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Parent-based Intervention for Language Delayed 2 to 3 Year Olds

A Randomised Controlled Trial of the Effectiveness of Parent-based Models of Speech and Language Therapy Intervention for 2 to 3 Year Old Children With Primary Language Delay in Areas of Social Disadvantage

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03083236
Enrollment
192
Registered
2017-03-17
Start date
2017-10-31
Completion date
2020-03-31
Last updated
2017-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Speech and Language Therapy

Brief summary

The aim of the study is to evaluate the impact of parent based intervention on the language of 2 to 3 year old children from socially disadvantaged populations with a clinical diagnosis of primary language delay.

Detailed description

This project is original in proposing to evaluate the effectiveness of a parent-based intervention for a clinical population of 2 to 3 year olds with a diagnosis of primary language delay in areas of social disadvantage. It is original in developing an interagency, integrated model of delivery in line with the health and social care agenda (NHS 5 Year Forward Plan). It is also original in examining the effect of parent attitudes on child outcomes.

Interventions

OTHERStandard PBI

Standard Parent Based Intervention (PBI)

Enhanced Parent Based Intervention (EPBI)

Sponsors

Solent NHS Trust
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
24 Months to 36 Months
Healthy volunteers
Yes

Inclusion criteria

Inclusion criteria (to diagnose primary language delay): * The child is 24-36 months old * The child has little or no expressive language (a vocabulary of 40 or less single words) * The child has no known aetiology; the language delay is not secondary to sensory, structural, neurological or cognitive impairments * The family have been assessed as having low socioeconomic status The study will use the Index of Multiple Deprivation (IMD) as a basis to determining a measure of deprivation. The IMD combines information from seven domains (income, employment, education, health, crime, housing and living environment) to produce an overall measure and it ranks how deprived areas are relative to others. This will be used to determine which areas and Children's Centres will be involved in the proposed RCT. However, as this is a geographical ranking, the RCT will include further refinement of eligibility of social disadvantage via assessment of individual measures of income deprivation, employment deprivation and education attainment. This information on employment and parent education levels will be collected via the case history taken at the initial assessment, as this is standard practice in a profile of risk for child language delay. The additional information on income will be taken at the first research assessment, as this does not form part of standard practice

Exclusion criteria

* The child's expressive language consists of a vocabulary of more than 40 single words * The child's language delay is secondary to sensory, structural, neurological or cognitive impairments * English is not the first language for the family. * Where English is not the first language, children would be excluded. Adjustments to the protocol and delivery of intervention would be required where English is an additional language (EAL) and there is a need to test the intervention first on an English-speaking population. If effective, a longer term programme plan would be to amend the programme and evaluate the effectiveness with EAL children.

Design outcomes

Primary

MeasureTime frameDescription
The Pre-School Language Scales 5 UK (PLS 5 UK)2 yearsThe planned primary outcome measure for the proposed RCT is a quantitative measure of child language using a standardised assessment measure, The Pre-School Language Scales 5 UK (PLS 5 UK) (Zimmerman et al, 2014). This will provide a sound measure of reliability and validity.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026