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Stuttering in AdolescenceCCRNCT03111524

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

A study testing Classroom Communication Resource in people with Stuttering in Adolescence and Bullying of Child, run by Rizwana Mallick.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 11 to 17 yearsHealthy volunteers can take part
Conditions the study is for
Stuttering in Adolescence, Bullying of Child
What is being tested?
Classroom Communication Resource
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
453 participants
Where
No sites listed yet
Study dates
15 Oct 2016to 31 Aug 2018
Phase
Interventional
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 11 to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

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

About this study

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

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.

Read the 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

Being tested
Classroom Communication Resource, No intervention
Keywords
stuttering, children who stutter, peer attitudes, classroom-based intervention, teasing, bullying
Medical subject headings
Stuttering, Bullying

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Classroom Communication ResourceOther

    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

  • No interventionOther

    No intervention is administered in this group as these are control groups

Study groups in NCT03111524
Study groupRoleWhat they receive
Intervention school 1Active comparatorAll 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.
Receives: Other: Classroom Communication Resource
Intervention school 2Active comparatorAll 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.
Receives: Other: Classroom Communication Resource
Intervention school 3Active comparatorAll 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.
Receives: Other: Classroom Communication Resource
Intervention school 4Active comparatorAll 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.
Receives: Other: Classroom Communication Resource
Intervention school 5Active comparatorAll 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.
Receives: Other: Classroom Communication Resource
control school 1Placebo comparatorAll participants complete the questionnaire at baseline. The Classroom Communication Resource Intervention is not administered by the teacher.
Receives: Other: No intervention
control school 2Placebo comparatorAll participants complete the questionnaire at baseline. The Classroom Communication Resource Intervention is not administered by the teacher.
Receives: Other: No intervention
control school 3Placebo comparatorAll participants complete the questionnaire at baseline. The Classroom Communication Resource Intervention is not administered by the teacher.
Receives: Other: No intervention
control school 4Placebo comparatorAll participants complete the questionnaire at baseline. The Classroom Communication Resource Intervention is not administered by the teacher.
Receives: Other: No intervention
control school 5Placebo comparatorAll participants complete the questionnaire at baseline. The Classroom Communication Resource Intervention is not administered by the teacher.
Receives: Other: No intervention

What is being measured

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

  1. Baseline rating of peer attitudes

    The Stuttering Resource Outcomes Measure is used to evaluate peer's rating of attitudes towards children who stutter.

    Measured: Baseline

  2. 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

    Measured: 6 months post-intervention

Secondary outcomes (1)
  1. 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

    Measured: Baseline and 6 months post-intervention

Timeline

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

  1. First posted13 Apr 2017
  2. Study start15 Oct 2016
  3. Primary completion31 Aug 2018 (estimated)
  4. Study completion31 Aug 2018 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
10 schools are included. The schools are assigned to control versus intervention groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
453 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03111524
Sponsor's protocol ID
PhD protocol 2017
Acronym
CCR
Status last verified
Oct 2017
First submitted
9 Mar 2017
Last updated
6 Nov 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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

Publications

  • 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.

    PubMed 31338480
  • 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.

    PubMed 30497490
  • 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.

    PubMed 29343283

Questions about this trial

What is this clinical trial studying?

A study testing Classroom Communication Resource in people with Stuttering in Adolescence and Bullying of Child, run by Rizwana Mallick.

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 1 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: status not confirmed, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

Results are not available in the source record.

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?

Baseline rating of peer attitudes (time frame: Baseline). The study lists 2 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 NCT03111524, which also lists 3 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 6 Nov 2017.

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