Online Support for Families with Heart Disease

Overseen By Marin M Taylor

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: The Hospital for Sick Children

Disqualifiers: Major medical issues, Current family therapy, Previous pilot study, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

382 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a virtual program called I-InTERACT-North to determine if it can help parents improve their skills and positively influence their child's behavior. It targets families with children aged 3 to 9 born with congenital heart disease (a heart condition present at birth). The study aims to assess the program's usefulness and ease of use for these families. Ideal participants are parents of children with this condition who are patients at SickKids in Ontario. As an unphased trial, this study provides families the chance to contribute to innovative research that could enhance support for children with congenital heart disease.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on a mental health program for parents, so it's unlikely that medication changes are required.

What prior data suggests that the I-InTERACT-North program is safe for families with children born with Congenital Heart Disease?

Research has shown that the I-InTERACT-North program is a well-received online tool for helping parents. This virtual program aims to improve parenting skills and child behavior. By focusing on behavior without using medication or physical treatments, it is generally safe.

The program's main goal is to support parents through online resources. No reports of negative effects have emerged from using the program, suggesting it is safe for families. Overall, it appears to be a promising option for families seeking to enhance parenting skills and support children with congenital heart disease, a condition present at birth that affects the heart. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the I-InTERACT-North program because it offers a new way to support families dealing with heart disease through a virtual positive parenting approach. Unlike standard care, which typically includes only routine clinical follow-ups and assessments, I-InTERACT-North provides an interactive, stepped-care method that focuses on enhancing parenting skills to improve family dynamics and potentially the child's health outcomes. This approach takes advantage of online platforms, making it more accessible and convenient for families compared to traditional in-person support methods.

What evidence suggests that I-InTERACT-North is effective for improving parenting and child behaviour in families with children born with CHD?

Research has shown that I-InTERACT-North, which participants in this trial may receive, can improve parenting skills and reduce behavior problems in children. Studies have found that this online program teaches parents positive parenting techniques and helps manage stress, common in families with children who have congenital heart disease (CHD). Families using the program have reported improvements in interactions and children's behavior. These results suggest that I-InTERACT-North could be a helpful tool for families with children who have CHD. ^{1 3 4 6 7}

Who Is on the Research Team?

Tricia S Williams, PhD

Principal Investigator

The Hospital for Sick Children

Are You a Good Fit for This Trial?

This trial is for parents of children aged 3-9 with congenital heart disease (CHD) who are patients at SickKids Hospital in Ontario, Canada. It aims to help these families by improving parenting skills and child behavior.

Inclusion Criteria

I am a parent of a child aged 3-9 with congenital heart disease.

Parent of a patient at The Hospital for Sick Children (SickKids)

Resident of Ontario, Canada

Exclusion Criteria

Current participation in an equivalent family/parent therapy program (e.g., Incredible Years Parenting Program (IYPP), Positive Parenting Program (Triple P))

Previous participation in an I-InTERACT-North pilot study

I am currently hospitalized for a major medical issue.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline questionnaires and are randomized

1 week

1 visit (virtual)

Treatment

Participants receive the I-InTERACT-North virtual stepped-care positive parenting program

12 weeks

Weekly or biweekly coaching sessions (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Follow-up questionnaires at 3, 6, and 12 months post-randomization

What Are the Treatments Tested in This Trial?

Interventions

• I-InTERACT-North

Trial Overview

The I-InTERACT-North program, a virtual mental health intervention for parents, is being tested to see if it can enhance positive parenting and improve child behavior among CHD affected families.

How Is the Trial Designed?

Group I: I-InTERACT-North Experimental Treatment 1 Intervention

Virtual stepped-care positive parenting program.

Group II: Care as Usual Active Control 1 Intervention

The CAU group will receive no direct parent treatment other than clinical care provided in cardiac follow-up (i.e., child assessment and consultation), which will be documented at each follow up. At end of trial, participants randomized to CAU will have the option to participate in I-InTERACT-North.

I-InTERACT-North is already approved in Canada for the following indications:

Approved in Canada as I-InTERACT-North for:

• Congenital Heart Disease (CHD)
• Neurodevelopmental Disorders
• Behavioral Concerns

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials

724

Recruited

6,969,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Published Research Related to This Trial

The Caring Connection Web site is being developed as a tailored online resource for caregivers of children with cancer, aiming to meet their specific information and communication needs.

Preliminary surveys and user testing indicate that both family caregivers and oncology healthcare providers find the prototype feasible and usable, highlighting its potential to improve access to vital health information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caring connection: developing an Internet resource for family caregivers of children with cancer. Lewis, D., Gunawardena, S., El Saadawi, G.[2019]

The study involved 38 participants, including 15 mothers, 12 fathers, and 11 children, and found that an evidence-based website for families of children with cancer received very high favorability ratings, especially from mothers.

While not statistically significant, there was a positive trend in mothers' evaluations of cancer communication after using the website, suggesting it may enhance cancer knowledge and improve family management of the situation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of a web-based educational and support intervention on parents' perception of their children's cancer quality of life: an exploratory study. Sigurdardottir, AO., Svavarsdottir, EK., Rayens, MK., et al.[2014]

Families of children and adolescents with chronic diseases can benefit from a wide range of online information, which supports them in managing care effectively.

However, there are weaknesses in the use of online information that need to be critically evaluated, highlighting the importance of discerning reliable sources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online information as support to the families of children and adolescents with chronic disease. Mazza, VA., Lima, VF., Carvalho, AKDS., et al.[2022]

The study surveyed 114 primary caregivers of children with special health care needs and found that most participants not only met their expectations from Internet Parent Support Groups (IPSGs) but also gained additional insights and trust from the community.

Improved relationships between caregivers and their children were the strongest factor linked to satisfaction with IPSGs, suggesting that these groups could be a valuable resource for social support in caregiving.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet parent support groups for primary caregivers of a child with special health care needs. Baum, LS.[2019]

A 4-month telehealth home monitoring program (REACH) added to usual care did not improve parenting stress, PTSD symptoms, or quality of life for parents of infants recovering from cardiac surgery, as shown in a study of 219 parent-infant dyads.

Infant growth was suboptimal in both groups, and the intervention group had a higher rate of hospital readmissions (66% vs. 57%), indicating that the REACH program did not enhance postdischarge outcomes for infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth Home Monitoring and Postcardiac Surgery for Congenital Heart Disease. Medoff Cooper, B., Marino, BS., Fleck, DA., et al.[2021]

Participation in a pediatric online support network provided hospitalized children with enjoyment, education, and social connection, helping them cope with their illness.

Barriers to accessing the network included limited computer availability and discomfort with online interactions, highlighting the need for improved access and support for these resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceptions of online support for hospitalized children and adolescents. Nicholas, DB., Darch, J., McNeill, T., et al.[2007]

A study involving 296 parents at a children's hospital showed that an inpatient portal application significantly improved parent satisfaction, with 90% of respondents finding it easy to use and 94% believing it enhanced care.

The portal facilitated better communication with healthcare teams, with 60% of parents reporting improved interactions, and 89% felt it helped reduce errors in care, particularly in monitoring medication lists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using an inpatient portal to engage families in pediatric hospital care. Kelly, MM., Hoonakker, PL., Dean, SM.[2022]

The 'Caring Connection' web-based resource was developed to meet the specific information and communication needs of family caregivers of children with cancer, providing individualized clinical information and facilitating communication.

Structured interviews with caregivers revealed insights into their internet usage and information needs, which were further supported by website server logs, indicating the resource's relevance and potential impact on caregiver support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caring Connection: Internet resources for family caregivers of children with cancer. Lewis, D., Cooper, J., Gunawardena, S.[2019]

The I-InTERACT telehealth intervention aims to enhance positive parenting skills for parents of children aged 3-9 who have experienced a traumatic brain injury, with a focus on live skills practice and coaching.

This study represents a significant effort as one of the first large multi-site randomized controlled trials to evaluate the effectiveness of a parenting intervention in this context, with expectations of improved parenting behaviors and reduced child behavior problems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-based Interacting Together Everyday, Recovery After Childhood TBI (I-InTERACT): Protocol for a multi-site randomized controlled trial of an internet-based parenting intervention. Narad, ME., Taylor, HG., Yeates, KO., et al.[2022]

The 'Caring Connection' is a web-based resource aimed at supporting caregivers of children with cancer by providing personalized clinical information and facilitating communication between families and healthcare providers.

Insights from structured interviews with caregivers and healthcare providers, along with user testing of the website prototype, are guiding the ongoing development to ensure it meets the specific information needs of families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caring Connection: developing an Internet resource for family caregivers of children with cancer. Lewis, D., Gunawardena, S., Harrison, JH., et al.[2016]

The co-design process for an online support program involved 32 informal caregivers and 25 content creators, resulting in a comprehensive program with 15 modules tailored to the needs of caregivers for people with heart failure.

This approach emphasizes the importance of including end users in healthcare intervention design, aligning with person-centered care principles and potentially improving caregivers' self-care abilities while addressing resource limitations in healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The co-design of an online support programme with and for informal carers of people with heart failure: A methodological paper. Allemann, H., Andréasson, F., Hanson, E., et al.[2023]

A pilot study involving 8 families with a child diagnosed with cancer showed that videotelephone-based support over three months was feasible and well-received, with families expressing high satisfaction with the service.

The hybrid approach used for videotelephony, combining home computers and telephone lines, proved to be a cost-effective solution compared to previous custom-made devices, with minimal technical issues reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of videotelephone-based support for newly diagnosed paediatric oncology patients and their families. Bensink, M., Armfield, N., Irving, H., et al.[2019]

eHealth tools are desired by parents of high-risk newborns in the NICU and can significantly enhance their experience by improving communication and education, leading to greater confidence in infant care.

The use of eHealth is associated with positive outcomes for both parents and infants, including increased parental satisfaction and knowledge, although the actual impact on the length of the infant's hospital stay was not clearly defined in the studies reviewed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Parent-Targeted eHealth on Parent and Infant Health Outcomes: A Scoping Review. Anwar Siani, S., Dol, J., Campbell-Yeo, M.[2019]

The CHF-CePPORT e-Counseling platform was found to be user-friendly and well-received by participants, with positive feedback on its content and layout, which helped them manage their chronic heart failure (CHF).

After initial navigation issues were addressed by redesigning the website, participants experienced significantly fewer errors, indicating that a clear navigation structure is crucial for enhancing user experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability Testing of an Internet-Based e-Counseling Platform for Adults With Chronic Heart Failure. Payne, AY., Surikova, J., Liu, S., et al.[2020]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39365658/

Stepped-Care Web-Based Parent Support Following ...

This study aims to test the effectiveness of I-InTERACT-North web-based stepped-care parent support in improving positive parenting skills and reducing child ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11489793/

Stepped-Care Web-Based Parent Support Following ...

This study aims to test the effectiveness of I-InTERACT-North in improving positive parenting skills and reducing child behavior problems in families of ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06659302

Feasibility of a Virtual Mental Health Intervention for ...

The current study leverages an existing evidenced-based virtual program (I-InTERACT-North) that contains key components to address stress and child behaviour ...

4.

researchgate.net

researchgate.net/publication/382811421_Stepped-care_online_parent_support_following_congenital_heart_disease_Protocol_for_a_randomized_control_trial_Preprint/download

(PDF) Stepped-care online parent support following congenital ...

Stepped-care online parent support ... Online Parent Training following Congenital. Heart Disease: A Randomized Control Trial. Page 3 ... problems (co-primary ...

5.

withpower.com

withpower.com/trial/phase-heart-diseases-9-2023-704da

Online Support for Families with Heart Disease

This study will evaluate a virtual mental health parenting stepped-care intervention (I-InTERACT-North) to determine if the program works to improve ...

6.

researchprotocols.org

researchprotocols.org/2024/1/e64216

Stepped-Care Web-Based Parent Support Following ...

This study aims to test the effectiveness of I-InTERACT-North web-based stepped-care parent support in improving positive parenting skills and reducing child ...

7.

lab.research.sickkids.ca

lab.research.sickkids.ca/neurooutcomes/research/

Research | NeuroOutcomes lab | SickKids

This study will evaluate the implementation of a stepped-care virtual parenting program (I-InTERACT-North) while observing and gathering ...