Verhaltensorientiertes Elterntraining für Familien mit gehörlosen und schwerhörigen Vorschulkindern (CHAMPS-DHH)
9. Juli 2026 aktualisiert von: Christina Studts
Gehörlose und schwerhörige Kinder (DHH) erhalten selten Verhaltensinterventionen, um die langfristigen kostspieligen Folgen von Verhaltensproblemen zu verhindern.
Dieses Projekt wird eine evidenzbasierte Elterntrainingsintervention systematisch anpassen, um ihre Akzeptanz und Relevanz für Eltern kleiner DHH-Kinder zu erhöhen.
Die Wirksamkeit der angepassten Intervention und ihre Umsetzung bei Eltern kleiner DHH-Kinder, die in „realen“ Hörkliniken verfolgt werden, wird bewertet.
Studienübersicht
Status
Aktiv, nicht rekrutierend
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Ziel 1: In diesem Teil der Studie wurde ein Community Advisory Board einberufen, um Input zur Studie zu erhalten. Die CAB-Mitglieder wurden als Mitarbeiter betrachtet und nicht als Forschungsteilnehmer. Sie stellten keine persönlichen Daten zur Verwendung in Veröffentlichungen oder anderen Forschungsverbreitungsbemühungen zur Verfügung. Es wurden keine Daten zu unerwünschten Ereignissen im Zusammenhang mit dem CAB gesammelt.
Ziel 2: Dieser Teil der Studie umfasste qualitative Interviews mit Eltern und Fokusgruppen mit Interessengruppen (Sprachtherapeuten, Audiologen und Lehrer für Gehörlose), um die Anpassung der Intervention zu leiten. Es gab keine Intervention in diesem Ziel und es handelte sich nicht um eine klinische Studie. Es wurden keine Daten zu unerwünschten Ereignissen im Zusammenhang mit den qualitativen Interviews gesammelt.
Ziel 3: Bitte siehe Datensatz NCT03483428 für Details und Ergebnisse von Ziel 3.
Ziel 4: Dieser Teil der Studie war eine randomisierte kontrollierte Studie der angepassten Elterntrainingsintervention. Eltern von DHH-Kindern wurden randomisiert, entweder die Intervention zu erhalten oder einer Kontrollbedingung zugeordnet zu werden.
Ziel 5: Dieser Teil der Studie sammelt Prozessdaten darüber, wie die Intervention in Ziel 4 durchgeführt wurde, sowie qualitative Daten zu Perspektiven bezüglich der Intervention von wichtigen Interessengruppen, einschließlich einer Untergruppe von Eltern aus Ziel 4, den Interventionsdurchführenden und anderen Interessengruppen. Es gibt keine Intervention in diesem Ziel und es handelt sich nicht um eine klinische Studie. Es werden keine Daten zu unerwünschten Ereignissen gesammelt.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
295
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Kentucky
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Lexington, Kentucky, Vereinigte Staaten, 40506
- University of Kentucky
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
3 Jahre bis 99 Jahre (Kind, Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
Einschlusskriterien:
- Elternteil ist 18 Jahre oder älter
- Der Elternteil ist der sorgeberechtigte Vormund des Kindes
- Eltern können entweder Englisch sprechen/verstehen oder die amerikanische Gebärdensprache verwenden
- Der Elternteil lebt in einem Staat mit einem etablierten Überweisungsnetzwerk für Eltern von DHH-Kindern, wenn zusätzliche Dienste benötigt werden
- Das Kind ist zu Studienbeginn zwischen 3 und 6 Jahre alt
- Zu Beginn lebt das Kind die meiste Zeit im Haushalt der Eltern/Erziehungsberechtigten
- Das Kind ist taub oder schwerhörig
- Das Kind verwendet seit mehr als 6 Monaten Hörgeräte, Cochlea-Implantate und/oder Knochenleitungsgeräte
Ausschlusskriterien:
- Der Fall des aktiven Kinderschutzdienstes ist offen
- Ein Elternteil hat bereits auf Verhaltensgesundheitsdienste für das Kind zugegriffen
- Ein Elternteil nahm an der formativen Forschung für diese Studie teil
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: 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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Angepasste Version der Intervention Familien-Check-Up/Elternalltag
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Kein Eingriff: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Parenting Young Children (PARYC) Scale Total Score
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change in Parenting Young Children Scale (PARYC) Total Scores Over Time
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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MacArthur Bates Communicative Development Inventories - Words & Sentences - Words Produced (Raw Score)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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 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
Zeitfenster: 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
Zeitfenster: 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 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.
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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 Autonomy
Zeitfenster: 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.
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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 Activity
Zeitfenster: 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.
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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 Verbalizations
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Christina Studts, PhD, MSPH, MSW, University of Colorado, Denver
- Hauptermittler: Julie Lowman, PhD, University of Kentucky
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
17. Juni 2021
Primärer Abschluss (Tatsächlich)
14. Oktober 2024
Studienabschluss (Geschätzt)
31. Mai 2027
Studienanmeldedaten
Zuerst eingereicht
11. April 2019
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
12. April 2019
Zuerst gepostet (Tatsächlich)
16. April 2019
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
3. August 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
9. Juli 2026
Zuletzt verifiziert
1. Juli 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 45213
- R01DC016957 (US NIH Stipendium/Vertrag)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Beschreibung des IPD-Plans
Anonymisierte Daten werden (auf Anfrage an den PI) unmittelbar nach der Annahme zur Veröffentlichung der wichtigsten Ergebnisse aus dem endgültigen Datensatz öffentlich zugänglich gemacht.
IPD-Sharing-Zeitrahmen
Anonymisierte Daten werden (auf Anfrage an den PI) unmittelbar nach der Annahme zur Veröffentlichung der wichtigsten Ergebnisse aus dem endgültigen Datensatz öffentlich zugänglich gemacht.
IPD-Sharing-Zugriffskriterien
Anonymisierte Daten werden (auf Anfrage an den PI) unmittelbar nach der Annahme zur Veröffentlichung der wichtigsten Ergebnisse aus dem endgültigen Datensatz öffentlich zugänglich gemacht.
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- ICF
- ANALYTIC_CODE
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Produkt, das in den USA hergestellt und aus den USA exportiert wird
Nein
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .