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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:
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tuning in to Kids | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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| Measure | Description | Time Frame |
|---|---|---|
| Child Strengths and Difficulties | Strengths and Difficulties Questionnaire (SDQ): 25-item, validated, widely-used behavioral screening measure with a mix of positive and negatively phrased items assessing five domains (emotional symptoms, conduct problems, hyperactivity-inattention, peer problems, pro-social behavior). Subscale scores are combined (excluding the pro-social scale) into a Total Difficulties score ranging from 0 to 40, with higher scores indicating more problems (with the exception of the pro-social behavior subscale). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nadine A Kasparian, PhD | Cincinnati Children's Hospital Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
Participant data that underlie the results reported in the published paper, after deidentification (text, tables, figures, and appendices).
Beginning 12 months and ending 24 months following publication.
Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D000080103 | Emotional Regulation |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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| From enrollment to 1-month post intervention period (up to approximately 12 weeks) |
| Parent Difficulties with Emotion Regulation | Difficulties with Emotion Regulation Scale - Short Form (DERS-SF): 18-item, widely-used, validated scale assessing emotional regulation reported by adults (i.e., parents and caregivers) across 6 domains (strategies, non-acceptance, impulse, goals, awareness, clarity). Response options range from 1 ('almost never') to 5 ('almost always'), with total scores ranging from 18 to 90, and higher scores indicating greater difficulties in emotion regulation. | From enrollment to 1-month post intervention period (up to approximately 12 weeks) |
| Parent Emotional Style | Parent Emotional Style Questionnaire (PESQ): Validated 21-item scale assessing parents' beliefs about their child's emotions, including sadness, anger, and fear. | From enrollment to 1-month post intervention period (up to approximately 12 weeks) |
| Parent Coping with Children's Negative Emotions | Coping with Children's Negative Emotions Scale (CCNES): 12 scenarios of child negative emotion; parents rate their likelihood of responding in each of six ways. | From enrollment to 1-month post intervention period (up to approximately 12 weeks) |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000068356 | Self-Control |
| D012919 | Social Behavior |
| D001519 | Behavior |
| D010549 | Personal Satisfaction |