NCT03111524

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
453

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 13, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
Last Updated

November 6, 2017

Status Verified

October 1, 2017

Enrollment Period

1.9 years

First QC Date

March 9, 2017

Last Update Submit

October 31, 2017

Conditions

Stuttering in AdolescenceBullying of Child

Keywords

stutteringchildren who stutterpeer attitudesclassroom-based interventionteasingbullying

Outcome Measures

Primary Outcomes (2)

  • Baseline rating of peer attitudes

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

    Baseline

  • 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

    6 months post-intervention

Secondary Outcomes (1)

  • Construct peer ratings of attitudes

    Baseline and 6 months post-intervention

Study Arms (10)

Intervention school 1

ACTIVE COMPARATOR

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

Intervention school 2

ACTIVE COMPARATOR

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

Intervention school 3

ACTIVE COMPARATOR

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

Intervention school 4

ACTIVE COMPARATOR

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

Intervention school 5

ACTIVE COMPARATOR

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

control school 1

PLACEBO COMPARATOR

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

Other: No intervention

control school 2

PLACEBO COMPARATOR

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

Other: No intervention

control school 3

PLACEBO COMPARATOR

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

Other: No intervention

control school 4

PLACEBO COMPARATOR

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

Other: No intervention

control school 5

PLACEBO COMPARATOR

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

Other: No intervention

Interventions

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

Intervention school 1Intervention school 2Intervention school 3Intervention school 4Intervention school 5
No interventionOTHER

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

control school 1control school 2control school 3control school 4control school 5

Eligibility Criteria

Age11 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 31338480DERIVED

  • 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.

    PMID: 30497490DERIVED

  • 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.

    PMID: 29343283DERIVED

MeSH Terms

Conditions

StutteringBullying

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsAggressionBehavioral SymptomsBehaviorHarassment, Non-SexualSocial Behavior

Study Officials

  • Lehana Thabane

    McMaster University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 10 schools are included. The schools are assigned to control versus intervention groups
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD student; investigator

Study Record Dates

First Submitted

March 9, 2017

First Posted

April 13, 2017

Study Start

October 15, 2016

Primary Completion

August 31, 2018

Study Completion

August 31, 2018

Last Updated

November 6, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

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