A Parent-child Yoga Intervention for Reducing Attention Deficits in Children with Congenital Heart Disease: a Feasibility Study

NCT05997680 | Recruiting DMC

• 2 other identifiers: 2020-2446G-23-0033984
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Congenital Heart Disease; Child Development; Neurodevelopmental Disorders; Parents

Keywords

Neurodevelopment; Attention; Yoga; Motor Skills; Parenting Stress; Congenital Heart Disease

Outcome Measures

Primary Outcomes (7)

• 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.

  2 months prior to the intervention.

• 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.

  The 8 weeks of the intervention.

• 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.

  The 8 weeks of the intervention.

• Acceptability of the randomisation process

  The number of refusals to enrol because of randomisation to intervention will be documented.

  Months prior to the intervention.

• Variation in delivery of the intervention

  To document the variation between yoga instructors and sites, the instructors will complete an intervention logbook after each session checking all planned steps and exercises that have been completed and detailing all protocol deviations and their reasons. At the end of the 8-week program, the number of deviations, the moments and the groups in which they occurred, and their reasons will be documented in the feasibility form.

  The 8 weeks of the intervention.

• Missing data assessment

  The missing data will be collected at the end of each neurodevelopmental assessment session by going through all questionnaires completed by the parent. The reasons why the parent did not answer all the questions will be discussed and collected, and the assessment and questionnaires at which the missing data occurred will be noted in the feasibility form.

  2 weeks following each wave of assessments (T0, T1, T2).

• Standard deviations of the main outcome to be evaluated in the full RCT

  The Variability score from the K-CPT2 is the main outcome of the future RCT. This data from the feasibility study will allow us to calculate the required standard deviation to be considered in the future RCT in accordance with the minimally clinical important difference (MCID) that should be measured between T0 and T1 for the yoga group.

  2 weeks following the post-intervention wave of assessments (T1).

Study Arms (2)

Yoga group

EXPERIMENTAL

Participants with CHD undergoing neurodevelopmental assessments and benefiting from the 8-week yoga intervention in addition to standard of care.

Behavioral: Parent-child yoga

Waitlist control group

NO INTERVENTION

Participants with CHD undergoing neurodevelopmental assessments at the same time as the yoga group participants and benefiting from standard of care only during the 8 weeks of the intervention. The yoga intervention will be made available to all waitlist control group participants once their trial wave is completed.

Interventions

Parent-child yoga BEHAVIORAL

The 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.

Yoga group

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• diagnosis of CHD requiring heart surgery;
• aged 4 to 6 years old;
• parent willing to participate to the 8-week parent-child yoga intervention and the pre/post/6-month follow-up assessments;
• for children with ADHD medication (approx. 5% of the 4-to-6-year-olds at our neurocardiac clinic), parent accept to temporary stop it to at least 48h prior to each assessment.

You may not qualify if:

• 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);
• children who have been engaged in a structured weekly yoga program for at least a month in the past year (based on our parents' poll, less than 5%). However, parents included could have past or actual experience in practicing yoga.
• Eligibility will be determined:
• by consulting the child's medical record;
• during a child medical visit at one of the sites or a virtual visit with the research team by administering the K-CPT2.

Sponsors & Collaborators

• Anne Gallagher: lead
• Centre Universitaire de Santé McGill: collaborator
• Heart and Stroke Foundation of Canada: collaborator

Study Sites (2)

Centre hospitalier universitaire Sainte-Justine

Montreal, Quebec, H3T1C5, Canada

RECRUITING

Centre universtaire de santé McGill

Montreal, Quebec, H4A3J1, Canada

RECRUITING

Related Publications (9)

• Marelli AJ, Ionescu-Ittu R, Mackie AS, Guo L, Dendukuri N, Kaouache M. Lifetime prevalence of congenital heart disease in the general population from 2000 to 2010. Circulation. 2014 Aug 26;130(9):749-56. doi: 10.1161/CIRCULATIONAHA.113.008396. Epub 2014 Jun 18.

  PMID: 24944314 BACKGROUND

• Wang CC, Weng WC, Chang LY, Chang HY, Wu MH, Wang JK, Lu CW, Lin MT, Chen CA, Chiu SN. Increased prevalence of inattention-related symptoms in a large cohort of patients with congenital heart disease. Eur Child Adolesc Psychiatry. 2021 Apr;30(4):647-655. doi: 10.1007/s00787-020-01547-y. Epub 2020 May 11.

  PMID: 32394091 BACKGROUND

• Lepage C, Gaudet I, Doussau A, Vinay MC, Gagner C, von Siebenthal Z, Poirier N, Simard MN, Paquette N, Gallagher A. The role of parenting stress in anxiety and sleep outcomes in toddlers with congenital heart disease. Front Pediatr. 2023 Jan 6;10:1055526. doi: 10.3389/fped.2022.1055526. eCollection 2022.

  PMID: 36683797 BACKGROUND

• Gaudet I, Paquette N, Bernard C, Doussau A, Harvey J, Beaulieu-Genest L, Pinchefsky E, Trudeau N, Poirier N, Simard MN, Gallagher A; Clinique d'Investigation Neuro-Cardiaque (CINC) interdisciplinary team. Neurodevelopmental Outcome of Children with Congenital Heart Disease: A Cohort Study from Infancy to Preschool Age. J Pediatr. 2021 Dec;239:126-135.e5. doi: 10.1016/j.jpeds.2021.08.042. Epub 2021 Aug 27.

  PMID: 34454950 BACKGROUND

• Lisanti AJ. Parental stress and resilience in CHD: a new frontier for health disparities research. Cardiol Young. 2018 Sep;28(9):1142-1150. doi: 10.1017/S1047951118000963. Epub 2018 Jul 11.

  PMID: 29991369 BACKGROUND

• Mak CK, Whittingham K, Boyd RN. Experiences of children and parents in MiYoga, an embodied mindfulness yoga program for cerebral palsy: A mixed method study. Complement Ther Clin Pract. 2019 Feb;34:208-216. doi: 10.1016/j.ctcp.2018.12.006. Epub 2018 Dec 19.

  PMID: 30712729 BACKGROUND

• Weaver LL, Darragh AR. Systematic Review of Yoga Interventions for Anxiety Reduction Among Children and Adolescents. Am J Occup Ther. 2015 Nov-Dec;69(6):6906180070p1-9. doi: 10.5014/ajot.2015.020115.

  PMID: 26565100 BACKGROUND

• Cohen SCL, Harvey DJ, Shields RH, Shields GS, Rashedi RN, Tancredi DJ, Angkustsiri K, Hansen RL, Schweitzer JB. Effects of Yoga on Attention, Impulsivity, and Hyperactivity in Preschool-Aged Children with Attention-Deficit Hyperactivity Disorder Symptoms. J Dev Behav Pediatr. 2018 Apr;39(3):200-209. doi: 10.1097/DBP.0000000000000552.

  PMID: 29538185 BACKGROUND

• Simard MN, Lepage C, Gaudet I, Paquette N, Doussau A, Poirier NC, Beauchamp MH, Cote SM, Pinchefsky E, Brossard-Racine M, Masse B, Gallagher A. A Parent-child yoga intervention for reducing attention deficits in children with congenital heart disease: the Yoga for Little Hearts Feasibility Study Protocol. BMJ Open. 2023 Oct 17;13(10):e079407. doi: 10.1136/bmjopen-2023-079407.

  PMID: 37848299 DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital; Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Mental Disorders

Central Study Contacts

Anne Gallagher, PhD

CONTACT

514-345-4931; anne.gallagher.hsj@ssss.gouv.qc.ca

Marie-Noëlle Simard, PhD

CONTACT

514-345-4931; marie-noelle.simard@umontreal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The intervention team including the research coordinator will not be blinded to intervention allocation. The primary and secondary outcomes of the full trial will be assessed by a research assistant who is not part of the intervention and who will be blinded to intervention allocation. Data will be anonymised, and data quality control will be conducted by staff blinded to the intervention group. The intervention team will be blinded to the initial level of attention functioning. There will be no interference with standard clinical care. All clinical follow-up, therapies and learning-support services received as part of the standard clinical care will be documented in the electronic case report form. Due to the nature of the intervention, participants and their parents will not be blinded.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Researcher and clinical neuropsychologist

Study Record Dates

• First Submitted: August 2, 2023
• First Posted: August 18, 2023
• Study Start: October 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: October 1, 2025
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)