Physical ViolenceGSSNCT01678846
Good Schools Study
A study testing Good School Toolkit in people with Physical Violence and Educational Achievement, run by London School of Hygiene and Tropical Medicine at 1 site in Uganda.
Trial summary
The purpose of this study is to determine whether use of the Good Schools Toolkit is effective in reducing violence against children in primary schools. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Physical Violence, Educational Achievement, Mental Health
- What is being tested?
- Good School Toolkit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,820 participants
- Where
- 1 siteUganda
- Study dates
- Jun 2012to Jul 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
- Inclusion Criteria:
- Schools
- in Luwero District, Uganda
- more than 40 students registered in Primary 5
- Participants
- registered as a Primary 5, 6 or 7 pupil
- any school staff member
- Exclusion Criteria:
- Schools -- existing program related to prevention of violence against children or school governance
- Participants -- not able to understand consent and study procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Good Schools Study: Cluster Randomised Controlled Trial of a Program to Prevent Violence Against Children in Schools
The purpose of this study is to determine whether use of the Good Schools Toolkit is effective in reducing violence against children in primary schools.
Read the detailed description
Violence against children has profound effects on both children's health and their ability to do well at school. Fear, anxiety and injuries caused by violence may play a large role in both children's absenteeism and low educational achievement, and there is increasing interest from large bilateral donors in investigating this link in low income countries. The Good School Toolkit has been developed and refined for 6 years in Uganda by Raising Voices. The toolkit takes a systemic approach, involving an entire school in a process of change to reduce violence and improve teaching techniques. The Toolkit draws on the Transtheoretical Model and incorporates standard behaviour change techniques such as setting a goal and making an action plan, which are effective in modifying behaviour. This study aims to determine whether use of the Good School Toolkit reduces children's experience of violence by school staff. The investigators will also examine the effects of the Toolkit on children's educational outcomes, mental health and well-being.
The investigators will conduct a cluster randomised controlled trial in 40 primary schools in Luwero District, Uganda. More than 3500 children in Primary 5, 6 and 7 will be surveyed (aged about 11-16 years). Half of the schools will receive the Toolkit, and other half will be put on a waiting list to receive the Toolkit at the end of the study. The results from this evaluation will be used to brief policy-makers within the Ministry of Education and Sports involved in developing country-wide policy and practice around violence against children in schools.
- Conditions
- Physical Violence, Educational Achievement, Mental Health, Sexual Violence, Violence Against Children
- Being tested
- Good School Toolkit
- Keywords
- corporal punishment, violence, education, depression, anxiety, conduct disorder
- Medical subject headings
- Psychological Well-Being, Depression, Anxiety Disorders, Conduct Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Good School ToolkitBehavioural
The Toolkit uses a six step process to create a school wide intervention that engages teachers, students, administration, and parents to reflect on how they can promote quality of education in their school. The Toolkit articulates complex ideas (what is a good learning environment, a good teacher, how to create positive discipline without using violence) through booklets, posters and school initiated learning processes. Specific modules on alternative discipline techniques and how staff can use positive discipline are included in the Toolkit. The intervention includes sessions on knowledge, attitudes and opportunities to practice new behavioural skills. Work is led by teachers and students, and supported by visits from Raising Voices staff. The Toolkit can be reviewed at (http://www.raisingvoices.org/children/good_school_toolkit.php).
| Study group | Role | What they receive |
|---|---|---|
| Good School Toolkit | Experimental | Schools in the intervention arm will receive the Good Schools Toolkit materials and implementation support. Receives: Behavioral: Good School Toolkit |
| Control | No intervention | Schools in this arm will receive the Good Schools Toolkit materials and some implementation support after the end of the trial. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Violence From School Staff
past week experience of any physical violence from school staff
Measured: 2-year follow-up
Secondary outcomes (3)
Child Mental Health
score on the Strengths and Difficulties Questionnaire (SDQ): 20 questions. Total difficulties score, divided by the number of completed items. Modelled as a continuous variable. Range 0 (no difficulties) to 2 (high difficulties).
Measured: 2-year follow-up
Educational Achievement: Word Recognition in English
Word recognition in English(words per minute). Early Grade Reading Assessment, Uganda version. Calculated as number of words read correctly (out of a maximum of 50), divided by the time (out of a maximum of 60 seconds).
Measured: 2-year follow-up
Safety and Well-being at School
Five questions. Each question asked with response options: all the time, most of the time, sometimes, never:
I feel that my teachers care about me. I feel safe in school. I feel like I belong at school. I like to spend time at school. I am scared of my teachers (reverse coded). Scores summed, modelled as a continuous variable. Range 0 (low) to 15 (high). Higher score is better safety and well-being at school.
Measured: At 2 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2012 (estimated)
- Study startJun 2012
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Physical ViolenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,820 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Raising Voices, Institute of Education, UK, Makerere University
- Responsible party
- Sponsor
- Investigators
- Karen M Devries, PhD, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01678846
- Sponsor's protocol ID
- LSHTM_6183
- Acronym
- GSS
- Status last verified
- Jun 2015
- First submitted
- 24 Aug 2012
- Last updated
- 26 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Knight L, Atuhaire L, Bhatia A, Allen E, Namy S, Anton-Erxleben K, Nakuti J, Mirembe A, Nakiboneka M, Seeley J, Weiss HA, Parkes J, Bonell C, Naker D, Devries K. Violence outcomes in later adolescence with the Good School Toolkit-Primary: a nonrandomized controlled trial in Uganda. BMC Public Health. 2024 Jun 7;24(1):1532. doi: 10.1186/s12889-024-19024-5.
PubMed 38849782Carlson C, Namy S, Norcini Pala A, Wainberg ML, Michau L, Nakuti J, Knight L, Allen E, Ikenberg C, Naker D, Devries K. Violence against children and intimate partner violence against women: overlap and common contributing factors among caregiver-adolescent dyads. BMC Public Health. 2020 Jan 29;20(1):124. doi: 10.1186/s12889-019-8115-0.
PubMed 31996179Devries K, Parkes J, Knight L, Allen E, Namy S, Datzberger S, Nalukenge W, Atuhaire L, Kyegombe N, Walakira E, Seeley J, Weiss HA, Naker D. Context of Violence in Adolescence Cohort (CoVAC) study: protocol for a mixed methods longitudinal study in Uganda. BMC Public Health. 2020 Jan 13;20(1):43. doi: 10.1186/s12889-019-7654-8.
PubMed 31931768Knight L, Allen E, Mirembe A, Nakuti J, Namy S, Child JC, Sturgess J, Kyegombe N, Walakira EJ, Elbourne D, Naker D, Devries KM. Implementation of the Good School Toolkit in Uganda: a quantitative process evaluation of a successful violence prevention program. BMC Public Health. 2018 May 9;18(1):608. doi: 10.1186/s12889-018-5462-1.
PubMed 29743105Devries K, Kuper H, Knight L, Allen E, Kyegombe N, Banks LM, Kelly S, Naker D. Reducing Physical Violence Toward Primary School Students With Disabilities. J Adolesc Health. 2018 Mar;62(3):303-310. doi: 10.1016/j.jadohealth.2017.09.004. Epub 2017 Dec 6.
PubMed 29217214Kayiwa J, Clarke K, Knight L, Allen E, Walakira E, Namy S, Merrill KG, Naker D, Devries K. Effect of the good school toolkit on school staff mental health, sense of job satisfaction and perceptions of school climate: Secondary analysis of a cluster randomised trial. Prev Med. 2017 Aug;101:84-90. doi: 10.1016/j.ypmed.2017.05.022. Epub 2017 Jun 2.
PubMed 28579503Grundlingh H, Knight L, Naker D, Devries K. Secondary distress in violence researchers: a randomised trial of the effectiveness of group debriefings. BMC Psychiatry. 2017 Jun 2;17(1):204. doi: 10.1186/s12888-017-1327-x.
PubMed 28578682Devries KM, Knight L, Child JC, Kyegombe N, Hossain M, Lees S, Watts C, Naker D. Witnessing intimate partner violence and child maltreatment in Ugandan children: a cross-sectional survey. BMJ Open. 2017 Feb 28;7(2):e013583. doi: 10.1136/bmjopen-2016-013583.
PubMed 28246136Thumann BF, Nur U, Naker D, Devries KM. Primary school students' mental health in Uganda and its association with school violence, connectedness, and school characteristics: a cross-sectional study. BMC Public Health. 2016 Jul 29;16:662. doi: 10.1186/s12889-016-3351-z.
PubMed 27473040Clarke K, Patalay P, Allen E, Knight L, Naker D, Devries K. Patterns and predictors of violence against children in Uganda: a latent class analysis. BMJ Open. 2016 May 24;6(5):e010443. doi: 10.1136/bmjopen-2015-010443.
PubMed 27221125Devries KM, Child JC, Elbourne D, Naker D, Heise L. "I never expected that it would happen, coming to ask me such questions":Ethical aspects of asking children about violence in resource poor settings. Trials. 2015 Nov 11;16:516. doi: 10.1186/s13063-015-1004-7.
PubMed 26558829Devries KM, Knight L, Child JC, Mirembe A, Nakuti J, Jones R, Sturgess J, Allen E, Kyegombe N, Parkes J, Walakira E, Elbourne D, Watts C, Naker D. The Good School Toolkit for reducing physical violence from school staff to primary school students: a cluster-randomised controlled trial in Uganda. Lancet Glob Health. 2015 Jul;3(7):e378-86. doi: 10.1016/S2214-109X(15)00060-1.
PubMed 26087985Child JC, Naker D, Horton J, Walakira EJ, Devries KM. Responding to abuse: Children's experiences of child protection in a central district, Uganda. Child Abuse Negl. 2014 Oct;38(10):1647-58. doi: 10.1016/j.chiabu.2014.06.009. Epub 2014 Jul 14.
PubMed 25035172Devries KM, Allen E, Child JC, Walakira E, Parkes J, Elbourne D, Watts C, Naker D. The Good Schools Toolkit to prevent violence against children in Ugandan primary schools: study protocol for a cluster randomised controlled trial. Trials. 2013 Jul 24;14:232. doi: 10.1186/1745-6215-14-232.
PubMed 23883138
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Good Schools Study: Cluster Randomised Controlled Trial of a Program to Prevent Violence Against Children in Schools
- ClinicalTrials.gov ID
- NCT01678846
- Acronym / sponsor ID
- GSS / LSHTM_6183
- Conditions
- Physical Violence, Educational Achievement, Mental Health, Sexual Violence, Violence Against Children
- Keywords
- corporal punishment, violence, education, depression, anxiety, conduct disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,820 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Raising Voices, Institute of Education, UK, Makerere University
- Study start
- Jun 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 5 Sep 2012 (estimated)
- Results
- Posted 26 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether use of the Good Schools Toolkit is effective in reducing violence against children in primary schools.
Detailed description
Violence against children has profound effects on both children's health and their ability to do well at school. Fear, anxiety and injuries caused by violence may play a large role in both children's absenteeism and low educational achievement, and there is increasing interest from large bilateral donors in investigating this link in low income countries. The Good School Toolkit has been developed and refined for 6 years in Uganda by Raising Voices. The toolkit takes a systemic approach, involving an entire school in a process of change to reduce violence and improve teaching techniques. The Toolkit draws on the Transtheoretical Model and incorporates standard behaviour change techniques such as setting a goal and making an action plan, which are effective in modifying behaviour. This study aims to determine whether use of the Good School Toolkit reduces children's experience of violence by school staff. The investigators will also examine the effects of the Toolkit on children's educational outcomes, mental health and well-being.
The investigators will conduct a cluster randomised controlled trial in 40 primary schools in Luwero District, Uganda. More than 3500 children in Primary 5, 6 and 7 will be surveyed (aged about 11-16 years). Half of the schools will receive the Toolkit, and other half will be put on a waiting list to receive the Toolkit at the end of the study. The results from this evaluation will be used to brief policy-makers within the Ministry of Education and Sports involved in developing country-wide policy and practice around violence against children in schools.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Good School Toolkit | Experimental | Behavioral: Good School ToolkitSchools in the intervention arm will receive the Good Schools Toolkit materials and implementation support. |
| Control | No intervention | –Schools in this arm will receive the Good Schools Toolkit materials and some implementation support after the end of the trial. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Good School ToolkitThe Toolkit uses a six step process to create a school wide intervention that engages teachers, students, administration, and parents to reflect on how they can promote quality of education in their school. The Toolkit articulates complex ideas (what is a good learning environment, a good teacher, how to create positive discipline without using violence) through booklets, posters and school initiated learning processes. Specific modules on alternative discipline techniques and how staff can use positive discipline are included in the Toolkit. The intervention includes sessions on knowledge, attitudes and opportunities to practice new behavioural skills. Work is led by teachers and students, and supported by visits from Raising Voices staff. The Toolkit can be reviewed at (http://www.raisingvoices.org/children/good_school_toolkit.php). | Behavioural | Good School Toolkit |
Primary outcome
Physical Violence From School Staff
Time frame: 2-year follow-up
past week experience of any physical violence from school staff
3 secondary outcomes
Child Mental Health
Time frame: 2-year follow-up
Educational Achievement: Word Recognition in English
Time frame: 2-year follow-up
Safety and Well-being at School
Time frame: At 2 year follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38849782Knight L, Atuhaire L, Bhatia A, Allen E, Namy S, Anton-Erxleben K, Nakuti J, Mirembe A, Nakiboneka M, Seeley J, Weiss HA, Parkes J, Bonell C, Naker D, Devries K. Violence outcomes in later adolescence with the Good School Toolkit-Primary: a nonrandomized controlled trial in Uganda. BMC Public Health. 2024 Jun 7;24(1):1532. doi: 10.1186/s12889-024-19024-5.
- Derived from this study: PubMed 31996179Carlson C, Namy S, Norcini Pala A, Wainberg ML, Michau L, Nakuti J, Knight L, Allen E, Ikenberg C, Naker D, Devries K. Violence against children and intimate partner violence against women: overlap and common contributing factors among caregiver-adolescent dyads. BMC Public Health. 2020 Jan 29;20(1):124. doi: 10.1186/s12889-019-8115-0.
- Derived from this study: PubMed 31931768Devries K, Parkes J, Knight L, Allen E, Namy S, Datzberger S, Nalukenge W, Atuhaire L, Kyegombe N, Walakira E, Seeley J, Weiss HA, Naker D. Context of Violence in Adolescence Cohort (CoVAC) study: protocol for a mixed methods longitudinal study in Uganda. BMC Public Health. 2020 Jan 13;20(1):43. doi: 10.1186/s12889-019-7654-8.
- Derived from this study: PubMed 29743105Knight L, Allen E, Mirembe A, Nakuti J, Namy S, Child JC, Sturgess J, Kyegombe N, Walakira EJ, Elbourne D, Naker D, Devries KM. Implementation of the Good School Toolkit in Uganda: a quantitative process evaluation of a successful violence prevention program. BMC Public Health. 2018 May 9;18(1):608. doi: 10.1186/s12889-018-5462-1.
- Derived from this study: PubMed 29217214Devries K, Kuper H, Knight L, Allen E, Kyegombe N, Banks LM, Kelly S, Naker D. Reducing Physical Violence Toward Primary School Students With Disabilities. J Adolesc Health. 2018 Mar;62(3):303-310. doi: 10.1016/j.jadohealth.2017.09.004. Epub 2017 Dec 6.
- Derived from this study: PubMed 28579503Kayiwa J, Clarke K, Knight L, Allen E, Walakira E, Namy S, Merrill KG, Naker D, Devries K. Effect of the good school toolkit on school staff mental health, sense of job satisfaction and perceptions of school climate: Secondary analysis of a cluster randomised trial. Prev Med. 2017 Aug;101:84-90. doi: 10.1016/j.ypmed.2017.05.022. Epub 2017 Jun 2.
- Derived from this study: PubMed 28578682Grundlingh H, Knight L, Naker D, Devries K. Secondary distress in violence researchers: a randomised trial of the effectiveness of group debriefings. BMC Psychiatry. 2017 Jun 2;17(1):204. doi: 10.1186/s12888-017-1327-x.
- Derived from this study: PubMed 28246136Devries KM, Knight L, Child JC, Kyegombe N, Hossain M, Lees S, Watts C, Naker D. Witnessing intimate partner violence and child maltreatment in Ugandan children: a cross-sectional survey. BMJ Open. 2017 Feb 28;7(2):e013583. doi: 10.1136/bmjopen-2016-013583.
- Derived from this study: PubMed 27473040Thumann BF, Nur U, Naker D, Devries KM. Primary school students' mental health in Uganda and its association with school violence, connectedness, and school characteristics: a cross-sectional study. BMC Public Health. 2016 Jul 29;16:662. doi: 10.1186/s12889-016-3351-z.
- Derived from this study: PubMed 27221125Clarke K, Patalay P, Allen E, Knight L, Naker D, Devries K. Patterns and predictors of violence against children in Uganda: a latent class analysis. BMJ Open. 2016 May 24;6(5):e010443. doi: 10.1136/bmjopen-2015-010443.
- Derived from this study: PubMed 26558829Devries KM, Child JC, Elbourne D, Naker D, Heise L. "I never expected that it would happen, coming to ask me such questions":Ethical aspects of asking children about violence in resource poor settings. Trials. 2015 Nov 11;16:516. doi: 10.1186/s13063-015-1004-7.
- Derived from this study: PubMed 26087985Devries KM, Knight L, Child JC, Mirembe A, Nakuti J, Jones R, Sturgess J, Allen E, Kyegombe N, Parkes J, Walakira E, Elbourne D, Watts C, Naker D. The Good School Toolkit for reducing physical violence from school staff to primary school students: a cluster-randomised controlled trial in Uganda. Lancet Glob Health. 2015 Jul;3(7):e378-86. doi: 10.1016/S2214-109X(15)00060-1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen M Devries, PhD principal investigator
London School of Hygiene and Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Good School Toolkit in people with Physical Violence and Educational Achievement, run by London School of Hygiene and Tropical Medicine at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. 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?
Yes. Results are posted in the registry (first posted 26 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Physical Violence From School Staff (time frame: 2-year follow-up). 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 NCT01678846, which also lists 14 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 26 Jan 2016.