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NCT06659302
Feasibility of a Virtual Mental Health Intervention for Children with Congenital Heart Disease
NA trial testing I-inTERACT North Step 1 in Congenital Heart Disease (CHD) in 20 participants. Not yet recruiting.
31 December 2025
Quick facts
| Lead sponsor | University of Calgary |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 15 December 2024 |
| Primary completion | 31 December 2025 |
| Estimated completion | 31 December 2025 |
Drugs / interventions tested
- I-inTERACT North Step 1
- I-inTERACT North step 2
- I-inTERACT North
Conditions studied
- Congenital Heart Disease (CHD) — all drugs for Congenital Heart Disease (CHD) →
Sponsor
University of Calgary
Who can join
Eligibility, any sex, with Congenital Heart Disease (CHD). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06659302
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Congenital Heart Disease (CHD)
Currently open trials in the same condition.
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- NCT06861998 — Preoperative Sleep Intervention on Postoperative Delirium in Infants and Toddlers Undergoing Congenital Heart Surgery · NA · recruiting
- NCT06879431 — Preoperative Sleep Intervention on Postoperative Delirium in School-aged Children Undergoing Congenital Heart Surgery · NA · recruiting
- NCT06783933 — Artificial Intelligence-assisted Diagnosis · active not recruiting
Other University of Calgary trials
Trials by the same sponsor.
- NCT06885996 — Psilocybin-assisted Therapy for Post-Traumatic Stress Disorder in Survivors of Intimate Partner Violence · Phase 2 · not yet recruiting
- NCT05729503 — Effect of SPG Block for Patients With Anxiety at Electronic Dance Music Festivals · Phase 2 · not yet recruiting
- NCT07463339 — Microbiome-guided Prophylaxis to Reduce Ventilator-Associated Pneumonia in Intensive Care Units: A Pilot Randomized Cont · Phase 2 · not yet recruiting
- NCT07145645 — Topical Diclofenac vs.Oral Ibuprofen for MSK Pain in Children · Phase 3 · recruiting
- NCT07280325 — Moxie Self-Management and Education Support Program · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06659302 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Calgary
- Last refreshed: 26 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06659302.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing