Evaluating a Targeted Selective Speech, Language, and Communication Intervention at Scale - Protocol for the 'Happy Talk' Cluster Randomised Controlled Trial. (HappyTalk)

University College Cork (UCC)

Status: Not yet enrolling

Conditions: Developmental Language Disorder and Language Impairment; Deprivation

Treatments: Behavioral: Happy Talk

Study type: Interventional

Funder types: Other

Identifiers

NCT06460090

DIFA-2023-001 (Other Grant/Funding Number)

Details and patient eligibility

About

The overall aim of this clinical trial is to evaluate an at scale version of 'Happy Talk' in a large scale effectiveness study (examining inputs, outputs and outcomes) based on a sample of children from socially disadvantaged areas. Researchers will compare Happy Talk to usual care and children's allocation to the programme will be decided on randomly.

The investigators also aim to

• complete a pre-trial process evaluation to inform intervention implementation - examining factors which promote parental engagement and partnership between SLTs and educators and incorporating these into SLT training and future rollouts of the programme.
• complete a concurrent process evaluation from a realist perspective to examine how the mechanisms underpinning Happy Talk are influenced by the implementation context and therefore what would need to be considered for successful implementation across varied settings. Our SWAT is embedded in this process evaluation and addresses the Trials Methodology Research Network methodological priority questions 1 and 5 https://priorityresearch.ie/priority-one-questions/
• Complete an economic evaluation in which compare the costs and benefits of Happy Talk are compared to standard pre/school care.

The study aims to answer the following research questions:

When implemented at scale

1. Does 'Happy Talk', a targeted selective intervention focused on increasing parent and early educator responsive interaction, improve language and quality of-life (QoL) outcomes in socially disadvantaged preschool and young school-aged children?
2. Does Happy Talk enhance responsiveness and language promoting behaviours in home and pre/school contexts?
3. What programme features support successful real-world application of 'Happy Talk' including factors which promote parental engagement; partnership between SLTs and educators; and fidelity of implementation?
4. How do contextual factors influence Happy Talk implementation /outcomes?
5. How can trials become part of routine care?
6. Is Happy Talk cost effective compared to usual care?

Intervention: The programme is informed by general systems theory and is embedded in the preschools, and homes of socially disadvantaged children with the aim of effecting change in parent and educator behaviour. There are both parent and preschool staff components to the programme.

Enrollment: 840 estimated patients

Sex: All

Ages: 2 to 6 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for pre/schools:

• Those falling within the Health Services Executive Community Healthcare Organisation (CHO) area for which support has been offered.
• Those attached to DEIS schools (Delivering Equality of Opportunity in Schools i.e., those including a high concentration of students from socioeconomically disadvantaged backgrounds)
• Child and Family Resource centres (established in Ireland for children from disadvantaged backgrounds)

Exclusion Criteria:

• Pre/schools outside of supported areas.
• Schools that are not defined as DEIS schools.
• Preschools not attached to DEIS schools.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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840 participants in 2 patient groups

Intervention arm

Experimental group

Description:

The intervention has two components, parent and preschool. The parent component includes twelve 1-hour sessions delivered in two 30-min units, over the three terms of the preschool year (in 4 week blocks). For the first 30 min, parents engage in group training with the SLT in a room within the preschool, in which they are introduced to language promoting strategies and techniques. This is followed by 30 min of coaching, with parents practising their newly acquired skills, with their children in the preschool. The preschool component is made up of 4 workshops. The first takes place in each preschool before the 12-week parent programme begins and the remaining three take place following each 4-week parent intervention block. Workshops focus on core interaction skills covered with parents as well as literacy skills and phonological awareness skills. Staff also get the opportunity to practice their skills and engage in coaching.

Treatment:

Behavioral: Happy Talk

Usual Care

No Intervention group

Description:

Usual care is the Early Childhood care and Education programme (ECCE) for preschool. The programme is provided for three hours per day, five days per week over 38 weeks per year. Childcare services taking part in the programme provide a pre-school educational programme which adheres to the principles of Síolta, the national framework for early years care and education. The most commonly implemented programme is 'Aistear' which is based on 12 principles of early learning and development, presented in three groups 1) children and their lives in early childhood 2) children's connections with others and 3) how children learn and develop. Communication and language is one element of the third component. Junior infants is the first year of an 8 year cycle in primary education. The primary curriculum is presented in 7 areas: Art; Mathematics, Social Environmental and Scientific Education; Physical Education; Religious Education; Primary Language; and Social, personal and Health Education.