Clinical trial NCT06609707: Tuning in to Kids: An Online, Group Program Tailored for Parents of Children With Congenital Heart Disease
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Heart Defects, Congenital
Parenting
Emotion Regulation
Keywords: Congenital Heart Disease
Mental Health
Parenting
Psychological Intervention
Randomized Controlled Trial
Parent Mental Health
Child Mental Health
Emotion Coaching
Parent-Focused Intervention
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2024-09-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Child is aged between 3 and 6 years.
2. Child is receiving care from the Cincinnati Children's Heart Institute (at least one cardiology visit in the past 12 months).
3. Child has congenital heart disease requiring cardiopulmonary bypass during infancy (i.e., by age 12 months).
4. Parent or primary caregiver can give consent and participate in the study in English.

Exclusion Criteria:

1. 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.
2. Child current medical status or treatment precludes study participation.
3. Parent is aged under 18 years.
4. Parent is currently participating in another parent-focused or parent training program (e.g., Parent-Child Interaction Therapy).
5. Parent suffers from substance misuse or severe, unmanaged mental illness.
6. Parent has an intellectual disability impacting capacity to independently provide informed consent.
7. 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.

Primary outcomes:
measure: Enrollment Rate
timeFrame: Enrollment
measure: Retention Rate
timeFrame: From enrollment to 1-month post intervention period (up to approximately 12 weeks)
measure: Proportion of Participants Who Receive All Intervention Content (Fidelity)
timeFrame: From enrollment to 1-month post intervention period (up to approximately 12 weeks)
measure: Proportion of Participants with Complete Data (Assessment Completion)
timeFrame: From enrollment to 1-month post intervention period (up to approximately 12 weeks)
measure: Intervention Acceptability
timeFrame: After Tuning in to Kids Session 3
measure: Satisfaction with the Intervention
timeFrame: After Tuning in to Kids Session 6 (at approximately 8 weeks)
Secondary outcomes:
Other outcomes:
measure: Child Strengths and Difficulties
timeFrame: From enrollment to 1-month post intervention period (up to approximately 12 weeks)
measure: Parent Difficulties with Emotion Regulation
timeFrame: From enrollment to 1-month post intervention period (up to approximately 12 weeks)
measure: Parent Emotional Style
timeFrame: From enrollment to 1-month post intervention period (up to approximately 12 weeks)
measure: Parent Coping with Children's Negative Emotions
timeFrame: From enrollment to 1-month post intervention period (up to approximately 12 weeks)
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children&amp;#39;s Hospital Medical Center
state: Ohio
Study officials:
affiliation: Cincinnati Children&#39;s Hospital Medical Center
name: Nadine A Kasparian, PhD
role: PRINCIPAL_INVESTIGATOR
References: