Formazione genitoriale comportamentale per famiglie con bambini in età prescolare non udenti e con problemi di udito (CHAMPS-DHH)
9 luglio 2026 aggiornato da: Christina Studts
I bambini sordi e con problemi di udito (DHH) raramente ricevono interventi comportamentali per prevenire i costosi esiti a lungo termine dei problemi comportamentali.
Questo progetto adatterà sistematicamente un intervento di formazione dei genitori basato sull'evidenza per aumentarne l'accettabilità e la rilevanza per i genitori di giovani bambini DHH.
Verrà valutata l'efficacia dell'intervento adattato e la sua attuazione con i genitori di bambini DHH seguiti nelle cliniche sanitarie dell'udito del "mondo reale".
Panoramica dello studio
Stato
Attivo, non reclutante
Intervento / Trattamento
Descrizione dettagliata
Obiettivo 1: Questa parte dello studio ha convocato un Consiglio Consultivo della Comunità per fornire input sullo studio.
I membri del CAB sono stati considerati collaboratori piuttosto che soggetti di ricerca.
Non hanno fornito dati personali per l'uso in pubblicazioni o altre attività di diffusione della ricerca.
Non sono stati raccolti dati sugli eventi avversi relativi al CAB.
Obiettivo 2: Questa parte dello studio ha coinvolto interviste qualitative con i genitori e gruppi di discussione con le parti interessate (logopedisti, audiologi e insegnanti di studenti sordi) per guidare l'adattamento dell'intervento.
Non c'era alcun intervento in questo obiettivo e non era una sperimentazione clinica.
Non sono stati raccolti dati sugli eventi avversi relativi alle interviste qualitative.
Obiettivo 3: Si prega di consultare il Record NCT03483428 per i dettagli e i risultati dell'Obiettivo 3.
Obiettivo 4: Questa parte dello studio era una sperimentazione controllata randomizzata dell'intervento di formazione per genitori adattato.
I genitori di bambini con ipoacusia sono stati randomizzati per ricevere l'intervento o per una condizione di controllo.
Obiettivo 5: Questa parte dello studio sta raccogliendo dati di processo su come l'intervento è stato erogato nell'Obiettivo 4, nonché dati qualitativi riguardanti le prospettive sull'intervento da parte delle parti interessate chiave, inclusi un sottogruppo di genitori dell'Obiettivo 4, gli interventisti che hanno erogato l'intervento e altre parti interessate.
Non c'è alcun intervento in questo obiettivo e non è una sperimentazione clinica.
Non verranno raccolti dati sugli eventi avversi.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
295
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Kentucky
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Lexington, Kentucky, Stati Uniti, 40506
- University of Kentucky
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-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 3 anni a 99 anni (Bambino, Adulto, Adulto più anziano)
Accetta volontari sani
No
Descrizione
Criterio di inclusione:
- Il genitore ha almeno 18 anni
- Il genitore è tutore affidatario del bambino
- Il genitore può parlare/capire l'inglese o usare la lingua dei segni americana
- Il genitore vive in uno stato con una rete di riferimento consolidata per i genitori di bambini DHH se sono necessari servizi aggiuntivi
- Al basale, il bambino ha un'età compresa tra 3 e 6 anni
- Al basale, il bambino vive la maggior parte del tempo a casa del genitore/tutore
- Il bambino è sordo o con problemi di udito
- Il bambino ha utilizzato apparecchi acustici, impianti cocleari e/o dispositivi a conduzione ossea per più di 6 mesi
Criteri di esclusione:
- Il caso dei servizi di protezione dei minori attivi è aperto
- Il genitore ha già avuto accesso ai servizi di salute comportamentale per il bambino
- Parent ha partecipato alla ricerca formativa per questo studio
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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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Versione adattata dell'intervento Family Check-Up/Everyday Parenting
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Nessun intervento: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Parenting Young Children (PARYC) Scale Total Score
Lasso di tempo: 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.
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6 months after parent baseline
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in Parenting Young Children Scale (PARYC) Total Scores Over Time
Lasso di tempo: 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.
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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
Lasso di tempo: 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.
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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
Lasso di tempo: 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.
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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
Lasso di tempo: 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.
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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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
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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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
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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
Lasso di tempo: 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.
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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
Lasso di tempo: 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.
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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
Lasso di tempo: 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.
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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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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MacArthur Bates Communicative Development Inventories - Words & Sentences - Words Produced (Raw Score)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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 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.
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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 On-Task
Lasso di tempo: 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.
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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 Verbalizations
Lasso di tempo: 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 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.
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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 Responsiveness
Lasso di tempo: 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
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Parent Child Interaction System (PARCHISY) - Child Autonomy
Lasso di tempo: 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
|
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Parent Child Interaction System (PARCHISY) - Child Activity
Lasso di tempo: 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
|
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Parent Child Interaction System (PARCHISY) - Child Verbalizations
Lasso di tempo: 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
|
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Parent Child Interaction System (PARCHISY) - Reciprocity
Lasso di tempo: 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.
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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) - Cooperation
Lasso di tempo: 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.
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Every 6 months from baseline to up to 18 months after baseline
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Christina Studts, PhD, MSPH, MSW, University of Colorado, Denver
- Investigatore principale: Julie Lowman, PhD, University of Kentucky
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
17 giugno 2021
Completamento primario (Effettivo)
14 ottobre 2024
Completamento dello studio (Stimato)
31 maggio 2027
Date di iscrizione allo studio
Primo inviato
11 aprile 2019
Primo inviato che soddisfa i criteri di controllo qualità
12 aprile 2019
Primo Inserito (Effettivo)
16 aprile 2019
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
3 agosto 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
9 luglio 2026
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 45213
- R01DC016957 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
I dati resi anonimi saranno resi disponibili al pubblico (su richiesta al PI) immediatamente dopo l'accettazione per la pubblicazione dei risultati principali del set di dati finale.
Periodo di condivisione IPD
I dati resi anonimi saranno resi disponibili al pubblico (su richiesta al PI) immediatamente dopo l'accettazione per la pubblicazione dei risultati principali del set di dati finale.
Criteri di accesso alla condivisione IPD
I dati resi anonimi saranno resi disponibili al pubblico (su richiesta al PI) immediatamente dopo l'accettazione per la pubblicazione dei risultati principali del set di dati finale.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- ICF
- CODICE_ANALITICO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
prodotto fabbricato ed esportato dagli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .