Clinical trial NCT06659302: Feasibility of a Virtual Mental Health Intervention for Children with Congenital Heart Disease
Official title: Evaluating the Feasibility of a Virtual Stepped Mental Health Care Intervention for Children with Congenital Heart Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Congenital Heart Disease (CHD)
Keywords: heart
CHD
behavior
family stress
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: The Hospital for Sick Children
name: Alberta Children's Hospital
First posted: 2024-10-26
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Accrual Rate
timeFrame: 56 weeks from first participant contact
measure: Dropout Rate
timeFrame: 70 weeks after contacting first participant
measure: Fidelity:
timeFrame: 70 weeks after contacting first participant
measure: Acceptability & Satisfaction
timeFrame: 70 weeks after first participant contact
measure: Engagement & Adherence:
timeFrame: 70 weeks after first participant contact
Secondary outcomes:
measure: Child behavior concerns and intensity baseline
timeFrame: 1 day after signing consent
measure: Parental stress baseline
timeFrame: 1 day after signing consent
measure: Child behavior at end of study
timeFrame: up to 25 weeks after signing consent
measure: Parent stress end of study
timeFrame: up to 25 weeks after signing consent
Other outcomes:
Locations:
Study officials:
References:
citation: Burek B, Ford MK, Hooper M, Green R, Kohut SA, Andrade BF, Ravi M, Sananes R, Desrocher M, Miller SP, Wade SL, Williams TS. Transdiagnostic feasibility trial of internet-based parenting intervention to reduce child behavioural difficulties associated with congenital and neonatal neurodevelopmental risk: introducing I-InTERACT-North. Clin Neuropsychol. 2021 Jul;35(5):1030-1052. doi: 10.1080/13854046.2020.1829071. Epub 2020 Oct 8.
citation: Wiggins TL, Sofronoff K, Sanders MR. Pathways Triple P-positive parenting program: effects on parent-child relationships and child behavior problems. Fam Process. 2009 Dec;48(4):517-30. doi: 10.1111/j.1545-5300.2009.01299.x.
citation: Masten AS, Hubbard JJ, Gest SD, Tellegen A, Garmezy N, Ramirez M. Competence in the context of adversity: pathways to resilience and maladaptation from childhood to late adolescence. Dev Psychopathol. 1999 Winter;11(1):143-69. doi: 10.1017/s0954579499001996.
citation: Antonini TN, Raj SP, Oberjohn KS, Cassedy A, Makoroff KL, Fouladi M, Wade SL. A pilot randomized trial of an online parenting skills program for pediatric traumatic brain injury: improvements in parenting and child behavior. Behav Ther. 2014 Jul;45(4):455-68. doi: 10.1016/j.beth.2014.02.003. Epub 2014 Feb 13.
citation: Cohen GH, Tamrakar S, Lowe S, Sampson L, Ettman C, Linas B, Ruggiero K, Galea S. Comparison of Simulated Treatment and Cost-effectiveness of a Stepped Care Case-Finding Intervention vs Usual Care for Posttraumatic Stress Disorder After a Natural Disaster. JAMA Psychiatry. 2017 Dec 1;74(12):1251-1258. doi: 10.1001/jamapsychiatry.2017.3037.