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

NCT ID: NCT03083236

Last Updated: 2017-10-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-31
• Study Completion Date: 2020-03-31

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.

Conditions

Speech and Language Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Standard PBI

Standard Parent Based Intervention (PBI)

Intervention Type: OTHER

Enhanced

Enhanced Parent Based Intervention (EPBI)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 24 Months
• Maximum Eligible Age: 36 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Solent NHS Trust

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

Solent NHS Trust

Identifier Type: -

Identifier Source: org_study_id