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Eine Studie entspricht den Filterkriterien
Kartenansicht
Tuning in to Kids: An Online, Group Program Tailored for Parents of Children With Congenital Heart Disease
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT06609707 ist eine interventionsstudie zur Untersuchung von Angeborene Herzfehler, Erziehung, Emotionsregulation und hat den Status noch nicht rekrutierend. Der Start ist für 30. September 2024 geplant, bis 40 Teilnehmer aufgenommen werden. Durchgeführt von Children's Hospital Medical Center, Cincinnati wird der Abschluss für 31. Dezember 2025 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 24. September 2024 aktualisiert.
Kurzbeschreibung
The goal of this clinical trial is to learn if a virtually-delivered, group-based psychological intervention, called Tuning in to Kids, is feasible and acceptable for parents of children aged 3 to 6 years with congenital heart disease. The main questions this study aims to answer are:
- What do parents of children with congenital heart disease think of the Tuning in to Kids intervention?
- Is the intervention helpful for parents?
- Is the intervention easy for parents to take part in?
- Do the researchers find it easy or difficult to deliver the Tuning in to Kids intervention to parents of children with congenital heart disease?
Participants will:
- Fill out 3 online surveys at home.
- Take part in the Tuning in to Kids intervention (which includes six 90-minute, weekly, online group sessions and two booster sessions) or standard cardiac care.
- Take part in an interview.
Ausführliche Beschreibung
Mental health conditions are common among children with congenital heart disease (CHD) and are strongly associated with cardiovascular morbidity and mortality, as well as lower quality of life. Despite increasing awareness, the mental health needs of children with CHD remain largely unmet, especially among those from historically marginalized and underserved communities. To address this gap, this study will test, for the first time in CHD, a virtually-delivered, group-based psychological intervention, called Tuning in to Kids, designed to teach parents how to help their children understand, regulate, and manage their emotions. The intervention includes six, 90-minute, weekly, online group sessions and two 'booster' sessions, coupled with educational resources and home practice activities to improve parent-child interactions, and enhance child emotional and behavioral functioning. Each group is facilitated by two qualified health professionals who are trained in, and certified to deliver, the Tuning in to Kids intervention. In this pilot randomized controlled trial, we will enroll 40 parents (or other primary caregivers) of children aged 3 or 6 years with CHD who underwent surgical intervention in infancy. The primary aim of this study is to assess intervention acceptability and feasibility, and the results generated will directly inform the design of, and provide preliminary data for, a multicenter efficacy trial to examine short- and longer-term intervention effects.
Offizieller Titel
Tuning in to Kids: A Virtually-delivered, Group-based, Psychological Intervention for Parents to Improve Emotional and Behavioral Wellbeing Among Children With Congenital Heart Disease
Erkrankungen
Angeborene HerzfehlerErziehungEmotionsregulationWeitere Studien-IDs
- 2024-0337
NCT-Nummer
Studienbeginn (tatsächlich)
2024-09-30
Zuletzt aktualisiert
2024-09-24
Studienende (vorauss.)
2025-12-31
Geplante Rekrutierung
40
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Noch nicht rekrutierend
Stichwörter
Congenital Heart Disease
Mental Health
Parenting
Psychological Intervention
Randomized Controlled Trial
Parent Mental Health
Child Mental Health
Emotion Coaching
Parent-Focused Intervention
Mental Health
Parenting
Psychological Intervention
Randomized Controlled Trial
Parent Mental Health
Child Mental Health
Emotion Coaching
Parent-Focused Intervention
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Einfach verblindet
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
Keine InterventionStandard Cardiac Care Participants assigned to the Standard Cardiac Care group will continue to participate in their child's usual cardiac care and can access any supports available to their child and family. Participants in this group will not take part in the Tuning in to Kids program as part of this study; however, once the study has ended, participants will be offered an opportunity to receive Tuning in to Kids, if they would like to. | Nicht zutreffend |
ExperimentellTuning in to Kids (Treatment Arm) Participants will receive Standard Cardiac Care plus the Tuning in to Kids intervention. | Tuning in to Kids Tuning in to Kids is an evidence-based, emotion-focused, group parenting program designed to teach caregivers skills in recognizing, understanding, and managing their own and their children's emotions. The program includes six 90-minute, weekly, online group sessions and two optional 'booster' sessions to consolidate skills. Parents are taught five steps of emotion coaching and participate in exercises sequentially targeting each step. Intervention components include psychoeducation, emotion coaching demonstrations, role plays, group discussion, written resources, and home practice exercises. The program teaches parents skills in emotion coaching as a way of responding to their child's emotions. These skills help children to understand and regulate their emotions. As per the Tuning in to Kids manual, two trained, licensed health professionals will co-facilitate each group. |
Hauptergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Enrollment Rate | ≥70% of eligible approached parents enrolled. | Enrollment |
Retention Rate | ≥80% of parents who complete all study procedures. | From enrollment to 1-month post intervention period (up to approximately 12 weeks) |
Proportion of Participants Who Receive All Intervention Content (Fidelity) | ≥80% of parents who receive all intervention content (intervention group only). | From enrollment to 1-month post intervention period (up to approximately 12 weeks) |
Proportion of Participants with Complete Data (Assessment Completion) | ≥80% of parents with complete data. | From enrollment to 1-month post intervention period (up to approximately 12 weeks) |
Intervention Acceptability | Treatment Acceptability Scale (TAS) score ≥28 (intervention group only). TAS total scores can range from 7 to 56, with higher scores indicating greater intervention acceptability. | After Tuning in to Kids Session 3 |
Satisfaction with the Intervention | Tuning in to Kids Experiences Scale (intervention group only): study-specific measure designed to assess participant satisfaction with the Tuning in to Kids program. | After Tuning in to Kids Session 6 (at approximately 8 weeks) |
Eignungskriterien
Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
- Child is aged between 3 and 6 years.
- Child is receiving care from the Cincinnati Children's Heart Institute (at least one cardiology visit in the past 12 months).
- Child has congenital heart disease requiring cardiopulmonary bypass during infancy (i.e., by age 12 months).
- Parent or primary caregiver can give consent and participate in the study in English.
- Child has a diagnosed neurodevelopmental disorder (e.g., autism, Trisomy 18), is not speaking, or is not functioning at the developmental level of a typical 3-year-old at the time of study recruitment.
- Child current medical status or treatment precludes study participation.
- Parent is aged under 18 years.
- Parent is currently participating in another parent-focused or parent training program (e.g., Parent-Child Interaction Therapy).
- Parent suffers from substance misuse or severe, unmanaged mental illness.
- Parent has an intellectual disability impacting capacity to independently provide informed consent.
- The child's treating physician or the study interventionalist identifies the parent or child as having a condition or circumstance that is contraindicative to engagement with the Tuning in to Kids program.
Children's Hospital Medical Center, CincinnatiVerantwortliche Partei
Nadine Kasparian, Hauptprüfer, Professor, Children's Hospital Medical Center, Cincinnati
Zentrale Studienkontakte
Kontakt: Nadine A Kasparian, PhD, 513-636-5575, [email protected]
Kontakt: Olivia Cleary, MSSW, 513-636-7442, [email protected]
1 Studienstandorte in 1 Ländern
Ohio
Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, 45229, United States
Nadine Kasparian, PhD, Kontakt, 513-636-5575, [email protected]
Olivia Cleary, MA, Kontakt, 513-636-7442, [email protected]
Nadine A Kasparian, PhD, Hauptprüfer