Pre-Trial Process Evaluation

Phase 1: Pre-Trial Process Evaluation

This work involved specific focus group and survey questions which were given to SLTs who previously delivered Happy Talk for a minimum of 2 years, as well as parents and early years educators who have been recipients of the programme.

The aim of this qualitative research was to identify and make explicit the aspects of ‘Happy Talk’ that have helped to build social capital, (i.e. engagement, good work practices etc) between parents and educators, and which we believe are central to the success of the programme. By making these components explicit we were able to actively integrate them into the Happy Talk SLT training programme.

The following aspects of Happy Talk have been identified to actively build positive work practices:

• Existing relationships are key to parental engagement – including teacher-parent relationships, relationships between parents and networks within the schools.
• Addressing the needs of individual parents and families is key to good attendance– their time, their commitments to younger children, and sessions being held in a convenient location
• Creating an environment of effective communication and mutual respect. Parents and educators are at the forefront of this intervention with SLTs providing guidance and support at an individual and class level. Parents and teachers also benefit from direct access to SLTs to seek feedback and express concerns.
• Parent and Educator confidence increases through the program with a recognition of how they can actively improve children’s speech and language development, and use what they have learnt with all children they are exposed to.
• Parents appreciate relatability and a warm demeanour. SLTs’ use of basic concepts and real world scenarios, allowed parents to use language promoting strategies in the everyday lives when interacting with their children at home.

Intervention Implementation

Phase 2 - Intervention Implementation

The intervention will be evaluated using a cluster-randomized controlled trial over 2 years (2 periods of 28-weeks including baseline- implementation and post-intervention measures).

Our measures to evaluate if the programme has been effective include:

• a language measure that evaluates children understanding and use of language, called the Preschool language scale,5^th (PLS- 5) 
• a functional measure which looks more broadly at children’s communication in an everyday context, called the Focus on the Outcomes of Communication Under Six (FOCUS)
• a measure that captures any overall changes within the setting, specifically relating to interaction, communication and language, called the Classroom Assessment Scoring System (the CLASS) .

We will also use Health-related Quality of Life indicators:

•   the  Paediatric Quality of Life Inventory (PedsQL) Parent report
• the Child Health Utility 9D Index (CHU9D)

We will use each of these measures before the intervention begins, immediately post intervention and at 6 months follow up. The health related quality of life measure will be carried out 1 year post intervention. 

Year one is currently in progress as baseline assessments have been completed and Happy Talk programme sessions are being delivered in intervention settings.

Recruitment:

Pre/schools for iteration 1 were recruited from a range of health areas in Ireland and selected for inclusion in the study, based on levels of social disadvantage. It was made explicit from the outset that all settings will not receive the intervention. The same procedure will be completed for iteration 2.

We will recruit 80 pre/schools in total (over the two years) half of which will be randomly selected to receive the programme and half of which will engage in their usual pre/school activities.  Pre/schools who do not get the programme will receive books and a webinar on using language promoting strategies in their pre/school.

What is Happy Talk?

Happy Talk is a manualized training and support programme delivered by SLTs to parents and early childhood educators in socially disadvantaged areas. The overall programme aims to support children between 0 and 6 years. However, the focus of this trial is solely on the preschool/Junior infant class programme. The programme is embedded in the preschools, and homes of socially disadvantaged children with the aim of effecting change in parent and educator behaviour.

Parent component: This includes twelve 1-hour sessions delivered in two 30-min units, over the three terms of the pre/school year (September–December, January–March and April–June). For the first 30 minutes of each session, parents engage in group training with the SLT in a room within the pre/school. This is followed by 30 minutes of coaching, with parents practicing their newly acquired skills with their children in the pre/school. The skills targeted in the programme include listening skills; modelling and expanding language; balancing questions and comments; practicing language promoting techniques during free play; phonological awareness (such as rhythm, blending and segmenting syllables); learning new words; pretend play through stories; and bringing books alive.

Pre/school staff component and communication champions: Pre/school staff complete four workshops. Workshop 1 takes place in each pre/school before the 12-week parent programme begins. The first workshop:

• Focuses on the three core interaction skills to be covered with parents in term 1 (modelling, expanding and balancing questions and comments) as well as early literacy and phonological awareness skills
• gives staff the opportunity to practice these skills using a range of pre/school toys.
• is followed by a 30-min coaching session where staff practice using the skills under the SLT’s supervision.

Workshops 2 – 4 take place following each 4-week parent intervention block and include the following core components

• revision of the interaction skills previously outlined
• sharing language rich environment resources
• giving information on language development in young children and on identifying children with speech, language, and communication needs
• sharing speech and language tools that aid with the transition from preschool to school.

In addition to these workshops each setting is asked to nominate at least one communication champion who commits to attending three Communication Champions workshops over the course of the academic year. These workshops focus on providing staff with the skills necessary to support the successful implementation of Happy Talk in their setting. Themes include multiculturalism; early literacy; engaging parents; and identifying speech, language and communication needs. Workshops are delivered once a term, and last 2.5 – 3 hours.

Process Evaluation

Phase 3 - Process Evaluation

A process evaluation will be completed during and after the trial and will include questions that directly relate to our Study within a Trial (SWAT) (see below).

The evaluation will include children, parents, teachers/ preschool staff and SLTs who participated in the trial. SLT interventionists and pre/school staff will be asked to note their reflections during and immediately post-trial. Parents and pre/school staff (representing each area) will be invited to be interviewed over the phone to share their experiences.

We will also capture the voice of the child using photographed sessions where children will be asked to view the photographs and reflect on what was fun / what they would change about the programme.

This evaluation will allow us to:

• get feedback from all participants who have received Happy Talk for the first time
• explore participant perspectives / experiences of taking part in the evaluation
• facilitate an exploration of how intervention mechanisms are influenced by the context to inform successful wider implementation
• inform future roll outs of the program.

SWAT

For this part of the work, we will address the Trials Methodology Research Network methodological priority questions 1 and 5 through the questions below:

• How can trials co-exist alongside routine clinical care, with the aim of maximising evidence-based practice, with minimal burden on already limited resources ?
• What are the barriers and enablers for clinicians in helping to conduct randomised trials ?

To address the first research question, parents, educators and SLTs will be asked to reflect on the impact of participating in the trial (during and immediately post-trial). Semi structured interviews will also be carried out (via teams) with a representative sample of those who agree to take part. The interviews will aim to address participants’ experiences taking part in the trial and to ascertain if there were aspects of the evaluation that could have been completed differently, so that the trial could co-exist without significant burden.

In relation to the second research question, SLT interventionists (clinicians) will be asked to reflect specifically on the barriers and enablers that would help conduct trials and to consider how trials can become part of routine care in the context of current service delivery models / healthcare pathways.

Semi-structured interviews (conducted over the phone) will be used to allow clinicians to elaborate further on their reflections.

Economic Evaluation

Phase 4: Economic Evaluation

This will be led by Dr Aileen Murphy, Department of Economics, University College Cork.

The evaluation will compare the costs and effects of the Happy Talk intervention, to usual care. The evaluation will also include a budget impact analysis, which predicts the potential financial impact of the adoption and diffusion of Happy Talk, to inform resource or budget planning in the future.  

 Following standard Health Information and Quality Authority (HIQA) guidelines on conducting economic evaluations a cost utility analysis will be undertaken. In the baseline analysis the perspective of the service provider will be adopted, therefore only direct resources utilised will be included. All resources utilised for the delivery of the intervention and standard care will be identified, measured and valued using micro-costing techniques.

Resources utilised will be captured by a dedicated resource utilisation questionnaire.

The evaluation will include a primary, secondary and sensitivity analyses. The primary analysis will include standardised Health Related Quality of Life (HRQoL) questionnaires pre-, post- and at 12 months follow-up. The secondary analysis will use clinical effectiveness measures and our sensitivity analyses will assess robustness of the effectiveness measures, uncertainty in input and resulting output parameters.