Bullying in Youth With Muscular Dystrophy and Congenital Myopathies
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| ClinicalTrials.gov Identifier: NCT04733976 |
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Recruitment Status :
Recruiting
First Posted : February 2, 2021
Last Update Posted : February 2, 2021
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Sponsor:
Holland Bloorview Kids Rehabilitation Hospital
Collaborator:
Children's Hospital of Eastern Ontario
Information provided by (Responsible Party):
Laura McAdam, Holland Bloorview Kids Rehabilitation Hospital
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Brief Summary:
Bullying is an epidemic in Canada, and rates may be underreported. Youth with a disability were more likely to be bullied that those without disabilities, specifically if the disability was visible. Research has been conducted on the prevalence and effects of bullying in youth with disabilities such as cerebral palsy, obesity, and chronic pain; however, there is a paucity of research involving youth with muscular dystrophy and congenital myopathies. The objectives of this study are to: (1) measure bullying frequency, (2) describe the types of bullying experiences; and (3) explore barriers and facilitators to dealing with bullying by youth with muscular dystrophy or congenital myopathies and their parents. The objectives will be met by an online survey and qualitative interviews of youth with muscular dystrophy and congenital myopathy and their parents.
| Condition or disease |
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| Muscular Dystrophies Congenital Myopathy |
Bullying is an epidemic in Canada. At least one in three Canadian youth report having been bullied. Bullying is defined as intentional aggressive behaviour with the intention to harm the victim. It is characterized by an imbalance of power between the perpetrator and the victim, and is often repetitive although it does not need to be. Studies have shown that youth with chronic illness or disability were more likely to be bullied that those without disabilities, specifically if the disability was visible. Research has been conducted on the prevalence and effects of bullying in youth with disabilities such as cerebral palsy, obesity, and chronic pain; however, there is a paucity of research involving youth with muscular dystrophy and congenital myopathies. The objectives of this study are to: (1) measure bullying frequency, (2) describe the types of bullying experiences; and (3) explore barriers and facilitators to dealing with bullying by youth and their parents. The objectives will be met using a cross-sectional, multi-centre, mixed methods approach. A survey will be administered online at a single time-point to youth and their parents. Then, purposefully selected participants and their parents will complete a qualitative interview.
| Study Type : | Observational |
| Estimated Enrollment : | 75 participants |
| Observational Model: | Cohort |
| Time Perspective: | Cross-Sectional |
| Official Title: | Assessing the Frequency and Experience of Bullying or Peer Victimization in Children With Muscular Dystrophy and Congenital Myopathies |
| Actual Study Start Date : | January 22, 2021 |
| Estimated Primary Completion Date : | July 2021 |
| Estimated Study Completion Date : | September 2022 |
Resource links provided by the National Library of Medicine
Primary Outcome Measures :
- Demographics Form [ Time Frame: Through study completion, 1 year ]This form was purposefully developed by the research team to capture characteristics such as age, gender, family demographics, schooling and academic success, muscular dystrophy or congenital myopathy diagnosis, comorbidities, physical function and mobility levels, and technology use. There is a participant version and a parent/guardian version.
- Bullying and Cyberbullying: Perpetrators, Victims and Witnesses Survey (B&C:PVWS) [ Time Frame: Through study completion, 1 year ]An amended version of the B&C:PVWS, developed by Mishna et al., to identify bullying and cyberbullying experiences of victims and perpetrators. The survey examines types of bullying experiences (e.g., physical, verbal, social, sexual), the context in which bullying occurs (e.g., race, sexual orientation, disability), and the participant's response to bullying and cyberbullying (e.g., sadness, actions taken, etc.). Perspectives on bullying and cyberbullying, as well as thoughts on potential interventions are sought. Questions measuring experiences of bully victimization and perpetration had good internal consistency with Cronbach alphas of .77 and .71, respectively.
- Bullying Perspectives [ Time Frame: Through study completion, 1 year ]A single question from The Bully Survey by Swearer et al. will be used to capture the youth participant's perspectives on bullying. They will be asked, "How much do you agree with each sentence?" on a 5-point scale (Totally false, somewhat false, both true and false, somewhat true, totally true).
- PedsQL(TM) 3.0 Neuromuscular Module [ Time Frame: Through study completion, 1 year ]The PedsQL(TM) 3.0 Neuromuscular Module assesses quality of life on three scales: 1) About my neuromuscular disease (17 items), 2) Communication (3 items), and 3) About our family resources (5 items). Participants are asked to indicate how much of a problem each of the statements has been for them on a 5-point Likert scale (0 = Never through 5 = Almost Always). Raw item scores are scaled linearly for a total score out of 100. As well, scale scores can be computed as an average of the total scale score. A higher score indicates better health-related quality of life (HRQoL). Two versions will be used in this study: Child Report (8-12 years old) and Teenager Report (13-18 years old), along with parent reports for each of these versions. All versions being used can be found in Appendix R. The child self-report has exemplary reliability (α = .85).
- KIDSCREEN-10 Index [ Time Frame: Through study completion, 1 year ]The KIDSCREEN-10 Index is a 10-item questionnaire developed to assess the HRQoL of children and young people 8-18 years old. Items in the questionnaire ask participants their thoughts on their health over the past week on a 5-point scale (Excellent, very good, good, fair, poor). Rasch analysis of raw scores provides a global unidimensional latent HRQoL score. Higher scores indicate better HRQoL. The KIDSCREEN-10 Index is reported to have good internal consistency (α = .82), and good test-retest reliability and stability (r = .73, ICC = .72).
- EPOCH Measure of Adolescent Well-being (EPOCH) [ Time Frame: Through study completion, 1 year ]The EPOCH assesses five positive psychological characteristics (i.e., engagement, perseverance, optimism, connectedness and happiness) that may facilitate the well-being, physical health and other positive outcomes in adulthood. Participants are instructed to indicate how much a statement describes them on a 5-point scale (Almost never, sometimes, often, very often, almost always). There are four items for each of the five domains. The EPOCH has exemplary overall reliability (α = .92).
- Qualitative Interview [ Time Frame: Through study completion, 1 year ]Participants will be purposefully selected to complete a semi-structured qualitative interview based on their survey results. Criteria for qualitative interview selection will be based on diversity of gender, school level, muscular dystrophy or congenital myopathy diagnosis, mobility, bullying and cyberbullying victimization, etc. Participants will be asked to describe specific bullying experiences, motivations, perspectives, and getting help.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 10 Years to 19 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Sampling Method: | Non-Probability Sample |
Study Population
Youth with a muscular dystrophy or congenital myopathy diagnosis from the neuromuscular clinics at the study sites (Holland Bloorview and CHEO) will be invited to participate in the study. The youth's parents will also be invited to participate with their child.
Criteria
Inclusion Criteria:
- Muscular dystrophy or congenital myopathy diagnosis
- 10-19 years old
- Speaks and reads English or French
Exclusion Criteria:
- N/A
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04733976
Contacts
| Contact: Laura McAdam, MD | 416-425-6220 ext 6123 | lmcadam@hollandbloorview.ca |
Locations
| Canada, Ontario | |
| Children's Hospital of Eastern Ontario | Not yet recruiting |
| Ottawa, Ontario, Canada, K1H 8L1 | |
| Contact: Hugh McMillan, MD 613-737-7600 ext 1605 HMcMillan@cheo.on.ca | |
| Holland Bloorview Kids Rehabilitation Hospital | Recruiting |
| Toronto, Ontario, Canada, M4G 1R8 | |
| Contact: Laura McAdam, MD 416-425-6220 ext 6123 lmcadam@hollandbloorview.ca | |
| Principal Investigator: Laura McAdam, MD | |
Sponsors and Collaborators
Holland Bloorview Kids Rehabilitation Hospital
Children's Hospital of Eastern Ontario
Additional Information:
Publications:
Publications:
Swearer SM, Cary PT. Perceptions and Attitudes Toward Bullying in Middle School Youth: A Developmental Examination Across the Bully/Victim Continuum. Journal of Applied School Psychology. 2003 Dec 12;19(2):63-79.
| Responsible Party: | Laura McAdam, Physician, Holland Bloorview Kids Rehabilitation Hospital |
| ClinicalTrials.gov Identifier: | NCT04733976 |
| Other Study ID Numbers: |
McAdam_Bullying |
| First Posted: | February 2, 2021 Key Record Dates |
| Last Update Posted: | February 2, 2021 |
| Last Verified: | January 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Laura McAdam, Holland Bloorview Kids Rehabilitation Hospital:
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muscular dystophy congenital myopathy youth bullying cyberbullying |
Additional relevant MeSH terms:
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Muscular Dystrophies Muscular Diseases Bullying Muscular Disorders, Atrophic Musculoskeletal Diseases |
Neuromuscular Diseases Nervous System Diseases Genetic Diseases, Inborn Aggression Behavioral Symptoms |