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The Classroom Communication Resource (CCR) Intervention to Change Grade 7 Peer's Attitudes Towards Children Who Stutter (CWS) (CCR)

Primary Purpose

Stuttering in Adolescence, Bullying of Child

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Classroom Communication Resource
No intervention
Sponsored by
Rizwana Mallick
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stuttering in Adolescence focused on measuring stuttering, children who stutter, peer attitudes, classroom-based intervention, teasing, bullying

Eligibility Criteria

11 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Eligible participants for the primary objective of this study include grade 7 mixed- gender participants aged 11 and older attending public schools within the Cape Metro urban area across the lower (two and three) and higher (four and five) quintiles where the Language of learning and teaching (LoLT) is English.

Exclusion Criteria:

Participants in private schools, in grades 1-6 within the Cape Metro urban area with a LoLT other than English .

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm 7

    Arm 8

    Arm 9

    Arm 10

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Placebo Comparator

    Placebo Comparator

    Placebo Comparator

    Placebo Comparator

    Placebo Comparator

    Arm Label

    Intervention school 1

    Intervention school 2

    Intervention school 3

    Intervention school 4

    Intervention school 5

    control school 1

    control school 2

    control school 3

    control school 4

    control school 5

    Arm Description

    All participants complete the questionnaire at baseline. The Classroom Communication Resource Intervention is administered by the teacher. The participants observe the intervention which is a social story (read by the teacher), the class performs a role-play (same plot as the story) and then the teacher facilitates and leads a semi-structured discussion. The intervention takes place in 1 classroom lesson only. No further intervention is completed.

    All participants complete the questionnaire at baseline. The Classroom Communication Resource Intervention is administered by the teacher.The participants observe the intervention which is a social story (read by the teacher), the class performs a role-play (same plot as the story) and then the teacher facilitates and leads a semi-structured discussion. The intervention takes place in 1 classroom lesson only. No further intervention is completed.

    All participants complete the questionnaire at baseline. The Classroom Communication Resource Intervention is administered by the teacher. The participants observe the intervention which is a social story (read by the teacher), the class performs a role-play (same plot as the story) and then the teacher facilitates and leads a semi-structured discussion. The intervention takes place in 1 classroom lesson only. No further intervention is completed.

    All participants complete the questionnaire at baseline. The Classroom Communication Resource Intervention is administered by the teacher. The participants observe the intervention which is a social story (read by the teacher), the class performs a role-play (same plot as the story) and then the teacher facilitates and leads a semi-structured discussion. The intervention takes place in 1 classroom lesson only. No further intervention is completed.

    All participants complete the questionnaire at baseline. The Classroom Communication Resource Intervention is administered by the teacher. The participants observe the intervention which is a social story (read by the teacher), the class performs a role-play (same plot as the story) and then the teacher facilitates and leads a semi-structured discussion. The intervention takes place in 1 classroom lesson only. No further intervention is completed.

    All participants complete the questionnaire at baseline. The Classroom Communication Resource Intervention is not administered by the teacher.

    All participants complete the questionnaire at baseline. The Classroom Communication Resource Intervention is not administered by the teacher.

    All participants complete the questionnaire at baseline. The Classroom Communication Resource Intervention is not administered by the teacher.

    All participants complete the questionnaire at baseline. The Classroom Communication Resource Intervention is not administered by the teacher.

    All participants complete the questionnaire at baseline. The Classroom Communication Resource Intervention is not administered by the teacher.

    Outcomes

    Primary Outcome Measures

    Baseline rating of peer attitudes
    The Stuttering Resource Outcomes Measure is used to evaluate peer's rating of attitudes towards children who stutter.
    6 months post-intervention rating of peer attitudes
    The Stuttering Resource Outcomes Measure is used to evaluate peer's rating of attitudes towards children who stutter

    Secondary Outcome Measures

    Construct peer ratings of attitudes
    The Stuttering Resource Outcomes Measure is used to evaluate peer's rating of attitudes towards children who stutter. This questionnaire is made up of and measures the constructs: positive social distance, verbal interaction and social pressure. These constructs will be analsyed within constructs and compared to one another at each time frame

    Full Information

    First Posted
    March 9, 2017
    Last Updated
    October 31, 2017
    Sponsor
    Rizwana Mallick
    Collaborators
    University of Cape Town, National Research Fund - South Africa
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03111524
    Brief Title
    The Classroom Communication Resource (CCR) Intervention to Change Grade 7 Peer's Attitudes Towards Children Who Stutter (CWS)
    Acronym
    CCR
    Official Title
    The Classroom Communication Resource (CCR) Intervention to Change Grade 7 Peer's Attitudes Towards Children Who Stutter (CWS) in the Western Cape: A Protocol for a Cluster-Randomised Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 15, 2016 (Actual)
    Primary Completion Date
    August 31, 2018 (Anticipated)
    Study Completion Date
    August 31, 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Rizwana Mallick
    Collaborators
    University of Cape Town, National Research Fund - South Africa

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Children who stutter (CWS) are at high risk of being teased and bullied in primary school because of the negative peer attitudes and perceptions towards stuttering. Their experiences can lead to long-term negative psychosocial consequences which can in turn affect academic performance. There is little evidence to determine if classroom-based interventions are effective in changing peer attitudes to stuttering. This study is designed to assess whether a classroom-based CCR intervention versus usual practice in schools will lead to positive shift in attitudes about stuttering at 6-months among grade 7 students.
    Detailed Description
    Children who stutter (CWS) are placed at risk for being teased and bullied in Primary school (Blood & Blood, 2004; Blood, Boyle, Blood & Nalesnik, 2010; Evans, Healy, Kawai & Rowland, 2008; Langevin, Kleitman, Packman & Onslow, 2009) due to negative peer attitudes and perceptions (Blood & Blood, 2004; Blood et al., 2010; Evans at al., 2008; Langevin et al., 2009). Negative attitudes and interactions result in CWS being viewed as different or disabled leading to social rejection (Evans et al., 2008). Social rejection may lead to long term negative consequences such as reduced academic and social interactions, depression, and negative self-perceptions (Ferguson, Miguel, Kilburn & Sanchez, 2007; Hawker & Boulton, 2000) and are harmful if not urgently addressed. This is prevalent in the adolescent population due to stress and rapid changes of emotion at this age (Evans et al, 2008). Attitudes and perceptions overlap (Foster, 2006) which is useful as negative peer attitudes may lead to negative perceptions towards CWS (Blood & Blood, 2004; Blood et al., 2010; Evans et al., 2008; Langevin et al., 2009). While the relationships between attitudes, attitude change and behaviour change are complex and multifaceted (Prochaska, Redding & Evers 2008), this study focusseson f attitude as the precursor for change. (Scott, 2000). This study does not focus on behaviour change. Attitudes are described as an individual's evaluation of issues, objects and other individuals. The evaluation of another person or object can be positive or negative (Petty, Wegener & Tormala, 2003) Furthermore, attitude formation is known to continuously change over time, (Krahe & Altwasser, 2006) as it is learnt and shaped (Foster, 2006). The International Classification and Functioning of Disability (ICF) framework (Murphy, Yaruss & Quesal., 2007) considers holistic management of the CWS. It advocates for classroom-based interventions to reduce teasing and bullying (Merrell, Gueldner , Ross & Isava., 2008; Murphy et al., 2007; Langevin, 2009) because children spend a large amount of time with teachers (Blank et al, 2009). Classroom-based interventions also empowers teachers. International public education addresses stuttering-related stigma (Scott, 2000) through reducing the debilitating nature of stuttering and improving social environments and reactions (St Louis, 2011). These publicised campaigns have not documented effectiveness. However, the potential for classroom-based interventions to change attitudes to stuttering are emerging. Survey of Human Attributes- Stuttering (POSHA-S) showed that negative attitudes are prevalent in school-aged children (Flynn & St Louis, 2011) A follow-up study conducted in South Africa, using the POSHA-S, showed that teachers were requesting assistance with managing negative attitudes to stuttering (Abrahams, 2015). The Teasing and Bullying: Unacceptable Behaviour (TAB) included teacher administered activities and yielded positive results pre- and post- intervention (; Langevin, 2009; Langevin & Prasad, 2012). The TAB was however not suitable for South African classrooms due to time and technology constraints as well as contextual, cultural and linguistic differences. This led to the development of the South African specific intervention, the CCR intervention. It was developed and has been refined since 2009 as part of a series of the University of Cape Town projects. The CCR intervention yielded positive results at 1 month post-intervention within the lower and higher quintile population respectively (Kathard et al.,2014 & Walters, 2015) and more so at 6 months post-intervention (Badroodien, 2015). The feasibility study thus reported potential effectiveness of the CCR intervention at 1 and 6 months post-intervention (Badroodien, 2015). The findings were however inconclusive as it called for a more rigorous design method. The findings also reported that a RCT was feasible despite concerns regarding the retention of participants. A RCT was thus recommended as the next stage in these projects (Badroodien, 2015) The CCR intervention addresses prosocial behaviours and skills, including but not limited to the promotion of positive behaviour change, peer support and resilience through intervention (Blank et al, 2009) in the areas of Positive Social Distance (PSD), Verbal Interaction (VI) and Social Pressure (SP) in the CCR intervention. The areas of PSD, VI and SP are additionally measured where PSD represents the overall ease, acceptance of and comfort a child feels when around CWS (Langevin, 2009; e.g. 'I would let a child who stutters hang out with us'). VI evaluates peer's negative thoughts, emotions and feelings, e.g. frustration experienced towards a CWS (Langevin et al., 2009). SP evaluates general thoughts regarding CWS through examining social pressure and subjective norms (Langevin, 2009). An example is 'I would be ashamed to be seen with a child who stutters'. The promotion of these prosocial behaviours and skills may facilitate the prevention of anxiety and depression (Blank et al, 2009). In post-apartheid schools are unequal particularly in relation to resources. IN an attempt to address such inequality, a system based on the National Norms and Standards for school funding policy was developed to classify schools in relation to resources..) . (Motala, 2006) using the National Norms and Standards for School Funding (NNSSF) policy (Mestry & Ndhlovu, 2014). Lower quintiles one, two and three are no fee paying schools (Department of Education, 2009; Sayed & Motala, 2012).Higher quintiles four and five are fee-paying schools that are better resourced (Department of Education, 2009; Sayed & Motala, 2012). This study therefore aims to compare the treatment effect in the low and high quintiles, explored as a subgroup in this study

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stuttering in Adolescence, Bullying of Child
    Keywords
    stuttering, children who stutter, peer attitudes, classroom-based intervention, teasing, bullying

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    10 schools are included. The schools are assigned to control versus intervention groups
    Masking
    ParticipantInvestigator
    Masking Description
    The Principal investigator is blinded to the study. The researcher is able to observe while the research assistants are aware of who is in the control versus intervention groups.
    Allocation
    Randomized
    Enrollment
    453 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention school 1
    Arm Type
    Active Comparator
    Arm Description
    All participants complete the questionnaire at baseline. The Classroom Communication Resource Intervention is administered by the teacher. The participants observe the intervention which is a social story (read by the teacher), the class performs a role-play (same plot as the story) and then the teacher facilitates and leads a semi-structured discussion. The intervention takes place in 1 classroom lesson only. No further intervention is completed.
    Arm Title
    Intervention school 2
    Arm Type
    Active Comparator
    Arm Description
    All participants complete the questionnaire at baseline. The Classroom Communication Resource Intervention is administered by the teacher.The participants observe the intervention which is a social story (read by the teacher), the class performs a role-play (same plot as the story) and then the teacher facilitates and leads a semi-structured discussion. The intervention takes place in 1 classroom lesson only. No further intervention is completed.
    Arm Title
    Intervention school 3
    Arm Type
    Active Comparator
    Arm Description
    All participants complete the questionnaire at baseline. The Classroom Communication Resource Intervention is administered by the teacher. The participants observe the intervention which is a social story (read by the teacher), the class performs a role-play (same plot as the story) and then the teacher facilitates and leads a semi-structured discussion. The intervention takes place in 1 classroom lesson only. No further intervention is completed.
    Arm Title
    Intervention school 4
    Arm Type
    Active Comparator
    Arm Description
    All participants complete the questionnaire at baseline. The Classroom Communication Resource Intervention is administered by the teacher. The participants observe the intervention which is a social story (read by the teacher), the class performs a role-play (same plot as the story) and then the teacher facilitates and leads a semi-structured discussion. The intervention takes place in 1 classroom lesson only. No further intervention is completed.
    Arm Title
    Intervention school 5
    Arm Type
    Active Comparator
    Arm Description
    All participants complete the questionnaire at baseline. The Classroom Communication Resource Intervention is administered by the teacher. The participants observe the intervention which is a social story (read by the teacher), the class performs a role-play (same plot as the story) and then the teacher facilitates and leads a semi-structured discussion. The intervention takes place in 1 classroom lesson only. No further intervention is completed.
    Arm Title
    control school 1
    Arm Type
    Placebo Comparator
    Arm Description
    All participants complete the questionnaire at baseline. The Classroom Communication Resource Intervention is not administered by the teacher.
    Arm Title
    control school 2
    Arm Type
    Placebo Comparator
    Arm Description
    All participants complete the questionnaire at baseline. The Classroom Communication Resource Intervention is not administered by the teacher.
    Arm Title
    control school 3
    Arm Type
    Placebo Comparator
    Arm Description
    All participants complete the questionnaire at baseline. The Classroom Communication Resource Intervention is not administered by the teacher.
    Arm Title
    control school 4
    Arm Type
    Placebo Comparator
    Arm Description
    All participants complete the questionnaire at baseline. The Classroom Communication Resource Intervention is not administered by the teacher.
    Arm Title
    control school 5
    Arm Type
    Placebo Comparator
    Arm Description
    All participants complete the questionnaire at baseline. The Classroom Communication Resource Intervention is not administered by the teacher.
    Intervention Type
    Other
    Intervention Name(s)
    Classroom Communication Resource
    Intervention Description
    The Classroom Communication Resource intervention is a classroom- and group-based interventions administered by teachers. It includes a social story, role-play and teacher-led discussion
    Intervention Type
    Other
    Intervention Name(s)
    No intervention
    Intervention Description
    No intervention is administered in this group as these are control groups
    Primary Outcome Measure Information:
    Title
    Baseline rating of peer attitudes
    Description
    The Stuttering Resource Outcomes Measure is used to evaluate peer's rating of attitudes towards children who stutter.
    Time Frame
    Baseline
    Title
    6 months post-intervention rating of peer attitudes
    Description
    The Stuttering Resource Outcomes Measure is used to evaluate peer's rating of attitudes towards children who stutter
    Time Frame
    6 months post-intervention
    Secondary Outcome Measure Information:
    Title
    Construct peer ratings of attitudes
    Description
    The Stuttering Resource Outcomes Measure is used to evaluate peer's rating of attitudes towards children who stutter. This questionnaire is made up of and measures the constructs: positive social distance, verbal interaction and social pressure. These constructs will be analsyed within constructs and compared to one another at each time frame
    Time Frame
    Baseline and 6 months post-intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    11 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Eligible participants for the primary objective of this study include grade 7 mixed- gender participants aged 11 and older attending public schools within the Cape Metro urban area across the lower (two and three) and higher (four and five) quintiles where the Language of learning and teaching (LoLT) is English. Exclusion Criteria: Participants in private schools, in grades 1-6 within the Cape Metro urban area with a LoLT other than English .
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lehana Thabane
    Organizational Affiliation
    McMaster University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    The individual participant data willl be shared amongst the primary researcher, research assistants, contributing authors and the statistician. Once the data is analysed, the findings will be reported in an article. The study looks at clusters and thus it is not necessary to share IPD. If any researchers are wanting access to statistical data, this can be requested
    Citations:
    PubMed Identifier
    31338480
    Citation
    Borhan S, Mallick R, Pillay M, Kathard H, Thabane L. Sensitivity of methods for analyzing continuous outcome from stratified cluster randomized trials - an empirical comparison study. Contemp Clin Trials Commun. 2019 Jul 5;15:100405. doi: 10.1016/j.conctc.2019.100405. eCollection 2019 Sep.
    Results Reference
    derived
    PubMed Identifier
    30497490
    Citation
    Mallick R, Kathard H, Borhan ASM, Pillay M, Thabane L. A cluster randomised trial of a classroom communication resource program to change peer attitudes towards children who stutter among grade 7 students. Trials. 2018 Nov 29;19(1):664. doi: 10.1186/s13063-018-3043-3.
    Results Reference
    derived
    PubMed Identifier
    29343283
    Citation
    Mallick R, Kathard H, Thabane L, Pillay M. The Classroom Communication Resource (CCR) intervention to change peer's attitudes towards children who stutter (CWS): study protocol for a randomised controlled trial. Trials. 2018 Jan 17;19(1):43. doi: 10.1186/s13063-017-2365-x.
    Results Reference
    derived

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    The Classroom Communication Resource (CCR) Intervention to Change Grade 7 Peer's Attitudes Towards Children Who Stutter (CWS)

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