xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05997680</url>
    </required_header>
    <id_info>
      <org_study_id>2020-2446</org_study_id>
      <secondary_id>G-23-0033984</secondary_id>
      <nct_id>NCT05997680</nct_id>
    </id_info>
    <brief_title>A Parent-child Yoga Intervention for Reducing Attention Deficits in Children With Congenital Heart Disease: A Feasibility Study</brief_title>
    <official_title>A Parent-child Yoga Intervention for Reducing Attention Deficits in Children With Congenital Heart Disease: a Feasibility Study Prior to a Randomised Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Anne Gallagher</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Centre Universitaire de Santé McGill</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Heart and Stroke Foundation of Canada</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>St. Justine's Hospital</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The proposed study aims to determine the feasibility of the procedures for a future full&#xD;
        randomized controlled trial (RCT), which will test the efficacy of a parent-child yoga&#xD;
        intervention in reducing attention deficits in children with congenital heart disease (CHD).&#xD;
        Specific aims of this single-blind, two-arm, two-center feasibility trial are to evaluate&#xD;
        recruitment rates and capacity, withdrawal and dropout rates, adherence to the intervention,&#xD;
        acceptability of the randomization process by families, variation in delivery of the&#xD;
        intervention between yoga instructors, and standard deviation of main outcomes of the future&#xD;
        RCT in order to determine its appropriate sample size. This feasibility study will lead to&#xD;
        the first ever RCT to test the efficacy of an intervention strategy for reducing attention&#xD;
        deficits in children with CHD. Ultimately, the implementation of this parent-child yoga&#xD;
        program will lead to better long-term academic and psychosocial functioning and quality of&#xD;
        life for these children and their family.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Context&#xD;
  &#xD;
        Congenital heart disease (CHD) is the most common structural birth defect, affecting up to 1%&#xD;
        of newborns. Half of children with CHD present neurodevelopmental impairments, including&#xD;
        significant attention deficits. Compared to the general population, they are at 2.5 to 4&#xD;
        times greater risk for attention deficit hyperactivity disorder (ADHD). Despite the high&#xD;
        prevalence of these disabilities, very little interest has been given to the design and&#xD;
        implementation of CHD-specific interventions for improving attention. In fact, only one&#xD;
        randomised controlled trial (RCT) aimed at improving cognition in adolescents with CHD and&#xD;
        revealed promising results for attention and inhibitory control. To date, no RCT aiming to&#xD;
        improve attention has been conducted in young children with CHD, although attention has been&#xD;
        strongly associated with school readiness and can predict academic skills. Yet, a rich&#xD;
        literature supports the notion that early intervention is key to ensure success in the&#xD;
        crucial first years of education. There is emerging evidence from RCTs indicating that&#xD;
        parent-child yoga interventions improve attention and reduce ADHD symptoms in both typically&#xD;
        developing and clinical populations. However, no studies have tested this promising approach&#xD;
        in children with CHD although these children have their own challenges. Our ultimate goal is&#xD;
        to test the efficacy of a parent-child yoga intervention to reduce attention deficits in&#xD;
        children with CHD at school entry. Before launching a full RCT involving multiple sites&#xD;
        across Canada, we propose to conduct the 2-site Yoga for Little Hearts feasibility study,&#xD;
        which is a necessary and critical step to ensure future assessment and implementation of our&#xD;
        parent-child yoga intervention program. Results from this feasibility study will allow us to&#xD;
        optimize the subsequent large-scale RCT by preventing procedural and methodological issues.&#xD;
  &#xD;
        Aims and hypotheses&#xD;
  &#xD;
        The principal objectives of the proposed feasibility study are to evaluate: 1) recruitment&#xD;
        rates and capacity; 2) retention, dropout and withdrawal rates during the 8-week parent-child&#xD;
        yoga program and at 6-month follow-up; 3) adherence to the intervention; 4) acceptability of&#xD;
        the randomisation process by families; 5) heterogeneity in the delivery of the intervention&#xD;
        between yoga instructors, and use of home-based exercise between participants; 6) proportion&#xD;
        of missing data in the standardized neurodevelopmental assessment instruments and parental&#xD;
        questionnaires, and 7) standard deviation of primary outcomes of the full RCT in order to&#xD;
        determine an appropriate sample size for the future full trial.&#xD;
  &#xD;
        Following this feasibility study, we plan to conduct a full RCT including multiple centers&#xD;
        aiming to test the efficacy of our 8-week parent-child yoga intervention in addition to the&#xD;
        standard clinical care vs. standard clinical care alone in reducing attention deficits in&#xD;
        4-to-6-year-olds with CHD immediately and 6 months post-intervention.&#xD;
  &#xD;
        Population&#xD;
  &#xD;
        Children aged 4 to 6 years old with a diagnosis of CHD requiring heart surgery and their&#xD;
        parents.&#xD;
  &#xD;
        Procedure&#xD;
  &#xD;
        The Yoga for Little Hearts feasibility methodology follows the Standard Protocol Items for&#xD;
        Randomized Trials recommendations and the Consolidated Standards of Reporting Trials&#xD;
        (CONSORT) statement - extension to randomized pilot and feasibility trials. Our proposed&#xD;
        study is a single blind, two-center, two-arm randomized waitlist feasibility study. A total&#xD;
        of 24 parent-child dyads, including children aged 4 to 6 years old with CHD, will be&#xD;
        recruited in two centers and randomly assigned (2:1 allocation; 2 yoga intervention:1&#xD;
        standard of care) to receive either parent-child yoga intervention and standard clinical care&#xD;
        (yoga intervention group) or standard clinical care alone with the opportunity to receive the&#xD;
        yoga intervention after their participation in the study if desired (waitlist control group).&#xD;
  &#xD;
        Two waves of recruitment of 6 parent-child dyads will be held in each of the two&#xD;
        participating sites, for a total of 24 dyads recruited over an 18-month period. The two&#xD;
        participating sites are the CHU Ste-Justine and the Montreal Children's Hospital (MCH),&#xD;
        covering more than half of the pediatric population with CHD in the Québec province. For each&#xD;
        recruitment wave and site, 4 of the 6 recruited dyads will receive an 8-week parent-child&#xD;
        yoga intervention. Meanwhile, dyads allocated to the waitlist control group (2 of the 6&#xD;
        recruited dyads) will receive the standard of care only, with the opportunity to receive the&#xD;
        yoga intervention when their participation in the study will be completed. All participants&#xD;
        from the yoga intervention group (n = 16) and the waitlist control group (n = 8) will undergo&#xD;
        3 standardized interdisciplinary neurodevelopmental assessments: 1) at baseline, before&#xD;
        randomization (T0); 2) immediately post-intervention (T1); 3) 6-month post-intervention (T2).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">May 1, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>Double (Investigator, Outcomes Assessor)</masking>
      <masking_description>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.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Recruitment rate</measure>
      <time_frame>2 months prior to the intervention.</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Dropout and withdrawal rates</measure>
      <time_frame>The 8 weeks of the intervention.</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Adherence</measure>
      <time_frame>The 8 weeks of the intervention.</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acceptability of the randomisation process</measure>
      <time_frame>Months prior to the intervention.</time_frame>
      <description>The number of refusals to enrol because of randomisation to intervention will be documented.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Variation in delivery of the intervention</measure>
      <time_frame>The 8 weeks of the intervention.</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Missing data assessment</measure>
      <time_frame>2 weeks following each wave of assessments (T0, T1, T2).</time_frame>
      <description>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.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Standard deviations of the main outcome to be evaluated in the full RCT</measure>
      <time_frame>2 weeks following the post-intervention wave of assessments (T1).</time_frame>
      <description>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.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">24</enrollment>
    <condition>Congenital Heart Disease</condition>
    <condition>Child Development</condition>
    <condition>Neurodevelopmental Disorders</condition>
    <condition>Parents</condition>
    <arm_group>
      <arm_group_label>Yoga group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants with CHD undergoing neurodevelopmental assessments and benefiting from the 8-week yoga intervention in addition to standard of care.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Waitlist control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Parent-child yoga</intervention_name>
      <description>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.</description>
      <arm_group_label>Yoga group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          To be eligible for the study, children need to meet the following inclusion criteria:&#xD;
  &#xD;
            1. diagnosis of CHD requiring heart surgery;&#xD;
  &#xD;
            2. aged 4 to 6 years old;&#xD;
  &#xD;
            3. poor attentional skills measured with Variability score (0.5 standard deviation below&#xD;
               norms) at the Kiddie Conners Continuous Performance Test, 2nd Edition (K-CPT2), a&#xD;
               sensitive measure for attentional impairments. This inclusion criteria is important&#xD;
               since yoga intervention has shown larger effects on attention in children with greater&#xD;
               difficulties before the intervention;&#xD;
  &#xD;
            4. parent willing to participate to the 8-week parent-child yoga intervention and the&#xD;
               pre/post/6-month follow-up assessments;&#xD;
  &#xD;
            5. for children with ADHD medication (approx. 5% of the 4-to-6-year-olds at our&#xD;
               neurocardiac clinic), parent accept to temporary stop it to at least 48h prior to each&#xD;
               assessment.&#xD;
  &#xD;
          Exclusion criteria will be the following:&#xD;
  &#xD;
            1. having a medical contraindication to the practice of yoga;&#xD;
  &#xD;
            2. confirmed diagnosis of severe developmental or intellectual delay that would prevent&#xD;
               successful completion of the planned study testing;&#xD;
  &#xD;
            3. presence of severe physical handicap that would preclude the child from participating&#xD;
               in the yoga intervention without special adaptation;&#xD;
  &#xD;
            4. families who do not speak French or English (less than 3% of families followed in our&#xD;
               clinics);&#xD;
  &#xD;
            5. children who have been engaged in a structured weekly yoga program for at least a&#xD;
               month in the past year (based on our parents' poll, less than 5%). However, parents&#xD;
               included could have past or actual experience in practicing yoga.&#xD;
  &#xD;
          Eligibility will be determined:&#xD;
  &#xD;
            1. by consulting the child's medical record;&#xD;
  &#xD;
            2. during a child medical visit at one of the sites or a virtual visit with the research&#xD;
               team by administering the K-CPT2.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>4 Years</minimum_age>
      <maximum_age>6 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Anne Gallagher, PhD</last_name>
      <phone>514-345-4931</phone>
      <phone_ext>6409</phone_ext>
      <email>anne.gallagher.hsj@ssss.gouv.qc.ca</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Marie-Noëlle Simard, PhD</last_name>
      <phone>514-345-4931</phone>
      <phone_ext>5114</phone_ext>
      <email>marie-noelle.simard@umontreal.ca</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Centre hospitalier universitaire Sainte-Justine</name>
        <address>
          <city>Montréal</city>
          <state>Quebec</state>
          <zip>H3T1C5</zip>
          <country>Canada</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Anne Gallagher, PhD</last_name>
        <phone>5143454931</phone>
        <phone_ext>6409</phone_ext>
        <email>anne.gallagher.hsj@ssss.gouv.qc.ca</email>
      </contact>
      <contact_backup>
        <last_name>Marie-Noëlle Simard, PhD</last_name>
        <phone>5143454931</phone>
        <phone_ext>5114</phone_ext>
        <email>marie-noelle.simard@umontreal.ca</email>
      </contact_backup>
      <investigator>
        <last_name>Natacha Paquette, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Anne Gallagher, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Marie-Noëlle Simard, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Charles Lepage, BSc</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Amélie Doussau, MSc</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Benoît Masse, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Sylvana Côté, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Miriam Beauchamp, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Elana Pinchefsky, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Nancy Poirier, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Centre universtaire de santé McGill</name>
        <address>
          <city>Montréal</city>
          <state>Quebec</state>
          <zip>H4A3J1</zip>
          <country>Canada</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Marie Brossard-Racine, PhD</last_name>
        <phone>5149341934</phone>
        <phone_ext>76295</phone_ext>
        <email>marie.brossardracine@mcgill.ca</email>
      </contact>
      <investigator>
        <last_name>Marie Brossard-Racine, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Marie-Ève Bolduc, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <reference>
      <citation>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.</citation>
      <PMID>24944314</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>32394091</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>36683797</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>34454950</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>29991369</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>30712729</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>26565100</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>29538185</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>St. Justine's Hospital</investigator_affiliation>
      <investigator_full_name>Anne Gallagher</investigator_full_name>
      <investigator_title>Researcher and clinical neuropsychologist</investigator_title>
    </responsible_party>
    <keyword>Neurodevelopment</keyword>
    <keyword>Attention</keyword>
    <keyword>Yoga</keyword>
    <keyword>Motor Skills</keyword>
    <keyword>Parenting Stress</keyword>
    <keyword>Congenital Heart Disease</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Heart Diseases</mesh_term>
      <mesh_term>Heart Defects, Congenital</mesh_term>
      <mesh_term>Neurodevelopmental Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05997680
  org study id: 2020-2446
  secondary id: G-23-0033984
  nct id: NCT05997680
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  Context
  
        Congenital heart disease (CHD) is the most common structural birth defect, affecting up to 1%
        of newborns. Half of children with CHD present neurodevelopmental impairments, including
        significant attention deficits. Compared to the general population, they are at 2.5 to 4
        times greater risk for attention deficit hyperactivity disorder (ADHD). Despite the high
        prevalence of these disabilities, very little interest has been given to the design and
        implementation of CHD-specific interventions for improving attention. In fact, only one
        randomised controlled trial (RCT) aimed at improving cognition in adolescents with CHD and
        revealed promising results for attention and inhibitory control. To date, no RCT aiming to
        improve attention has been conducted in young children with CHD, although attention has been
        strongly associated with school readiness and can predict academic skills. Yet, a rich
        literature supports the notion that early intervention is key to ensure success in the
        crucial first years of education. There is emerging evidence from RCTs indicating that
        parent-child yoga interventions improve attention and reduce ADHD symptoms in both typically
        developing and clinical populations. However, no studies have tested this promising approach
        in children with CHD although these children have their own challenges. Our ultimate goal is
        to test the efficacy of a parent-child yoga intervention to reduce attention deficits in
        children with CHD at school entry. Before launching a full RCT involving multiple sites
        across Canada, we propose to conduct the 2-site Yoga for Little Hearts feasibility study,
        which is a necessary and critical step to ensure future assessment and implementation of our
        parent-child yoga intervention program. Results from this feasibility study will allow us to
        optimize the subsequent large-scale RCT by preventing procedural and methodological issues.
  
        Aims and hypotheses
  
        The principal objectives of the proposed feasibility study are to evaluate: 1) recruitment
        rates and capacity; 2) retention, dropout and withdrawal rates during the 8-week parent-child
        yoga program and at 6-month follow-up; 3) adherence to the intervention; 4) acceptability of
        the randomisation process by families; 5) heterogeneity in the delivery of the intervention
        between yoga instructors, and use of home-based exercise between participants; 6) proportion
        of missing data in the standardized neurodevelopmental assessment instruments and parental
        questionnaires, and 7) standard deviation of primary outcomes of the full RCT in order to
        determine an appropriate sample size for the future full trial.
  
        Following this feasibility study, we plan to conduct a full RCT including multiple centers
        aiming to test the efficacy of our 8-week parent-child yoga intervention in addition to the
        standard clinical care vs. standard clinical care alone in reducing attention deficits in
        4-to-6-year-olds with CHD immediately and 6 months post-intervention.
  
        Population
  
        Children aged 4 to 6 years old with a diagnosis of CHD requiring heart surgery and their
        parents.
  
        Procedure
  
        The Yoga for Little Hearts feasibility methodology follows the Standard Protocol Items for
        Randomized Trials recommendations and the Consolidated Standards of Reporting Trials
        (CONSORT) statement - extension to randomized pilot and feasibility trials. Our proposed
        study is a single blind, two-center, two-arm randomized waitlist feasibility study. A total
        of 24 parent-child dyads, including children aged 4 to 6 years old with CHD, will be
        recruited in two centers and randomly assigned (2:1 allocation; 2 yoga intervention:1
        standard of care) to receive either parent-child yoga intervention and standard clinical care
        (yoga intervention group) or standard clinical care alone with the opportunity to receive the
        yoga intervention after their participation in the study if desired (waitlist control group).
  
        Two waves of recruitment of 6 parent-child dyads will be held in each of the two
        participating sites, for a total of 24 dyads recruited over an 18-month period. The two
        participating sites are the CHU Ste-Justine and the Montreal Children's Hospital (MCH),
        covering more than half of the pediatric population with CHD in the Québec province. For each
        recruitment wave and site, 4 of the 6 recruited dyads will receive an 8-week parent-child
        yoga intervention. Meanwhile, dyads allocated to the waitlist control group (2 of the 6
        recruited dyads) will receive the standard of care only, with the opportunity to receive the
        yoga intervention when their participation in the study will be completed. All participants
        from the yoga intervention group (n = 16) and the waitlist control group (n = 8) will undergo
        3 standardized interdisciplinary neurodevelopmental assessments: 1) at baseline, before
        randomization (T0); 2) immediately post-intervention (T1); 3) 6-month post-intervention (T2).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Double (Investigator, Outcomes Assessor)
  masking description: 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.
  measure: Recruitment rate
  time frame: 2 months prior to the intervention.
  description: 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.
  measure: Dropout and withdrawal rates
  time frame: The 8 weeks of the intervention.
  description: 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.
  measure: Adherence
  time frame: The 8 weeks of the intervention.
  description: 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.
  measure: Acceptability of the randomisation process
  time frame: Months prior to the intervention.
  description: The number of refusals to enrol because of randomisation to intervention will be documented.
  measure: Variation in delivery of the intervention
  time frame: The 8 weeks of the intervention.
  description: 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.
  measure: Missing data assessment
  time frame: 2 weeks following each wave of assessments (T0, T1, T2).
  description: 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.
  measure: Standard deviations of the main outcome to be evaluated in the full RCT
  time frame: 2 weeks following the post-intervention wave of assessments (T1).
  description: 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.
  arm group label: Yoga group
  arm group type: Experimental
  description: Participants with CHD undergoing neurodevelopmental assessments and benefiting from the 8-week yoga intervention in addition to standard of care.
  arm group label: Waitlist control group
  arm group type: No Intervention
  description: 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.
  intervention type: Behavioral
  intervention name: Parent-child yoga
  description: 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.
  arm group label: Yoga group
  criteria: 
  gender: All
  minimum age: 4 Years
  maximum age: 6 Years
  healthy volunteers: No
  last name: Anne Gallagher, PhD
  phone: 514-345-4931
  phone ext: 6409
  email: anne.gallagher.hsj@ssss.gouv.qc.ca
  last name: Marie-Noëlle Simard, PhD
  phone: 514-345-4931
  phone ext: 5114
  email: marie-noelle.simard@umontreal.ca
  facility: 
  status: Recruiting
  contact: 
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  facility: 
  status: Recruiting
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  country: Canada
  citation: 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
  citation: 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
  citation: 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
  citation: 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
  citation: 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
  citation: 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
  citation: 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
  citation: 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
  responsible party type: Sponsor-Investigator
  investigator affiliation: St. Justine's Hospital
  investigator full name: Anne Gallagher
  investigator title: Researcher and clinical neuropsychologist
  mesh term: Heart Diseases
  mesh term: Heart Defects, Congenital
  mesh term: Neurodevelopmental Disorders
  sharing ipd: No