Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
080534
Study information
Scientific title
Promoting young childrens social and emotional competence and preventing conduct problems: a cluster randomised controlled trial
Acronym
Study hypothesis
A school-based, universal preventative intervention for 3 - 6 year old children aimed at reducing conduct problems and promoting social and emotional competence will lead to improvements in:
1. The behaviour of children who are at high risk for developing conduct problems at home and at school
2. Teachers' practices in preventing and remediating children's conduct problems and promoting children's social and emotional competence
3. Parents' involvement in school
Ethics approval
University Hospital of the West Indies/University of the West Indies/Faculty of Medical Sciences Ethics Committee approved on the 16th April 2009 (ref: ECP 222, 2008/2009)
Study design
Cluster randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Conduct problems in children
Intervention
The intervention is based on The Incredible Years Teacher Training Programme and will be delivered over the 2009/2010 academic year. The intervention will start in November 2009 and continue until May 2010. Teachers will attend monthly teacher training workshops throughout the intervention period and will be visited monthly in their classrooms.
Teachers in the control schools receive no training but are provided with additional educational materials.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Child behaviour through direct observation at school at baseline (beginning of the school year) and at follow up (end of the school year). Observations will include event recording of child aggression and child friendship skills, scan sampling of child disruptive behaviour and ratings of children's conduct problems, activity level, engagement in learning activities and ability to follow classroom rules and expectations.
Secondary outcome measures
1. Child behaviour through teacher and parent report at baseline and follow up using The Eyberg and Sutter/Eyberg Child Behaviour Inventories and The Strengths and Difficulties Questionnaire
2. Child social skills (using the Preschool and Kindergarten Behaviour Scales: social skills scale) and child ADHD (using the Conners ADHD index) by teacher report at baseline and follow up
3. Teacher's positive and negative interactions with children at high risk for developing conduct problems measured through direct observation (event sampling) at baseline and follow up
4. Teachers classroom management practices at baseline and follow up measured through direct observation. These teacher observations include event sampling of teachers' use of positive and negative strategies and observer ratings of the teachers' behaviour and classroom atmosphere.
5. Parent involvement in school at follow up measured by parent report
Overall trial start date
01/05/2009
Overall trial end date
31/07/2010
Reason abandoned
Eligibility
Participant inclusion criteria
Community preschools (catering to 3 - 6 year old children) will be included in the study if the school principal and all teachers are willing to participate and if the school:
1. Is situated in a defined disadvantaged, urban area of Kingston and St Andrew
2. Has 3 or 4 classes of children
3. Has a minimum of 20 children in each class
Three children from each class will be selected for evaluation of outcomes. Teachers in each class will rate the behaviour of all children in their class on 10 questions for conduct problems using age-appropriate items from the ICD-10 classification of mental and behavioural disorders: Diagnostic criteria for research. Children with the highest scores will be included in the evaluation.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
24 community preschools, 216 children
Participant exclusion criteria
All community preschools who meet the inclusion criteria are eligible for participation. Children will be excluded if:
1. They have an attendance rate of less than 70%
2. They have an identified disability
3. They live in a children's home or place of safety
Recruitment start date
01/05/2009
Recruitment end date
31/07/2010
Locations
Countries of recruitment
Jamaica
Trial participating centre
Epidemiology Research Unit
Kingston
7
Jamaica
Sponsor information
Organisation
University of the West Indies (Jamaica)
Sponsor details
c/o Professor Susan Walker
Epidemiology Research Unit
Tropical Medicine Research Institute
Mona
Kingston
7
Jamaica
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
The Wellcome Trust (UK) (ref: 080534)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22500015
Publication citations
-
Results
Baker-Henningham H, Scott S, Jones K, Walker S, Reducing child conduct problems and promoting social skills in a middle-income country: cluster randomised controlled trial., Br J Psychiatry, 2012, 201, 101-108, doi: 10.1192/bjp.bp.111.096834.