A Parent-child Yoga Intervention for Reducing Attention Deficits in Children with Congenital Heart Disease: a Feasibility Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-6
SponsorAnne Gallagher
About this trial
The proposed study aims to determine the feasibility of the procedures for a future full randomized controlled trial (RCT), which will test the efficacy of a parent-child yoga intervention in reducing attention deficits in children with congenital heart disease (CHD). Specific aims of this single-blind, two-arm, two-center feasibility trial are to evaluate recruitment rates and capacity, withdrawal and dropout rates, adherence to the intervention, acceptability of the randomization process by families, variation in delivery of the intervention between yoga instructors, and standard deviation of main outcomes of the future RCT in order to determine its appropriate sample size. This feasibility study will lead to the first ever RCT to test the efficacy of an intervention strategy for reducing attention deficits in children with CHD. Ultimately, the implementation of this parent-child yoga program will lead to better long-term academic and psychosocial functioning and quality of life for these children and their family.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
diagnosis of CHD requiring heart surgery;
aged 4 to 6 years old;
poor attentional skills measured with Variability score (0.5 standard deviation below norms) at the Kiddie Conners Continuous Performance Test, 2nd Edition (K-CPT2), a sensitive measure for attentional impairments. This inclusion criteria is important since yoga intervention has shown larger effects on attention in children with greater difficulties before the intervention;
parent willing to participate to the 8-week parent-child yoga intervention and the pre/post/6-month follow-up assessments;
Disqualifiers
having a medical contraindication to the practice of yoga;
confirmed diagnosis of severe developmental or intellectual delay that would prevent successful completion of the planned study testing;
presence of severe physical handicap that would preclude the child from participating in the yoga intervention without special adaptation;
families who do not speak French or English (less than 3% of families followed in our clinics);
Trial design
Design model
Parallel
Treatments tested in this trial
Parent-child yoga
BehavioralThe 45-minute yoga sessions are structured to include an opening and a closing ritual that remain the same throughout the 8 weeks, between which an active and a calming parts are scheduled. The active and calming parts are embedded in stories that align with the developmental level and interests typical of 4-to-6-year-olds. Each session is clearly structured with each exercise and transition well described in the Yoga for Little Hearts Yoga Program Manual. In addition to the yoga sessions, at-home exercises (5 min) including breathing, meditation and mindfulness activities will be explained to participants. We will ask them to practice them at home at least 3 times every week, for the 8-week duration of the intervention. Including the yoga session and home exercises, the 8-week intervention thus includes at least 60 minutes of yoga per week. Parents will be encouraged to pursue the at-home exercises after the end of the 8-week yoga program, up to the 6-month follow-up.
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Yoga groupExperimental treatment 1 intervention
Group B: Waitlist control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Recruitment rate
The number of eligible participants contacted, the number of consents to participation and the duration of the recruitment for each of the two waves of recruitment.
Time frame
2 months prior to the intervention.2
Dropout and withdrawal rates
The number of eligible participants contacted, the number of consents to participation and the duration of the recruitment for each of the two waves of recruitment.
Time frame
The 8 weeks of the intervention.3
Adherence
Adherence will be assessed by recording the number of sessions attended by each participant during the 8-week program. Acceptable adherence will be defined as completion of a minimum of 6/8 in-person yoga sessions otherwise the participant will be excluded from the analyses (withdrawals). Moreover, every week, parents will be asked to complete an at-home yoga exercise logbook to track the completion of yoga home practice and information will be collated at the end of the program.
Time frame
The 8 weeks of the intervention.4
Acceptability of the randomisation process
The number of refusals to enrol because of randomisation to intervention will be documented.
Time frame
Months prior to the intervention.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Anne Gallagher
Lead sponsor
St. Justine's Hospital
Sponsor institution
Centre Universitaire de Santé McGill
Collaborator
Heart and Stroke Foundation of Canada
Collaborator
Source ClinicalTrials.gov