Condition category
Mental and Behavioural Disorders
Date applied
21/10/2009
Date assigned
15/12/2009
Last edited
04/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.dartington.org.uk

Contact information

Type

Scientific

Primary contact

Dr Vashti Berry

ORCID ID

Contact details

The Social Research Unit
Lower Hood Barn
Dartington
TQ9 6AB
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

L680 TA-01631-01 RVPOG AOO

Study information

Scientific title

A randomised controlled trial of the PATHS® School-Based Programme delivered in sixty primary schools across Birmingham City

Acronym

Study hypothesis

1. Children whose teachers received Promoting Alternative Thinking Strategies (PATHS®) training will show a reduced problem behaviour and hyperactivity, and improved social competence and social and emotional wellbeing
2. The PATHS® School-Based Programme will offer value for money and net benefit to the Council

Ethics approval

Warren House Group Ethics Committee, 05/03/2009, ref: WHG 2009-1

Study design

Single-centre 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 school information sheet

Condition

Conduct disorder (CD), hyperactivity, deficits in social and emotional wellbeing

Intervention

The PATHS® programme (Promoting Alternative Thinking Strategies) curriculum is a programme for educators and counsellors and is designed to facilitate the development of self-control, emotional awareness, and interpersonal problem-solving skills. PATHS® is designed for use with elementary school-aged children. The purposes of the PATHS® Curriculum are to enhance the social competence and social understanding of children, as well as to facilitate educational processes in the classroom. PATHS® has been translated into Dutch, French, and Hebrew. It is used in a variety of schools for normal, deaf, and other special needs children in The Netherlands, Belgium, Wales, Great Britain, Norway, Canada, Australia, and Israel. In the United States, it is currently being used in sites in Washington State, Texas, Kansas, Illinois, South Carolina, New Mexico, and Pennsylvania.

The PATHS® programme is grounded in the science of children's brain development, which has determined that children experience and react to strong emotions before developing the cognitive abilities to verbalise them. The PATHS® programme's practical, effective strategies teach children how to label their feelings and apply self-control strategies, leading to significant improvements in coping skills, classroom behaviour, and verbal fluency.

The waiting list control schools will be offered the intervention after the final follow-up which is June 2011.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The parent-completed Strengths and Difficulties Questionnaire (SDQ) is the primary outcome measure for total child difficulties. We shall also analyse the subscales of conduct, peer relationships and hyperactivity problems, social competence, and the impact supplement, which assesses the impact problem behaviour can have in other areas of life. The clinical cut-off is 17 for total difficulties - the higher the score the worse the problems. This measure (and all secondary measures) will be administered at November 2009 baseline, and June 2010 and 2011 follow-ups.

Secondary outcome measures

Baseline data collection will be via teacher-completed questionnaires, teacher roles and background survey (baseline only), PATHS Outcome Measure, School Climate Survey, implementation content survey, and implementation observations.
1. School climate: this survey measures general school climate, orientation of the school to innovation, collective responsibility, and working with parents
2. Teacher demographic and professional information: this survey measures demographic and professional information (behavioural management strategies) at baseline. In the June follow-ups, items regarding specific PATHS implementation support for programme condition teachers will be added to intervention group.
3. Teacher-reported measures of child problem behaviour: the PATHS outcome measure to assess social, emotional and behavioural problems in the school children
4. Observations of behaviours: we will use an observation developed for Fast Track that is a global rating scale of student behaviour. Timed observations involve conducting a 15-30 minute observation of teacher and classroom behaviour (developed by American Institute for Research [AIR]). At least one class will be observed in each school at each time point.

Overall trial start date

01/06/2009

Overall trial end date

30/11/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Primary schools within Birmingham City
2. Children aged 4 - 6 years, either sex

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

60 schools, 30 intervention, 30 control

Participant exclusion criteria

Secondary schools and schools outside of the City

Recruitment start date

01/06/2009

Recruitment end date

30/11/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

The Social Research Unit
Dartington
TQ9 6AB
United Kingdom

Sponsor information

Organisation

Birmingham County Council (UK)

Sponsor details

CYP&F Directorate
Room 183
Council House Extension
Margaret Street
Birmingham
B3 3BU
United Kingdom

Sponsor type

Government

Website

http://www.birmingham.gov.uk/

Funders

Funder type

Government

Funder name

Birmingham County Council (UK) (ref: L680 TA-01631-01 RVPOG AOO)

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

Publication citations

Additional files

Editorial Notes