Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03111524
Recruitment Status : Active, not recruiting
First Posted : April 13, 2017
Last Update Posted : November 6, 2017
Sponsor:
Collaborators:
University of Cape Town
National Research Fund - South Africa
Information provided by (Responsible Party):
Rizwana Mallick, University of Cape Town

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.

Condition or disease Intervention/treatment Phase
Stuttering in Adolescence Bullying of Child Other: Classroom Communication Resource Other: No intervention Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 453 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 10 schools are included. The schools are assigned to control versus intervention groups
Masking: Double (Participant, Investigator)
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.
Primary Purpose: Treatment
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
Actual Study Start Date : October 15, 2016
Estimated Primary Completion Date : August 31, 2018
Estimated Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stuttering

Arm Intervention/treatment
Active Comparator: Intervention school 1
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.
Other: Classroom Communication Resource
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

Active Comparator: Intervention school 2
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.
Other: Classroom Communication Resource
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

Active Comparator: Intervention school 3
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.
Other: Classroom Communication Resource
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

Active Comparator: Intervention school 4
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.
Other: Classroom Communication Resource
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

Active Comparator: Intervention school 5
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.
Other: Classroom Communication Resource
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

Placebo Comparator: control school 1
All participants complete the questionnaire at baseline. The Classroom Communication Resource Intervention is not administered by the teacher.
Other: No intervention
No intervention is administered in this group as these are control groups

Placebo Comparator: control school 2
All participants complete the questionnaire at baseline. The Classroom Communication Resource Intervention is not administered by the teacher.
Other: No intervention
No intervention is administered in this group as these are control groups

Placebo Comparator: control school 3
All participants complete the questionnaire at baseline. The Classroom Communication Resource Intervention is not administered by the teacher.
Other: No intervention
No intervention is administered in this group as these are control groups

Placebo Comparator: control school 4
All participants complete the questionnaire at baseline. The Classroom Communication Resource Intervention is not administered by the teacher.
Other: No intervention
No intervention is administered in this group as these are control groups

Placebo Comparator: control school 5
All participants complete the questionnaire at baseline. The Classroom Communication Resource Intervention is not administered by the teacher.
Other: No intervention
No intervention is administered in this group as these are control groups




Primary Outcome Measures :
  1. Baseline rating of peer attitudes [ Time Frame: Baseline ]
    The Stuttering Resource Outcomes Measure is used to evaluate peer's rating of attitudes towards children who stutter.

  2. 6 months post-intervention rating of peer attitudes [ Time Frame: 6 months post-intervention ]
    The Stuttering Resource Outcomes Measure is used to evaluate peer's rating of attitudes towards children who stutter


Secondary Outcome Measures :
  1. Construct peer ratings of attitudes [ Time Frame: Baseline and 6 months post-intervention ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   11 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 .


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): NCT03111524


Sponsors and Collaborators
Rizwana Mallick
University of Cape Town
National Research Fund - South Africa
Investigators
Layout table for investigator information
Study Chair: Lehana Thabane McMaster University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Rizwana Mallick, PhD student; investigator, University of Cape Town
ClinicalTrials.gov Identifier: NCT03111524     History of Changes
Other Study ID Numbers: PhD protocol 2017
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rizwana Mallick, University of Cape Town:
stuttering
children who stutter
peer attitudes
classroom-based intervention
teasing
bullying

Additional relevant MeSH terms:
Layout table for MeSH terms
Stuttering
Bullying
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Aggression
Behavioral Symptoms