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Behavioral Intervention

Online Program for Parents of Children with Heart Disease

N/A

Waitlist Available

Led By Nadine A Kasparian, PhD

Research Sponsored by Children's Hospital Medical Center, Cincinnati

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Child is aged between 3 and 6 years

Child has congenital heart disease requiring cardiopulmonary bypass during infancy (i.e., by age 12 months)

Must not have

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

Parent has an intellectual disability impacting capacity to independently provide informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from enrollment to 1-month post intervention period (up to approximately 12 weeks)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to determine if an online psychological program called Tuning in to Kids is feasible and helpful for parents of young children with congenital heart disease. Parents will participate in online group sessions and surveys

Who is the study for?

This trial is for parents of children aged 3 to 6 with congenital heart disease. Participants will need to complete online surveys, attend virtual group sessions, and participate in an interview. There's no specific exclusion criteria provided.

What is being tested?

The study tests the 'Tuning in to Kids' program delivered online for its feasibility and acceptability among parents. It involves six weekly group sessions, two booster sessions, and compares this intervention against standard cardiac care.

What are the potential side effects?

Since 'Tuning in to Kids' is a psychological intervention focusing on emotion regulation rather than a medical treatment, it may not have typical physical side effects but could impact emotional or mental well-being.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My child is between 3 and 6 years old.

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My child had heart surgery with a heart-lung machine as a baby.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My child has a neurodevelopmental disorder and cannot speak or act like a typical 3-year-old.

Select...

My parent cannot fully understand consent forms due to an intellectual disability.

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I am a parent and I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from enrollment to 1-month post intervention period (up to approximately 12 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from enrollment to 1-month post intervention period (up to approximately 12 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to 1-month post intervention period (up to approximately 12 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Enrollment Rate

Intervention Acceptability

Proportion of Participants Who Receive All Intervention Content (Fidelity)

+3 more

Other study objectives

Child Strengths and Difficulties

Parent Coping with Children's Negative Emotions

Parent Difficulties with Emotion Regulation

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Tuning in to Kids (Treatment Arm)Experimental Treatment1 Intervention

Participants will receive Standard Cardiac Care plus the Tuning in to Kids intervention.

Group II: Standard Cardiac CareActive Control1 Intervention

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.

0 / 5Eligibility criteria met