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Updated: Jul 9, 2025
Involving Individuals with Developmental Language Disorder and Their Parents/Carers in Research Priority Setting
Published on: June 6, 2020
Protocol for a randomised controlled feasibility trial of parent-delivered early language intervention for children
Kelly Burgoyne1, Emma Pagnamenta2, Kirstie Hartwell3
1Manchester Institute of Education, University of Manchester, Manchester, M13 9PL, UK. Kelly.Burgoyne@manchester.ac.uk.
Insights
This study tested the feasibility of an adapted parent-delivered early language intervention for children with Down syndrome. The PACT-DS program shows potential for improving language and literacy skills in young children with Down syndrome.
Area of Science:
- Pediatric developmental disorders
- Speech and language therapy
- Genetics and genomics
Background:
- Down syndrome is the most common genetic cause of intellectual disability, impacting children's language development and long-term life outcomes.
- Early language intervention can significantly improve developmental trajectories for children with Down syndrome.
- The Parents and Children Together (PACT) program has previously demonstrated efficacy in typically developing children at risk for language delays.
Purpose of the Study:
- To conduct a feasibility randomized controlled trial (RCT) of an adapted PACT program (PACT-DS) for children with Down syndrome.
- To evaluate the feasibility of a definitive RCT for the PACT-DS intervention.
- To explore preliminary evidence of PACT-DS's effectiveness in supporting language and literacy development.
Main Methods:
- A two-arm feasibility RCT involving 28-30 children with Down syndrome (aged 3-6 years) and their parents/caregivers.
- Random allocation to either the PACT-DS intervention group or a wait-list control group.
- Daily 20-minute PACT-DS intervention delivered by parents for 30 weeks, with data collection at baseline, post-intervention, and 6-month follow-up.
Main Results:
- Data collection included child language and literacy assessments, parent wellbeing measures, and qualitative feedback.
- Feasibility outcomes such as recruitment, retention, adherence, and acceptability of the intervention were monitored.
- Cost-benefit analysis was incorporated to inform future trial design and resource allocation.
Conclusions:
- This feasibility study is a crucial initial step towards a definitive RCT of the PACT-DS program.
- The findings will contribute to the limited evidence base for early language interventions in children with Down syndrome.
- The PACT-DS program holds significant potential to advance early language intervention research and practice for this population.
Background:
Down syndrome is the most common genetic cause of intellectual disability, affecting 700-800 babies annually in the UK (Wu J, Morris J, Eur J Hum Genet 21:1016-9, 2013). Children with Down syndrome have difficulties developing language skills. These difficulties can have long-term negative consequences for all aspects of their lives including social development, education and employment opportunities, and emotional wellbeing and mental health (Irwin LG et. al 2007). These aspects all have the potential to be improved through targeted early language intervention. Parents and Children Together (PACT) is a parent-delivered early language teaching programme for typically developing pre-school children at risk of language delays. A previous project (Burgoyne K, J Child Psychol Psychiatry 59(5):545-55, 2018) showed that PACT leads to improvements in children's language and early literacy skills. Our team has worked closely with six families to adapt PACT for children with Down syndrome. The aim of the current study is to conduct a feasibility randomised controlled trial (RCT) to evaluate the feasibility of a definitive RCT and explore initial evidence of the adapted programme's potential to support children's language and literacy development.
Method:
This is a two-arm feasibility randomised controlled trial in which children will be randomly allocated to either a PACT-DS group or to a waiting control group (who will receive intervention at the end of the project). We aim to recruit 28-30 children with Down syndrome (aged 3-6 years) and their parents/caregivers to take part. The PACT-DS group will be trained to deliver PACT-DS every day (20 min a day; 5 days a week) to their child over 30 weeks. We will collect data using assessments of child language and early literacy, measures of parent wellbeing, qualitative surveys and interviews, and monitoring data to explore trial feasibility (including recruitment and retention of families and adherence and acceptability of intervention) and cost and benefits. Data will be collected before intervention, immediately after the 30-week intervention programme, and 6 months after intervention ends. Clear progression criteria will be used to assess suitability for a definitive trial.
Discussion:
This study represents initial steps in developing a definitive trial of the PACT-DS programme and will add to the limited evidence base on early language intervention for children with Down syndrome. This programme of research has the potential to make significant advancements in early language intervention research and practice for this group.
Trial Registration:
The trial is registered with the ISRCTN registry: study ID ISRCTN63251282 . Registered on 14 July 2023.
