Lifetime prevalence of congenital heart disease in the general population from 2000 to 2010.
Ariane J Marelli, Raluca Ionescu-Ittu, Andrew S Mackie...
https://pubmed.ncbi.nlm.nih.gov/24944314Actively Recruiting
Phase Not Applicable
Age: 4Years - 6Years
All Genders
ID05997680
A Parent-child Yoga Intervention for Reducing Attention Deficits in Children with Congenital Heart Disease: a Feasibility Study Prior to a Randomised Controlled Trial
Led by Anne Gallagher · Updated on 2024-11-29
24
Participants Needed
2
Research Sites
21 weeks
Total Duration
On this page
Sponsors
A
Anne Gallagher
Lead Sponsor
C
Centre Universitaire de Santé McGill
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the feasibility of a parent-child yoga intervention designed to reduce attention deficits in children aged 4 to 6 years with congenital heart disease (CHD). Children with CHD often face neurodevelopmental challenges, including a higher risk of attention deficit hyperactivity disorder (ADHD). This study is a preliminary step before conducting a larger randomized controlled trial (RCT) to test the effectiveness of this intervention in improving attention and long-term academic and psychosocial outcomes for these children and their families. The study is a single-blind, two-center, two-arm randomized feasibility trial involving 24 parent-child pairs. Participants will be randomly assigned in a 2:1 ratio to either an 8-week parent-child yoga program plus standard clinical care or standard clinical care alone with a waitlist option for yoga after the study. The yoga sessions last 45 minutes each week and include active and calming parts embedded in stories suitable for the child's developmental level. Parents and children will also be encouraged to practice 5-minute at-home exercises three times a week throughout the 8-week period and continue up to a 6-month follow-up. Participants will undergo three neurodevelopmental assessments: before the intervention, immediately after, and six months later. The study will monitor recruitment, dropout, and adherence rates; acceptability of randomization; variation in yoga delivery; and data completeness. These measurements will help determine the feasibility of the procedures and inform the sample size for the future full-scale RCT. Overall participation spans about eight months including the intervention and follow-up periods.
CONDITIONS
Brief Title
A Parent-child Yoga Intervention for Reducing Attention Deficits in Children with Congenital Heart Disease: a Feasibility Study
Who Can Participate
Age: 4Years - 6Years
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosis of congenital heart disease requiring heart surgery
- Aged 4 to 6 years old
- Poor attentional skills confirmed by a specific attention test (K-CPT2)
- Parent willing to participate in the 8-week yoga intervention and all assessments
- For children on ADHD medication, parent agrees to pause medication 48 hours before assessments
You will not qualify if you...
- Medical reasons preventing safe practice of yoga
- Severe developmental or intellectual delay preventing study participation
- Severe physical handicap requiring special adaptations for yoga
- Families who do not speak French or English
- Children involved in a structured weekly yoga program for at least one month in the past year
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Baseline Assessment
Duration - 1 day
Participants undergo standardized interdisciplinary neurodevelopmental assessments before starting the intervention.
1 visit (in-person)
Parent-child Yoga Intervention
Duration - 8 weeks
Participants in the yoga group take part in an 8-week parent-child yoga program alongside standard clinical care, including weekly 45-minute yoga sessions and home exercises practiced at least 3 times per week.
Weekly visits for 8 weeks plus home exercises 3 times per week
Post-intervention Assessment
Duration - 1 day
Participants undergo standardized neurodevelopmental assessments immediately after the 8-week intervention or observation period.
1 visit (in-person)
6-month Follow-up Assessment
Duration - 1 day
Participants complete standardized neurodevelopmental assessments 6 months after the intervention to evaluate long-term effects.
1 visit (in-person)
Trial Site Locations
Total: 2 locations
1
Centre hospitalier universitaire Sainte-Justine
Montreal, Quebec, Canada, H3T1C5
Actively Recruiting
2
Centre universtaire de santé McGill
Montreal, Quebec, Canada, H4A3J1
Actively Recruiting
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Research Team
A
Anne Gallagher, PhD
M
Marie-Noëlle Simard, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Published Research Related To This Trial
Increased prevalence of inattention-related symptoms in a large cohort of patients with congenital heart disease.
Chia-Ching Wang, Wen-Chin Weng, Ling-Yin Chang...
https://pubmed.ncbi.nlm.nih.gov/32394091The role of parenting stress in anxiety and sleep outcomes in toddlers with congenital heart disease.
Charles Lepage, Isabelle Gaudet, Amélie Doussau...
https://pubmed.ncbi.nlm.nih.gov/36683797Neurodevelopmental Outcome of Children with Congenital Heart Disease: A Cohort Study from Infancy to Preschool Age.
Isabelle Gaudet, Natacha Paquette, Catherine Bernard...
https://pubmed.ncbi.nlm.nih.gov/34454950Parental stress and resilience in CHD: a new frontier for health disparities research.
Amy J Lisanti
https://pubmed.ncbi.nlm.nih.gov/29991369Experiences of children and parents in MiYoga, an embodied mindfulness yoga program for cerebral palsy: A mixed method study.
Catherine K Mak, Koa Whittingham, Roslyn N Boyd
https://pubmed.ncbi.nlm.nih.gov/30712729Systematic Review of Yoga Interventions for Anxiety Reduction Among Children and Adolescents.
Lindy L Weaver, Amy R Darragh
https://pubmed.ncbi.nlm.nih.gov/26565100Effects of Yoga on Attention, Impulsivity, and Hyperactivity in Preschool-Aged Children with Attention-Deficit Hyperactivity Disorder Symptoms.
Samantha C L Cohen, Danielle J Harvey, Rebecca H Shields...
https://pubmed.ncbi.nlm.nih.gov/29538185A Parent-child yoga intervention for reducing attention deficits in children with congenital heart disease: the Yoga for Little Hearts Feasibility Study Protocol.
Marie-Noëlle Simard, Charles Lepage, Isabelle Gaudet...
https://pubmed.ncbi.nlm.nih.gov/37848299