Condition category
Mental and Behavioural Disorders
Date applied
31/07/2009
Date assigned
11/08/2009
Last edited
20/03/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Helen Baker-Henningham

ORCID ID

Contact details

Epidemiology Research Unit
University of the West Indies
Mona
Kingston
7
Jamaica

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

080534

Study information

Scientific title

Promoting young children’s 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

http://mona.uwi.edu/

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

  1. 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.

Additional files

Editorial Notes