Developmental Language Disorder and Language ImpairmentHappyTalkNCT06460090
Evaluating a Targeted Selective Speech, Language, and Communication Intervention at Scale - Protocol for the 'Happy Talk' Cluster Randomised Controlled Trial.
A study testing Happy Talk in people with Developmental Language Disorder and Language Impairment and Deprivation, run by University College Cork at 4 sites in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Developmental Language Disorder and Language Impairment, Deprivation
- What is being tested?
- Happy Talk
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 840 participants
- Where
- 4 sitesIreland
- Study dates
- Jun 2024to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- Pre/schools outside of supported areas.
- Schools that are not defined as DEIS schools.
- Preschools not attached to DEIS schools.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ireland4 sites
Dublin North West
Dublin
Iseult Macklin
Galway
Galway
Alma Collins
Wexford
Wexford
Emily Prendergast
Wicklow
Wicklow
Brenda Kenny
About this study
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
Read more
- 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
- 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?
- Does Happy Talk enhance responsiveness and language promoting behaviours in home and pre/school contexts?
- 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?
- How do contextual factors influence Happy Talk implementation /outcomes?
- How can trials become part of routine care?
- 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.
- Being tested
- Happy Talk
- Keywords
- Developmental language disorder, social disadvantage, public health, intervention, children, speech and language
- Medical subject headings
- Language Development Disorders, Language Disorders, Speech, Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Happy TalkBehavioural
A targeted selective speech language and communication programme embedded in the community, designed for people livling in social disadvantage.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | 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. Receives: Behavioral: Happy Talk |
| Usual Care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: The measure will be completed at baseline, immediately post the 12 week intervention and 6 months post-intervention.
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: The measure will be completed at baseline, immediately post the 12 week intervention and 6 months post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study startJun 2024 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Developmental Language Disorder and Language ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The design is a parallel cluster randomised trial of a 12-week manualised intervention delivered in pre/school settings serving socially disadvantaged communities, over two academic years in Ireland. Following baseline data and scoring, randomization will take place at the level of the setting whereby pre/schools will be allocated to either a treatment or a "business as usual" control group, stratified for geographical region.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 840 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Collaborators
- National University of Ireland, Galway, Ireland
- Responsible party
- Sponsor
- Investigators
- Pauline Frizelle, Principal investigator, University College Cork
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06460090
- Sponsor's protocol ID
- DIFA-2023-001
- Other IDs
- DIFA-2023-001
- Acronym
- HappyTalk
- Status last verified
- Jun 2024
- First submitted
- 20 May 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Frizelle P, Mullane E, O'Shea A, Ceroni A, Dahly D, Horgan A, Levickis P, Mckean C. Happy Talk: A pilot effectiveness study of a targeted-selective speech-language and communication intervention for children from areas of social disadvantage. Int J Lang Commun Disord. 2021 Sep;56(5):954-974. doi: 10.1111/1460-6984.12648. Epub 2021 Jul 28.
PubMed 34322955Frizelle P, Mckean C, O'Shea A, Horgan A, Murphy A. Economic evaluation of the Happy Talk pilot effectiveness trial: A targeted selective speech, language and communication intervention for children from areas of social disadvantage. Int J Speech Lang Pathol. 2022 Apr;24(2):200-211. doi: 10.1080/17549507.2021.1975815. Epub 2021 Sep 20.
PubMed 34543137Frizelle P, O'Shea A, Murphy A, Dahly D, McKean C. Evaluating a targeted selective speech, language, and communication intervention at scale - Protocol for the Happy Talk cluster randomised controlled trial. HRB Open Res. 2025 Jan 31;7:65. doi: 10.12688/hrbopenres.13973.3. eCollection 2024.
PubMed 39931387
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Targeted Selective Speech, Language, and Communication Intervention at Scale - Protocol for the 'Happy Talk' Cluster Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT06460090
- Acronym / sponsor ID
- HappyTalk / DIFA-2023-001
- Keywords
- Developmental language disorder, social disadvantage, public health, intervention, children, speech and language
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 840 participants (estimated)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Collaborators
- National University of Ireland, Galway, Ireland
- Study start
- Jun 2024 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 14 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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?
- Does Happy Talk enhance responsiveness and language promoting behaviours in home and pre/school contexts?
- 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?
- How do contextual factors influence Happy Talk implementation /outcomes?
- How can trials become part of routine care?
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The design is a parallel cluster randomised trial of a 12-week manualised intervention delivered in pre/school settings serving socially disadvantaged communities, over two academic years in Ireland. Following baseline data and scoring, randomization will take place at the level of the setting whereby pre/schools will be allocated to either a treatment or a "business as usual" control group, stratified for geographical region.
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: Happy TalkThe 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. |
| Usual Care | No intervention | –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. |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- Pre/schools outside of supported areas.
- Schools that are not defined as DEIS schools.
- Preschools not attached to DEIS schools.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Happy TalkA targeted selective speech language and communication programme embedded in the community, designed for people livling in social disadvantage. | Behavioural | Intervention arm |
Primary outcome
Expressive and receptive language on the standardised Preschool Language Scale 5 (PLS-5)
Time frame: The measure will be completed at baseline, immediately post the 12 week intervention and 6 months post-intervention.
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.
Focus on the Outcomes of Communication Under Six (FOCUS)
Time frame: The measure will be completed at baseline, immediately post the 12 week intervention and 6 months post-intervention.
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.
4 secondary outcomes
Parent - Maternal Responsive Behaviours Coding Scheme (MRBCS)
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
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).
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).
Time frame: The measure will be completed at baseline, immediately post the 12 week intervention and 6 months post-intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Background: PubMed 34322955Frizelle P, Mullane E, O'Shea A, Ceroni A, Dahly D, Horgan A, Levickis P, Mckean C. Happy Talk: A pilot effectiveness study of a targeted-selective speech-language and communication intervention for children from areas of social disadvantage. Int J Lang Commun Disord. 2021 Sep;56(5):954-974. doi: 10.1111/1460-6984.12648. Epub 2021 Jul 28.
- Background: PubMed 34543137Frizelle P, Mckean C, O'Shea A, Horgan A, Murphy A. Economic evaluation of the Happy Talk pilot effectiveness trial: A targeted selective speech, language and communication intervention for children from areas of social disadvantage. Int J Speech Lang Pathol. 2022 Apr;24(2):200-211. doi: 10.1080/17549507.2021.1975815. Epub 2021 Sep 20.
- Derived from this study: PubMed 39931387Frizelle P, O'Shea A, Murphy A, Dahly D, McKean C. Evaluating a targeted selective speech, language, and communication intervention at scale - Protocol for the Happy Talk cluster randomised controlled trial. HRB Open Res. 2025 Jan 31;7:65. doi: 10.12688/hrbopenres.13973.3. eCollection 2024.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pauline Frizelle principal investigator
University College Cork
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Happy Talk in people with Developmental Language Disorder and Language Impairment and Deprivation, run by University College Cork at 4 sites in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pauline Frizelle, PhD (00353878057394, p.frizelle@ucc.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expressive and receptive language on the standardised Preschool Language Scale 5 (PLS-5) (time frame: The measure will be completed at baseline, immediately post the 12 week intervention and 6 months post-intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06460090, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.