An interventional study of Happy Talk in Developmental Language Disorder and Language Impairment and Deprivation, sponsored by University College Cork. Not yet recruiting at 4 sites in Ireland. Open to participants aged 2 Years to 6 Years. Per ClinicalTrials.gov, last updated 2024-06-14.
Sponsored by University College Cork · Not applicable, Interventional, and Prevention
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
The study aims to answer the following research questions:
When implemented at scale
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.
121 studies on the registry are indexed under Language Development Disorders; 49 are open to participants now.
This study's planned enrollment of 840 is above the median of 74 across 106 interventional studies indexed under Language Development Disorders.
Browse Language Development Disorders studies →University College Cork is the lead sponsor of 119 studies on the registry; 25 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Behavioral: Happy Talk
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.
A targeted selective speech language and communication programme embedded in the community, designed for people livling in social disadvantage.
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.
Time frame: 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.
Time frame: The measure will be completed at baseline, immediately post the 12 week intervention and 6 months post-intervention.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: The measure will be completed at baseline, immediately post the 12 week intervention and 6 months post-intervention.
Plan to share: Yes — Electronic Data Capture platform (Castor EDC) will be used throughout this project. Data sharing and preservation: Data sharing repositories will be formerly identified via careful alignment of the expected data object outputs and evaluated using the re3data resource. This is to ensure maximum utility and interoperability of the final data package(s) and assignment of a persistent digital object identifier (DOI). Additional post-study data provenance will be enacted through sharing of analysis scripts and study protocols via Open Science Framework and/or the HRB Open Research platform projects with accompanying DOI(s). Study findings will be written up as journal publications, and published open access.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Data will be available when the study is completed.
Access criteria: All study information will be submitted to an open science repository.
This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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