Congenital Heart DiseaseNCT06075251
Online Support 4 CHD Kids & Caregivers
A study testing I-InTERACT-North in people with Congenital Heart Disease, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 3 to 9 years
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- I-InTERACT-North
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 382 participants
- Where
- 1 siteCanada
- Study dates
- 15 Feb 2024to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parent of a child aged 3 to 9 years with history of congenital heart disease
- Parent of a patient at The Hospital for Sick Children (SickKids)
- Resident of Ontario, Canada
Who cannot join
- Significant major medical issues requiring ongoing inpatient care (e.g., children participating in significant surgical or inpatient treatment)
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Marin M Taylor contact
Canada1 site, 1 recruiting
- Recruiting
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Marin Taylor
Tricia Williams, PhD, C.Psych, ABPP
About this study
Official title: Stepped-Care Online Parent Support Following Congenital Heart Disease: A Randomized Control 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.
Read the detailed description
The proposed Hybrid Type 1 study is a single-site, two-arm single blinded randomized clinical trial (RCT) designed to simultaneously assess: 1) efficacy of the stepped care I-InTERACT-North program in improving positive parenting skills and child behaviour among families of children with Congenital Heart Disease (CHD) and 2) feasibility and acceptability outcomes (i.e., adherence, fidelity, costs and acceptability). Our primary aim is to determine the efficacy of the I-InTERACT-North stepped-care program compared to care as usual in improving positive parenting skills (primary outcome) and reducing child emotional and behavioural problems (co-primary outcome) among CHD children. Our secondary aim is to examine feasibility and acceptability of the stepped-care program among key stakeholders (parents, therapists, medical providers). Our exploratory aim is to examine the association between neonatal white matter injury severity on treatment and implementation outcomes.
The study population will be parents of children currently ages 3 to 9 with histories of Congenital Heart Disease and are part of existing research cohorts (Cardiovascular Physiology and Brain Development in Neonates with Congenital Heart Disease; Pediatric Cardiac and Neurological Registry at SickKids) and have consented to be contacted for future studies.
I-InTERACT-North is an evidenced-based virtual parenting skills training program, which emphasizes building a warm, responsive relationship between parent and child and establishing guidelines for consistent behaviour management. It also provides education on the effects of medical conditions on children's learning and behaviour. The stepped-care program provides three steps that sequentially increase therapy content and degree of therapist involvement, (1) Psychoeducation-Podcast, (2) Intro to Positive Parenting (2 coaching sessions), and (3) Full Program (5 coaching sessions). Coaching sessions are offered via videoconference weekly or biweekly based on parent availability.
A care as usual (CAU) was chosen as the optimal comparator given its alignment with the primary research question, and consistent with prior studies of the program. 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, the CAU will be offered the program.
All consenting participants will complete baseline questionnaires. Following consent and completion of baseline measures (therefore hidden allocation), participants will be randomized by a research coordinator independent of our intervention team. Randomization will be balanced by 1) child sex assigned at birth, and 2) baseline child behaviour concern intensity (based on median split grouping; pilot study ECBI median t-score =60.00). All participants will complete follow-up questionnaires at 3 months, 6 months, and 12 months post-randomization.
- Conditions
- Congenital Heart Disease
- Being tested
- I-InTERACT-North
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-InTERACT-NorthBehavioural
I-InTERACT-North is a virtual stepped-care positive parenting program. It comprises online psychoeducational modules as well as live therapy and coaching sessions. The program lasts anywhere from 1 to 16 weeks depending on parents' progress.
| Study group | Role | What they receive |
|---|---|---|
| I-InTERACT-North | Experimental | Virtual stepped-care positive parenting program. Receives: Behavioral: I-InTERACT-North |
| Care as Usual | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive Parenting Skills
The primary proximal outcome will be positive parenting skills assessed through blinded (to allocation and follow up interval) coding of recorded parent-child interactions, using the Dyadic Parent-Child Interaction Coding System (DPICS). The DPICS will be used to rate positive parenting behaviors (e.g. praise, responsiveness, and enthusiasm). The DPICS is analyzed by independent blinded coders (to condition and time) observe and code parent-child interactions (5 minutes) for positive parenting behaviours (e.g., praise, responsiveness and enthusiasm).
Measured: Baseline, 3 months, 6 months, and 12 months
Child Behaviour
The Eyberg Child Behavior Inventory (ECBI), is a parent rated 36-item checklist of concerns (e.g., noncompliance, emotional regulation).
Measured: Baseline, 3 months, 6 months, and 12 months
Secondary outcomes (3)
Quality of Life
Parent reports of their child and family's Quality of Life (QoL) will be evaluated with EuroQol 5 Dimensions 5 Levels questionnaire (EQ5D-5L), previously used in the context of parent stress with favourable psychometric properties, and items related to child internalizing symptoms, i.e., anxiety/ depression, self-care and daily activities.
Measured: Baseline, 3 months, 6 months, and 12 months
Parent Mental Health
The Depression Anxiety and Stress Scale Short Form (DASS-21) is a self-report measure of mental health and includes three subscales (depression, anxiety, and stress). Parents rate a series of 21 statements describing depression, anxiety, and stress on a scale of 0 to 3. Higher scores on the DASS indicate greater mental health concerns.
Measured: Baseline, 3 months, 6 months, and 12 months
Service Utilisation
The Client Services Receipt Inventory (CSRI) includes questions for parents regarding the child and family's use of mental health, community rehabilitation, neuropsychology, and educational psychology services as well as paid and unpaid caregiver time and time off work.
Measured: Baseline, 3 months, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start15 Feb 2024
- Primary completion30 Aug 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a single-site, two-arm randomized clinical trial. Families will be randomized to receive care as usual or active I-InTERACT-North stepped-care treatment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 382 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Tricia Williams, The Hospital for Sick Children
- Investigators
- Tricia S Williams, PhD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06075251
- Sponsor's protocol ID
- 1000080752
- Status last verified
- Apr 2026
- First submitted
- 3 Oct 2023
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Taylor M, Bondi BC, Andrade BF, Au-Young SH, Chau V, Danguecan A, Desire N, Guo T, Ostojic-Aitkens D, Wade S, Miller S, Williams TS. Stepped-Care Web-Based Parent Support Following Congenital Heart Disease: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Oct 4;13:e64216. doi: 10.2196/64216.
PubMed 39365658
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stepped-Care Online Parent Support Following Congenital Heart Disease: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06075251
- Acronym / sponsor ID
- 1000080752
- Conditions
- Congenital Heart Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 382 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 30 Aug 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The proposed Hybrid Type 1 study is a single-site, two-arm single blinded randomized clinical trial (RCT) designed to simultaneously assess: 1) efficacy of the stepped care I-InTERACT-North program in improving positive parenting skills and child behaviour among families of children with Congenital Heart Disease (CHD) and 2) feasibility and acceptability outcomes (i.e., adherence, fidelity, costs and acceptability). Our primary aim is to determine the efficacy of the I-InTERACT-North stepped-care program compared to care as usual in improving positive parenting skills (primary outcome) and reducing child emotional and behavioural problems (co-primary outcome) among CHD children. Our secondary aim is to examine feasibility and acceptability of the stepped-care program among key stakeholders (parents, therapists, medical providers). Our exploratory aim is to examine the association between neonatal white matter injury severity on treatment and implementation outcomes.
The study population will be parents of children currently ages 3 to 9 with histories of Congenital Heart Disease and are part of existing research cohorts (Cardiovascular Physiology and Brain Development in Neonates with Congenital Heart Disease; Pediatric Cardiac and Neurological Registry at SickKids) and have consented to be contacted for future studies.
I-InTERACT-North is an evidenced-based virtual parenting skills training program, which emphasizes building a warm, responsive relationship between parent and child and establishing guidelines for consistent behaviour management. It also provides education on the effects of medical conditions on children's learning and behaviour. The stepped-care program provides three steps that sequentially increase therapy content and degree of therapist involvement, (1) Psychoeducation-Podcast, (2) Intro to Positive Parenting (2 coaching sessions), and (3) Full Program (5 coaching sessions). Coaching sessions are offered via videoconference weekly or biweekly based on parent availability.
A care as usual (CAU) was chosen as the optimal comparator given its alignment with the primary research question, and consistent with prior studies of the program. 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, the CAU will be offered the program.
All consenting participants will complete baseline questionnaires. Following consent and completion of baseline measures (therefore hidden allocation), participants will be randomized by a research coordinator independent of our intervention team. Randomization will be balanced by 1) child sex assigned at birth, and 2) baseline child behaviour concern intensity (based on median split grouping; pilot study ECBI median t-score =60.00). All participants will complete follow-up questionnaires at 3 months, 6 months, and 12 months post-randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a single-site, two-arm randomized clinical trial. Families will be randomized to receive care as usual or active I-InTERACT-North stepped-care treatment.
| Arm | Type | Receives |
|---|---|---|
| I-InTERACT-North | Experimental | Behavioral: I-InTERACT-NorthVirtual stepped-care positive parenting program. |
| Care as Usual | No 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. |
Who may qualify
- Ages
- 3 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Parent of a child aged 3 to 9 years with history of congenital heart disease
- Parent of a patient at The Hospital for Sick Children (SickKids)
- Resident of Ontario, Canada
Key exclusion criteria (3 listed)
- Significant major medical issues requiring ongoing inpatient care (e.g., children participating in significant surgical or inpatient treatment)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| I-InTERACT-NorthI-InTERACT-North is a virtual stepped-care positive parenting program. It comprises online psychoeducational modules as well as live therapy and coaching sessions. The program lasts anywhere from 1 to 16 weeks depending on parents' progress. | Behavioural | I-InTERACT-North |
Primary outcome
Positive Parenting Skills
Time frame: Baseline, 3 months, 6 months, and 12 months
The primary proximal outcome will be positive parenting skills assessed through blinded (to allocation and follow up interval) coding of recorded parent-child interactions, using the Dyadic Parent-Child Interaction Coding System (DPICS). The DPICS will be used to rate positive parenting behaviors (e.g. praise, responsiveness, and enthusiasm). The DPICS is analyzed by independent blinded coders (to condition and time) observe and code parent-child interactions (5 minutes) for positive parenting behaviours (e.g., praise, responsiveness and enthusiasm).
Child Behaviour
Time frame: Baseline, 3 months, 6 months, and 12 months
The Eyberg Child Behavior Inventory (ECBI), is a parent rated 36-item checklist of concerns (e.g., noncompliance, emotional regulation).
3 secondary outcomes
Quality of Life
Time frame: Baseline, 3 months, 6 months, and 12 months
Parent Mental Health
Time frame: Baseline, 3 months, 6 months, and 12 months
Service Utilisation
Time frame: Baseline, 3 months, 6 months, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Derived from this study: PubMed 39365658Taylor M, Bondi BC, Andrade BF, Au-Young SH, Chau V, Danguecan A, Desire N, Guo T, Ostojic-Aitkens D, Wade S, Miller S, Williams TS. Stepped-Care Web-Based Parent Support Following Congenital Heart Disease: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Oct 4;13:e64216. doi: 10.2196/64216.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marin M Taylor contact
Tricia S Williams, PhD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I-InTERACT-North in people with Congenital Heart Disease, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tricia S Williams, PhD (416 813 8507, tricia.williams@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive Parenting Skills (time frame: Baseline, 3 months, 6 months, and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06075251, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.