FCT With Young Children With ID in the UK: A Feasibility Project V.1

Study Overview
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Brief Summary
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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.

Official Title
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Conducting Functional Communication Training (FCT) With Young Children With Intellectual Disabilities in NHS Settings in the UK: A Feasibility Project

Conditions
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Intellectual Disability

Intervention / Treatment
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* Behavioral: Functional Communication Training


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Researcher Implemented FCT<br>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. | Behavioral: Functional Communication Training<br>* Functional Communication Training (which aims to teach the child a communicative alternative to challenging behaviour) implemented by either the researcher or family carer.<br>|
| Experimental: Family Carer Implemented FCT 1<br>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. | Behavioral: Functional Communication Training<br>* Functional Communication Training (which aims to teach the child a communicative alternative to challenging behaviour) implemented by either the researcher or family carer.<br>|
| Experimental: Family Carer Implemented FCT 2<br>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. | Behavioral: Functional Communication Training<br>* Functional Communication Training (which aims to teach the child a communicative alternative to challenging behaviour) implemented by either the researcher or family carer.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | During functional analysis (2 sessions), intervention (4 sessions), maintenance (3 sessions) & follow up (1 session). Across a total of approximately 6 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | 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. | 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). | 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). | 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). | 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). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Challenging Behaviour, Functional Communication Training, Positive Behavioural Support, Family carer training