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

Trial Summary

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 data supports the effectiveness of the treatment I-InTERACT-North, I-InTERACT, Stepped-Care Web-Based Parent Support for families with heart disease?

Research on Internet Parent Support Groups (IPSGs) shows that caregivers often find more support and insight than expected, improving relationships and well-being. Additionally, eHealth tools have been shown to enhance parental confidence and satisfaction, suggesting that online support can be beneficial for families dealing with health challenges. ^{1 2 3 4 5}

Is the online support for families with heart disease safe?

The research on similar web-based support programs, like I-InTERACT and Caring Connection, suggests they are generally safe and well-received by users, with no reported safety concerns. ^{6 7 8 9 10}

How is the I-InTERACT-North treatment different from other treatments for heart disease?

I-InTERACT-North is unique because it provides online support specifically designed for families dealing with heart disease, focusing on improving caregiver relationships and offering a platform for social support, which is not typically addressed by standard heart disease treatments. ^{1 11 12 13 14}

What is the purpose of this trial?

This study will evaluate a virtual mental health parenting stepped-care intervention (I-InTERACT-North) to determine if the program works to improve positive parenting skills and child behaviour among families with children born with Congenital Heart Disease (CHD). Recruitment will target children ages 3-9 years old from SickKids. We will also evaluate the acceptability and feasibility of the program among children and families to inform future delivery and multi-site trials. Results will evaluate whether I-InTERACT-North can improve parenting and child behaviour in these families and inform future best clinical practices for this population.

Research Team

Tricia S Williams, PhD

Principal Investigator

The Hospital for Sick Children

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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 '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 '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 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]

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 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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. United States pubmed.ncbi.nlm.nih.gov

Telehealth Home Monitoring and Postcardiac Surgery for Congenital Heart Disease. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Impact of Parent-Targeted eHealth on Parent and Infant Health Outcomes: A Scoping Review. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Perceptions of online support for hospitalized children and adolescents. [2007]

5. England pubmed.ncbi.nlm.nih.gov

Using an inpatient portal to engage families in pediatric hospital care. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Caring connection: developing an Internet resource for family caregivers of children with cancer. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Caring Connection: Internet resources for family caregivers of children with cancer. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Caring Connection: developing an Internet resource for family caregivers of children with cancer. [2016]

9. United States 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. [2014]

10. United States 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. [2022]

11. England 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. [2023]

12. Brazil pubmed.ncbi.nlm.nih.gov

Online information as support to the families of children and adolescents with chronic disease. [2022]

13. Canada pubmed.ncbi.nlm.nih.gov

Usability Testing of an Internet-Based e-Counseling Platform for Adults With Chronic Heart Failure. [2020]

14. England pubmed.ncbi.nlm.nih.gov

A pilot study of videotelephone-based support for newly diagnosed paediatric oncology patients and their families. [2019]