Online Support 4 CHD Kids & Caregivers
ConditionCongenital Heart Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-9
SponsorThe Hospital for Sick Children
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
I-InTERACT-North
BehavioralI-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.
Treatment groups
382 Participants
are divided into 2 treatment groupsGroup A: I-InTERACT-NorthExperimental treatment 1 intervention
Group B: Care as UsualNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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).
Time frame
Baseline, 3 months, 6 months, and 12 months2
Child Behaviour
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 monthsSecondary outcomes
1
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.
Time frame
Baseline, 3 months, 6 months, and 12 months2
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.
Time frame
Baseline, 3 months, 6 months, and 12 months3
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.
Time frame
Baseline, 3 months, 6 months, and 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
The Hospital for Sick Children
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
Source ClinicalTrials.gov