Behaviorální školení rodičů pro rodiny s neslyšícími a nedoslýchavými předškoláky (CHAMPS-DHH)
9. července 2026 aktualizováno: Christina Studts
Děti, které jsou neslyšící a nedoslýchavé (DHH), zřídka dostávají behaviorální intervence, aby se zabránilo dlouhodobým nákladným následkům problémů s chováním.
Tento projekt bude systematicky přizpůsobovat tréninkovou intervenci rodičů založenou na důkazech, aby se zvýšila její přijatelnost a relevance pro rodiče malých dětí DHH.
Bude posouzena efektivita adaptované intervence a její implementace u rodičů malých DHH dětí sledovaných v „reálných“ klinikách sluchové péče.
Přehled studie
Postavení
Aktivní, ne nábor
Podmínky
Intervence / Léčba
Detailní popis
Cíl 1: Tato část studie svolala Poradní výbor komunity pro vstupní informace ke studii. Členové CAB byli považováni za spolupracovníky spíše než za výzkumné subjekty. Neposkytli žádné osobní údaje pro použití v publikacích nebo jiných snahách o šíření výzkumu. Nebyly shromažďovány žádné údaje o nežádoucích příhodách souvisejících s CAB.
Cíl 2: Tato část studie zahrnovala kvalitativní rozhovory s rodiči a fokusní skupiny se zainteresovanými stranami (logopedy, audiologové a učitelé neslyšících) za účelem vedení adaptace intervence. V tomto cíli nedošlo k žádné intervenci a nejednalo se o klinickou studii. Nebyly shromažďovány žádné údaje o nežádoucích příhodách souvisejících s kvalitativními rozhovory.
Cíl 3: Podrobnosti a výsledky cíle 3 naleznete v záznamu NCT03483428.
Cíl 4: Tato část studie byla randomizovanou kontrolovanou studií adaptovaného tréninku pro rodiče. Rodiče dětí se sluchovým postižením byli randomizováni tak, aby buď dostali intervenci, nebo byli zařazeni do kontrolní podmínky.
Cíl 5: Tato část studie shromažďuje procesní údaje o tom, jak byla intervence v cíli 4 poskytována, a také kvalitativní údaje týkající se pohledů na intervenci od klíčových zainteresovaných stran, včetně podskupiny rodičů z cíle 4, intervencionistů, kteří intervenci poskytovali, a dalších zainteresovaných stran. V tomto cíli nedochází k žádné intervenci a nejedná se o klinickou studii. Nebudou shromažďovány žádné údaje o nežádoucích příhodách.
Typ studie
Intervenční
Zápis (Aktuální)
295
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Kentucky
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Lexington, Kentucky, Spojené státy, 40506
- University of Kentucky
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
3 roky až 99 let (Dítě, Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Popis
Kritéria pro zařazení:
- Rodič je starší 18 let
- Rodič je opatrovnickým opatrovníkem dítěte
- Rodič může buď mluvit/rozumět anglicky, nebo používat americký znakový jazyk
- Rodič žije ve státě se zavedenou sítí doporučení pro rodiče dětí DHH, pokud jsou potřeba další služby
- Na začátku je dítě ve věku 3 až 6 let
- Na začátku žije dítě většinu času v domě rodičů/opatrovníka
- Dítě je hluché nebo špatně slyšící
- Dítě používá sluchadlo(a), kochleární implantát(y) a/nebo zařízení pro kostní vedení déle než 6 měsíců
Kritéria vyloučení:
- Případ aktivních služeb ochrany dětí je otevřen
- Rodič již využil služby behaviorálního zdraví pro dítě
- Rodič se účastnil formativního výzkumu pro tuto studii
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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.
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Upravená verze kontroly rodiny / každodenního rodičovského zásahu
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Žádný zásah: Control
Parents are not offered the intervention but are not precluded from accessing other services for their young deaf and hard of hearing chidren.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Parenting Young Children (PARYC) Scale Total Score
Časové okno: 6 months after parent baseline
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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.
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6 months after parent baseline
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Parenting Young Children Scale (PARYC) Total Scores Over Time
Časové okno: Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment
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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.
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Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment
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Change in Parenting Young Children Scale (PARYC) Supporting Positive Behavior Subscale Scores Over Time
Časové okno: Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment
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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.
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Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment
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Change in Parenting Young Children Scale (PARYC) Setting Limits Subscale Scores Over Time
Časové okno: Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment
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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.
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Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment
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Change in Parenting Young Children Scale (PARYC) Proactive Parenting Subscale Scores Over Time
Časové okno: Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment
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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.
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Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment
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Child Behavior Checklist (CBCL) Total Problems T-Score
Časové okno: Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment
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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.
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Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment
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Child Behavior Checklist (CBCL) Internalizing Problems T-Score
Časové okno: Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment
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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.
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Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment
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Child Behavior Checklist (CBCL) Externalizing Problems T-Score
Časové okno: Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment
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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.
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Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment
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Parent Sense of Competence Scale (PSCS) Total Score
Časové okno: Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment.
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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.
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Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment.
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Parent Sense of Competence Scale (PSCS) Self-efficacy Score
Časové okno: Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment
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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.
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Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment
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Parent Sense of Competence Scale (PSCS) Satisfaction Score
Časové okno: Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment
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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.
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Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment
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Beck Depression Inventory-II (BDI-II)
Časové okno: Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment
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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.
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Every 6 months from completion of baseline assessment to up to 36 months after baseline assessment
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Parent Child Interaction System (PARCHISY) - Parent Positive Control
Časové okno: Every 6 months from baseline to up to 18 months after baseline
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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.
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Every 6 months from baseline to up to 18 months after baseline
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Parent Child Interaction System (PARCHISY) - Parent Negative Control
Časové okno: Every 6 months from baseline to up to 18 months after baseline
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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.
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Every 6 months from baseline to up to 18 months after baseline
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Parent Child Interaction System (PARCHISY) - Parent Positive Affect
Časové okno: Every 6 months from baseline to up to 18 months after baseline
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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.
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Every 6 months from baseline to up to 18 months after baseline
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Parent Child Interaction System (PARCHISY) - Parent Negative Affect
Časové okno: Every 6 months from baseline to up to 18 months after baseline
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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.
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Every 6 months from baseline to up to 18 months after baseline
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Parent Child Interaction System (PARCHISY) - Child Positive Affect
Časové okno: Every 6 months from baseline to up to 18 months after baseline
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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.
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Every 6 months from baseline to up to 18 months after baseline
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Parent Child Interaction System (PARCHISY) - Child Negative Affect
Časové okno: Every 6 months from baseline to up to 18 months after baseline
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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.
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Every 6 months from baseline to up to 18 months after baseline
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Parent Child Interaction System (PARCHISY) - Child On-Task
Časové okno: Every 6 months from baseline to up to 18 months after baseline
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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.
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Every 6 months from baseline to up to 18 months after baseline
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Parent Child Interaction System (PARCHISY) - Child Noncompliance
Časové okno: Every 6 months from baseline to up to 18 months after baseline
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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.
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Every 6 months from baseline to up to 18 months after baseline
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Parent Child Interaction System (PARCHISY) - Conflict
Časové okno: Every 6 months from baseline to up to 18 months after baseline
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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.
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Every 6 months from baseline to up to 18 months after baseline
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Parent Motivation Inventory (PMI) Total Score
Časové okno: Annually from 12 months after baseline up to 36 months after baseline
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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.
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Annually from 12 months after baseline up to 36 months after baseline
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Parent Motivation Inventory (PMI) Desire for Change Subscale
Časové okno: Annually from 12 months after baseline up to 36 months after baseline
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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.
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Annually from 12 months after baseline up to 36 months after baseline
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Parent Motivation Inventory (PMI) Readiness to Change Subscale
Časové okno: Annually from 12 months after baseline up to 36 months after baseline
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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.
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Annually from 12 months after baseline up to 36 months after baseline
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Parent Motivation Inventory (PMI) Perceived Ability to Change Subscale
Časové okno: Annually from 12 months after baseline up to 36 months after baseline
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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.
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Annually from 12 months after baseline up to 36 months after baseline
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Hearing Aid Adherence Questionnaire
Časové okno: Every 12 months from completion of baseline assessment up to 36 months after baseline assessment
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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.
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Every 12 months from completion of baseline assessment up to 36 months after baseline assessment
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Therapy Attitude Inventory (TAI)
Časové okno: Annually from 6 months after baseline up to 30 months after baseline
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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.
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Annually from 6 months after baseline up to 30 months after baseline
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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MacArthur Bates Communicative Development Inventories - Words & Sentences - Words Produced (Raw Score)
Časové okno: Annually from baseline through up to 36 months.
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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.
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Annually from baseline through up to 36 months.
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MacArthur Bates Communicative Development Inventories - Words & Sentences - Sentence Complexity Score
Časové okno: Annually from baseline through up to 36 months.
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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.
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Annually from baseline through up to 36 months.
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Peabody Picture Vocabulary Test (PPVT) Standard Score
Časové okno: Annually from baseline assessment through up to 36 months after baseline
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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.
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Annually from baseline assessment through up to 36 months after baseline
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Clinical Evaluation of Language Fundamentals (CELF) - Core Language Score (Standard Scores)
Časové okno: Annually from baseline through up to 36 months after baseline
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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.
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Annually from baseline through up to 36 months after baseline
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Beginner's Intelligibility Test (BIT)
Časové okno: Every 6 months beginning with baseline through up to 36 months
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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.
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Every 6 months beginning with baseline through up to 36 months
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Meaningful Auditory Integration Scale (MAIS) - Bonding/Attachment to Hearing Device Domain
Časové okno: Annually from baseline through up to 36 months
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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.
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Annually from baseline through up to 36 months
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Clinical Evaluation of Language Fundamentals (CELF) - Expressive Language Index (Standard Scores)
Časové okno: Annually from baseline through up to 36 months after baseline
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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.
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Annually from baseline through up to 36 months after baseline
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Parent Child Interaction System (PARCHISY) - Parent Responsiveness
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Christina Studts, PhD, MSPH, MSW, University of Colorado, Denver
- Vrchní vyšetřovatel: Julie Lowman, PhD, University of Kentucky
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
17. června 2021
Primární dokončení (Aktuální)
14. října 2024
Dokončení studie (Odhadovaný)
31. května 2027
Termíny zápisu do studia
První předloženo
11. dubna 2019
První předloženo, které splnilo kritéria kontroly kvality
12. dubna 2019
První zveřejněno (Aktuální)
16. dubna 2019
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
3. srpna 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
9. července 2026
Naposledy ověřeno
1. července 2026
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 45213
- R01DC016957 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu IPD
Údaje bez identifikace budou zpřístupněny veřejnosti (na žádost PI) ihned po přijetí hlavních zjištění z konečného souboru údajů ke zveřejnění.
Časový rámec sdílení IPD
Údaje bez identifikace budou zpřístupněny veřejnosti (na žádost PI) ihned po přijetí hlavních zjištění z konečného souboru údajů ke zveřejnění.
Kritéria přístupu pro sdílení IPD
Údaje bez identifikace budou zpřístupněny veřejnosti (na žádost PI) ihned po přijetí hlavních zjištění z konečného souboru údajů ke zveřejnění.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- ICF
- ANALYTIC_CODE
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
produkt vyrobený a vyvážený z USA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .