Feasibility of a Virtual Mental Health Intervention for Children with Congenital Heart Disease
- Conditions
- Congenital Heart Disease (CHD)
- Registration Number
- NCT06659302
- Lead Sponsor
- University of Calgary
- Brief Summary
Children with congenital heart disease are at much higher risk for behavioral and emotional difficulties in early childhood and beyond 1. However, intervention programs aimed at this population are limited and few have explored the efficacy of behavioral parent training on child behavior and parent stress in children with CHD. Few evidence-based behavior intervention programs are available in the community for families of children with CHD and behavioral struggles and many families struggle to stick with long-term treatment given the multiple appointments and responsibilities that are often already associated in parenting children with chronic health conditions. As such, more targeted, shorter and more accessible interventions are very needed. Established internet-based treatments such as I-InTERACT-North, are particularly well-suited for adaptation to stepped-care delivery due to prior implementation success, readily adaptable intensity of online content and therapist contact.
This study will evaluate whether I-InTERACT North is a feasible intervention to implement in a step-care model and whether it is acceptable to families and impacts behavior and family functioning.
- Detailed Description
I-InTERACT-North was designed to be delivered online with a longstanding record of success in virtual service among children and families with behavioural challenges and parenting stress associated with acquired brain injury. The program contains key components that can be used in a stepped-care model to address parent stress and child behavioural concerns: 1) psychoeducation regarding the impact of heart disease on brain development, as well as behavior and emotion regulation skills in children, and 2) parenting strategies that foster responsiveness and consistency in the home. These two components have been shown to be effective in optimizing child behavior outcomes and reducing parental distress.
The program combines online learning modules with 1:1 parent-coaching provided in the family's home by videoconferencing. Coaching sessions reinforce content and provide direct live coaching on parent-responsivity skills. There is flexibility in when online modules are completed and video conference sessions are scheduled, essential considerations for families balancing simultaneous work and child-care demands. One of the co-investigators (Williams) recently completed an open-label pre-post pilot feasibility trial of the transdiagnostic program at SickKids among families following neonatal medical illness/injury, an important cause of early behaviour and emotional regulation issues, with promising implementation outcomes and preliminary indices of improvement in child behaviour and parent stress.15 In this study, approximately 69% of eligible families contacted consented; and 86% enrolled completed the 7-session program. Parents and therapists reported high overall satisfaction with the program (100%), including acceptability of both the online modules (95%) and the videoconference sessions (95%). Child behaviour (d=0.50, See Figure 1) and parenting confidence and skill (d = 0.45, 0.64) also improved. Among participants who did not complete the program, families cited lack of time as the number one barrier to participation. This stepped care approach directly addresses this concern by matching mental health services to the needs of families.
The current study leverages an existing evidenced-based virtual program (I-InTERACT-North) that contains key components to address stress and child behaviour concerns within a stepped-care model: 1) general psychoeducation regarding the impact of medical diagnosis on children and families, and 2) graduated intensity in coaching of parenting strategies that foster responsiveness, warmth and consistency in the home. These two components have longstanding effectiveness in optimizing child behavior and reducing parental distress.
Study Purpose and Objectives 2.1 Primary Objectives
1. To evaluate whether a stepped-care adaptation of I-InTERACT-North can be implemented as planned, measuring fidelity, acceptability, and engagement.
2. To assess accrual and dropout rates at each step.
3. To investigate program fidelity between our site and the main intervention site
4. To examine participant and care provider perceptions regarding intervention acceptability and satisfaction.
5. To evaluate the relationship between parent and child needs, key social demographic factors and program participation
Secondary Objectives
1) To measure the association between pre-and post-intervention short-term child behaviour and parent stress outcomes, parent responsivity and behavioural management skills, with hypothesized greater improvement following higher steps of engagement.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 20
- Consent provided
- parent of a child aged 3 to 9 years,
- parent reported concerns regarding their child's externalizing behaviour
- child is followed in cardiology clinic at Alberta Children's Hospital.
- parent is able to speak and read English.
- Child is outside of age range of the program (<3 or > 9 years of age)
- Significant major medical issues requiring ongoing inpatient care
- Currently participating in an equivalent family/parent therapy program (e.g., Incredible Years Parenting Program (IYPP), Positive Parenting Program (Triple P))
- Inability to read/write and communicate in English
- Inability to consent or complete study measures electronically (online)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Accrual Rate 56 weeks from first participant contact the proportion of invited participants who consent to participate
Dropout Rate 70 weeks after contacting first participant the proportion of participants who drop out of the study during Step 1, 2 or 3
Fidelity: 70 weeks after contacting first participant the proportion of content covered from therapy protocols and questionnaires completed;
Acceptability & Satisfaction 70 weeks after first participant contact the proportion of participants and therapists who rate the program as satisfactory or very satisfactory based on post-intervention; dropouts considered not-satisfied
Engagement & Adherence: 70 weeks after first participant contact the amount of time (in hours/weeks) to complete intervention steps will be estimated by parents and therapists (for steps 2 and 3), the number of sessions completed an adherence index (sessions completed/total sessions scheduled)
- Secondary Outcome Measures
Name Time Method Child behavior concerns and intensity baseline 1 day after signing consent Child behavior concerns and intensity will be measured using the Eyberg Child Behavior Inventory (ECBI), a 36-item checklist of mental health concerns. Following Step 1, reported elevated scores (T score\>60) will be considered at-risk.
Parental stress baseline 1 day after signing consent The Depression Anxiety and Stress Scale Short Form (DASS-21) will measure general distress in parents, with three subscales (depression, anxiety, and stress) with strong internal consistency, adequate construct validity and sensitivity to parent therapy; using cut-off scores of 60 for step 2
Child behavior at end of study up to 25 weeks after signing consent ECBI will be used to measure child behavior concerns
Parent stress end of study up to 25 weeks after signing consent DASS-21 will be used to measure parent stress