Evidence map›Paper›PMID 38062458›Full record

ArticlePilot and feasibility studies2023

Protocol for a randomised controlled feasibility trial of parent-delivered early language intervention for children with Down syndrome (PACT-DS).

Kelly Burgoyne, Emma Pagnamenta, Kirstie Hartwell, Vesna Stojanovik

Registry-linked trialAbstract read
In one paragraph

Article in Pilot and feasibility studies, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06813625 (Shared Book Reading to Promote Mental Well-being Among Young People with and Without Down's Syndrome), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06813625 naenrolling by invitationnot on this mapstarted 2025, after this paper: background citation

Shared Book Reading to Promote Mental Well-being Among Young People with and Without Down's Syndrome: a Pilot Dyadic Randomized Controlled Trial

TypeinterventionalSponsorUniversity of MacauRan2025 to 2026Enrolled40ConditionsDown SyndromeArmsShared book reading intervention
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Kelly BurgoyneManchester Institute of Education, University of Manchester, Manchester, M13 9PL, UK. Kelly.Burgoyne@manchester.ac.uk.ORCID http://orcid.org/0000-0001-8765-5154
Emma PagnamentaUniversity of Reading, Reading, UK.
Kirstie HartwellManchester Institute of Education, University of Manchester, Manchester, M13 9PL, UK.
Vesna StojanovikUniversity of Reading, Reading, UK.

Funding

Economic and Social Research Council ES/V016946/1
6 · The paper itself

Abstract

backgroundDown 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.

methodThis 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 registrationThe trial is registered with the ISRCTN registry: study ID ISRCTN63251282 . Registered on 14 July 2023.

Indexed as

Down syndromeInterventionLanguageLiteracyParents

Identifiers

PMID38062458
PMCPMC10702108

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.