Intellectual DisabilityNCT02721394
FCT With Young Children With ID in the UK: A Feasibility Project V.1
A study testing Functional Communication Training in people with Intellectual Disability, run by University of Kent at 2 sites in United Kingdom.
Trial summary
The current project aims to assess the feasibility of conducting Functional Communication Training in the UK with a small sample of young children (aged under 9) in an NHS setting. Read more about this study
- Who is it for?
- Ages Up to 9 years
- Conditions the study is for
- Intellectual Disability
- What is being tested?
- Functional Communication Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Feb 2016to Dec 2018
- 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 Up to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child aged under 9
- Child has identified intellectual disability or genetic syndrome associated with intellectual disability (e.g. Fragile X Syndrome)
- Child uses only phrase speech (i.e. 2-3 word utterances)
- Child displays self injury, aggression, property destruction at home
- Family carers aged over 18 with capacity to consent
- Family carer speaks English as first language (to ensure that the child understands English and will therefore understand researcher)
Who cannot join
- Child experiences health condition involving pain that is not well controlled by treatment
- Child is fully deaf / blind
- Child or family carer receiving active treatment in relation to child's behaviour (e.g. direct behavioural support, parenting programme etc.)
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Mencap Northern Ireland
Belfast, BT8 6BT
East Kent Hospitals University NHS Foundation Trust
Canterbury, Kent
About this study
Official title: Conducting Functional Communication Training (FCT) With Young Children With Intellectual Disabilities in NHS Settings in the UK: A Feasibility Project
The current project aims to assess the feasibility of conducting Functional Communication Training in the UK with a small sample of young children (aged under 9) in an NHS setting. Three delivery formats will be assessed in order to demonstrate the feasibility of conducting FCT via different delivery methods within an NHS context. Participants will be four children aged under 9 who have an identified intellectual / developmental disability and display either self-injury, property destruction, or aggression at home. In addition, one family carer per child will be coached to implement the intervention, either following researcher intervention, or from the beginning. Data will be collected on challenging behaviour, communication responses, family carer confidence in managing behaviour, fidelity of intervention implementation, family quality of life, and acceptability of the intervention.
- Conditions
- Intellectual Disability
- Being tested
- Functional Communication Training
- Keywords
- Challenging Behaviour, Functional Communication Training, Positive Behavioural Support, Family carer training
- Medical subject headings
- Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Communication TrainingBehavioural
Functional Communication Training (which aims to teach the child a communicative alternative to challenging behaviour) implemented by either the researcher or family carer.
| Study group | Role | What they receive |
|---|---|---|
| Researcher Implemented FCT | Experimental | Children receive functional communication training. Assessment and initial intervention sessions are completed by the researcher and family carers are trained to continue the intervention at home. Receives: Behavioral: Functional Communication Training |
| Family Carer Implemented FCT 1 | Experimental | Children receive functional communication training. Family carers are trained to implement all sessions (including assessment and initial intervention sessions) with coaching from the researcher in person. Receives: Behavioral: Functional Communication Training |
| Family Carer Implemented FCT 2 | Experimental | Children receive functional communication training. Family carers are trained to implement all sessions (including assessment and initial intervention sessions) with coaching from the researcher via videoconferencing and support from a family carer assistant in person. Receives: Behavioral: Functional Communication Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observation of frequency or duration challenging behaviour
Observational measure of the frequency or duration of child target behaviours. This measure is expected to show a change over time as the intervention progresses, therefore data is collected during every session.
Measured: During functional analysis (2 sessions), intervention (4 sessions), maintenance (3 sessions) & follow up (1 session). Across a total of approximately 6 months.
Secondary outcomes (6)
Observation of occurrence of communication
Observational measure of the frequency of the child's use of the alternative communication response. This measure is expected to show a change over the course of the intervention and data will therefore be collected during each session.
Measured: During intervention (4 sessions), maintenance (3 sessions), & follow up (1 session). Across a total of approximately 5 months.
Beech Centre Family Quality of Life Scale (Park et al., 2003)
Questionnaire evaluating family quality of life. This measure is expected to show a change over time as the intervention progresses, therefore data is collected at 3 time points (pre intervention, post intervention, and at final follow up).
Measured: At beginning of study, immediately after intervention (approximately 6-8 weeks later), and at final follow up session (approximately 6 months after beginning of the study).
Rating scale measuring intervention fidelity
Individualised rating scales assessing fidelity of researcher or family carer implementation of the intervention.
Measured: During intervention sessions (4 sessions), maintenance sessions (3 sessions), and during follow up (1 session). Across a total of approximately 5 months.
Modified Challenging Behaviour Checklist (Harris, Humphreys, & Thomson, 1994)
Questionnaire to assess changes in non-targeted behaviours. This measure is expected to show a change over time as the intervention progresses, therefore data is collected at 3 time points (pre intervention, post intervention, and at final follow up).
Measured: At beginning of study, immediately after intervention (approximately 6-8 weeks later), and at final follow up session (approximately 6 months after beginning of the study).
Functional Assessment Interview Communication Section (O'Neill, Albin, Storey, Horner, & Sprague, 2014)
Questionnaire used to assess changes in non-targeted areas of communication. This measure is expected to show a change over time as the intervention progresses, therefore data is collected at 3 time points (pre intervention, post intervention, and at final follow up).
Measured: At beginning of study, immediately after intervention (approximately 6-8 weeks later), and at final follow up session (approximately 6 months after beginning of the study).
Modified Parenting Task Checklist (Sanders & Woolley, 2001; 2005)
Questionnaire to assess family carer confidence in doing a range of activities with their child. This measure is expected to show a change over time as the intervention progresses, therefore data is collected at 3 time points (pre intervention, post intervention, and at final follow up).
Measured: At beginning of study, immediately after intervention (approximately 6-8 weeks later), and at final follow up session (approximately 6 months after beginning of the study).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intellectual DisabilityStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02721394
- Sponsor's protocol ID
- ResGov 325
- Status last verified
- Jan 2018
- First submitted
- 29 Feb 2016
- Last updated
- 30 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conducting Functional Communication Training (FCT) With Young Children With Intellectual Disabilities in NHS Settings in the UK: A Feasibility Project
- ClinicalTrials.gov ID
- NCT02721394
- Acronym / sponsor ID
- ResGov 325
- Conditions
- Intellectual Disability
- Keywords
- Challenging Behaviour, Functional Communication Training, Positive Behavioural Support, Family carer training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- University of KentUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 29 Mar 2016 (estimated)
- 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 current project aims to assess the feasibility of conducting Functional Communication Training in the UK with a small sample of young children (aged under 9) in an NHS setting. Three delivery formats will be assessed in order to demonstrate the feasibility of conducting FCT via different delivery methods within an NHS context. Participants will be four children aged under 9 who have an identified intellectual / developmental disability and display either self-injury, property destruction, or aggression at home. In addition, one family carer per child will be coached to implement the intervention, either following researcher intervention, or from the beginning. Data will be collected on challenging behaviour, communication responses, family carer confidence in managing behaviour, fidelity of intervention implementation, family quality of life, and acceptability of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Researcher Implemented FCT | Experimental | Behavioral: Functional Communication TrainingChildren receive functional communication training. Assessment and initial intervention sessions are completed by the researcher and family carers are trained to continue the intervention at home. |
| Family Carer Implemented FCT 1 | Experimental | Behavioral: Functional Communication TrainingChildren receive functional communication training. Family carers are trained to implement all sessions (including assessment and initial intervention sessions) with coaching from the researcher in person. |
| Family Carer Implemented FCT 2 | Experimental | Behavioral: Functional Communication TrainingChildren receive functional communication training. Family carers are trained to implement all sessions (including assessment and initial intervention sessions) with coaching from the researcher via videoconferencing and support from a family carer assistant in person. |
Who may qualify
- Ages
- Up to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Child aged under 9
- Child has identified intellectual disability or genetic syndrome associated with intellectual disability (e.g. Fragile X Syndrome)
- Child uses only phrase speech (i.e. 2-3 word utterances)
- Child displays self injury, aggression, property destruction at home
- Family carers aged over 18 with capacity to consent
Key exclusion criteria (3 listed)
- Child experiences health condition involving pain that is not well controlled by treatment
- Child is fully deaf / blind
- Child or family carer receiving active treatment in relation to child's behaviour (e.g. direct behavioural support, parenting programme etc.)
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 |
|---|---|---|
| Functional Communication TrainingFunctional Communication Training (which aims to teach the child a communicative alternative to challenging behaviour) implemented by either the researcher or family carer. | Behavioural | Family Carer Implemented FCT 1, Family Carer Implemented FCT 2, Researcher Implemented FCT |
Primary outcome
Observation of frequency or duration challenging behaviour
Time frame: During functional analysis (2 sessions), intervention (4 sessions), maintenance (3 sessions) & follow up (1 session). Across a total of approximately 6 months.
Observational measure of the frequency or duration of child target behaviours. This measure is expected to show a change over time as the intervention progresses, therefore data is collected during every session.
6 secondary outcomes
Observation of occurrence of communication
Time frame: During intervention (4 sessions), maintenance (3 sessions), & follow up (1 session). Across a total of approximately 5 months.
Beech Centre Family Quality of Life Scale (Park et al., 2003)
Time frame: At beginning of study, immediately after intervention (approximately 6-8 weeks later), and at final follow up session (approximately 6 months after beginning of the study).
Rating scale measuring intervention fidelity
Time frame: During intervention sessions (4 sessions), maintenance sessions (3 sessions), and during follow up (1 session). Across a total of approximately 5 months.
Modified Challenging Behaviour Checklist (Harris, Humphreys, & Thomson, 1994)
Time frame: At beginning of study, immediately after intervention (approximately 6-8 weeks later), and at final follow up session (approximately 6 months after beginning of the study).
Functional Assessment Interview Communication Section (O'Neill, Albin, Storey, Horner, & Sprague, 2014)
Time frame: At beginning of study, immediately after intervention (approximately 6-8 weeks later), and at final follow up session (approximately 6 months after beginning of the study).
Modified Parenting Task Checklist (Sanders & Woolley, 2001; 2005)
Time frame: At beginning of study, immediately after intervention (approximately 6-8 weeks later), and at final follow up session (approximately 6 months after beginning of the study).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2018.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Communication Training in people with Intellectual Disability, run by University of Kent at 2 sites in United Kingdom.
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 6 inclusion and 3 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 30 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Observation of frequency or duration challenging behaviour (time frame: During functional analysis (2 sessions), intervention (4 sessions), maintenance (3 sessions) & follow up (1 session). Across a total of approximately 6 months.). 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 30 Jan 2018.