Congenital Heart Disease (CHD)NCT06659302
Feasibility of a Virtual Mental Health Intervention for Children with Congenital Heart Disease
A study testing I-inTERACT North Step 1, I-inTERACT North step 2 and I-inTERACT North in people with Congenital Heart Disease (CHD), run by University of Calgary.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Congenital Heart Disease (CHD)
- What is being tested?
- I-inTERACT North Step 1, I-inTERACT North step 2 and I-inTERACT North
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluating the Feasibility of a Virtual Stepped Mental Health Care Intervention for Children with Congenital Heart Disease
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.
Read the 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
- To evaluate whether a stepped-care adaptation of I-InTERACT-North can be implemented as planned, measuring fidelity, acceptability, and engagement.
- To assess accrual and dropout rates at each step.
- To investigate program fidelity between our site and the main intervention site
- To examine participant and care provider perceptions regarding intervention acceptability and satisfaction.
- To evaluate the relationship between parent and child needs, key social demographic factors and program participation
Secondary Objectives
- 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.
- Conditions
- Congenital Heart Disease (CHD)
- Being tested
- I-inTERACT North Step 1, I-inTERACT North step 2, I-inTERACT North
- Keywords
- heart, CHD, behavior, family stress
- Medical subject headings
- Heart Defects, Congenital, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-inTERACT North Step 1Behavioural
Initial questionnaires completed followed by initial meeting with therapist for baseline evaluation.
I-inTERACT North step 2Behavioural
Two online modules completed by family plus two online zoom coaching sessions with therapist.
I-inTERACT NorthBehavioural
Full program will consist of an additional 5 sessions with online modules and virtual coaching sessions with therapist.
| Study group | Role | What they receive |
|---|---|---|
| Intro meeting | Experimental | Participants will be sent baseline questionnaires online through REDCap (Research Electronic Data Capture; see Appendix 1-email templates), a secure web application, and housed on a secure server. Participants will access a unique REDCap survey link via email to complete questionnaire measures after consenting to the study. After completion of the baseline questionnaires, participants will be connected with an I-InTERACT-North therapist for an Introductory Meeting to conduct a baseline elevation session. If participants do not wish to enroll in the full program, post-intervention questionnaires will be administered online through REDCap post step 1. If they wish to proceed to the full program, they will complete the questionnaires after step 2 or 3. Receives: Behavioral: I-inTERACT North Step 1 |
| Two sessions | Experimental | Step 2: Parents who were identified as high stress/behaviour on the baseline questionnaires and/or based on the introduction meeting in Step 1, will be invited to participate in the initial two therapist-guided I-InTERACT-North sessions that focus on family stress and positive parenting strategies. Each session includes both an online psychoeducational module and a video conferencing session with a therapist. Session frequency is subject to change based on parent schedule preference and availability. Each session will last 60 minutes and will be video recorded (with consent from the participants). Sessions will be delivered to parents using Zoom, a secure online video conferencing platform (https://zoom.us/). If they wish to proceed to the full program, they will complete the questionnaires after step 3. Receives: Behavioral: I-inTERACT North step 2 |
| Full Program | Experimental | Step 3: Families will be invited to participate in the full I-InTERACT-North program. The full program will provide an additional 5 online modules with live therapist videoconference coaching sessions. All sessions are strongly encouraged but for parents who do not complete the additional sessions, we will track what is completed and parents may still complete outcome measures. Based on previous work, average time of completion for the full program is 8-12 weeks. Each session will last 60 minutes and will be video recorded (with consent from the participants). Sessions will be delivered to parents using Zoom, a secure online video conferencing platform (https://zoom.us/). Before each session, parents will receive a meeting invitation link via email. After completing the program, participants will complete online questionnaires through REDCap. All participants will be invited to complete study follow-up questionnaires. Receives: Behavioral: I-inTERACT North |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accrual Rate
the proportion of invited participants who consent to participate
Measured: 56 weeks from first participant contact
Dropout Rate
the proportion of participants who drop out of the study during Step 1, 2 or 3
Measured: 70 weeks after contacting first participant
Fidelity:
the proportion of content covered from therapy protocols and questionnaires completed;
Measured: 70 weeks after contacting first participant
Acceptability & Satisfaction
the proportion of participants and therapists who rate the program as satisfactory or very satisfactory based on post-intervention; dropouts considered not-satisfied
Measured: 70 weeks after first participant contact
Engagement & Adherence:
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)
Measured: 70 weeks after first participant contact
Secondary outcomes (4)
Child behavior concerns and intensity baseline
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.
Measured: 1 day after signing consent
Parental stress baseline
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
Measured: 1 day after signing consent
Child behavior at end of study
ECBI will be used to measure child behavior concerns
Measured: up to 25 weeks after signing consent
Parent stress end of study
DASS-21 will be used to measure parent stress
Measured: up to 25 weeks after signing consent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start15 Dec 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart Disease (CHD)Studies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- The Hospital for Sick Children, Alberta Children's Hospital
- Responsible party
- Principal investigator, Marsha Vasserman, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06659302
- Sponsor's protocol ID
- REB24-1232
- Status last verified
- Oct 2024
- First submitted
- 21 Oct 2024
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: deidentified fidelity data related to program implementation will be shared with Hospital for Sick Kids in Toronto who will be providing program support and supervision.
Publications
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.
PubMed 33028141Wiggins 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.
PubMed 19930436Masten 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.
PubMed 10208360Antonini 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.
PubMed 24912459Cohen 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.
PubMed 28979968
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Feasibility of a Virtual Stepped Mental Health Care Intervention for Children with Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT06659302
- Acronym / sponsor ID
- REB24-1232
- Conditions
- Congenital Heart Disease (CHD)
- Keywords
- heart, CHD, behavior, family stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- The Hospital for Sick Children, Alberta Children's Hospital
- Study start
- 15 Dec 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Oct 2024 (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.
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
- To evaluate whether a stepped-care adaptation of I-InTERACT-North can be implemented as planned, measuring fidelity, acceptability, and engagement.
- To assess accrual and dropout rates at each step.
- To investigate program fidelity between our site and the main intervention site
- To examine participant and care provider perceptions regarding intervention acceptability and satisfaction.
- To evaluate the relationship between parent and child needs, key social demographic factors and program participation
Secondary Objectives
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intro meeting | Experimental | Behavioral: I-inTERACT North Step 1Participants will be sent baseline questionnaires online through REDCap (Research Electronic Data Capture; see Appendix 1-email templates), a secure web application, and housed on a secure server. Participants will access a unique REDCap survey link via email to complete questionnaire measures after consenting to the study. After completion of the baseline questionnaires, participants will be connected with an I-InTERACT-North therapist for an Introductory Meeting to conduct a baseline elevation session. If participants do not wish to enroll in the full program, post-intervention questionnaires will be administered online through REDCap post step 1. If they wish to proceed to the full program, they will complete the questionnaires after step 2 or 3. |
| Two sessions | Experimental | Behavioral: I-inTERACT North step 2Step 2: Parents who were identified as high stress/behaviour on the baseline questionnaires and/or based on the introduction meeting in Step 1, will be invited to participate in the initial two therapist-guided I-InTERACT-North sessions that focus on family stress and positive parenting strategies. Each session includes both an online psychoeducational module and a video conferencing session with a therapist. Session frequency is subject to change based on parent schedule preference and availability. Each session will last 60 minutes and will be video recorded (with consent from the participants). Sessions will be delivered to parents using Zoom, a secure online video conferencing platform (https://zoom.us/). If they wish to proceed to the full program, they will complete the questionnaires after step 3. |
| Full Program | Experimental | Behavioral: I-inTERACT NorthStep 3: Families will be invited to participate in the full I-InTERACT-North program. The full program will provide an additional 5 online modules with live therapist videoconference coaching sessions. All sessions are strongly encouraged but for parents who do not complete the additional sessions, we will track what is completed and parents may still complete outcome measures. Based on previous work, average time of completion for the full program is 8-12 weeks. Each session will last 60 minutes and will be video recorded (with consent from the participants). Sessions will be delivered to parents using Zoom, a secure online video conferencing platform (https://zoom.us/). Before each session, parents will receive a meeting invitation link via email. After completing the program, participants will complete online questionnaires through REDCap. All participants will be invited to complete study follow-up questionnaires. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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)
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 North Step 1Initial questionnaires completed followed by initial meeting with therapist for baseline evaluation. | Behavioural | Intro meeting |
| I-inTERACT North step 2Two online modules completed by family plus two online zoom coaching sessions with therapist. | Behavioural | Two sessions |
| I-inTERACT NorthFull program will consist of an additional 5 sessions with online modules and virtual coaching sessions with therapist. | Behavioural | Full Program |
Primary outcome
Accrual Rate
Time frame: 56 weeks from first participant contact
the proportion of invited participants who consent to participate
Dropout Rate
Time frame: 70 weeks after contacting first participant
the proportion of participants who drop out of the study during Step 1, 2 or 3
Fidelity:
Time frame: 70 weeks after contacting first participant
the proportion of content covered from therapy protocols and questionnaires completed;
Acceptability & Satisfaction
Time frame: 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:
Time frame: 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)
4 secondary outcomes
Child behavior concerns and intensity baseline
Time frame: 1 day after signing consent
Parental stress baseline
Time frame: 1 day after signing consent
Child behavior at end of study
Time frame: up to 25 weeks after signing consent
Parent stress end of study
Time frame: up to 25 weeks after signing consent
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Background: PubMed 33028141Burek 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.
- Background: PubMed 19930436Wiggins 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.
- Background: PubMed 10208360Masten 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.
- Background: PubMed 24912459Antonini 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.
- Background: PubMed 28979968Cohen 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.
- Individual participant dataSharing planned: Yes. deidentified fidelity data related to program implementation will be shared with Hospital for Sick Kids in Toronto who will be providing program support and supervision.
Related trials for Congenital Heart Disease (CHD)
Not yet recruiting
Autologous Thymus Transplant in Children With Congenital Heart Disease: A Pilot Study
Congenital Heart Disease (CHD)
Active, not recruiting
Learning by Heart: The Effectiveness of an EF Training Program for Pre-schoolers With Critical CHD
Congenital Heart Disease, Executive Dysfunction
Not yet recruiting
UltraTrac for Cardiac Output Monitoring in Congenital Heart Disease
Congenital Heart Disease, Cardiac Output
RecruitingPhase 1/2
Butyric Acid Supplementation for Gut Improvement After Cardiac Surgery in Kids
Congenital Heart Disease (CHD)
Not yet recruiting
Starry-Sky Projection and Maternal Voice for Sleep After Pediatric Cardiac Surgery
Congenital Heart Disease (CHD), Postoperative Sleep
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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing I-inTERACT North Step 1, I-inTERACT North step 2 and I-inTERACT North in people with Congenital Heart Disease (CHD), run by University of Calgary.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marsha Vasserman, Psy.D. (403-955-5048, marsha.vasserman@ahs.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accrual Rate (time frame: 56 weeks from first participant contact). The study lists 5 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 NCT06659302, which also lists 5 linked publications.
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 26 Oct 2024.