Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06609707
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
Tuning in to Kids An Online Group Program Tailored for Parents of Children With Congenital Heart Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None