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Muscular DystrophiesNCT04733976

Bullying in Youth With Muscular Dystrophy and Congenital Myopathies

An observational study of Muscular Dystrophies and Congenital Myopathy, run by Holland Bloorview Kids Rehabilitation Hospital at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 10 to 19 years
Conditions the study is for
Muscular Dystrophies, Congenital Myopathy
How many people
29 participants
Where
2 sitesCanada
Study dates
22 Jan 2021to 1 Sep 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 19 years
  • All sexes
  • Child, Adult

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.

Who may be able to join

  • Muscular dystrophy or congenital myopathy diagnosis
  • 10-19 years old
  • Speaks and reads English or French

Who cannot join

  • N/A

Trial locations and contacts

2 sites in 1 country.

Canada2 sites
  • Children's Hospital of Eastern Ontario

    Ottawa, Ontario, K1H 8L1

  • Holland Bloorview Kids Rehabilitation Hospital

    Toronto, Ontario, M4G 1R8

Other trials in Canada

About this study

Official title: Assessing the Frequency and Experience of Bullying or Peer Victimization in Children With Muscular Dystrophy and Congenital Myopathies

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.

Read the detailed description

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.

Keywords
muscular dystophy, congenital myopathy, youth, bullying, cyberbullying
Medical subject headings
Muscular Dystrophies, Myotonia Congenita, Bullying, Cyberbullying

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Demographics Form

    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.

    Measured: Through study completion, 1 year

  2. Bullying and Cyberbullying: Perpetrators, Victims and Witnesses Survey (B&C:PVWS)

    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.

    Measured: Through study completion, 1 year

  3. Bullying Perspectives

    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).

    Measured: Through study completion, 1 year

  4. PedsQL(TM) 3.0 Neuromuscular Module

    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).

    Measured: Through study completion, 1 year

  5. KIDSCREEN-10 Index

    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).

    Measured: Through study completion, 1 year

  6. EPOCH Measure of Adolescent Well-being (EPOCH)

    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).

    Measured: Through study completion, 1 year

  7. Qualitative Interview

    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.

    Measured: Through study completion, 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2021
  2. Study start22 Jan 2021
  3. Primary completion1 Sep 2022
  4. Study completion1 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04733976
Sponsor's protocol ID
McAdam_Bullying
Status last verified
Nov 2022
First submitted
22 Jan 2021
Last updated
7 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Molcho M, Craig W, Due P, Pickett W, Harel-Fisch Y, Overpeck M; HBSC Bullying Writing Group. Cross-national time trends in bullying behaviour 1994-2006: findings from Europe and North America. Int J Public Health. 2009 Sep;54 Suppl 2:225-34. doi: 10.1007/s00038-009-5414-8.

    PubMed 19618108
  • Pinquart M. Systematic Review: Bullying Involvement of Children With and Without Chronic Physical Illness and/or Physical/Sensory Disability-a Meta-Analytic Comparison With Healthy/Nondisabled Peers. J Pediatr Psychol. 2017 Apr 1;42(3):245-259. doi: 10.1093/jpepsy/jsw081.

    PubMed 27784727
  • Whitney DG, Peterson MD, Warschausky SA. Mental health disorders, participation, and bullying in children with cerebral palsy. Dev Med Child Neurol. 2019 Aug;61(8):937-942. doi: 10.1111/dmcn.14175. Epub 2019 Feb 1.

    PubMed 30710352
  • van Geel M, Vedder P, Tanilon J. Are overweight and obese youths more often bullied by their peers? A meta-analysis on the correlation between weight status and bullying. Int J Obes (Lond). 2014 Oct;38(10):1263-7. doi: 10.1038/ijo.2014.117. Epub 2014 Jul 8.

    PubMed 25002148
  • Fales JL, Rice S, Aaron RV, Palermo TM. Traditional and cyber-victimization among adolescents with and without chronic pain. Health Psychol. 2018 Mar;37(3):291-300. doi: 10.1037/hea0000569. Epub 2017 Nov 20.

    PubMed 29154604
  • Mishna F, McInroy LB, Lacombe-Duncan A, Bhole P, Van Wert M, Schwan K, Birze A, Daciuk J, Beran T, Craig W, Pepler DJ, Wiener J, Khoury-Kassabri M, Johnston D. Prevalence, Motivations, and Social, Mental Health and Health Consequences of Cyberbullying Among School-Aged Children and Youth: Protocol of a Longitudinal and Multi-Perspective Mixed Method Study. JMIR Res Protoc. 2016 May 24;5(2):e83. doi: 10.2196/resprot.5292.

    PubMed 27220556
  • 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.

  • Ravens-Sieberer U, Herdman M, Devine J, Otto C, Bullinger M, Rose M, Klasen F. The European KIDSCREEN approach to measure quality of life and well-being in children: development, current application, and future advances. Qual Life Res. 2014 Apr;23(3):791-803. doi: 10.1007/s11136-013-0428-3. Epub 2013 May 18.

    PubMed 23686556
  • Kern ML, Benson L, Steinberg EA, Steinberg L. The EPOCH Measure of Adolescent Well-Being. Psychol Assess. 2016 May;28(5):586-97. doi: 10.1037/pas0000201. Epub 2015 Aug 24.

    PubMed 26302102
  • Iannaccone ST, Hynan LS, Morton A, Buchanan R, Limbers CA, Varni JW; AmSMART Group. The PedsQL in pediatric patients with Spinal Muscular Atrophy: feasibility, reliability, and validity of the Pediatric Quality of Life Inventory Generic Core Scales and Neuromuscular Module. Neuromuscul Disord. 2009 Dec;19(12):805-12. doi: 10.1016/j.nmd.2009.09.009. Epub 2009 Oct 28.

    PubMed 19846309

Questions about this trial

What is this clinical trial studying?

An observational study of Muscular Dystrophies and Congenital Myopathy, run by Holland Bloorview Kids Rehabilitation Hospital at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Demographics Form (time frame: Through study completion, 1 year). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04733976, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2022.

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