Evaluating a Targeted Selective Speech, Language, and Communication Intervention at Scale - Protocol for the 'Happy Talk' Cluster Randomised Controlled Trial.
NCT Number: NCT06460090
Acronym: HappyTalk
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Developmental Language Disorder and Language Impairment|Deprivation
Interventions: BEHAVIORAL: Happy Talk
Sponsor: University College Cork
Collaborators: National University of Ireland, Galway, Ireland
Sex: ALL
Age: CHILD
Enrollment: 840
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-06
Completion Date: 2027-06
Locations: Dublin North West, Dublin, Ireland|Galway, Galway, Ireland|Wexford, Wexford, Ireland|Wicklow, Wicklow, Ireland

Summary:
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.

Primary Outcome Measures: Expressive and receptive language on the standardised Preschool Language Scale 5 (PLS-5), This is a standardized norm referenced language assessment that yields standard scores for total language, auditory comprehension, and expressive communication. A standard score of 100 represents the performance of a typical child at a given age, the higher the standard score the better the performance. Standard scores between 85 and 115 correspond to one standard deviation below and above the mean, respectively; scores within this range are considered to be within normal limits., The measure will be completed at baseline, immediately post the 12 week intervention and 6 months post-intervention.|Focus on the Outcomes of Communication Under Six (FOCUS), The Focus on the outcomes of communication under 6 (FOCUS-34) is a clinical tool designed to evaluate change in communicative-participation in preschool children. The parent form consists of 34 statements - aimed at taking a snapshot of children's skills as they are on that day. Parents are asked to rate each statement using a 7 point scale, ranging from 'not at all like my child' to 'exactly like my child'. This yields a total score ranging from 50 to 350 with a higher score indicating a better outcome., The measure will be completed at baseline, immediately post the 12 week intervention and 6 months post-intervention.
Secondary Outcome Measures: Parent - Maternal Responsive Behaviours Coding Scheme (MRBCS), The Maternal Responsive Behaviours Coding Scheme (MRBCS - Levickis et al. 2014) is an observational coding scheme of parent- child interaction. Implementation of the MRBCS yields a total number of occurrences of one of four parental responsive behaviours (Expansions; Imitations; Responsive Questions; and Labels), for a given period. By summing the frequency scores for each behaviour, an overall score of parental responsiveness can be calculated. The lowest score is 0 and the highest score is not specified. The higher the score the greater the number of parental responsive behaviours - yielding better outcomes., The measure will be completed at baseline, immediately post the 12 week intervention and 6 months post-intervention.|Child - Paediatric Quality of Life Inventory (PedsQL) Parent report for Toddlers, This is a parent proxy-report scale of health-related QoL in young children. The PedsQL for toddlers contains 21 items and measures four health dimensions: physical, emotional, social, and school functioning (questions related to school or daycare if attended). The tool asks, "please tell us how much of a problem each item has been for your child during the past one month." Parents are required to rate each item on a scale of 0- 4 (0 indicating never a problem and 4 almost always a problem). The ratings are tallied yielding a total score for each section, the higher score indicating a greater level of difficulty., Quality of life measures will be completed at baseline, immediately post the 12 week intervention and 6 months post-intervention.|Setting - Classroom assessment scoring system (CLASS)., The Classroom Assessment Scoring System (Pianta, La Paro, \& Hamre, 2008) is a theoretically-based and empirically-supported observation instrument designed to assess the quality of interactions between teachers and students in the classroom. The CLASS measures three broad domains of teacher-student interactions: Emotional Support, Classroom Organization, and Instructional Support. These three domains are comprised of 10 specific dimensions of teacher-student interactions. Assessors assign scores to classrooms on each of the 10 dimensions on a 7-point scale., The measure will be completed at baseline, immediately post the 12 week intervention and 6 months post-intervention.|Child - Child Health Utility Instrument (CHU9D)., This is a parent proxy-report scale of health related quality of life in young children. The CHU9D for children \< 5years) consists of 11 questions and parents are asked to base their responses on how their child is feeling on the day of completion. It consists of a descriptive system and a set of preference weights, which give utility values for each health state described by the descriptive system, allowing the calculation of QALYs., The measure will be completed at baseline, immediately post the 12 week intervention and 6 months post-intervention.