Heart Defects, CongenitalNCT06609707
Tuning in to Kids: An Online, Group Program Tailored for Parents of Children With Congenital Heart Disease
A study testing Tuning in to Kids in people with Heart Defects, Congenital and Parenting, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Defects, Congenital, Parenting, Emotion Regulation
- What is being tested?
- Tuning in to Kids
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2024to 6 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
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
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?
Read more
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.
Read the 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.
- Conditions
- Heart Defects, Congenital, Parenting, Emotion Regulation
- Being tested
- Tuning in to Kids
- Keywords
- Congenital Heart Disease, Mental Health, Parenting, Psychological Intervention, Randomized Controlled Trial, Parent Mental Health, Child Mental Health, Emotion Coaching, Parent-Focused Intervention
- Medical subject headings
- Heart Defects, Congenital, Emotional Regulation, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tuning in to KidsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Cardiac Care | No 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. |
| Tuning in to Kids (Treatment Arm) | Experimental | Participants will receive Standard Cardiac Care plus the Tuning in to Kids intervention. Receives: Behavioral: Tuning in to Kids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment Rate
≥70% of eligible approached parents enrolled.
Measured: Enrollment
Retention Rate
≥80% of parents who complete all study procedures.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: After Tuning in to Kids Session 6 (at approximately 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start26 Sep 2024
- Primary completion6 Nov 2025
- Study completion6 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Defects, CongenitalStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadine Kasparian, Children's Hospital Medical Center, Cincinnati
- Investigators
- Nadine A Kasparian, PhD, Principal investigator, Cincinnati Children's Hospital Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06609707
- Sponsor's protocol ID
- 2024-0337
- Status last verified
- Dec 2025
- First submitted
- 18 Sep 2024
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participant data that underlie the results reported in the published paper, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06609707
- Acronym / sponsor ID
- 2024-0337
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 26 Sep 2024 (actual)
- Primary completion
- 6 Nov 2025 (actual)
- Study completion
- 6 Nov 2025 (actual)
- First posted
- 24 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Cardiac Care | No 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. |
| Tuning in to Kids (Treatment Arm) | Experimental | Behavioral: Tuning in to KidsParticipants will receive Standard Cardiac Care plus the Tuning in to Kids intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tuning in to KidsTuning 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. | Behavioural | Tuning in to Kids (Treatment Arm) |
Primary outcome
Enrollment Rate
Time frame: Enrollment
≥70% of eligible approached parents enrolled.
Retention Rate
Time frame: From enrollment to 1-month post intervention period (up to approximately 12 weeks)
≥80% of parents who complete all study procedures.
Proportion of Participants Who Receive All Intervention Content (Fidelity)
Time frame: From enrollment to 1-month post intervention period (up to approximately 12 weeks)
≥80% of parents who receive all intervention content (intervention group only).
Proportion of Participants with Complete Data (Assessment Completion)
Time frame: From enrollment to 1-month post intervention period (up to approximately 12 weeks)
≥80% of parents with complete data.
Intervention Acceptability
Time frame: After Tuning in to Kids Session 3
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.
Satisfaction with the Intervention
Time frame: After Tuning in to Kids Session 6 (at approximately 8 weeks)
Tuning in to Kids Experiences Scale (intervention group only): study-specific measure designed to assess participant satisfaction with the Tuning in to Kids program.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: Yes. Participant data that underlie the results reported in the published paper, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadine A Kasparian, PhD principal investigator
Cincinnati Children's Hospital Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tuning in to Kids in people with Heart Defects, Congenital and Parenting, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment Rate (time frame: Enrollment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.