Tidsramme: 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.
|
Every 6 months from baseline to up to 18 months after baseline
|
|
Parent Child Interaction System (PARCHISY) - Parent Positive Affect
Tidsramme: 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.
|
Every 6 months from baseline to up to 18 months after baseline
|
|
Parent Child Interaction System (PARCHISY) - Parent Negative Affect
Tidsramme: 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.
|
Every 6 months from baseline to up to 18 months after baseline
|
|
Parent Child Interaction System (PARCHISY) - Child Positive Affect
Tidsramme: 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.
|
Every 6 months from baseline to up to 18 months after baseline
|
|
Parent Child Interaction System (PARCHISY) - Child Negative Affect
Tidsramme: 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.
|
Every 6 months from baseline to up to 18 months after baseline
|
|
Parent Child Interaction System (PARCHISY) - Child On-Task
Tidsramme: 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.
|
Every 6 months from baseline to up to 18 months after baseline
|
|
Parent Child Interaction System (PARCHISY) - Child Noncompliance
Tidsramme: 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.
|
Every 6 months from baseline to up to 18 months after baseline
|
|
Parent Child Interaction System (PARCHISY) - Conflict
Tidsramme: 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.
|
Every 6 months from baseline to up to 18 months after baseline
|
|
Parent Motivation Inventory (PMI) Total Score
Tidsramme: 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.
|
Annually from 12 months after baseline up to 36 months after baseline
|
|
Parent Motivation Inventory (PMI) Desire for Change Subscale
Tidsramme: 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.
|
Annually from 12 months after baseline up to 36 months after baseline
|
|
Parent Motivation Inventory (PMI) Readiness to Change Subscale
Tidsramme: 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.
|
Annually from 12 months after baseline up to 36 months after baseline
|
|
Parent Motivation Inventory (PMI) Perceived Ability to Change Subscale
Tidsramme: 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.
|
Annually from 12 months after baseline up to 36 months after baseline
|
|
Hearing Aid Adherence Questionnaire
Tidsramme: 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.
|
Every 12 months from completion of baseline assessment up to 36 months after baseline assessment
|
|
Therapy Attitude Inventory (TAI)
Tidsramme: 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.
|
Annually from 6 months after baseline up to 30 months after baseline
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
MacArthur Bates Communicative Development Inventories - Words & Sentences - Words Produced (Raw Score)
Tidsramme: Annually from baseline through up to 36 months.
|
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
Tidsramme: Annually from baseline through up to 36 months.
|
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
Tidsramme: Annually from baseline assessment through up to 36 months after baseline
|
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)
Tidsramme: Annually from baseline through up to 36 months after baseline
|
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)
Tidsramme: Every 6 months beginning with baseline through up to 36 months
|
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
Tidsramme: Annually from baseline through up to 36 months
|
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)
Tidsramme: Annually from baseline through up to 36 months after baseline
|
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
Tidsramme: 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 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
Tidsramme: 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 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
Tidsramme: 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 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
Tidsramme: 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 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
Tidsramme: 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 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
Tidsramme: 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 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
Tidsramme: 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 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
Tidsramme: 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 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
Tidsramme: 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 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Christina Studts, PhD, MSPH, MSW, University of Colorado, Denver
- Ledende efterforsker: Julie Lowman, PhD, University of Kentucky
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
17. juni 2021
Primær færdiggørelse (Faktiske)
14. oktober 2024
Studieafslutning (Anslået)
31. maj 2027
Datoer for studieregistrering
Først indsendt
11. april 2019
Først indsendt, der opfyldte QC-kriterier
12. april 2019
Først opslået (Faktiske)
16. april 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
3. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 45213
- R01DC016957 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Afidentificerede data vil blive gjort offentligt tilgængelige (efter anmodning til PI) umiddelbart efter accept til offentliggørelse af de vigtigste resultater fra det endelige datasæt.
IPD-delingstidsramme
Afidentificerede data vil blive gjort offentligt tilgængelige (efter anmodning til PI) umiddelbart efter accept til offentliggørelse af de vigtigste resultater fra det endelige datasæt.
IPD-delingsadgangskriterier
Afidentificerede data vil blive gjort offentligt tilgængelige (efter anmodning til PI) umiddelbart efter accept til offentliggørelse af de vigtigste resultater fra det endelige datasæt.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- ICF
- ANALYTIC_CODE
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .