Speech and Language TherapyNCT03083236
Parent-based Intervention for Language Delayed 2 to 3 Year Olds
A study testing Standard PBI and Enhanced in people with Speech and Language Therapy, run by Solent NHS Trust.
Trial 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. Read more about this study
- Who is it for?
- Ages 24 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Speech and Language Therapy
- What is being tested?
- Standard PBI and Enhanced
- How many people
- 192 participants
- Where
- No sites listed yet
- Study dates
- Oct 2017to Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 24 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: 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
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.
Read the 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
- Being tested
- Standard PBI, Enhanced
- Medical subject headings
- Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard PBIOther
Standard Parent Based Intervention (PBI)
EnhancedOther
Enhanced Parent Based Intervention (EPBI)
What is being measured
The primary outcome is the main question the study is designed to answer.
The Pre-School Language Scales 5 UK (PLS 5 UK)
The 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study startOct 2017 (estimated)
- Primary completionMar 2020 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Speech and Language TherapyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Solent NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03083236
- Sponsor's protocol ID
- Solent NHS Trust
- Status last verified
- Oct 2017
- First submitted
- 8 Mar 2017
- Last updated
- 10 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03083236
- Acronym / sponsor ID
- Solent NHS Trust
- Conditions
- Speech and Language Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Solent NHS TrustOther government
- Study start
- Oct 2017 (estimated)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 17 Mar 2017 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 24 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Standard PBIStandard Parent Based Intervention (PBI) | Other | – |
| EnhancedEnhanced Parent Based Intervention (EPBI) | Other | – |
Primary outcome
The Pre-School Language Scales 5 UK (PLS 5 UK)
Time frame: 2 years
The 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2017.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Standard PBI and Enhanced in people with Speech and Language Therapy, run by Solent NHS Trust.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 10 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Pre-School Language Scales 5 UK (PLS 5 UK) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Oct 2017.