Back to resultsFCT With Young Children With ID in the UK: A Feasibility Project V.1
Primary Purpose
Intellectual Disability
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Functional Communication Training
Sponsored by
About this trial
This is an interventional treatment trial for Intellectual Disability focused on measuring Challenging Behaviour, Functional Communication Training, Positive Behavioural Support, Family carer training
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.)
Sites / Locations
- East Kent Hospitals University NHS Foundation Trust
- Mencap Northern Ireland
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Researcher Implemented FCT
Family Carer Implemented FCT 1
Family Carer Implemented FCT 2
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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).
Rating scale measuring intervention fidelity
Individualised rating scales assessing fidelity of researcher or family carer implementation of the intervention.
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).
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).
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02721394
Brief Title
FCT With Young Children With ID in the UK: A Feasibility Project V.1
Official Title
Conducting Functional Communication Training (FCT) With Young Children With Intellectual Disabilities in NHS Settings in the UK: A Feasibility Project
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kent
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intellectual Disability
Keywords
Challenging Behaviour, Functional Communication Training, Positive Behavioural Support, Family carer training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Researcher Implemented FCT
Arm Type
Experimental
Arm Description
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.
Arm Title
Family Carer Implemented FCT 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Family Carer Implemented FCT 2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Functional Communication Training
Intervention Description
Functional Communication Training (which aims to teach the child a communicative alternative to challenging behaviour) implemented by either the researcher or family carer.
Primary Outcome Measure Information:
Title
Observation of frequency or duration challenging behaviour
Description
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.
Time Frame
During functional analysis (2 sessions), intervention (4 sessions), maintenance (3 sessions) & follow up (1 session). Across a total of approximately 6 months.
Secondary Outcome Measure Information:
Title
Observation of occurrence of communication
Description
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.
Time Frame
During intervention (4 sessions), maintenance (3 sessions), & follow up (1 session). Across a total of approximately 5 months.
Title
Beech Centre Family Quality of Life Scale (Park et al., 2003)
Description
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).
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).
Title
Rating scale measuring intervention fidelity
Description
Individualised rating scales assessing fidelity of researcher or family carer implementation of the intervention.
Time Frame
During intervention sessions (4 sessions), maintenance sessions (3 sessions), and during follow up (1 session). Across a total of approximately 5 months.
Title
Modified Challenging Behaviour Checklist (Harris, Humphreys, & Thomson, 1994)
Description
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).
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).
Title
Functional Assessment Interview Communication Section (O'Neill, Albin, Storey, Horner, & Sprague, 2014)
Description
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).
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).
Title
Modified Parenting Task Checklist (Sanders & Woolley, 2001; 2005)
Description
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).
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).
Other Pre-specified Outcome Measures:
Title
Treatment Acceptability Rating Form - Revised (Reimers & Wacker, 1988)
Description
Questionnaire assessing the acceptability of the intervention to family carers.
Time Frame
At final follow up session approximately 6 months after the beginning of the study.
10. Eligibility
Sex
All
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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.)
Facility Information:
Facility Name
East Kent Hospitals University NHS Foundation Trust
City
Canterbury
State/Province
Kent
Country
United Kingdom
Facility Name
Mencap Northern Ireland
City
Belfast
ZIP/Postal Code
BT8 6BT
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
FCT With Young Children With ID in the UK: A Feasibility Project V.1
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