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Online Support 4 CHD Kids & Caregivers

Primary Purpose

Congenital Heart Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
I-InTERACT-North
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Heart Disease

Eligibility Criteria

3 Years - 9 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    I-InTERACT-North

    Care as Usual

    Arm Description

    Virtual stepped-care positive parenting 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, participants randomized to CAU will have the option to participate in I-InTERACT-North.

    Outcomes

    Primary Outcome Measures

    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).
    Child Behaviour
    The Eyberg Child Behavior Inventory (ECBI), is a parent rated 36-item checklist of concerns (e.g., noncompliance, emotional regulation).

    Secondary Outcome Measures

    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.
    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.
    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.

    Full Information

    First Posted
    October 3, 2023
    Last Updated
    October 10, 2023
    Sponsor
    The Hospital for Sick Children
    Collaborators
    Canadian Institutes of Health Research (CIHR)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06075251
    Brief Title
    Online Support 4 CHD Kids & Caregivers
    Official Title
    Stepped-Care Online Parent Support Following Congenital Heart Disease: A Randomized Control Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    August 30, 2028 (Anticipated)
    Study Completion Date
    December 31, 2028 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The Hospital for Sick Children
    Collaborators
    Canadian Institutes of Health Research (CIHR)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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). 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Congenital Heart Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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
    Outcomes Assessor
    Masking Description
    Outcomes assessors responsible for coding the primary outcome will be masked to condition. Due to the nature of the intervention (behavioural program), participants and care providers cannot be masked to condition.
    Allocation
    Randomized
    Enrollment
    382 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    I-InTERACT-North
    Arm Type
    Experimental
    Arm Description
    Virtual stepped-care positive parenting program.
    Arm Title
    Care as Usual
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    I-InTERACT-North
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Positive Parenting Skills
    Description
    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).
    Time Frame
    Baseline, 3 months, 6 months, and 12 months
    Title
    Child Behaviour
    Description
    The Eyberg Child Behavior Inventory (ECBI), is a parent rated 36-item checklist of concerns (e.g., noncompliance, emotional regulation).
    Time Frame
    Baseline, 3 months, 6 months, and 12 months
    Secondary Outcome Measure Information:
    Title
    Quality of Life
    Description
    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.
    Time Frame
    Baseline, 3 months, 6 months, and 12 months
    Title
    Parent Mental Health
    Description
    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.
    Time Frame
    Baseline, 3 months, 6 months, and 12 months
    Title
    Service Utilisation
    Description
    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.
    Time Frame
    Baseline, 3 months, 6 months, and 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Maximum Age & Unit of Time
    9 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tricia S Williams, PhD
    Phone
    416 813 8507
    Email
    tricia.williams@sickkids.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Marin M Taylor
    Email
    marin.taylor@sickkids.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tricia S Williams, PhD
    Organizational Affiliation
    The Hospital for Sick Children
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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