Emotion Regulation, Heart Defects, Congenital, Parenting
Conditions
Keywords
Congenital Heart Disease, Mental Health, Parenting, Psychological Intervention, Randomized Controlled Trial, Parent Mental Health, Child Mental Health, Emotion Coaching, Parent-Focused Intervention
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.
Interventions
BEHAVIORALTuning in to Kids
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.
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction with the Intervention | 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. |
| Proportion of Participants with Complete Data (Assessment Completion) | From enrollment to 1-month post intervention period (up to approximately 12 weeks) | ≥80% of parents with complete data. |
| Enrollment Rate | Enrollment | ≥70% of eligible approached parents enrolled. |
| Retention Rate | From enrollment to 1-month post intervention period (up to approximately 12 weeks) | ≥80% of parents who complete all study procedures. |
| Intervention Acceptability | 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. |
| Proportion of Participants Who Receive All Intervention Content (Fidelity) | From enrollment to 1-month post intervention period (up to approximately 12 weeks) | ≥80% of parents who receive all intervention content (intervention group only). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Parent Difficulties with Emotion Regulation | From enrollment to 1-month post intervention period (up to approximately 12 weeks) | 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. |
| Parent Emotional Style | From enrollment to 1-month post intervention period (up to approximately 12 weeks) | Parent Emotional Style Questionnaire (PESQ): Validated 21-item scale assessing parents' beliefs about their child's emotions, including sadness, anger, and fear. |
| Parent Coping with Children's Negative Emotions | From enrollment to 1-month post intervention period (up to approximately 12 weeks) | 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. |
| Child Strengths and Difficulties | From enrollment to 1-month post intervention period (up to approximately 12 weeks) | 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). |
Countries
United States
Outcome results
None listed