Title: Evaluating the efficacy of the Promoting Alternative Thinking Strategies (PATHS) curriculum in promoting social and emotional wellbeing among children in primary school: a cluster randomised controlled trial
Funder: Department of Health (England)

Abstract: DESIGN: Cluster randomized controlled trialSETTING: Primary schools in England TARGET POPULATION: Children in primary school aged 7-11 INTERVENTION: Promoting Alternative Thinking Strategies (PATHS) (see section C) HYPOTHESES: (1) Children in primary schools implementing PATHS over a two-year period will demonstrate significant improvements in social and emotional competence (1a) health-related quality of life (1b) exclusions (reduction) (1c) attendance (1d) and academic attainment (1e) when compared to those attending control schools. (2) The effects outlined in H1 will be sustained at two-year post-intervention follow-up. (3) Children in primary schools implementing PATHS over a two-year period will demonstrate significantly better psychosocial adjustment upon transfer to secondary school when compared to those attending control schools. (4) Quality of implementation will be associated with improved outcomes in school implementing PATHS. (5) Proximal changes in social and emotional competence and the learning environment will be associated with distal improvements in motivation to learn psychological wellbeing and (reduced) internalising and externalising difficulties which in turn will impact upon attendance academic attainment and exclusions. (6) The PATHS intervention will demonstrate cost-effectiveness. PRIMARY OUTCOME MEASURE*: Social and emotional competence - the Social Skills Improvement System (SSIS)/Strengths and Difficulties Questionnaire (SDQ) (5051)SECONDARY OUTCOME MEASURES*: Health-related quality of life - the Kidscreen-27 (KS27) (55); attendance (% half-days of unauthorized absence) and attainment (end of Key Stage 2 Points Scores for Maths and English)** - school data; psychosocial adjustment to secondary school (KS27 school environment peers/social support and psychological wellbeing subscales)CONTROL/BACKGROUND MEASURES: At cluster level we will survey schools usual practice (e.g. involvement and implementation status for related initiatives such as Social and Emotional Aspects of Learning Targeted Mental Health in Schools Circle Time Nurture Groups) plus their salient characteristics (e.g. size urbanicity OFSTED ratings) and collect data on PATHS implementation processes (e.g. fidelity dosage). At participant level school data on sex age ethnicity free school meal eligibility (FSM) and special educational needs (SEN) (primary need and stage of provision) will be sought.SAMPLE SIZE: Based upon previous evaluations of PATHS and a recent meta-analysis of SEL interventions (16) an effect size of at least d=0.2 is anticipated for the primary outcome measure. With Power = 0.8 Alpha = 0.05(60) taking into account an average of N=75 per cluster (school) (3 classes x 25 pupils per class) and an estimated ICC of no more than 0.05 (5758) 50 clusters are needed (25 in each arm of the trial). This yields a total sample of 75 x 50 N = 3750 (see SD1 CONSORT diagram) ANALYSIS: Hierarchical linear modelling (HLM)*** to evaluate the efficacy of the intervention on the primary and secondary outcome measures (H1a-e H2 H3) and to investigate impact on health inequalities for key sub-groups; path analysis to evaluate the association between fidelity to treatment model and outcomes (H4) and the underlying SEL change theory (H5); cost-effectiveness analysis to determine the ratio of implementation costs relative to the improvements in measured outcomes and indicative cost-benefit analysis to determine the ratio of implementation costs to monetary savings caused by reductions in exclusions and increases in attendance and attainment (H6). TIMESCALE: Start Jan 2012 End March 2017 (63 months). LEAD-IN PHASE (01-08/2012). Key tasks to include recruitment of project staff formation of funders network and public advisory group (see section G) development and piloting of online survey system for outcome measures recruitment of schools (and initial PATHS training for staff) ethical approval and random allocation procedure. MAIN TRIAL PHASE (09/2012- 08/2014). Schools randomly allocated to the treatment arm of the trial will implement PATHS with support and technical assistance from the implementation team (see section C) with children in three classes (Years 3 4 and 5). Schools in the control arm of the trial to continue usual practice. At the beginning (Time 1 - 09/2012) mid-point (Time 2 - 09/2013) and end (Time 3 - 07/2014) of this period the research team will administer our primary and secondary outcome measures. Control/background measures will be taken at Times 1 and 3. We will visit each intervention school on a half-termly basis and conduct structured observations of sessions and interviews with key stakeholders to develop a rich picture of the intervention process. FOLLOW-UP PHASE (09/2014 - 08/2016). We will follow-up and continue to take outcome measures for the children from the main trial (N=1250) who have transferred to secondary school. This will follow the same pattern established in the main trial with measures at the beginning (T3) mid-point (T4) and end (T5) of the phase. WRITING-UP/DISSEMINATION PHASE (09/2016 - 03/2017). We will complete all analyses prepare and submit journal articles and disseminate our findings at academic and practitioner conferences. *To maximise validity we will use multi-informant (child teacher and/or parent as appropriate) sources for the SSIS SDQ and KS27. **Measure applies to sub-sample of participants (N=1250) who transfer to secondary school at the end of the main trial. ***HLM also allows analysis of differential impact by gender ethnicity FSM and SEN (health inequalities).


Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: MENTAL HEALTH